1 11 ART

Overview of HIV/AIDS: 

Overview of HIV/AIDS Unit 1 HIV Care and ART: A Course for Healthcare Providers

Learning Objectives: 

Learning Objectives Describe the national HIV/AIDS epidemiological profile Describe the Ethiopian national AIDS strategies, guideline for implementation of ART, and roadmap to accelerate care and treatment for PLWHA List the major achievements, challenges and opportunities during the implementation of the ART program in Ethiopia

Learning Objectives (2): 

Learning Objectives (2) Explain the Ethiopian National Policy on ARV drugs, supply and use Convey the current status of the ART program in Ethiopia List prevention strategies to reduce the spread of HIV infection in the country

Global Summary of HIV/AIDS Epidemic: 

Global Summary of HIV/AIDS Epidemic

Global Summary of the AIDS Epidemic, December 2005: 

Global Summary of the AIDS Epidemic, December 2005 PLWHA 40.3 million (36.7 – 45.3) Adults 38.0 Million (34.5-42.6) Women 17.5 Million (16.2-19.3) Children <15 yrs 2.3 Million (2.1-2.8) New infections 4.9 million (4.3–6.6) Adults 4.2 Million (3.6-5.8) Children <15 yrs 700,000 (630,000 – 820,000) AIDS Deaths 3.1 million (2.8 – 3.6) Adults 2.6 Million (2.3 – 2.9 million) Children <15 yrs (570,000-670,000)

Global Picture of HIV/AIDS: 

Global Picture of HIV/AIDS Source: UNAIDS, 2006

Est. Number Newly Infected With HIV During 2005: 4.9 Million: 

Est. Number Newly Infected With HIV During 2005: 4.9 Million North America 44,000 Caribbean 53,000 Latin America 240,000 Western Europe 21,000 North Africa & Middle East 92,000 Sub-Saharan Africa 3.1 million Eastern Europe & Central Asia 210,000 East Asia & Pacific 290,000 South & South-East Asia 890,000 Australia & New Zealand 5,000 Source: UNAIDS/WHO

Est. Deaths From HIV/AIDS During 2005: 3.1 Million: 

Est. Deaths From HIV/AIDS During 2005: 3.1 Million North America 16,000 Caribbean 36,000 Latin America 95,000 Western Europe 65,000 North Africa & Middle East 28,000 Sub-Saharan Africa 2.3 million Eastern Europe & Central Asia 60,000 East Asia & Pacific 51,000 South & South-East Asia 490,000 Australia & New Zealand 700 Source: UNAIDS/WHO

Slide9: 

Source: UNAIDS/WHO 2004

Impact on Rural Households: 

Impact on Rural Households Loss of income (50% or more) Loss of labor Loss of skilled manpower and knowledge Loss of land Loss of remittances Reduction in savings and investment Expenses for treatment, funeral Need to sell livestock to meet expenses

Impact on Industry: 

Impact on Industry Loss of workers Expenses for recruiting and training replacements Reduced productivity in cases of skilled workers or managers Lost work days due to sickness and funeral leave Increased health care costs 50% illness due to AIDS Loss of skilled professionals

HIV/AIDS Treatment: 

HIV/AIDS Treatment

HIV/AIDS Intervention Strategies: 

HIV/AIDS Intervention Strategies Prevention Social mobilization IEC/BCC HIV counseling and testing Voluntary (VCT) Provider initiated (PIHCT) STI prevention and control Condom promotion Infection prevention Prevention of mother to child transmission (PMTCT) Post exposure prophylaxis

HIV/AIDS Intervention Strategies (2): 

HIV/AIDS Intervention Strategies (2) Care and Treatment Palliative care Community home based care Opportunistic infection treatment Tuberculosis treatment Treatment of AIDS patients Support for Orphans and vulnerable children (OVC) People living with HIV/AIDS (PLWHA)

Policy of ARV Supply and Use: 

Policy of ARV Supply and Use

Introduction : 

Introduction Care and support of PLWHA plays an important role in preventing the spread of HIV/AIDS ART is an important component of care for PLWHA ARVs also have an important place in PMTCT and PEP ARVs have enormous benefits, but affordability, toxicity, adherence and resistance are challenging

National ARV Policies: 

National ARV Policies General objectives of national policies: Reduce MTCT Prolong and improve the quality of lives of PLWHA Reduce accidental HIV infection within health institutions Determines type of ARVs that will be used in health care services

General Policies: 

General Policies Government involvement may include: Coordinate & facilitate the supply of ARVs Build capacity for making available safe, effective and quality antiretroviral drugs, and for ensuring proper use of these drugs Ensure sustainable supply of ARVs by encouraging involvement of all stakeholders

General Policies (2): 

General Policies (2) Government involvement may include (cont): Nurture international partnerships to strengthen sustainable supply and use of ARVs Encourage research on modern and traditional HIV/AIDS treatment Establish strong systems to monitor ARV supply and use

General Strategies: 

General Strategies Selection of ARVs Determine the type of ARVs to be used in a country Incorporate selected ARVs into the national drug list Permit the import of ARVs that are not included in the national drug list

General Strategies (2): 

General Strategies (2) Supply of ARVs ARVs for ART: Exempted from taxation Supplied at reduced prices through government negotiation with manufacturers, importers and distributors Purchased by a system of bulk and generic substitution Local production of ARVs encouraged

General Strategies (3): 

General Strategies (3) Drug Use Prepare and implement standardized prescription paper Prepare and implement national guidelines for safe and effective use of ARVs Sustainable public education on ARV drugs

General Strategies (4): 

General Strategies (4) Research and Development Research on modern and traditional HIV/AIDS treatment Efforts to strengthen the capacity of research institutions Rights and benefits of citizens that enroll in research studies shall be respected National and international ethical norms and values in human experimentations shall be observed

Scaling up ART Uptake: 

Scaling up ART Uptake Need capacity development to: Initiate treatment Help patients adhere to their treatment regimens Monitor the efficacy and toxicity of the regimens Diagnose treatment failure Monitor overall resistance in society

Key Points: 

Key Points AIDS is a global, regional, and national crisis ARVs have enormous benefits and challenges. The challenges include: Developing capacity to initiate treatment Supporting adherence Monitoring efficacy and toxicity Diagnosing treatment failure Monitoring resistance

HIV Counseling and Testing (HCT): 

HIV Counseling and Testing (HCT) Unit 2 HIV Care and ART: A Course for Healthcare Providers

Learning Objectives: 

Learning Objectives Define HCT, VCT, and PIHCT Explain the purpose and benefits of HCT as the entry point to HIV prevention, care, and treatment List the basic components of a HCT program and pre- and post-test counseling Identify the skills and characteristics of an effective HCT counselor

Values Clarification Exercise: 

Values Clarification Exercise

HIV Counseling and Testing: 

HIV Counseling and Testing HIV Counseling and Testing (HCT) is composed of two types of testing: VCT – Voluntary Counseling and Testing PIHCT – Provider Initiated HIV Counseling and Testing

Providing HCT In High & Low Prevalence Areas: 

Providing HCT In High & Low Prevalence Areas High HIV prevalence in general population, >8% Universal access for HCT services recommended Low HIV prevalence in general population, <1% HCT should target high-risk groups

HIV Testing Algorithm: 

Source: WHO 2004 HIV Testing Algorithm

Parallel Test: 

Sample Neg Neg Neg Pos Pos Pos Test 1 (Determine®) Test 2 (Capillus™) Tie Breaker (Uni-Gold™ or SeroCard™) Parallel Test Source: WHO 2004

Knowing your HIV Status: 

Knowing your HIV Status HCT is a cornerstone for early access to prevention, as well as care and support Why? “Think About It” exercise

Objectives of HCT: 

Objectives of HCT HCT assists individuals and couples to: Assess their HIV risk behaviors Develop a risk reduction plan Discuss testing of children Access HIV testing Adopt risk reduction behavior Access medical and psychosocial referral services

HCT: Foundation of HIV Prevention and Care: 

ACCEPTING AND COPING WITH HIV STATUS LIVING POSITIVELY NUTRITION CLEAN WATER REDUCED STRESS WELLBEING SUPPORT FAMILY FELLOWSHIP HIV POSITIVE PEERS MEDICAL CARE STI & TB TREATMENT TB & OI PROPHYLAXSIS PEDIATRICS HIV DIAGNOSIS, CARE AND TREATMENT COMMUNITY INTERVENTIONS   SENSITIZATION MOBILIZATION DESTIGMATIZATION PREVENTION OF MOTHER TO CHILD TRANSMISSION PLANNING FOR FUTURE FAMILY PLANNING ORPHAN CARE FINANCIAL PLANNING RISK REDUCTION BEHAVIOR CHANGE DISCLOSURE OF STATUS PARTNER REFERRAL TO VCT CONDOM ACCESS HCT HCT: Foundation of HIV Prevention and Care

VCT Overview : 

VCT Overview Voluntary Counseling & Testing (VCT) is an HIV-prevention intervention initiated by the client at his or her free will VCT provides the opportunity for the client to confidentially explore and understand his/her HIV risks and to learn his/her HIV infection status with the support of a counselor VCT is composed of: Counseling Testing Referral

VCT Models: 

VCT Models Integrated within existing health services, i.e., general clinical care settings and specialized clinics, such as ANC, TB, STI Free-standing VCT sites Mobile (outreach) VCT services Private VCT services Youth-friendly VCT services Workplaces

Seeking VCT: Logic Model: 

Seeking VCT: Logic Model Community Education Individuals/Couples/Family Want to Have HIV Test Decision to Seek Testing VCT/Pre- and Post-Test Counseling Risk Reduction Ongoing Counseling (Preventive & Supportive)

VCT Program Components: 

VCT Program Components Type of counseling session Individual Couple Family Pre-test counseling Introduction and orientation Risk assessment Discussion of testing children, if applicable Options for risk reduction Preparation for the test result

VCT Program Components (2): 

VCT Program Components (2) HIV Test Post-test counseling HIV negative test result Negotiate risk reduction plan Support for risk reduction plan Negotiate disclosure & partner referral HIV positive test result Identify source of support Negotiate disclosure and partner referral Risk reduction issues Referral

What are the Concerns and Benefits of VCT?: 

What are the Concerns and Benefits of VCT? To the individual To the couple, children, and family To the community

Provider Initiated HIV Counseling and Testing: 

Provider Initiated HIV Counseling and Testing PIHCT is routine, confidential, HIV testing offered to patients visiting health institutions Routine HIV testing (opt-out) at health institutions increases access to HIV testing Many people prefer to be tested by a medical provider within the context of a regular health care visit PIHCT takes less time as the focus is more on post-test counseling and referral

Indications for Offering PIHCT: 

Indications for Offering PIHCT Patient reporting high risk behavior Patient with tuberculosis Patient presenting with STI Symptom complex suggestive of HIV/AIDS Pregnant women attending antenatal clinic Patients receiving in-patient care

Differences: VCT vs. PIHCT: 

Differences: VCT vs. PIHCT

Counseling Skills for HCT: 

Counseling Skills for HCT

Counseling is a Relationship: 

Counseling is a Relationship Client and counselor both bring: Hope Knowledge Questions and answers Personal experiences

Seven Qualities of a Good Counselor: 

Seven Qualities of a Good Counselor Self-confidence Empathy Acceptance Genuineness Trustworthiness Confidentiality Competence

Skills and Characteristics of Effective HCT Counselors: 

Skills and Characteristics of Effective HCT Counselors Believes that HIV prevention counseling can make a difference in preventing and controlling HIV for the individual, the family, and the community Balances well-selected, open-ended questions with statements, summaries, and reflections that guide the session and maintain the focus on risk issues

Skills and Characteristics of Effective HCT Counselors (2): 

Skills and Characteristics of Effective HCT Counselors (2) Uses active listening skills Feels and behaves comfortably when discussing specific HIV risk activities Able to help a client develop a realistic and relevant risk reduction plan

Counseling Essentials: 

Counseling Essentials Remember to always: Demonstrate professionalism and maintain rapport throughout the session Convey to the client that his or her confidentiality will be strictly protected Speak with the client at his or her level of understanding Conduct an interactive session focused on risk reduction

Counseling Essentials (2): 

Counseling Essentials (2) Clarify important misconceptions, but avoid extended talk on issues not related to risk Stay organized, and avoid counseling outside the protocol’s structure Know that it is all right to tell the client that you will be covering something later Avoid collecting data about the client during the counseling session

Questioning Skills: 

Questioning Skills Acknowledge that you have heard and understood the client Blend reflective, guiding, and directive statements with well chosen open-ended questions Ask questions that guide the client to consider their HIV risk, risk reduction, coping, and support Ask appropriate follow-up questions Ask client to elaborate on unclear issues Ask client to clarify confusing or contradictory information

Closing a Counseling Session: 

Closing a Counseling Session Remind client of pre-test information Assess client’s emotional state Give client space to ask questions Schedule client for further sessions Refer to appropriate services

Referrals: 

Referrals Developing linkages with other services Referral directory of services Referring clients Developing a system for tracking referrals

VCT Client Referral: 

VCT Client Pre and Post Test Counseling Referral Medical Examination (Clinical and Lab) YES NO ART administration and follow up ART counseling VCT Client Referral

Working With Couples: 

Working With Couples Make sure both partners have an understanding of HIV/AIDS Review willingness to have HIV test Explain the process of testing and receiving results Discuss advantages and disadvantages of knowing results as a couple

Working With Couples: Making a Plan: 

Working With Couples: Making a Plan Review options for positive, negative, and discordant results Explore the possibility of discordant results Identify others who may be affected by the outcome Discuss testing their children

Ethical Principles: 

Ethical Principles Counselors must be respectful toward the patient’s/client’s dignity and rights Dignity Acceptance Non-judgment Rights Confidentiality Privacy Autonomy Self-determination

Ethical and Legal Issues: Disclosure: 

Ethical and Legal Issues: Disclosure Counselors cannot force disclosure of HIV status To whom and when is always the choice of the patient Can encourage the partner to have an HIV test Can prevent the spread of HIV to the partner

Ethical and Legal Issues: Children: 

Ethical and Legal Issues: Children Persons 15 years-old and above can give informed consent for testing Children under 15 years-old may only be tested with consent of their parents or guardians “Mature minors” between 13-15 years of age are allowed to consent for HIV testing

Ethical and Legal Issues: Children (2): 

Ethical and Legal Issues: Children (2) Mature minors should be informed of their results like adults Children 12 years-old and above should be informed after appropriate counseling, and with the involvement of their parents or guardians Children under 12 should not be informed of results until they reach an age when they can understand and parents/guardians give consent Counselors should carefully consider to whom they disclose results, with the child’s best interests in mind

Pre/Post-Test Counseling : 

Pre/Post-Test Counseling Trainer Role Plays

Pre-Test Counseling: 

Pre-Test Counseling What does the client understand about HIV? What does the client understand about HIV testing? How does this information apply to the client?

Pre-Test Counseling in the PIHCT Setting: 

Pre-Test Counseling in the PIHCT Setting Trainer Role Play

HIV-Negative Results: 

HIV-Negative Results Give time and space for the client to express emotions Explore the client’s reaction Review the meaning of the test result (revisit the window period) Discuss prevention/risk reduction Refer for ongoing support/counseling at appropriate site

Giving HIV-Negative Results: 

Giving HIV-Negative Results Trainer Role Play

Giving HIV-Positive Results: 

Giving HIV-Positive Results Allow some time Discuss what this means Identify a coping strategy Emphasize risk reduction Link with support services

Giving HIV-Positive Results: 

Giving HIV-Positive Results Trainer Role Play

Key Points: 

Key Points HCT is a cornerstone of early access to prevention, care and support HCT is composed of Voluntary Counseling and Testing (VCT) and Provider Initiated Counseling and Testing (PIHCT)

Key Points (2): 

Key Points (2) VCT is a HIV-prevention intervention initiated by the client at his or her free will. VCT provides an opportunity to individuals and couples to work confidentially with a counselor to: Assess their HIV risk behaviors Develop a risk reduction plan Adopt risk reduction behavior Access medical and psychosocial referral services

Key Points (3): 

Key Points (3) PIHCT is routine confidential testing of HIV offered to patients visiting health institutions by their providers Effective counseling requires a number of qualities, characteristics and skills that can be developed and improved with practice.

ﴀART Set-up and Procurement: 

ﴀART Set-up and Procurement Unit 3

Learning Objectives: 

Learning Objectives Explain the continuum of HIV Care Recognize the multidisciplinary (MD, RN, RP, CHCW) team approach to the chronic illness care model Explain why the ART practice model requires patient flow and interventional definition at every clinic stop Describe the clinical communication tools and forms required for effective multidisciplinary team practice

Learning Objectives (2): 

Learning Objectives (2) Describe ART practice setup Identify the minimum requirements for ART practice Describe the art of maximizing minimum resources Identify the components of drug management

Practice Care Model: 

Practice Care Model

ART Practice: 

ART Practice Family-centered without the exclusion of the individual MD-led RN-coordinated Multidisciplinary (MD, RN, RP, Lab, CHCW) team practice

Continuum of Care Model: 

Continuum of Care Model Continuity of care provided at home to care or evaluation performed in any health care setting by specialists, generalists and primary care providers: Home based care Community care Health facility based care

ART Care Model: 

ART Care Model Multidisciplinary (Team) Effort: Minimum Team Members: MD, RN, RP, CHCW TGK/ITECH/9.03 Patient Physician Nurse Community HC Worker Pharmacist Social Worker

Maximizing the Minimum: 

SP MD Non-MD PA/ HO, MSW, RPh Nut, RN 5% 35% 60% “Workload could safely and legally be delegated to the appropriate level.” TGK/PSHCS, Primary Care Maximizing the Minimum Patients with chronic illness’ care provider needs

ART Patient Flow: 

ART Patient Flow

Think About the Patient Experience: 

Think About the Patient Experience Safety: Communicable diseases, emergency Comfort: Seats, shelter Wait time Distance between services Unnecessary travel between stops

Justify the Stops: 

Justify the Stops Is it essential? What would the patient lose if it was not there? What would the organization lose if it were not there? Is more than one stop necessary on the same visit?

The Patient’s Route: 

The Patient’s Route Registration Record room OPD HIV/ART clinic Lab Pharmacy

Ideal Patient Flow: 

Ideal Patient Flow

ART Patient Flow: 

ART Patient Flow

ARV Visits: 

ARV Visits Medical Evaluation - H & P 1. Screening visit - Eligibility ARV Evaluation visit - Lab, counsel 2. ARV initiation visit - Initiate, counsel ARV FU visit - 2, 4, 6, 8 weeks

ART Practice Setup: 

ART Practice Setup

ART Practice Setup Minimum Needs: 

ART Practice Setup Minimum Needs Structure Staff Space Tools Process Clinic stop interventions Follow up Monitoring System Clinical Safety Efficacy Operations/management Outcome Performance

ART Practice: 

ART Practice Multidisciplinary, generalist or specialist led Family-centered primary care Comprehensive Continuous Accountable (quality, cost) To patients To management Teaching institutions should consider a stand alone HIV care clinic

Management of Waiting List: : 

Management of Waiting List: Establish HIV/AIDS committee Committee will have to meet weekly Set up an open access HIV clinic Grandfather those on Tx Mothers first priority Gender equity Prioritize anyone under 18 years old Take family size and family earner into account Priority of last resort= 1st come 1st served

HIV/AIDS Committee: 

Coordinator Review ART DATA + waiting list status Report to Committee Update list Prepare action-plan Take action Report to management Members: Director/Chair ART MD ART RN ART pharmacists ART Lab technician Coordinator staffs the meeting HIV/AIDS Committee

Pediatrics Priorities: : 

Pediatrics Priorities: Age cut off <10 years (because children older than 10 can swallow pills, therefore are grouped with adults) The sickest children must go first Children <5 years tend to perish rapidly with HIV/AIDS

Clinical Tools & Resources: 

Clinical Tools & Resources Provider resources: 3x5 cards: WHO staging, Karnofsky’s performance scale, etc Ring Pocket books: Pathophysiology, medicine dosages, interactions, side-effects, OIs Wall Posters: Flow charts & algorithms, etc Patient resources: Brochures Patient instructions Forms: Provider documentation Communication forms Data capture and collection In major local languages

Communication Forms: 

Communication Forms Inter-facility referral forms Hospital Hospital Hospital Health Center Hospital Community Intra-facility referral forms ART Clinic Clinic ART Clinic Lab ART Clinic Pharmacy

Primary Care Provider: 

  Primary Care Provider Previous antiretrovirals: None  Proposed regimen (discussed Y/N): AZT + 3TC + EFV Concerns/problems anticipated: Not sure whether he has told me or RN all about his life style Signature: GKMD Date: 07/25/05 Provider: please give form to nursing staff, so appointments can be scheduled

Pharmacy: 

Pharmacy Education Conducted: Introduction to HAART. Adherence & consequences of non-adherence. Introduction to healthy living. Need for drug Tx Problems Identified: Binge drinker and intermittent drug user, gambler, marginal financial support Comments/follow-up: Referred to MSW & ATP. Review for referral to adherence protocol group __ Suggest HAART X Suggest delay Signature: JB Date: 07/25/05

Clinical Documentation Forms: 

Clinical Documentation Forms

Customer Requirements: 

Customer Requirements Customer Satisfaction Quality Value Service Capture all essential data elements Legible Simple User friendly Time saver Comprehensive Facilitates/reminds/prompts/ promotes practice model Patients Providers Managers Facility Regional National Donors

Proposed Form Data Flow Sheet: 

Proposed Form Data Flow Sheet Data flow sheet Captures chronologically: Dates ARVs (1, 2, 3) TB Status, OI Tx, OIP Labs Referrals Designed to benefit MD, RN, Data manager Simplifies continuity & record review

Patient Medication Record: 

. . In the past three days, how many days have you had missed doses? [ ] None [ ] One day [ ] Two days [ ]Three days Since last visit how has the patient taken his/her ARVs? [ ] About as prescribed [ ] Less often than prescribed [ ] More often than prescribed [ ] Not at all Patient Medication Record

Clinical Tools: 

Clinical Tools Standardize documentation Save time Facilitate continuity of care Help during record review Foundation for clinical research Help in the delegation of clinical workload

Systems Issues: 

Systems Issues M&E Pharmacy MIS Quota management system Follow-up system

Follow-up System: 

Follow-up System Structure Appointment book Patient passport Clinic schedules Confidential patient directory Follow up coordinators Process Test your system to see if it works Have patient repeat follow up schedules Show patient that it is in his/her passport Instruct patient to call you if he/she wants to reschedule or for any other question

Follow up System: 

Follow up System No Show Tele # of patient or support Yes No Call until contact established Case manager (CHCW) Visit

Drug Management System: 

Drug Management System

Drug Supply Management: 

Drug Supply Management Develop required infrastructure Establish process Assure an uninterrupted supply of standard drugs Install information system

Selection, Quantification, Procurement, Distribution and Use of ARV Drugs: 

Selection, Quantification, Procurement, Distribution and Use of ARV Drugs

ARV Drugs Selection: 

ARV Drugs Selection The selection of ARV drugs is based on: The purpose of use ART (Adult, pediatrics) PEP PMTCT The level of available health institution (hospitals, drug retail outlets) Availability of authorized prescribers and dispensers Guidelines for the use of ARV drugs National drug lists

Quantification of ARV Drugs: 

Quantification of ARV Drugs Quantification of ARV drugs is impacted by a complex web of factors related to: ARV product ART Demand (continuation and scaling up/rollout) Supply

Quantification of ARV Drugs (2): 

Quantification of ARV Drugs (2) Issues related to ARV Product: Shelf Life Short expiry date Cost Expensive Handling Requirements Require secure storage Require refrigeration/temperature control

Quantification of ARV Drugs (3): 

Quantification of ARV Drugs (3) Issues related to ART: Rapidly evolving scientific field Impact of stock out Taken for life ARVs used for prevention and treatment Multiple drug therapy (3 or more and all must be available) Multiple regimens Resistance evolves quickly and is inevitable

Quantification of ARV Drugs (4): 

Quantification of ARV Drugs (4) Issues related to demand: Availability of historical consumption data Efficient patient tracking (Up-to-date patient information): Deaths Lost for follow-up Transfer out, transfer in Treatment interruptions Unpredictable scale up Capacity to deliver services Changes in regimen (Wt., pregnancy, Tx failure, ADR) Pediatrics (change in regiment/dose, wastage of liquids)

Quantification of ARV Drugs (5): 

Quantification of ARV Drugs (5) Issues related to supply: Facility capacity to overcome handling costs of large stock Delays in disbursement of funds by donors Level of available funding Very few suppliers Rapidly changing market Prequalification/regulatory approval Special pricing/donation Unpredictable and long lead time

Quantification of ARV Drugs (6): 

Quantification of ARV Drugs (6) Issues to consider when quantifying ARV drug requirements: Consumption data at each health facilities Working and buffer stock kept at different levels Quantity of stock on hand and on back order Lead time (time it take from ordering to delivery) Expected consumptions during the lead time

Quantification of ARV Drugs (7): 

Quantification of ARV Drugs (7) Expected consumption is influenced by: Number of current patients and their regimen Anticipated scaling-up pattern New patients on 1st line, 2nd line (adult and pediatrics) Likely changes in prescribing patterns due to: Revised STG, changes in registration status of ARV drugs, procurement constraints, varying composition of patient groups, non-naïve patients with non-standard regimen

Quantification of ARV Drugs (8): 

Quantification of ARV Drugs (8) Procurement Cycle without scale up Working Stock Working Stock Working Stock Buffer Stock Lead time Lead time Lead time Lead time

Quantification of ARV Drugs (9): 

Quantification of ARV Drugs (9) Procurement cycle during scale up Working Stock Working Stock Working Stock Buffer Stock Lead time Lead time Lead time Lead time

Quantification of ARV Drugs (10): 

Quantification of ARV Drugs (10) Other quantification issues Reduced NVP requirements due to initial phase is not usually accounted for ARV drugs for PMTCT when guidelines change Affect the stock for ART patients (e.g. if NVP  HAART) Over stock of the old PMTC product (e.g. NVP) Quantification for PEP requirements

ARV Drugs Procurement: 

ARV Drugs Procurement The procurement cycle involve the following steps: Review drug selection Determine quantities needed Reconcile needs and funds Choose procurement method Locate and select suppliers Specify contract terms Monitor order status Receive and check drugs Make payment Distribute drugs Collect consumption information

ARV Drugs Procurement (2): 

ARV Drugs Procurement (2) Essential factors for calculating order quantity Average monthly consumption Supplier lead time Safety stock Stock on order Stock in inventory

Quality Assurance : 

Quality Assurance Drug quality is affected by: The manufacturing process Packaging Transportation Storage conditions

Quality Assurance (2): 

Quality Assurance (2) Possible consequences of poor quality drugs: Lack of therapeutic effect leading to death or prolonged illness Toxic and adverse reactions Wastage of limited financial resources Loss of credibility of the health care delivery system

Quality Assurance (3): 

Quality Assurance (3) Defining and assessing drug quality: Identity Purity Potency Uniformity of dosage forms Bioavailability Stability

Quality Assurance (4): 

Quality Assurance (4) Maintaining drug quality Appropriate storage and transport Appropriate dispensing and use Monitoring drug quality Product problem reporting system Product recalls

Distribution and Use of ARV Drugs: 

Distribution and Use of ARV Drugs Effective drug distribution relies on good system design and good management A well run distribution system should: Maintain a constant supply of ARV drugs Keep drugs in good condition throughout the distribution process Minimize drug losses due to spoilage and expiry Maintain accurate inventory records Rationalize drug storage points Use available transport as efficiently as possible Reduce theft and fraud Provide information for forecasting drug needs

Distribution and Use of ARV Drugs (2): 

Distribution and Use of ARV Drugs (2) The distribution cycle include the following steps: Port clearing Receipt and inspection Inventory control Storage Requisition of supplies Delivery (push or pull) Dispensing to patients Reporting consumption

Distribution and Use of ARV Drugs (3): 

Distribution and Use of ARV Drugs (3) After being received at health facilities, ARV drugs require special handling: Appropriate storage warehouses Adequate space/size Clean Shelves or pallets Ventilated Secured Availability of equipment/facilities Refrigerators Lockable cupboards AC (hot regions)

Distribution and Use of ARV Drugs (4): 

Distribution and Use of ARV Drugs (4) Intensive recording and stock monitoring Stock cards, bin cards, stock movement cards Expiry date tracking chart Temperature monitoring chart Ordering and receiving forms, models Regular reporting of stock status At least monthly

Supply Chain and Information Tracking: 

Supply Chain and Information Tracking At Supplier Level MIS (Info Tracking) Formats

Supply Chain and Information Tracking (2): 

Supply Chain and Information Tracking (2) At Facility Level MIS (Info Tracking) Formats

ARV Drugs Management Information System (DMIS): 

ARV Drugs Management Information System (DMIS) Coordinating the elements of a drug supply system requires accurate and timely information DMIS is an organized system for collecting, processing, reporting and using information for decision-making Such information is collected by means of Record-keeping documents, a combination of registers, ledgers and filing systems Data reporting forms Feedback reports

ARV Drugs Management Information System (DMIS) (2): 

ARV Drugs Management Information System (DMIS) (2) Following are examples of key information tracking formats currently in use

ARV Drugs Management Information System (DMIS) (3): 

ARV Drugs Management Information System (DMIS) (3) Information/data generated from such sources is the basis for quantification and procurement Errors made at any step (during recording or reporting) will add up and bring about an impact on the national volumes of procurement  Destroys the balance between demand and supply  Shortage of ARV Drugs  National Crisis Every one involved in ART should try his/her level best in generating and reporting reliable data/information

Lab Supply Management Information System (LSMIS): 

Lab Supply Management Information System (LSMIS) Lab supply should be managed likewise 3 month buffer stock Similar MIS

Group Discussion: Barriers and Solutions: 

Group Discussion: Barriers and Solutions Discuss: What are structural barriers to implementing ART? What are strategies for overcoming these barriers?

Key Points: 

Key Points HIV care should be comprehensive and include a spectrum of care activities A multidisciplinary approach to ART care is recommended for: Improved adherence Optimizing capacity Assuring continuity Overall improved outcome

Key Points (2): 

Key Points (2) Minimally, a multidisciplinary team should include: MD, RN, RP, Lab, (CHCW for case management) An algorithm for HIV patient flow should be adapted and followed Clinical tools such as pocket books, wall posters, 3x5 cards should be issued to providers. Patient education materials and medication instructions should be in the local language Standardized communication forms are essential with a multidisciplinary approach to care

Key Points (3): 

Key Points (3) Launching a national ARV drug program requires coordinated efforts of government, private investors, and local and international organizations The guidelines for the procurement, storage, inventory control, distribution, recording and reporting of ARV drugs should be properly followed The quantification and hence procurement of ARV drugs is impacted by a complex web of factors that require special considerations

Key Points (4): 

Key Points (4) The handling and use of ARV drugs involves quite expensive procedures that need the commitment of health professionals and facility managers Reporting on a regular basis (monthly) is expected from each health facility The quality of the data/information obtained from health facilities is as important as the ARV drugs itself

Understanding HIV: 

Understanding HIV Unit 4 HIV Care and ART: A Course for Healthcare Providers

Course Learning Objectives: 

Course Learning Objectives Describe HIV and its impact on nursing practice Explain how ARV drugs are used to treat HIV patients Describe the patient flow framework Describe how resistance to ARV drugs can occur List common side effects, toxicities & drug interactions related to ARV drugs Describe opportunistic infections (OIs) associated with HIV disease

Course Learning Objectives (2): 

Course Learning Objectives (2) Explain palliative care and medical ethics Explain how HIV-positive pregnant women and their babies can be treated with ARV drugs Describe treatment for children living with HIV Describe common issues that arise for nurses as they treat HIV patients and their families Explain the role of the nurse in the era of HIV and ART Describe the relationship between nutrition & HIV

Unit Learning Objectives: 

Unit Learning Objectives Describe the pathophysiology of HIV Explain the disease progression and clinical manifestations of HIV/AIDS Describe how the HIV epidemic in Ethiopia has impacted nursing Explain preventive measures of HIV

Activity: What do you know about HIV?: 

Activity: What do you know about HIV? Are the statements below “Always True,” “Never True,” or “Sometimes True”? STIs, including HIV, are more easily transmitted from men to women than from women to men One can generally identify a person with HIV infection by looking at him or her A person can get HIV infection from French or tongue kissing TB co-infection may lead to faster progression to AIDS Once a patient starts ARV treatment, she or he can no longer transmit HIV infection to others

Activity: What do you know about HIV? (2): 

Activity: What do you know about HIV? (2) Are the statements below “Always True,” “Never True,” or “Sometimes True”? When one family member with HIV infection begins ARV treatment, it is helpful if they share the drugs with HIV+ family members who do not have access to ARV treatment Health care workers are able to predict who will be adherent to ARV treatment and who will not A woman who is HIV-infected should not get pregnant If a woman is HIV-infected her partner is HIV-infected

Why Learning about HIV is Important: 

Why Learning about HIV is Important Antiretroviral drugs are freely available Nurses have a vital role to play in the national ART program In order to understand antiretroviral drugs we must understand HIV The more we understand about HIV, the better we will be at caring for patients with HIV

What is HIV?: 

What is HIV? HIV stands for Human Immunodeficiency Virus HIV weakens the immune system, ultimately leading to AIDS HIV is a retro virus and its genetic material, RNA, must be converted into DNA during replication Like all viruses, HIV must enter into the human cell in order to replicate

HIV Transmission: 

HIV Transmission HIV can be passed from one person to another through: Sexual contact (vaginal and anal intercourse), vaginal secretions, semen Blood and body fluids Pregnancy, birth and breastfeeding from mother to child Percutaneous What about tears, sweat, saliva, urine or feces?

Characteristics of HIV: 

Characteristics of HIV HIV infects cells that express CD4 receptor molecules T4-lymphocytes (T-helper cells) Monocyte-macrophage cell lines T4-lymphocytes are a type of white blood cell that ‘switch on’ the immune system to fight disease HIV uses CD4 cells for reproduction

Characteristics of HIV (2): 

Characteristics of HIV (2) Successful entry of the virus to a target cell also requires cellular co-receptors A fusion co-receptor is designated CXCR5 for T-cell tropic stain and CCR4 for monocyte-macrophage tropic strains The receptor and co-receptors of CD4 cells interact with HIV’s gp-120 and gp-41 proteins during entry into a cell

HIV & the Immune System: 

HIV & the Immune System The CD4 cells are like soldiers Strong CD4 cells are able to fight off infection But, HIV damages the CD4 cell, eventually killing it So, HIV damages the system that usually protects the body from infection

HIV Factory: 

HIV Factory When HIV binds to a CD4 cell, it turns that cell into an HIV ‘factory’ Billions of HIV viruses are produced everyday, and the CD4 cell is eventually killed The new HIV viruses go on to infect other CD4 cells, and reproduce In the long term, it’s a losing battle for the CD4 cells…

Assessing the Damage: 

Assessing the Damage Over the years HIV weakens the body’s immune system by decreasing the number of CD4 cells The state of an HIV+ person’s immune system is measured by counting the CD4 cells that remain (CD4 count)

Assessing the Damage (2): 

Assessing the Damage (2) Viral Load is another useful blood test It tells us how much HIV is in the blood Over time the Viral Load increases as more and more virus is produced

Disease Progression: 

Disease Progression Source: Fauci A, Pantaleo D, Stanley S, Weismann D. Ann Intern Med. 1996.

Acquired Immune Deficiency Syndrome: 

Acquired Immune Deficiency Syndrome AIDS develops as HIV slowly destroys CD4 cells over years of infection As the CD4 count drops, infections take ‘opportunity’ of this weakened immune system, resulting in opportunistic infections (OI) When an individual’s immune system is damaged to the extent that these OIs occur, the individual is said to have AIDS

WHO Staging of HIV/AIDS: 

WHO Staging of HIV/AIDS Primary HIV Infection Stage I - asymptomatic Stage II - mild disease Stage III - moderate disease Stage IV - advanced immunocompromised

WHO Clinical Stage I: 

WHO Clinical Stage I Asymptomatic or Persistent generalized lymphadenopathy (PGL) Swollen lymph nodes will present bilaterally in the cervical area, under the arm, or groin. Usually not painful Performance scale 1: able to carry on normal activity

Persistent Generalized Lymphadenopathy (PGL): 

Photograph courtesy of Charles Steinberg MD Persistent Generalized Lymphadenopathy (PGL)

WHO Clinical Stage II: 

WHO Clinical Stage II Moderate unexplained weight loss (<10% of presumed or measured body weight) Recurrent upper respiratory tract infections Herpes zoster Angular cheilitis Recurrent oral ulcerations Papular pruritic eruptions Seborrheic dermatitis Fungal fingernail infections And/or performance scale 2

Pruritic Papular Eruption: 

Pruritic Papular Eruption Photograph courtesy of Charles Steinberg MD

Seborrheic Dermatitis (Dandruff): 

Courtesy of Dr. R. Ojoh Seborrheic Dermatitis (Dandruff)

Folliculitis: 

Folliculitis © Slice of Life and Suzanne S. Stensaas

Apthous Ulcer: 

Source: www.HIVdent.org. Copyright © 1996-2000 David Reznik, D.D.S. Apthous Ulcer

Dermatomal Herpes (Varicella) Zoster: 

Dermatomal Herpes (Varicella) Zoster Image courtesy of Tom Thacher, MD

WHO Stage III: 

WHO Stage III Severe weight loss (>10% of presumed or measured body weight) Unexplained chronic diarrhea for longer than one month Unexplained persistent fever (intermittent or constant for longer than one month) Oral candidiasis Oral hairy leukoplakia Pulmonary tuberculosis (TB) diagnosed in last two years

WHO Stage III (2): 

WHO Stage III (2) Severe presumed bacterial infections (e.g. pneumonia, empyema, pyomyositis, bone or joint infection, meningitis, bacteraemia) Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis Unexplained anemia (<8 g/dl) Neutropenia (<500/mm3) Thrombocytopenia (<50 000/ mm3) for more than one month

Oral Candidiasis: 

Source: http://members.xoom.virgilio.it/Aidsimaging Oral Candidiasis

Oral Hairy Leukoplakia: 

Oral Hairy Leukoplakia Courtesy of Dr. R. Ojoh

WHO Stage IV: 

WHO Stage IV HIV wasting syndrome Pneumocystis pneumonia Recurrent severe or radiological bacterial pneumonia Chronic herpes simplex infection (orolabial, genital or anorectal of more than one month’s duration) Esophageal candidiasis Extrapulmonary TB Kaposi’s sarcoma Central nervous system (CNS) toxoplasmosis HIV encephalopathy

WHO Stage IV (2): 

WHO Stage IV (2) Extrapulmonary cryptococcosis including meningitis Disseminated non-tuberculous mycobacteria infection Progressive multifocal leukoencephalopathy (PML) Candida of trachea, bronchi or lungs Cryptosporidiosis Isosporiasis Visceral herpes simplex infection

WHO Stage IV (3): 

WHO Stage IV (3) Cytomegalovirus (CMV) infection (retinitis or of an organ other than liver, spleen or lymph nodes) Any disseminated mycosis (e.g. histoplasmosis, coccidiomycosis, penicilliosis) Recurrent non-typhoidal salmonella septicaemia Lymphoma (cerebral or B cell non-Hodgkin) Invasive cervical carcinoma Visceral leishmaniasis

Wasting Syndrome: 

Wasting Syndrome © ITECH India, 2005

Kaposi’s Sarcoma (KS): 

Kaposi’s Sarcoma (KS) Usually, multiple dark raised lesions Lesions themselves are not itchy and are rarely painful Courtesy of Tom Thacher, MD

Kaposi’s Sarcoma: 

Kaposi’s Sarcoma Courtesy of Toby A. Maurer, MD, Timothy G. Berger, MD, From HIV InSite Knowledge Base Courtesy of CDC, Dr. Steve Kraus

Oral Kaposi’s Sarcoma: 

Oral Kaposi’s Sarcoma Courtesy of Tom Thacher, MD

Severe Chronic Herpes Simplex Ulcers: 

Severe Chronic Herpes Simplex Ulcers Persistence for >1 month is an AIDS-defining condition © Slice of Life and Suzanne S. Stensaas

Molluscum Contagiosum/ Cryptococcus: 

Molluscum Contagiosum/ Cryptococcus Similar appearance

Esophageal Candidiasis: 

Esophageal Candidiasis HIV infected patient with oral candidiasis and chest (sub-sternal) pain with swallowing has presumed Candida esophagitis Endoscopy would prove the diagnosis but is unnecessary if the patient responds to antifungal therapy

Esophageal Candidiasis: 

Esophageal Candidiasis Linear ulcerations of the esophagus as seen on barium x-ray Source:http://members.xoom.virgilio.it/Aidsimaging

Esophageal Candidiasis: 

Esophageal Candidiasis Courtesy of CDC

Your Role as a Nurse: 

Your Role as a Nurse Care for patients with HIV Educate patients, families, fellow nurses and communities in HIV prevention, care and treatment Assist with the establishment of multidisciplinary HIV care teams: First at your site Then, help others in your region Continue to raise awareness and visibility surrounding HIV/AIDS prevention and treatment

Nurses are Crucial!: 

Nurses are Crucial!

Implications for Nursing Practice : 

Implications for Nursing Practice Understanding the pathophysiology of HIV and the immune system response will enhance your ability and confidence to provide optimal nursing care Integrating secondary prevention teaching into a patient care plan: Protects others from acquiring HIV Minimizes co-infections What are some ways in which you provide secondary prevention teaching for your patients?

Implications for Nursing Practice (2): 

Implications for Nursing Practice (2) Knowing the continuum of HIV disease allows for patient care planning so you can delay disease progression You can significantly improve the quality of life for your patients living with HIV and prolong life

Implications for Nursing Practice (3): 

Implications for Nursing Practice (3) Educating patients and families about how to manage HIV will Decrease anxiety and fear Encourage family members and caregivers Advocating in the care setting and the community for acceptance and compassion will decrease fear, stigma and isolation

Implications for Nursing Practice (4): 

Implications for Nursing Practice (4) Being a role model for other health care personnel in providing empathetic and knowledgeable quality HIV care and advocacy is crucial Sharing HIV disease knowledge and training acquired is essential to: Improving patient outcomes Obtaining community involvement and support

Key Points: 

Key Points AIDS is a global crisis and Ethiopia has been significantly impacted In order to prepare for ARV treatment nurses must have a good understanding of HIV Nurses have an important role to play in educating others about HIV and advocating for their patients

Treatment of HIV : 

Treatment of HIV Unit 5

Learning Objectives: 

Learning Objectives Describe the benefits of antiretroviral (ARV) therapy Identify first and second-line antiretroviral therapy (ART) Explain general principles regarding the use of ARVs Explain the limitations and barriers to success with the use of ARV therapy Explain the nursing considerations involved in caring for patients on ARV therapy

Important Terms: 

Important Terms ART: AntiRetroviral Treatment/Therapy ARVs: AntiRetroVirals Triple Therapy: Three Antiretrovirals HAART: Highly Active AntiRetroviral Treatment/Therapy

What are Antiretrovirals?: 

What are Antiretrovirals? ARVs are drugs which inhibit replication or fusion therapy reversing the progression of HIV disease ARVs reduce the ability of the HIV virus to replicate In turn, this increases the ability of the body to fight disease HIV Replication Immune Response

ARVs at Work….: 

ARVs at Work…. Remember – HIV uses the CD4 cell as an HIV factory ARVs get inside the factory and reduce the ability of the virus to replicate Each kind of ARV blocks the virus in a different place In the end, fewer viruses are made CD4

Benefits of ARV Therapy : 

Benefits of ARV Therapy Restores immunity (increases CD4 cell count) Alters/reverses course of existing opportunistic infections Prevents opportunistic infections Decreases hospitalizations Increases survival Improves quality of life Restores hope Reduces HIV transmission Benefits both adults and children Reduces vertical transmission from mother to child

Primary Factors to Consider when Starting Therapy: 

Primary Factors to Consider when Starting Therapy Ethiopia ARV guidelines Potential side effects Concurrent health conditions Including abnormal laboratory values Drug interactions Potential for pregnancy Ability to ADHERE Adherence is considered to be the primary indicator of ART success This must be a primary factor

Clinical Evaluation Before Starting ART: 

Clinical Evaluation Before Starting ART Assess stage of infection Identify other co-existing medical conditions (e.g., chronic hepatitis) May affect the choice of drugs and risk of adverse effects List current medications (including herbal and traditional) Assess sexual and drug-using behaviors: Assess patient’s personal readiness to start therapy Commitment to taking these medications correctly and consistently for life

When to Start Therapy : 

When to Start Therapy If CD4 testing is available: WHO Stage IV (clinical AIDS): irrespective of CD4 cell count WHO stage III: if CD4 cell count is [see country guidelines] WHO Stage I, II: if CD4 cell count is [see country guidelines] If CD4 testing is unavailable: WHO Stage IV disease (clinical AIDS): irrespective of total lymphocyte count WHO stage III: [see country guidelines] WHO Stage II plus total lymphocyte count is [see country guidelines]

When to Start Therapy (2): 

When to Start Therapy (2) Anemia Common in limited-resource settings especially in malaria endemic areas Common in HIV-infected individuals from HIV itself or underlying OIs Not specifically part of the WHO staging system but may be an indication to start ARV therapy Viral Load Specific viral load in the absence of symptoms or low CD4 cell count should not be routinely used as an indicator to start ART

Main Point: 

Main Point Starting antiretroviral medication is not an emergency!!

Classes of ARVs: 

Classes of ARVs Each class acts at a different stage and in a different way, to prevent HIV from replicating within the CD4 cell Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Protease Inhibitors (PIs) Fusion Inhibitors (Not available in Ethiopia and not widely used in western countries)

Recommended HAART Regimens in HIV-infected Adults & Adolescents: 

Recommended HAART Regimens in HIV-infected Adults & Adolescents

Patient Factors in Choice of Initial Regimen: 

Patient Factors in Choice of Initial Regimen Stage of disease Likelihood of adherence Pregnancy or likelihood of pregnancy Concurrent TB and other illnesses (e.g., hepatitis B, C) Ability of the patient to return for regular, reliable follow-up visits Disclosure status

Nucleoside Reverse Transcriptase Inhibitors (NRTIs): 

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Nucleoside Reverse Transcriptase Inhibitors (NRTIs): 

Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Stavudine (d4T) Zidovudine (ZDV, AZT) Lamivudine (3TC) Didanosine (ddI) Tenofovir (TDF) Abacavir (ABC)

Stavudine (d4T): 

Stavudine (d4T) Dosing: 40 mg bid for weight >60 kg 30 mg bid for weight <60 kg Food Interactions: none Toxicity (side effects): Pain, tingling, and numbness in extremities Nausea Peripheral neuropathy Lactic acidosis Steatosis Pancreatitis Hepatitis

Zidovudine (ZDV, AZT): 

Zidovudine (ZDV, AZT) Dosing: 300 mg bid Food Interactions: none Toxicity (side effects): Nausea, headaches Bone marrow suppression (anemia, neutropenia) Insomnia Myalgia Pigmentation of nail beds Lactic acidosis, fatty liver Granulocytopenia

Lamivudine (3TC): 

Lamivudine (3TC) Dosing: 150 mg BID or 300mg QD Food Interactions: none Toxicity: Mild abdominal discomfort Occasional nausea

Lamivudine + Zidovudine: 

Lamivudine + Zidovudine Dosing: 1 Tablet (150/300mg) BID Food Interactions: None Food decreases ZDV − related nausea

Didanosine (ddI): 

Didanosine (ddI) Dosing: 1 x 400mg enteric coated capsule daily Food Interactions: Take on empty stomach Toxicity Peripheral Neuropathy - common Nausea - common Diarrhea, abdominal pain - common Pancreatitis Lactic acidosis Steatosis

Abacavir (ABC): 

Abacavir (ABC) Dosing: 1 x 300mg tablet BID Food Interactions: none Toxicity: Allergic reaction: occurs with first 6 weeks of therapy Diarrhea Nausea Headache Lactic acidosis Hepatic steatosis

Hypersensitivity to Abacavir: 

Hypersensitivity to Abacavir Observed in approximately 5% of all patients receiving abacavir Multi-organ system involvement Most common signs and symptoms: Fever Rash Fatigue Flu-like symptoms GI (nausea, vomiting, diarrhea, abdominal pain) Cannot be prescribed again once a patient has had a hypersensitivity reaction

Tenofovir (TDF): 

Tenofovir (TDF) Actually a nucleoTIDE, not an NRTI Dosing: 1 x 300mg tablet QD Food Interactions: take with food Toxicity: Headache Nausea Diarrhea Lactic acidosis Fatty liver Renal insufficiency Not recommended if CrCl <60 mL/min

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): 

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs): 

Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz (EFZ) Nevirapine (NVP) Note: Not effective against HIV-2 or HIV-1 Group O viruses

Efavirenz (EFZ): 

Efavirenz (EFZ) Dosing: 600 mg bedtime Food Interactions: take on empty stomach Fat increases absorption Toxicity: CNS Changes (52%) - Insomnia, nightmares, poor concentration, mood change, dizziness, disequilibrium, depression, psychosis Rash (15-27%)- usually does not require discontinuation Nausea CONTRAINDICATED DURING PREGNANCY

Nevirapine (NVP): 

Nevirapine (NVP) Dosing: 2 weeks of 200 mg qd, then 200 mg bid Food Interactions: none Toxicity: Rash Fever Nausea Stevens-Johnson syndrome Hepatitis Severe hepatotoxicity

Nevirapine-induced Rash: 

Nevirapine-induced Rash Rash appearance On the body and arms Usually within the first month of therapy Occasionally may start a few weeks later To reduce risk of rash: Dose should be escalated after the first 2 weeks: 200mg QD for 2 weeks Then increasing to 200mg BID Courtesy of HIV Web Study, www.hivwebstudy.org

Nevirapine-induced Rash (2): 

Nevirapine-induced Rash (2) Restarting medication: Rash develops, patient stops nevirapine on their own: Do not reintroduce nevirapine with dose escalation until rash has resolved Prednisone and antihistamine have not shown to be effective in treating a rash Patient stops nevirapine for other reasons than rash) for > 7 days: Restart regimen with dose escalation: Daily dosing for 2-weeks, then increase to 200mg BID Drug interactions Nevirapine and other medications that often cause rash Nevirapine and Rifampicin

Co-Formulated Reverse Transcriptase Inhibitors: 

Co-Formulated Reverse Transcriptase Inhibitors Zidovudine (ZDV,AZT)/Lamivudine (3TC) Stavudine(D4T)/Lamivudine(3TC) Abacavir(ABC)/Zidovudine (ZDV,AZT)/Lamivudine (3TC) Nevirapine (NVP)/Stavudine (d4T)/Lamivudine (3TC) Nevirapine (NVP)/Zidovudine (ZDV,AZT)/Lamivudine (3TC) Efavirenz (EFZ)/Didanosine (ddI)/Lamivudine (3TC)

Protease Inhibitors (PIs): 

DNA Host Cell Protease Inhibitors (PIs)

Protease Inhibitors (PIs): 

Protease Inhibitors (PIs) Lopinavir/ritonavir (LPV/r) Nelfinavir (NFV) Saquinavir (SQV/ritonavir)

Lopinavir (LPV/r): 

Lopinavir (LPV/r) Dosing: (200 mg/50 mg) 2 tabs BID Food Interactions: take with food Toxicity: Diarrhea Nausea Fat redistribution Metabolic complications Hyperglycemia Increased transminase

Nelfinavir (NFV): 

Nelfinavir (NFV) Dosing: 1,250 mg bid or 750 mg tid Food Interactions: take with meal or snack Toxicity: Diarrhea Nausea Fat redistribution Metabolic complications Hyperglycemia Increased transminase

Saquinavir/r (SQV): 

Saquinavir/r (SQV) Dosing: SQV 1600mg plus Ritonavir (RTV) 200mg QD or SQV 1000mg plus RTV 100mg BID Interactions: take with large meal Toxicity: Diarrhea Nausea Flatulence Fat redistribution Metabolic complications Hyperglycemia Increased transminase

Role of Nurses in ART: 

Role of Nurses in ART Understand how HIV works and how ARVs are used to fight the disease Understand the challenges and difficulty of managing ARVs: a realistic picture is essential Understand the challenges patients face in fighting HIV Help patients and their families deal with these challenges Collaborate with physicians and pharmacists as a “health care team” in order to provide the best care for patients

Key Points : 

Key Points Starting ARVs is not an emergency ARV therapy is NOT a CURE for HIV/AIDS; even the most powerful antiretroviral therapies can not eliminate HIV from the body HIV can still be transmitted when an individual is on ARV therapy or HIV RNA levels are below the limits of detection However, ARV therapy can significantly reduce HIV-related mortality and morbidity

Key Points (2): 

Key Points (2) For therapy to be effective, ARV medications must be used in combination Patients on ARV therapy require close monitoring and frequent evaluation Decisions about ARV therapy are complex and require consideration of potential adverse effects, drug interactions, resistance issues and the need for proper adherence

ARV Side Effects and Drug Interactions: 

ARV Side Effects and Drug Interactions Unit 6

Learning Objectives: 

Learning Objectives Describe common side effects related to taking ARVs from each of the three ARV drug classes Explain the purpose of monitoring ART Determine when clinical and lab monitoring should be conducted Identify laboratory tests necessary for ART monitoring Identify potential adverse drug interactions while on ART Explain the role of the nurse in detecting and managing side effects and drug interactions

Are ARVs Dangerous?: 

Are ARVs Dangerous? Common perceptions of ARVs: “Aren’t they toxic?” “People say they are like poison” ARVs do have side effects but it should not be forgotten that many other drugs do too Because those drugs are more common, they are not as often discussed Side effects of ARVs depend on the person and the drug

Side Effects: Acceptable: 

Side Effects: Acceptable Transient May be experienced in the first few weeks Other medications can be used to manage/alleviate these symptoms SUPPORT needed Encourage adherence

Side Effects: Unacceptable: 

Side Effects: Unacceptable Severe, unsafe Some side effects may be severe The doctor may need to change the ARVs Early identification and prompt, appropriate management is essential!

Signs of Adverse Effects and Toxicity: 

Signs of Adverse Effects and Toxicity Clinical signs/symptoms: Rash Jaundice Abdominal pain Numbness or pain in extremities Laboratory abnormalities (i.e. bone marrow, erythrocyte, neutrophils, platelets)

Serious Adverse Effects of NRTIs : 

Serious Adverse Effects of NRTIs Neuropathy ddI d4T Increased motor weakness d4T Hypersensitivity reaction* ABC Lactic acidosis/fatty liver* All NRTIs All NRTIs Anemia ZDV Myopathy ZDV (occasionally) Lipodistrophy ZDV, d4T *Pancreatitis ddI, d4T *Potentially life-threatening

Zidovudine (ZDV, AZT): 

Zidovudine (ZDV, AZT) Can cause bone marrow suppression and result in anemia and other abnormalities reflected in an abnormal complete blood count Also been associated with the occasional development of myopathy Presents with pain and aching in muscles

Didanosine (ddI) & Stavudine (d4T) : 

Didanosine (ddI) & Stavudine (d4T) Stavudine Rare occurrence of ascending motor weakness Similar to the Guillain-Barre syndrome and often accompanied by lactic acidosis Peripheral neuropathy Presents with numbness, tingling, or pain in the extremities Both Can cause potentially life-threatening pancreatitis Increased risk of neuropathy when used together

Abacavir (ABC): 

Abacavir (ABC) Can cause a hypersensitivity reaction in a small percentage of patients Reaction typically presents with fever, muscle aches and other flu-like symptoms, and sometimes with a rash Usually occurring in the first six weeks of therapy Note: Patient should NEVER be put back on abacavir once hypersensitivity has occurred!

Lipodystrophy or Body Fat Changes: 

Lipodystrophy or Body Fat Changes Fat gain (lipohypertrophy) Fat deposits in other locations Fat loss (lipoatrophy) Loss of subcutaneous fat in all parts of the body, most visibly in the limbs Metabolic disorders Changes in blood fat (lipid) levels Blood sugar increases Insulin resistance

Dorsocervical Fat Pad: 

Dorsocervical Fat Pad Courtesy of HIVInsite Knowledge Base/ Chow DC, Day LJ, Shikuma CM.

Central Fat Accumulation: 

Central Fat Accumulation Visceral fat accumulation, before ART Visceral fat accumulation, four months after starting ART Courtesy of Dr. Stefan Mauss

Facial Lipoatrophy: 

Facial Lipoatrophy Courtesy of HIVInsite Knowledge Base/ Chow DC, Day LJ, Shikuma CM.

Body Fat Changes: Implications: 

Body Fat Changes: Implications Psychosocial Self-esteem Stigmatization Antiretroviral adherence Clinical Neck pain Respiratory difficulty Umbilical hernia Pain associated with breast enlargement Gastroesophageal reflux

Body Fat Changes: Management Approaches: 

Body Fat Changes: Management Approaches Many approaches are available, but outcomes are minimal or unsatisfactory For lipoatrophy on d4T, changing to either abacavir or tenofovir (if available) may prevent progression Weight-bearing exercise to maintain muscle mass and diet can be beneficial

Serious Adverse Effects of NNRTIs : 

Serious Adverse Effects of NNRTIs Hepatitis* All NNRTIs Skin rash All NNRTIs Central nervous system symptoms Efavirenz Teratogenicity Efavirenz Stevens-Johnson syndrome* Nevirapine *Potentially life-threatening

Nevirapine-Induced Rash: 

Nevirapine-Induced Rash Courtesy of HIV Web Study, www.hivwebstudy.org

Nevirapine-Induced Rash (2): 

Nevirapine-Induced Rash (2) To reduce the risk The dose should be escalated after the first 2 weeks Starting at 200mg QD for 2 weeks and then increasing to 200mg BID

Serious Adverse Effects of PIs: 

Serious Adverse Effects of PIs Hyperglycemia and insulin resistance All PIs Elevated serum lipids All PIs Liver toxicity* All PIs Pancreatitis Lopinavir/r Changes in body fat distribution All PIs *Potentially life-threatening

Effects of HIV and Antiretroviral Drugs on Bone Marrow Cells: Erythrocytes: 

Effects of HIV and Antiretroviral Drugs on Bone Marrow Cells: Erythrocytes

Effects of HIV and Antiretroviral Drugs on Bone Marrow Cells: Neutrophils: 

Effects of HIV and Antiretroviral Drugs on Bone Marrow Cells: Neutrophils

Effects of HIV and Antiretroviral Drugs on Bone Marrow Cells: Platelets: 

Effects of HIV and Antiretroviral Drugs on Bone Marrow Cells: Platelets

Effects of HIV and Antiretroviral Drugs on Kidney and Liver: 

Effects of HIV and Antiretroviral Drugs on Kidney and Liver

Lab Monitoring : 

Lab Monitoring Should be done on a regular basis Detects side effects (toxicity) of drugs before clinical symptoms and signs appear Used for early detection of response to therapy (both immunologic & virologic) Detects treatment failure Investigations should be based on the expected side effects of the drugs used

Lab Monitoring (2): 

Lab Monitoring (2) CD4 follow-up test is used to monitor immunological response Standard CD4 testing is at baseline, 3 and 6 months, then every 6 months Use viral load testing at baseline and 3 months to detect early treatment success, then at 6 months to ensure VL is undetectable

Antiretroviral Drug Interactions: 

Antiretroviral Drug Interactions These are of clinical importance if they: Increase likelihood of drug toxicity Decrease therapeutic effectiveness of an administered drug Important interactions may be seen between ARV agents and: Other ARV agents Prescribed or non-prescription drugs (e.g., rifampin) Herbal or traditional remedies Certain foods Certain illicit drugs including chat

Important ARV Drug Interactions: 

Important ARV Drug Interactions Rifampin with PIs (except SQV/r) or NNRTIs (except efavirenz) Should not be used together Oral contraceptives with ritonavir, nelfinavir, amprenavir, lopinavir, nevirapine, efavirenz May decrease effectiveness of oral contraceptives Use additional or alternative methods, Depo-Provera can be used Anticonvulsants with PIs, NNRTIs May decrease ARV levels and promote the development of resistance Cotrimoxazole, hydroxyurea, isoniazid, dapsone, ketoconazole May have overlapping toxicities with ARV agents

Shared Side Effects of TB and ARV Therapy: 

Shared Side Effects of TB and ARV Therapy

Drug Interactions with ART and TB Agents: NNRTIs: 

Drug Interactions with ART and TB Agents: NNRTIs RFP = Rifampin RFB = Rifabutin

Case Study Activity: 

Case Study Activity

Key Points: 

Key Points Decisions about ARV therapy are complex and require consideration of potential adverse side effects and drug interactions Patients on ARV therapy require close monitoring and frequent evaluation ART monitoring is essential for: Detecting drug toxicity, interactions and side effects

Key Points (2): 

Key Points (2) Assessing a patient’s response to therapy Assessing adherence to treatment Recognizing treatment failure ART Monitoring is done through: Patient History Clinical assessment Lab monitoring

Prevention and Management of Opportunistic Infections: 

Prevention and Management of Opportunistic Infections Unit 7

Learning Objectives: 

Learning Objectives Show the relationship between CD4 count and the development of opportunistic infections (OIs) Describe the major clinical features, management and prevention of common OIs Explain the interaction between HIV and TB Describe management of HIV/TB co-infection

Introduction : 

Introduction OIs are the leading causes of morbidity and mortality in HIV-infected persons Most of the common OIs are preventable and treatable Treatment should be initiated prior to initiation of antiretroviral medication In resource-limited settings, it may be difficult to diagnose and manage OIs

OIs and CD4 Count: 

OIs and CD4 Count Most opportunistic infections develop when the CD4 count drops below 200cells/ml TB, herpes simplex or zoster, and Kaposi’s sarcoma can occur at any CD4 count

WHO Staging and Disease Correlation: 

WHO Staging and Disease Correlation Information courtesy of WHO

Candidiasis: 

Candidiasis Etiology: Candida albicans Affects the oral cavity and genitalia commonly Esophagus and trachea may also be affected Clinical features: Change in taste or increase in sensation in the oral cavity Pain or difficulty swallowing (esophageal involvement) Whitish coating of the tongue and palate

Candidiasis (Thrush): 

Courtesy of HIV Web Study, www.hivwebstudy.org Candidiasis (Thrush)

Candidiasis: Treatment: 

Candidiasis: Treatment Oropharyngeal candidiasis: Nystatin suspension or miconazole oral gel Severe and persistent cases: Fluconazole 100 to 200mg PO daily for 7-14 days or Ketoconazole 200mg PO daily for 7-14 days Esophageal candidiasis: Fluconazole 200-400mg PO for 14-21 days or Ketoconazole 200mg PO BID for 14-21 days

Neurological Manifestations of HIV: 

Neurological Manifestations of HIV Common causes of CNS disorders in HIV patients include: Cryptococcal meningitis Brain toxoplasmosis Tuberculosis (meningitis or tuberculoma) HIV encephalopathy (AIDS dementia complex)

Case Study: Melke: 

Case Study: Melke Melke, a 25 year-old HIV positive woman, presented with weakness of left upper and lower extremities of 5 days duration Has been complaining of fever, severe headache and vomiting for the last 2 weeks Not taking any medication Examination revealed a confused woman with weakness of left extremities but no meningeal signs What is Melke’s differential diagnosis?

CNS Toxoplasmosis: 

CNS Toxoplasmosis Etiology: Toxoplasma gondii (a protozoan) The disease is caused by reactivation of a latent infection when CD4 <100 Clinical features: Fever Headache and vomiting Hemiparesis: weakness of one half of the body Change in mental status

CNS Toxoplasmosis (2): 

CNS Toxoplasmosis (2) Treatment: Fansidar (sulfadoxine-pyrimethamine) 2 tab PO BID for 2 days – loading; and then, Fansidar 1 tab daily for 3 to 6 weeks followed by cotrimoxazole 2 tabs daily as secondary prophylaxis Major side effect of Fansidar is bone marrow suppression causing potentially fatal bleeding Folinic acid decreases the risk of bone marrow suppression Sulfadiazine + Pyrimethamine: not available Prophylaxis: Cotrimoxazole 960mg PO daily

Cryptococcal Meningitis: 

Cryptococcal Meningitis Etiology: Cryptococcus neoformans (a fungus) Occurs when CD4 <100 Clinical features: Fever Severe headache Change in mental status Hemiparesis is rare Diagnosis: Indian ink staining of CSF

Cryptococcal Meningitis: 

Cryptococcal Meningitis Treatment: Amphotericin B: not routinely available Fluconazole can be used as alternative 400mg PO BID for 2 weeks and then 400mg daily for 8 weeks Secondary prophylaxis: fluconazole 200mg PO daily until CD4 > 200 for > 3 months with ART

Respiratory Manifestations of HIV: 

Respiratory Manifestations of HIV Common causes of respiratory symptoms in HIV patients include: Bacterial pneumonia Pneumocystis jirovecii pneumonia (PCP) Tuberculosis Fungal infections

Case Study: Ato Alemu: 

Case Study: Ato Alemu Ato Alemu, a 50 year-old HIV positive man, presented to the OPD with cough of 3 weeks duration Scanty whitish sputum Low grade fever Developed shortness of breath one week ago On examination he was in respiratory distress with RR of 64/min and cyanosis What are the likely causes? What important tests would you request?

Case Study: Ato Alemu (2): 

Case Study: Ato Alemu (2) Results of tests: Sputum AFB: negative 3 times CXR: bilateral infiltrates CD4: 110/mm3 © Slice of Life, Suzanne Stensaas

Pneumocystis Jirovecii Pneumonia (PCP): 

Pneumocystis Jirovecii Pneumonia (PCP) Etiology: Pneumocystis jirovecii (a fungus) Usually occurs when CD4 count <200 Clinical features: Cough with scanty or no sputum Progressive respiratory distress Usually minimal chest findings: may have crackles CXR: bilateral interstitial infiltrates

Pneumocystis Jirovecii Pneumonia (2): 

Pneumocystis Jirovecii Pneumonia (2) Treatment: cotrimoxazole 100-120mg/kg/d divided into 3-4 doses for 21 days Steroids added for severe cases Prophylaxis: cotrimoxazole 960 mg/day until CD4 increased to >200 for >3months with ART Indications: Symptomatic HIV (oral candidiasis, etc) CD4 count <200 History of PCP

HIV/TB Co-Infection: 

HIV/TB Co-Infection Prevalence Very high in developing countries 50% in Ethiopia Increased incidence of TB among patients with HIV infection Risk of developing symptomatic TB is increased by 5-10 fold Implications: Need for HIV testing among persons with TB Need for TB screening among HIV-positive persons TB accelerates the rate of HIV progression

HIV/TB Co-infection (2): 

HIV/TB Co-infection (2) Clinical features of TB change in the late stages of HIV infection: Extra-pulmonary TB more likely Atypical pulmonary TB: TB involving the lower lungs Diagnosis of TB is more difficult in HIV infected patients because: Sputum smear is usually negative for AFB CXR features are atypical and difficult to differentiate from other conditions

ART and TB: 

ART and TB Problems encountered when treating TB and HIV: Indications for initiation of ART Choice of ARV drugs Dose of drugs High pill burden which leads to poor adherence Overlapping side effects of anti-TB and ARV drugs Hepatotoxicity and rash from INH, PZA, RIF and NVP/EFV Drug interaction Rifampicin decreases levels of NVP, EFV and PIs

ART and TB Scenario 1: 

ART and TB Scenario 1 Patient develops TB while on ART Start anti-TB treatment according to national guideline Continue ART with appropriate change to the regimen If patient is taking NVP, change it to EFV Increase dose of EFV to 800mg when patient is taking Rifampicin containing anti-TB regimen If this is not possible, continue NVP but with close clinical and lab monitoring (ALT monthly)

ART and TB Scenario 2: 

ART and TB Scenario 2 Patient presents with TB before initiation of ART Start anti-TB immediately Decision to start ART depends on CD4 count If CD4 <200, start anti-TB and then start ART after anti-TB is tolerated (usually between 2 weeks and 2 months) If CD4 is 200-350, start anti-TB immediately and start ART after completion of the intensive phase of anti-TB If CD4 >350, start anti-TB and defer ART

INH Prophylaxis Therapy (IPT): 

INH Prophylaxis Therapy (IPT) IPT The administration of Isoniazid (INH) to sterilize sub-clinical (asymptomatic) TB infections To prevent the development of symptomatic disease Why IPT for HIV patients? Lifetime risk of developing symptomatic TB in a person with asymptomatic TB infection is: About 5-10% in non-HIV infected people More than 50% in HIV infected people Decreased to <4% in HIV infected people treated with IPT

INH Prophylaxis Therapy (2): 

INH Prophylaxis Therapy (2) Who should be offered IPT? HIV positive Persons without active TB: active TB must be ruled out by all available means before initiation of IPT CXR Sputum for AFB Dose: INH 5mg/kg/day (maximum 300mg daily) for 6 months

Cotrimoxazole Prophylaxis: 

Cotrimoxazole Prophylaxis Cotrimoxazole can prevent different infections in HIV infected patients: PCP Toxoplasmosis Bacterial pneumonia Diarrhea caused by isospora and bacteria Indications: CD4 count <200 WHO Stage 3 Symptomatic HIV disease like oral thrush and chronic fever Cotrimoxazole prophylaxis should be started before ART

Cotrimoxazole Prophylaxis (2): 

Cotrimoxazole Prophylaxis (2) Dose: 960mg (2 tabs) daily Duration of prophylaxis: until CD4 count is persistently increased above 200/mm3 for 3 months Common allergic skin reaction may limit continued administration

Key Points: 

Key Points OIs are the leading cause of morbidity and mortality in patients with HIV/AIDS Many OIs occur in a predictable way when CD4 count drops below a certain level Most OIs are preventable and treatable TB is the most common cause of morbidity and mortality in HIV patients

Key Points (2): 

Key Points (2) When given together, anti-TB and ART cause significant problems, including drug interaction, overlapping side effects and high pill burden IPT decreases the risk of developing active TB in HIV infected people with latent TB infection Cotrimoxazole prophylaxis is a very important component of comprehensive HIV/AIDS care

Treatment Failureand Resistance: 

Treatment Failure and Resistance Unit 8

Learning Objectives: 

Learning Objectives Describe why ART fails in some patients Explain why ARV resistance occurs in some patients Describe when and how to change or discontinue therapy

Treatment Failure : 

Treatment Failure Treatment failure, but not resistance, occurs when medications are stopped A TB patient who stops all medications after 3 months is likely to relapse, but will almost always relapse with drug susceptible TB An HIV patient who stops all medications will allow the virus to grow, but the growing virus will still be drug susceptible

Treatment Failure (2) : 

Treatment Failure (2) When there is no medication in the body (the patient), the microorganisms can grow There is no advantage for drug resistant organisms There is no selection for drug resistant organisms The same medications are likely to work again if they are taken properly the next time

Indicators of Treatment Failure: 

Indicators of Treatment Failure Clinical Clinical progression (signs and symptoms) of disease Examples: weight loss, oral thrush, or development of a new opportunistic infection Immunologic (CD4): Return to pre-treatment CD4 baseline OR Fall in TLC or CD4 count > 30% from peak value Virologic Failure of viral load to become undetectable Indicates need for change in therapy Reappearance of detectable virus after being undetectable Need to ensure failure is not due to lack of resistance

Factors Contributing to ARV Failure : 

Factors Contributing to ARV Failure Ineffective ARV regimen May provide temporary relief, but will ultimately fail Example: single agent or a dual-nucleoside combination Suboptimal drug level Suboptimal dose Generic drugs that are not equal in quality and potency Drug interactions between ARV and other medications Malabsorption due to diarrhea intestinal parasites, nausea and vomiting, etc Lack of proper adherence to therapy

Factors Contributing to ARV Failure (2): 

Factors Contributing to ARV Failure (2) Interruptions in treatment: Cost It is critical not to miss doses or delay getting refills due to concerns about cost Drug “stock outs” It is critical to ensure a continuous supply of drugs to prevent treatment interruptions Side effects/toxicity Lack of proper adherence to therapy Especially in complex regimens Resistance to ARV drugs

Everyone is Different: 

Everyone is Different People respond differently to ARV drugs While one regimen may suppress viral replication well in one person, another person may develop resistance

Drug Resistance: 

Drug Resistance Drug resistance occurs when a germ (TB or HIV) continues to grow in the presence of medications Drug resistance may be caused by: Therapy that is not potent Missed doses Mutating viruses

Impotent Therapy: 

Impotent Therapy Resistance occurs with therapy that is not potent A patient with HIV will develop drug resistance if treated with only 1-2 drugs or 3 drugs from the same class May also occur if all drugs are from the same class such as triple NRTI treatment These treatments are not potent enough to prevent the growth of TB or HIV, but the presence of the drug helps select resistant organisms

Missed Doses: 

Missed Doses Resistance occurs with missed doses such as Just the morning dose is taken Taken only a few days each week The treatment is not potent enough to prevent the growth of HIV, but the drug that is present may select for resistant organisms

Mutating Viruses: 

Mutating Viruses Left alone, HIV grows and multiplies As it grows, HIV changes itself or mutates Monotherapy (one-drug therapy) The one ARV drug is able to kill all of the original (unmutated) HIV BUT the mutated virus is RESISTANT to the one ARV drug being used Mutant HIV

Stopping the Mutated Viruses: 

Stopping the Mutated Viruses The mutated virus grows and multiplies It is RESISTANT to the one ARV drug Dual therapy Two drugs together Can keep the original as well as the mutated virus from replicating Mutant HIV

Triple Therapy : 

Triple Therapy The use of three different drugs More effective than two drugs Powerful in stopping most HIV from replicating and allowing mutant viruses to proliferate Unfortunately, it is NOT able to cure HIV

Resistance is a Big Problem: 

Resistance is a Big Problem If resistance develops: Drugs start failing and the virus is able to replicate As the virus replicates The immune system is damaged People become unwell again OIs occur HIV progresses to AIDS Caution: there are only limited drug options available!

Cross Resistance: 

Cross Resistance Resistance to a drug in one class of ARVs commonly results in resistance to other drugs within that same class

Reducing Resistance: 

Reducing Resistance The BEST way to reduce the development of resistance is to ensure maximum viral suppression Using three drugs Before long, the mutated viruses increase in number and due to resistance the ART will not be as effective

Public Health: 

Public Health Resistant HIV may be transmitted to someone else If someone becomes infected with resistant HIV, they too will be resistant to one or more ARVs, even though they have never taken them before Potentially, ARVs could become less helpful for people across Sub-Saharan Africa due to resistance, a problem occurring in Europe and North America Abstinence and safer sex practices are the best ways to prevent this from occurring

Nurses’ Role: 

Nurses’ Role Nurses play an essential role in reducing resistance through: Educating patients about resistance Promoting adherence Recognising non-adherence Explaining to patients resistance testing Laboratory testing for resistance Encouraging abstinence and safer sex

Drug Failure and Resistance: Treatment Options: 

Drug Failure and Resistance: Treatment Options When treatment fails, or resistance is developed, there are two options for treatment: Changing therapy Discontinuing therapy

Changing Therapy: 

Changing Therapy Not done unless absolutely necessary! To avoid loss of effective ART for future regimens Main reasons to change treatment are: Occurrence/development of active TB If they are to be treated with rifampin and are taking ARV drugs that interact with rifampin Drug toxicity Drug intolerance leading to poor adherence Pregnancy Should be changed from efavirenz to another drug (usually nevirapine)

Changing Therapy (2): 

Changing Therapy (2) Main Reasons (continued) Treatment failure May be detected by CD4 count: decline or failure to rise, or by loss of virologic control, Clinical observations: during physical exam; the development of new OIs, or progression of disease Is most commonly associated with non-adherence.

Factors to Consider When Changing Therapy: 

Factors to Consider When Changing Therapy The Ethiopian guideline Prior antiretroviral history Antiretroviral resistance Side effects Drug toxicity Barriers to adherence Patient life-style and preferences Ability to follow-up in clinic Drug interactions Cost and sustainability Pregnancy

Discontinuing Therapy: 

Discontinuing Therapy Sometimes therapy must be discontinued either temporarily or permanently, depending on: Drug toxicity Adherence Other co-morbid conditions that would prevent appropriate therapy Considerations when discontinuing therapy: Potential benefits Reduction of toxicity and interactions Decreased risk of selecting drug resistant strains Improved quality of life

Discontinuing Therapy (2): 

Discontinuing Therapy (2) Considerations when discontinuing therapy (cont): Rebound in viral replication Risks Renewed immunologic deterioration Patient and clinician agreement to discontinue therapy Patient should be closely monitored

Key Points: 

Key Points Treatment failure indications may include clinical symptoms, decrease in CD4 count, or lack of sustained decrease in viral load It may be necessary to change an ARV drug regimen if there is intolerance to certain medications, occurrence of active TB, pregnancy or treatment failure Resistant HIV refers to a virus that has found a way to mutate itself, making the ARV drug being taken ineffective against the new form of virus

Key Points (2): 

Key Points (2) The best way to fight a mutated virus is to use triple therapy, to which the virus has not been previously exposed, at the right time, in the right dosage, in the right way Individuals can pass on resistant HIV to a partner, even if that partner has never been on ART

Adherence: 

Adherence Unit 9

Learning Objectives: 

Learning Objectives Define “adherence” Explain the importance of adherence in ARV therapy Identify factors that influence adherence Assess patient readiness to initiate ARV therapy Identify nursing strategies that maximize adherence

ARV Success: 

ARV Success ARV success is achieving AND maintaining maximum suppression of the virus

How Does that Happen?: 

Replication How Does that Happen? If ARV drugs are taken consistently: Viral load decreases Replication of virus prevented CD4 increases Decreased morbidity and mortality Treatment Success!

Maximum Suppression is Not Reached: 

Maximum Suppression is Not Reached Replication Take away One Drug or Miss Too Many Doses… Viral replication continues CD4 decreases OIs occur Resistance emerges Treatment Failure

Treatment Success: 

Treatment Success Treatment success is largely dependent on the patient’s ability to take the drugs exactly as prescribed This is known as ADHERENCE

Adherence Means…..: 

Adherence Means….. A shared decision making process between the patient and the healthcare provider The patient understands and agrees to make behavior changes to improve their health

Adherence is…..: 

Adherence is….. The right drugs In the right way At the right time

Taking the Right Drugs: 

Taking the Right Drugs The right drugs and the right doses (i.e. number of tablets) MUST be taken If not, the virus continues to replicate and resistance can develop

At the Right Time: 

At the Right Time The timing of the drug doses is extremely important There is usually a window period of approximately one hour (i.e. taking ARVs one hour later or earlier than normal) This varies with drugs and people It is best to stress exact times of doses, or the amount of virus will increase and resistant virus may emerge

In the Right Way: 

In the Right Way Some drugs have dietary restrictions i.e taken with or without food Ignoring these can be like only taking half a dose – you will not absorb enough of the drug for it to work properly If not enough of the drug is absorbed, the amount of virus will increase and resistance is more likely to occur

Dietary Restrictions: 

Dietary Restrictions With Food Nelfinavir (NLV) Ritonavir (RTV) Efavirenz (EFV) (avoid fatty food) Without Food Didanosine (ddI) Indinavir (IDV) (or light meal)

Importance of Adherence: 

Importance of Adherence Adherence is the most important factor for successful ARV treatment and improved health status Poor adherence is the most frequent cause of treatment failure and the development of resistance

How Much Adherence is Good Enough?: 

95% 90% 100% 60% 50% 75% 20% How Much Adherence is Good Enough?

In Other Chronic Diseases:: 

In Other Chronic Diseases: About 50% of patients fail to take their medications as prescribed Adherence is considered successful when a patient takes their medications greater than 80% of the time

Successful Adherence to ARV Treatment is Different: 

Successful Adherence to ARV Treatment is Different Even missing one or two doses a week can have a big impact on the chance of successful treatment

Adherence and Viral Load: 

Adherence and Viral Load Source: Paterson, D. L. et. al. Ann Intern Med 2000;133:21-30

How Much Adherence is Good Enough?: 

How Much Adherence is Good Enough? Unfortunately, the answer is 100% Adherence

Take All These?.....For Life?: 

Take All These?.....For Life? Should I eat or not with my tablets? Will these really help me? Which drug am I supposed to take now? But they make me feel so sick! Tablets every day for the rest of my life..? How can I remember to take these every single time? How can I take these without friends & family knowing?

A HUGE Challenge…..: 

A HUGE Challenge….. There are many reasons why patients may struggle with adherence It may not be their fault and It is not just about remembering to take them

Factors Affecting Adherence: 

Factors Affecting Adherence Patient Factors Knowledge, attitudes, unstable social circumstances, support network, state of health, lifestyle, disclosure, lack of interest, drug addiction, depression, history of non-adherence Medication Factors Pill burden, side effects, timing of doses, dietary requirements Patient-Health Professional Relationship Communication and interpersonal skills; non-judgemental attitude; open, trusting relationship Health Services Accessible clinic and pharmacy; experienced, well-trained staff; patient follow-up

Other Factors Affecting Adherence: 

Other Factors Affecting Adherence Although many factors that influence adherence are universal, other factors will be specific to the community or individual Competing religious and/or cultural beliefs, such as the use of traditional remedies or religious healers, should be explored with your patient

Nurses Role: 

Nurses Role All people on ARVs need immense support and encouragement Nurses have an essential role to play Recognising & understanding difficulties faced by patients Supporting patients and using appropriate interventions to promote adherence

Influencing Adherence: 

Influencing Adherence A trusting nurse-patient relationship where the patient feels safe and comfortable promotes adherence Nurses who believe that ARV treatment works, positively influences adherence

Promoting Adherence: 

Promoting Adherence Promoting adherence requires a Multidimensional Multidisciplinary Continuous approach Where the patient is Supported Counseled at every opportunity

Promoting Adherence From the Start!: 

Promoting Adherence From the Start! Promoting adherence must start from the very beginning, prior to beginning treatment!!! Never rush to treat!

Assessing Patient Readiness : 

Assessing Patient Readiness Has the patient disclosed their HIV status to anyone? Does the patient express fear of discrimination or stigmatization due to HIV? Is there support at home or from friends? Is there an adherence “buddy”? Is there a stable and safe living situation? Access to water, food, and transportation to the clinic...? Does the patient understand ARVs, expected outcomes and side effects? Does the patient understand the need for intensive follow-up?

Assessing Patient Readiness (2): 

Assessing Patient Readiness (2) Does the patient have a plan for taking ARVs and not missing a dose? Does the patient understand the need to take treatment for life, even if there are no symptoms or he/she feels better? Does the patient understand the impact of non-adherence? Is the patient committed to participating in on-going care? Has the patient talked with you about religious or traditional beliefs that might impact their ability to adhere?

Strategies to Promote Adherence : 

Strategies to Promote Adherence Spend more time and have multiple encounters to explain goals of therapy and needs for adherence Consider monitoring of medication such as cotrimoxazole or other surrogate prior to ARV initiation Negotiate a treatment plan that the patient understands and to which he/she commits Encourage disclosure to family or friends who can support the treatment plan Inform patient of side effects - severity, duration and coping mechanisms

Strategies to Promote Adherence (2): 

Strategies to Promote Adherence (2) Provide adherence tools where available: written calendar/daily schedule of medications, pill boxes or other appropriate tools Encourage use of alarms or other available mechanical aids for adherence Avoid adverse drug interactions: advise patients to avoid use of over-the counter drugs and traditional medicines Anticipate, monitor and treat side effects Create links with support groups and patient advocates and encourage discussions on adherence Develop links with community-based organizations to support adherence

Common Patient Questions: 

Common Patient Questions How many tablets should I take? What do they look like? How often do I need to take them? How exact do I have to be with timing? Are there any food or storage restrictions? What will happen if I miss doses? How can I fit these in to my daily routine? What should I do if I feel unwell on these drugs? REFER TO HANDOUT 9.2 Medication Adherence Checklist

Remember…: 

Remember… These drugs are not easy to take! Patients must feel comfortable telling us that they are having difficulties or have missed doses Only then can we support and assist them We must: Listen Teach Empathise Support!

Key Points: 

Key Points Adherence is a critical component of ARV treatment and vital to the successful care of patients with HIV/AIDS Poor adherence is the most frequent cause of treatment failure and the development of resistant strains of HIV Assessing for readiness to initiate ARV treatment is essential for successful adherence There are multiple factors that influence adherence and they change over time Adherence is difficult but there are effective strategies that can significantly maximize adherence Nurses play an essential role in the promotion of successful adherence

Symptom Management: 

Symptom Management Unit 10

Learning Objectives: 

Learning Objectives Understand that patients with HIV experience a wide spectrum of challenging symptoms throughout the course of their disease Explain that the underlying causes of symptoms are varied and require careful assessment and proper management Provide effective symptom management of common clinical manifestations along with effective diagnosis of the underlying disease of HIV Recognize the leadership role nurses play in the symptom management of care of the HIV patient

Progression of HIV Disease: 

Progression of HIV Disease Primary HIV Syndrome (acute infection): Occurs within weeks/months of infection Symptoms: fever, rash, muscle & joint aches, swollen lymph glands – “flu-like symptoms” Occasionally more serious: severe diarrhea, mental confusion Asymptomatic Infection: No obvious clinical manifestations of HIV infection Patient is frequently unaware of HIV status

Progression of HIV Disease (2): 

Progression of HIV Disease (2) Symptomatic Infection: Minor to moderately severe symptoms appear Disease begins to interfere with activities of daily life (ADL) Advanced Disease: AIDS Presence of AIDS-defining illnesses and opportunistic infections Without intervention, death will occur Provision of palliative care measures must be made

Underlying Causes of Symptoms: 

Underlying Causes of Symptoms Symptoms can be caused by: HIV associated diseases, such as opportunistic infections ARV treatments Traditional therapies Overlapping causes

Immune Reconstitution Inflammatory Syndrome (IRIS): 

Immune Reconstitution Inflammatory Syndrome (IRIS) Clinical manifestation of a sub-clinical infection that was already present at baseline, brought about by ART-induced reconstitution of the immune system Typically seen within the first several weeks after initiating ART Diverse group of symptoms Patients with advanced HIV disease more at risk

Immune Reconstitution Inflammatory Syndrome (2): 

Immune Reconstitution Inflammatory Syndrome (2) First appearance or recurrence of previously-treated OIs, for example, TB, MAI, PCP or CMV Flare-up of viral infections such as hepatitis Dermatological problems: genital herpes simplex, genital warts (HPV), molluscum contagiosum and varicella zoster Following initiation of ART: New immunologic response to pathogen Heightened immunologic or inflammatory response causes symptoms

Management of IRIS: 

Management of IRIS Screen for active or subclinical infections in patients with advanced disease prior to initiation of ART Counsel patients about possibility of IRIS and importance of follow-up for a new infection or worsening of an existing infection OIs should be treated appropriately while maintaining the antiretroviral regimen IRIS vs. drug toxicity vs. treatment failure Symptoms can include fever, abdominal pain and lymphadenopathy

The Baseline Assessment: 

The Baseline Assessment Care of the patient with HIV is determined by the impact that the disease has on the patient, clinically and psychologically The baseline assessment is an organized and systematic approach to determining: Disease progression Symptom management needs Psychosocial concerns

Components of Baseline Assessment: 

Components of Baseline Assessment Patient self-appraisal Physical exam Medical History Social History Lab findings

Medical History : 

Medical History What is the chief complaint? There may be a variety of complaints Consider and document all of them Put the chief complaint into context When was the patient diagnosed with HIV? Any complications? Other diseases? Malaria, TB, STD?

Medical History (2): 

Medical History (2) Is the patient taking any medications? Traditional remedies? Side effects from medications or traditional remedies must always be evaluated History of mental illness? Depression? How one copes with disease, especially HIV, can result in depression, loss of appetite, weight loss, etc. Previous hospitalizations? Surgery?

Social History: 

Social History Family structure? Married, children? Is anyone else in the family ill? Have HIV? Does anyone else know of patient’s HIV status? Employed? Living situation? Does the patient identify a church or other community group where they receive support?

Social History (2): 

Social History (2) Does the patient use alcohol? chat? smoke? All affect the immune system and can cause many of the symptoms associated with HIV disease progression The use of these substances also interferes with adherence to ARVs and can cause resistance Is the patient sexually active?

Patient Self-Appraisal: 

Patient Self-Appraisal How is she/he feeling? Change in weight Mood changes Weakness or fatigue Respiratory symptoms (cough, SOB) GI symptoms (nausea, vomiting, loss of appetite, diarrhea, thrush) Neurological symptoms (memory loss, headaches, visual changes Dermatological (rash, itching) Pain

Physical Exam: 

Physical Exam Note general appearance Weight, height, temperature Head & neck, including mouth & oral cavity (candidiasis, hairy leukoplakia) Cardiac, lungs Lymph nodes Abdomen Skin (fugal infection, KS, etc) Neuro-muscular

Laboratory Values: 

Laboratory Values If needed, confirmatory HIV test CD4 count Viral load CBC – full chemistry panel TST – chest x-ray Others, if needed

Your Nursing Care Plan: 

Your Nursing Care Plan Your care plan to determine appropriate action is determined by the findings of the assessment The care plan goal is to improve the quality of life for your patient The nurses role in symptom management is clear! You have the: Skills Knowledge Creativity

Common Symptoms and Strategies for Management: 

Common Symptoms and Strategies for Management

Weight Loss: 

Weight Loss Definition: Involuntary loss of body weight Related to: Loss of appetite Difficulty in swallowing Nausea and vomiting Diarrhea Depression Inadequate nutrition

Weight Loss: Intervention : 

Weight Loss: Intervention Determine and treat underlying cause: Oral/pharyngeal lesions/chronic diarrhea: Identify cause and treat Depression: provide counseling and support Nausea and vomiting: give anti-emetic as prescribed Refer to community-based support groups & NGOs for access to food programs

Weight Loss: Intervention (2): 

Weight Loss: Intervention (2) Nutritional interventions: Small frequent meals High protein, high calorie snacks May want to consider vitamin supplements Social interventions: Family or community support to prepare meals Community health workers to deliver food baskets, prepared meals Desired outcome: Weight gained and maintained

Diarrhea: 

Diarrhea Very common problem Definition: 3 or more loose or watery stools per day Acute: lasts for less than 2 weeks Persistent: more than 2 weeks Related to: Enteric opportunistic infections (bacteria, viruses, parasites, protozoa) HIV related change to the GIT ART side effects Food intolerance Emotional disturbance

Diarrhea: Diagnosis: 

Diarrhea: Diagnosis Subjective data: Patient may describe Loose, watery stools (upwards of 20 per day) Abdominal cramping and urgency Perianal pain and tenderness Difficulty to perform daily activities Objective data: Caregivers and significant others may describe Hyperactive bowel sounds in all four quadrants Wasting Abdominal tenderness Perianal irritation Stool analysis Signs of dehydration

Diarrhea: Intervention: 

Diarrhea: Intervention Treat underlying cause, if possible Anti-diarrheals such as Imodium, Kaopectate Aggressive IV re-hydration, if needed ORS as tolerated BRAT diet: bananas, rice, applesauce, toast Skin care: keep rectal area clean and dry Have all caregivers wear gloves, when possible; always wash hands before and after care

Diarrhea: Outcome Criteria: 

Diarrhea: Outcome Criteria Decreased frequency/amount of bowel movements Bowel movements less watery/more formed No irritation & breakdown of the perianal area No dehydration

Chronic Diarrhea: 

Chronic Diarrhea Definition: Diarrhea lasting for more than two weeks with a single watery bowel motion and/or three or more loose stools per day Frequency of diarrhea increases as the CD4 count falls With HAART, incidence of chronic diarrhea decreases

Common Infectious Causes of Chronic Diarrhea in HIV-infected Patients: 

Common Infectious Causes of Chronic Diarrhea in HIV-infected Patients

Chronic Diarrhea: Treatment Interventions: 

Chronic Diarrhea: Treatment Interventions Identify the organism and give specific therapy If organism couldn’t be identified, empiric treatment with combination of drugs may be tried Ciprofloxacin + Metronidazole Albendazole + Cotrimoxazole Rehydration with ORS Antidiarrheal agents like loperamide ART is important in the long term control of chronic diarrhea

Oral Ulcerations: 

Oral Ulcerations Definition: Painful lesions along the mucous membrane of the mouth and throat Related to: Secondary infections due to candidiasis (thrush), virus (hairy leukoplakia, herpes) Malnutrition Dehydration

Oral Ulcerations: Treatment Interventions: 

Oral Ulcerations: Treatment Interventions Determine and treat underlying cause: Anti-fungals (Ketoconazole/Fluconazole) Anti-virals (Acyclovir) Increase fluid and food intake If available, use topical pain medication (oral rinses) prior to eating Good oral hygiene before and after eating Choose bland and soft foods over spicy Avoid cold/hot foods and liquids Limit tobacco and alcohol use Keep lips moist and lubricated

Oral Ulcerations: Desired Outcomes: 

Oral Ulcerations: Desired Outcomes Able to take oral nourishment and medications Pain is controlled Ulcerations resolved

Fever: 

Fever Definition: 37-38 degrees C is low-grade Above 38 degrees C for prolonged periods is cause for concern Can be an indication of: Many HIV related conditions: HIV infection itself OIs Drug side effects A co-infection such as malaria or TB

Fever: Treatment Interventions: 

Fever: Treatment Interventions Determine cause and treat accordingly with appropriate medications Encourage patient to drink fluids: tea, broth, juices, water Keep patient covered, avoid drafts and chilling Tepid (lukewarm) sponge baths should be used sparingly

Nausea and Vomiting: 

Nausea and Vomiting Definitions: Nausea: upset or unpleasant stomach Vomiting: the ejection of stomach contents through the mouth Can be related to: Medications Usually most severe during the first 4-6 weeks of use Nausea usually decreases as the body adjusts HIV disease Infections Such as opportunistic diseases or ingested food borne bacteria/viruses/toxins Other factors

Nausea and Vomiting: Defining Characteristics: 

Nausea and Vomiting: Defining Characteristics Subjective Data - Patient may report: Queasiness, upset stomach, gagging, vomiting, or a strong urge to throw up Interference in daily activities Adherence to medication: Missing or vomiting up doses Objective data - Care providers and significant others may observe: Patient focusing on discomfort of nausea Vomiting Abdominal tenderness Signs of dehydration

Nausea and Vomiting: Treatment Interventions: 

Nausea and Vomiting: Treatment Interventions Evaluate any accompanying symptoms Thorough physical exam should be performed Especially when symptoms are severe, recurrent, or accompanied by other symptoms Focus on identifying symptom severity Prepare the patient With information about what s/he may experience What to do if nausea and vomiting occur Treat nausea & vomiting Provide anti-emetic prescriptions for use as needed

Nausea and Vomiting: Symptom Control: 

Nausea and Vomiting: Symptom Control Pharmacological: Antiemetics (Metoclopramide) Prokinetic agent (Metochlopramide) Dopamine antagonists (Promethazine) Sertononin antagonists (Ondnsetron Hcl) Cannabinoids (Dronabinol) Antianxiety (Lorazepam) Antihistamines (diphenhydramine) & anticholinergics (Hyoscine/Scopolamin) H2-receptor blockers (Tagamet) & proton pump inhibitors (Omeprazole) Antacids

Nausea and Vomiting: Symptom Control (2): 

Nausea and Vomiting: Symptom Control (2) Non Pharmacological: Relaxation: help the patient reach a state of relaxation that may lessen nausea Lie down, play soothing music or environmental sounds, get a massage Distraction techniques: focuses thoughts away from nausea Read, watch TV, participate in conversation Environmental measures: helps the individual avoid or reduce the impact of triggers that stimulate nausea Avoid offensive sights, odors, sounds; ventilate room adequately, dim lights Dietary change: eat frequent small meals

Nausea and Vomiting: Persistent Nausea: 

Nausea and Vomiting: Persistent Nausea Adjust dosage of medication Switch to less nauseating medication Drug desensitization Treat underlying causes Symptom control

Nausea and Vomiting: Outcome Criteria: 

Nausea and Vomiting: Outcome Criteria Patient will be able to: Recognize & intervene when nausea occurs Prevent vomiting Maintain adequate nutrition & fluid intake Maintain adherence to medication Continue daily activities

Fatigue: 

Fatigue A multidimensional symptom involving physical, mental, emotional & spiritual energy Can be a response of the body to extreme or extended psychic pressure Most common & debilitating complaint associated with HIV, accruing in 20-60% of people with the infection

Fatigue: Causative Factors: 

Fatigue: Causative Factors Decreased CD4 cell count Decreased hemoglobin, hematocrit anemia Depressed thyroid function: fatigue is a cardinal symptom of hypothyroidism Impaired pulmonary function resulting in hypoxia and dyspnea Poor nutrition Psychosocial factors

Fatigue: Defining Characteristics: 

Fatigue: Defining Characteristics Subjective Total body fatigue  unable to get out of bed Lack of energy Depression Objective Decreased mental function Decreased activity Isolation from others Disturbed sleep pattern

Fatigue: Treatment Interventions: 

Fatigue: Treatment Interventions Obtain history and current situation of psychosocial stressors Assess the impact of treatment and related factors Work up potential causes of HIV related fatigue and treat Teach basic nutrition Help patient identify support system Explore current coping strategies to determine need to explore alternate tactics Explore moderate use of exercise and resources for acceptable activities Teach time management skills Refer to mental health professionals, if necessary

Fatigue: Outcome Criteria: 

Fatigue: Outcome Criteria Patient will be able to: Recognize the presence of fatigue and define contributing factors Accept assistance from others Confront ineffective coping behaviors, including substance use Adopt a lifestyle of positive coping strategies that balance activity and rest

Dysphoria: 

Dysphoria Characterized by mood alterations, including anxiety, fear, depression and stress Requires supportive intervention by health care professionals and significant others Related to: HIV as a chronic disease Diagnosis of HIV Cultural conditions

Dysphoria (2): 

Dysphoria (2) Related to disease progression leading to: Alteration in mood Lack of adequate social support Lack of access to adequate health care Nutritional deficiencies Substance abuse Hormonal and physical change

Dysphoria: Defining Characteristics: 

Dysphoria: Defining Characteristics Subjective Data Depressed mood change Passive or active death wish Loss of interest Elevated mood--mania Hallucination Change in eating habits Change in sleeping pattern Objective data Episodes of crying, anxiety, emotional distress Suicide attempts Weight changes Isolative behaviors Substance use Change in appearance and hygiene

Dysphoria: Treatment Interventions: 

Dysphoria: Treatment Interventions Identify feelings of anger and vent in a safe environment Teach relaxation techniques Appropriate use of anxiolytic medications Assess potential for self-harm Identify and encourage patient strengths Encourage patient to engage in activities to prevent isolation

Dysphoria: Treatment Interventions (2): 

Dysphoria: Treatment Interventions (2) Explore situations that create or increase anxiety or fear Promote access to support groups and facilitate the mobilization of social support systems Use antidepressant medications appropriately Psychiatric consultation Focus on the meaning of personal experiences Facilitate the expression of strong emotions

Dysphoria: Outcome Criteria: 

Dysphoria: Outcome Criteria Patient will be able to: Use more adaptive coping strategies Adhere to medication regimens Verbalize understanding of limitations and identify personal strengths Use exercise and other therapeutic activities as physical limitations permit Identify and incorporate social supports into daily living

Other Symptom Management Strategies : 

Other Symptom Management Strategies ARV Treatment: Many symptoms of HIV disease will be resolved or seen less frequently Local Remedies: Many herbal and traditional remedies are known to alleviate the symptoms related to HIV/AIDS. Be aware of what the patient is taking to avoid possible interactions

Other Symptom Management Strategies (2): 

Other Symptom Management Strategies (2) Cotrimoxazole Prophylaxis: Greatly reduces the risk of: Bacterial and parasitic diarrhea Bacterial pneumonia PCP Candidiasis Other common manifestations of progressive HIV disease

Pain Control: 

Pain Control Medication should be given on a regular basis: Nonopiate: aspirin, paracetamol, nonsteroidal anti-inflammatory Mild opiate: codeine with/without nonopiate Strong opiates: morphine Massage, back rubs, cool cloths, touch Keep room quiet, well ventilated Address any emotional and spiritual concerns that may impact pain/discomfort

The Nurse’s Role : 

The Nurse’s Role Educate caregivers as to symptom management, universal precautions, nutritional needs, basic physical care Help mobilize NGOs, community church groups, volunteers to assist with care Provide support, both emotional and spiritual Nurse’s relationship with the patient and family, together with knowledge and skill, are central to palliative care nursing

The Ultimate Goal of Symptom Management : 

The Ultimate Goal of Symptom Management Patient is comfortable and dignity is preserved Caregivers feel confident that they are providing proper care

Key Points: 

Key Points Symptom management is central to the care of the patient with HIV/AIDS Effective management of difficult symptoms depends on a careful and comprehensive nursing assessment Incorporating principals of nursing process and proper symptom management is an important part of the continuum of care for HIV/AIDS patients Improved quality of life is the goal of all nursing care

Women, HIV and PMTCT: 

Women, HIV and PMTCT Unit 11

Learning Objectives: 

Learning Objectives Part 1: Women and HIV List women’s risk factors for HIV and identify strategies to reduce risk Identify gynecological conditions associated with HIV in women Describe gender differences in ARV treatment

Learning Objectives: 

Learning Objectives Part 2: HIV and PMTCT List the factors that affect HIV transmission during pregnancy, labor, delivery and breastfeeding Identify how to prescribe ART appropriately for pregnant women and exposed newborns Describe labor, delivery and postpartum care for HIV+ women and their infants

HIV and Pregnancy: 

HIV and Pregnancy TRUE or FALSE Pregnancy makes HIV disease worse If an HIV positive woman has a Caesarian section, her risk of having a baby with HIV is 0% If a woman is HIV+, her pregnancy should automatically be considered high-risk   HIV-infected sperm can directly infect the infant even if the mother does not have HIV infection 

HIV and Pregnancy (2): 

HIV and Pregnancy (2) TRUE or FALSE If the mother and the father are both HIV-infected, using condoms during pregnancy isn’t necessary   If a woman is HIV positive, all her babies will be HIV-infected because they share the same blood Giving Nevirapine to babies after they are born is like giving a nurse post-exposure prophylaxis after a needle stick Delivery procedures which cause the mixing of maternal/infant body fluids should be avoided whenever possible

Part 1:Women and HIV: 

Part 1: Women and HIV

Global Facts: 

Global Facts Of 40 million people living with HIV/AIDS worldwide, 17.5 are women (2005) 77% of all women living with HIV are in sub-Saharan Africa (2005) Among HIV positive adults, women account for 57% in sub-Saharan Africa, 26% in southeast Asia, 27% in Europe, and 25% in the US (2005)

Prevalence of HIV in Young Women (Sub-Saharan Africa): 

Prevalence of HIV in Young Women (Sub-Saharan Africa) Source: UNAIDS Report on the Global AIDS Epidemic 2004

Vulnerability Factors: 

Vulnerability Factors Biological Economic Social Cultural “Women are most vulnerable to HIV infection, given the social and economic disadvantages they face in their day to day lives.” Dr. Nafis Sadik, Executive Director of the United Nations Population Fund

Fostering Empowerment: 

Fostering Empowerment Combat ignorance Provide women friendly services Develop female controlled prevention methods Build safer norms Reinforce women’s economic independence Reduce women’s vulnerability through advocacy and policy change

Gender Differences : 

Gender Differences Viral load Disease progression Drug pharmocokinetics Lipodystrophy Lactic acidosis Contraceptives Adherence Gynecological issues

Viral Load and Disease Progression: 

Viral Load and Disease Progression Women may have lower viral loads than men in early disease Low viral load may NOT truly reflect low risk for progression Women and men progress at similar rates Gender not significantly associated with time to AIDS or survival time

Drug Pharmacokinetics : 

Drug Pharmacokinetics Body size—differences in weight Fat to muscle distribution Concentration of enzymes needed for drug metabolism is different Hormonal effects Pregnancy Hormonal replacement therapy Oral contraceptives

Lipodystrophy: 

Lipodystrophy Fat accumulation more common in women; fat depletion more common in men Accumulation and depletion in different body areas of same person occurs equally in men and women Lipid abnormalities: triglyceride and cholesterol level elevations more common in men

Lactic Acidosis: 

Lactic Acidosis The FDA has received 60 reports of lactic acidosis associated with dual nucleosides, with 55% mortality 83% in women; 50% >175lbs Presented with nonspecific symptoms Link between mitochondrial dysfunction and lactic acidosis? Occurs in women with high CD4

Contraception and ART: 

Contraception and ART NNRTIs and PIs interfere with blood levels of combination oral contraceptives. Additional barrier methods are recommended to prevent pregnancy and transmission of HIV and STIs. Because Efavirenz is contraindicated during pregnancy, dual methods of contraception are highly recommended for sexually active EFV users: barriers plus Progestins (Depo-Provera) IUCD Nelfinavir, Nevirapine and Ritonavir Associated with decreased levels of ethinyl estradiol, resulting in decreased contraceptive effectiveness Do not combine

Women and Adherence: 

Women and Adherence Adherence issues are more complicated for women who need special attention and support: Often don’t disclose HIV status due to stigma May feel isolated Caregivers Challenges in accessing and maintaining care include child care, transportation, inexperienced providers, etc.

Optimal Adherence for Women: 

Optimal Adherence for Women Evaluate for mental health, substance abuse and other “adherence interruptus” problems Assess HAART readiness Develop a mutually agreeable HAART regimen specific to her lifestyle Prepare for side effects Encourage atmosphere of communication and trust Be accessible and available

Gynecological Issues: 

Gynecological Issues Conditions causing inflammation or infection increase the likelihood a woman will acquire or transmit HIV Bacterial vaginosis Cervicitis Herpes ulcers Genital warts Condyloma Recurrent candidiasis Prevalent in 25-30% of women with HIV Risk increases 20-fold with CD4<100 HPV genital warts associated with increased incidence of cervical cancer

Care for HIV+ Women: 

Care for HIV+ Women Regular gynecologic care Pap smear (yearly and as needed) Detects cervical dysplasia (human papillomavirus) and sexually transmitted diseases Untreated HIV disease is associated with increased risk of cervical abnormalities Reproductive counseling

Care for HIV+ Women Desiring Pregnancy: 

Care for HIV+ Women Desiring Pregnancy Give accurate information on MTCT Maintain good health and nutrition status Provide ARVs to eligible women, or consider delaying until after the first trimester

Ongoing Care for Women with HIV Infection: 

Ongoing Care for Women with HIV Infection Psychological support Social support Medical support Nutritional advice Prophylaxis of TB, PCP, malaria, other infections Physical examination that includes gynecologic exam and cervical smears

Treatment Guidelines for Women: 

Treatment Guidelines for Women Guidelines are the same for women and men Women and men have similar responses to initial ART Because many women weigh less than men, it is important to monitor for toxicity

Part 2:HIV, Pregnancy and Preventing Maternal to Child Transmission: 

Part 2: HIV, Pregnancy and Preventing Maternal to Child Transmission

Introduction: 

Introduction HIV is a family infection Mothers and fathers have an impact on transmission of HIV to the baby There is increased chance of transmission to the baby when a woman becomes infected with HIV when she is pregnant or breastfeeding Partners should have safer sex throughout pregnancy and while breastfeeding

Pregnancy Outcome: Goals: 

Pregnancy Outcome: Goals Uncomplicated pregnancy Healthy, uninfected infant Healthy mother who has not compromised her future options for HIV therapy

HIV and Pregnancy: 

HIV and Pregnancy Pregnancy does not accelerate the progression of HIV disease to AIDS Patients with AIDS are more likely to suffer from pregnancy-related complications

Effect of Advanced HIV on Pregnancy: 

Effect of Advanced HIV on Pregnancy Decreased fertility Spontaneous abortion Infections (opportunistic, GU, postpartum, post-surgical) Preterm labor Premature rupture of membranes Low birth weight babies Stillbirths

Current Status of Mother-to-Child Transmission: 

Current Status of Mother-to-Child Transmission Estimates of HIV transmission rates from women to children are about 20-40% MTCT is by far the largest source of HIV infection in children under 15

Estimated risk and timing of MTCT in the absence of interventions: 

Estimated risk and timing of MTCT in the absence of interventions Source: World Health Organization. HIV transmission through breastfeeding. A review of available evidence.

Factors Influencing MTCT: 

Factors Influencing MTCT Viral Load The higher the viral load, the higher the risk of MTCT Lower risk through: Use of ART during pregnancy and postpartum to mother and newborn Adequate nutrition, particularly vitamin A

Factors Influencing MTCT (2): 

Factors Influencing MTCT (2) Maternal Factors Increasing Risk Viral or parasitic placental infection (especially malaria) Becoming infected with HIV during pregnancy Severe immune deficiency Advanced clinical and immunological state Maternal malnutrition

Factors Influencing MTCT (3): 

Factors Influencing MTCT (3) Labor and Delivery Factors Increasing Risk Prolonged rupture of membranes (>4 hours) Injury to birth canal during child birth Antepartum procedures Acute chorioamnionitis Invasive fetal monitoring Instrumental delivery Mixing of maternal and fetal body fluids Delayed infant cleaning and eye care Routine infant airway suctioning

Factors Influencing MTCT (4): 

Factors Influencing MTCT (4) Fetal Conditions Premature delivery Low birth weight Immature immune status First infant in a multiple birth Oral diseases

Providing Information: 

Providing Information Nurses play an essential role in reducing HIV mother to child transmission Nurses can coordinate the dissemination of PMTCT information to patients, families, communities and colleagues

Strategies for PMTCT: 

Strategies for PMTCT Primary prevention of HIV in childbearing women Prevention of unintended pregnancy in HIV-positive women Prevention of transmission from HIV+ women to their infants Treatment, care and support of women infected with HIV, their infants and their families

ANC: 

ANC Primary prevention during pregnancy Education about safer sex with use of condoms for mother and father Early treatment of STIs Safer sex during pregnancy and lactation

ANC (2): 

ANC (2) Offer VCT to all pregnant women Antenatal visits are vital opportunities for PMTCT for both HIV-positive and HIV-negative women

Initial Examination : 

Initial Examination All pregnant women Syphilis test Hgb HIV counseling and consent HIV test (rapid, if available) Rule out active TB If HIV positive: Baseline TLC CD4 and CD8 counts CD4/CD8 ratio and all other baseline tests (CBC, LFT, etc.) Viral load screening

Initial Examination (2): 

Initial Examination (2) Additionally, if HIV+: Past history of HIV-related illness and HAART Duration of known HIV+ status WHO Staging Status of other children, partner, and partner disclosure and referral Any medications taken for HIV-related illness since beginning of pregnancy

Assess Maternal Psychosocial Status: 

Assess Maternal Psychosocial Status Headaches Anxiety General malaise Depression Palpitations Insomnia Irritability

Care of the HIV+ Pregnant Woman : 

Care of the HIV+ Pregnant Woman Prophylaxis Anemia Tetanus (Toxic-TT) Vitamin deficiency Malaria Pneumonia (PCP) TB Treatment OIs STI UTI Vaginal candidiasis ARV Vitamin supplements

PMTCT Clinical Scenarios : 

PMTCT Clinical Scenarios Six possible clinical scenarios of a pregnant woman: On ART and become pregnant Pregnant and eligible for ART Pregnant and not requiring ART Pregnant and presenting after 34 weeks Pregnant and presenting in labor Woman and child presenting post partum

Scenario 1: On ART and Becomes Pregnant : 

Scenario 1: On ART and Becomes Pregnant Woman on efavirenz Counsel about potential teratogenicity Stop EFV and start NVP if in first trimester Woman on D4T/3TC/nevirapine Continue treatment or change D4T to ZDV (full blood count monthly if on ZDV) ALT monthly & when indicated Women on ZDV/DDI/LPV/r Continue treatment Full blood count monthly Monitor blood glucose levels as appropriate

Scenario 2: Pregnant and Eligible for ART: 

Scenario 2: Pregnant and Eligible for ART Begin first line therapy Follow national guidelines

Scenario 3: Pregnant and Not Requiring ART: 

Scenario 3: Pregnant and Not Requiring ART Early stage HIV (WHO Stage I or II disease with CD4 >200) Follow the national PMTCT guidelines

Scenario 4: Pregnant Woman Presenting After 34 Weeks: 

Scenario 4: Pregnant Woman Presenting After 34 Weeks Defer ART Provide PMTCT Review need for ART after delivery

Scenario 5: Pregnant Woman Presenting in Labor : 

Scenario 5: Pregnant Woman Presenting in Labor NVP single dose given at the onset of labor and post delivery to the infant OR AZT & 3TC to the mother during labor and infant post delivery OR IV AZT (alone or with NVP) to the mother and AZT syrup to the infant post partum for six weeks in addition to a single dose of Nevirapine

Scenario 6: Woman and Child Presenting Post Partum : 

Scenario 6: Woman and Child Presenting Post Partum Initiate 6 week neonatal AZT protocol, preferably within 6-12 hours of delivery OR Single dose Nevirapine plus AZT for the infant for four weeks Mother should be evaluated for HAART

We can reduce transmission of HIV with nevirapine: 

We can reduce transmission of HIV with nevirapine Single-dose nevirapine for mother and baby reduces rates of transmission at 18 months in a breastfeeding population: 10.1% absolute reduction in infection rate 47% more effective than zidovudine *HIVNET 012, Lancet 2003

Intrapartum Nevirapine: 

Intrapartum Nevirapine Single dose (200 mg) to mother in labor Rapidly absorbed May rapidly reduce mother’s viral load in blood and birth canal NVP crosses placenta and enters baby NVP provides prophylaxis to the baby during the birth No side effects with single dose (hepatotoxicity or rash)

Postpartum Nevirapine : 

Postpartum Nevirapine Single dose (2 mg/kg, 0.2 ml/kg) to newborn 48-72 hours after birth Maintains therapeutic levels in baby’s bloodstream for the first week of life Acts as post-exposure prophylaxis No side effects with single dose If mother received her dose of NVP less than 2 hours prior to delivery, give one dose of NVP to baby at birth and a second dose at 48-72 hrs

Antiretroviral Resistance with Nevirapine: 

Antiretroviral Resistance with Nevirapine Following single-dose NVP, resistance mutations present 6 weeks postpartum in 20-30% of women 46% of infants No longer detectable 12 months postpartum (due to reappearance of wild type virus). Mutant virus archived indefinitely

Antiretroviral Resistance with Nevirapine (2): 

Antiretroviral Resistance with Nevirapine (2) Following single-dose intrapartum NVP, some mothers have a decreased response to NVP-based HAART Problem is the greatest if HAART is given within a few months of single-dose NVP Risk of NVP resistance appears greatly increased with second maternal dose

ARV Therapy: HAART: 

ARV Therapy: HAART Results in the lowest risk of transmission to the infant (<2%) Reduces the risk of the mother developing resistance, thereby preserving her future treatment options Improves maternal immune status, improving survival Risks to infant appear to be minimal for most regimens

Safety of NRTI Drugs in Pregnancy: 

Safety of NRTI Drugs in Pregnancy Balance between PMTCT and therapy for mother vs. potential teratogenicity, toxicity, and drug resistance Human pregnancy data only for AZT, 3TC, ddI, d4T No increase in birth defects have been observed NRTIs and mitochondrial toxicity: symptomatic lactic acidosis and hepatic steatosis may be more prevalent in women

Safety of NRTI Drugs in Pregnancy (2): 

Safety of NRTI Drugs in Pregnancy (2) Fatal lactic acidosis described in pregnant women receiving ddI/d4T along with other ART ddI/d4T SHOULD NOT BE USED IN PREGNANT WOMEN

Safety of NNRTIs in Pregnancy: 

Safety of NNRTIs in Pregnancy Single dose nevirapine has not been associated with adverse side effects in women and children Nevirapine resistance risk as above Nevirapine elimination may be accelerated in infants whose mother received chronic nevirapine as part of ART. Significance? No human pregnancy data on long term use of NNRTIs

Safety of NNRTIs in Pregnancy (2): 

Safety of NNRTIs in Pregnancy (2) Efavirenz causes birth defects in exposed newborns Significant birth defects in 15% of newborn monkeys Birth defects reported in newborn humans Efavirenz should never be used in the first trimester Efavirenz is best avoided entirely during pregnancy

Safety of PIs in Pregnancy : 

Safety of PIs in Pregnancy Studies of blood levels and safety during pregnancy in progress for: Indinavir Ritonavir Saquinavir Nelfinavir Studies in progress for Lopinavir/ritonavir (Kaletra) Amprenavir or fosamprenavir Atazanavir

Combination ART and Pregnancy Outcome: 

Combination ART and Pregnancy Outcome Development of typical adverse symptoms is common May increase risk of pre-term deliveries Combination therapy started before pregnancy may carry a higher risk of teratogenicity than starting in the 2nd or 3rd trimester Until more information is known, HIV-infected pregnant women who are receiving a successful combination ART regimen should continue (unless on efavirenz or ddI/d4T)

Labor and Delivery Care: 

Labor and Delivery Care

Labor and Delivery Care: 

Labor and Delivery Care To facilitate an opportunity for PMTCT: Offer HIV testing for women in labor If a woman accepts an HIV test, provide counseling and rapid test

Labor and Delivery Care (2): 

Labor and Delivery Care (2) Critical issues during labor Emotional support Confidentiality Secrecy, disclosure Fear and concern about transmission

Labor and Delivery Care (3): 

Labor and Delivery Care (3) Do: Follow universal precautions to avoid occupational exposure Limit vaginal examinations during labor Treat acute chorioamnionitis Perform early infant eye and cord care Don’t: Isolate Shave pubic area Perform routine episiotomy Rupture membranes Use vacuum extraction and forceps if not indicated

Cesarean Section (CS): 

Cesarean Section (CS) Reduces the risk of MTCT Not available and safe in many settings Not routinely performed for women with HIV infection in developing countries Risks of morbidity associated with CS needs to be carefully balanced with risk of MTCT

Postnatal Care of Mother: 

Postnatal Care of Mother Routine postnatal care Infant follow-up Close monitoring for secondary postpartum hemorrhage Early recognition and treatment of infections Continue on HAART if patient is eligible (if on HAART while pregnant) Commence on HAART if patient is eligible (if HAART was not started while pregnant)

Postnatal Care of Mother (2): 

Postnatal Care of Mother (2) Extra nutrition and micronutrient support Counseling about safe disposal of infectious soiled pads or other garments Family planning counseling Infant feeding counseling Social support

Family Planning: 

Family Planning Discuss family planning BEFORE discharge Assess risk behaviors and counsel on suitable and effective methods Review birth control and infection control Dual protection to prevent and reduce further HIV infection, STIs and pregnancy Data suggests hormonal contraception is less effective with ARVs Access to emergency contraception

Infant Follow-up Schedule: 

Infant Follow-up Schedule Follow-up at 6 hours, 6 days, 6 weeks, and every 3 months Do full reassessment, and reclassification for HIV at each visit Virological testing after 6 weeks Cotrimoxazole prophylaxis to all exposed infants

Case Studies: PMTCT : 

Case Studies: PMTCT

Case Study: Sosina: 

Case Study: Sosina A pregnant 22-year-old woman, Sosina, with previously diagnosed HIV infection comes for her first antenatal clinic visit. She is in her first trimester of her first pregnancy. No other complaints

Case Study: Sosina (2): 

Case Study: Sosina (2) What information do you need from her history and physical, in addition to the usual information collected in the antenatal clinic? What laboratory tests will you request? What education and counseling will you provide while you wait for the results of the laboratory tests?

Case Study: Sara: 

Case Study: Sara Sara, a 29-year-old woman in her third pregnancy, delivered a healthy 3.5 kg baby girl an hour after she arrived at the maternity. After the birth, she told the staff she had a positive HIV test done in clinic, but did not take the tablet given her before rushing to the maternity because she did not want her family to know about her HIV infection

Case 2 Questions: 

Case 2 Questions What treatment does Sara require now? What treatment does her baby require?

Case Study: Azeb : 

Case Study: Azeb Azeb, a 21 year-old woman presents to the clinic with pain in her mouth and chest upon swallowing. She has had night sweats and diarrhea for one month. Her usual weight was 58 kg On exam she weighed 51 kg, had no palpable lymph nodes, and had oral candidiasis. She was diagnosed with presumed esophageal candidiasis and treated with oral fluconazole for 3 weeks. Her pain subsided and she began to eat

Case Study: Azeb (2): 

Case Study: Azeb (2) Based on the esophageal candidiasis, she had WHO Stage IV disease, although no CD4 count was available. She began daily cotrimoxazole for opportunistic infection prophylaxis. She was started on first line HAART with stavudine 30 mg bid, lamivudine 150 mg bid, and nevirapine with the usual dose escalation over 2 weeks. She has been adherent with her medications. The night sweats and diarrhea have stopped, her appetite has increased, and she gained 6 kg

Case Study: Azeb (3): 

Case Study: Azeb (3) At her 6-month follow-up visit she reports that her menstrual period is 2 months late. A pregnancy test is positive

Case Study: Azeb (4): 

Case Study: Azeb (4) Should she continue her antiretroviral therapy? How will you manage her intrapartum care? How will you treat her after her delivery? How will you treat her newborn?

Key Points: 

Key Points Women are more vulnerable to HIV due to biological, economic, social, and cultural factors Women with HIV have special gynecological needs and concerns Women and men with HIV progress at similar rates; ART guidelines are not gender specific

Key Points (2): 

Key Points (2) All pregnant women should know their HIV status in order to protect their children and themselves Women with AIDS are more likely to suffer from pregnancy-related complications Pregnant women who present with CD4 <200/mm3 irrespective of WHO stage should be started on first line treatment

Key Points (3): 

Key Points (3) Pregnant women should not receive efavirenz or ddI/d4T Effective strategies are available for reducing the risk of MTCT Nevirapine can reduce the risk of MTCT by 41% Use of HAART can reduce MTCT to less than 2%