Best Practices in HIV Treatment
Stephen Lee, MD Office of HIV/AIDS Bureau for Global Health U.S. Agency for International Development
Opportunistic Infections
Natural History of HIV Infection
Target population for treatment
Death
1200
CD4 count/ mm3
0.001 0.01 0.1 1
12 11 6 1 3 5 7 9
titre
Weeks
1000 800 600 400 200 0
0
CD4
Viral Titre
Years
Source: Fauci AS, et al. Ann Intern Med, 1996;124:654).
Natural History of HIV Infection
Target population for treatment based on symptoms
Death
1200
CD4 count/ mm3
0.001 0.01 0.1 1
12 11 6 1 3 5 7 9
titre
Weeks
1000 800 600 400 200 0
0
CD4
Viral Titre
Years
Source: Fauci AS, et al. Ann Intern Med, 1996;124:654).
8 Year Survival in HAART Era
Updated from Chen, et al, 8th CROI, 2001
Comprehensive HIV/AIDS Care and Support
Clinical Care (medical & & nursing) Clinical Care (medical nursing)
VCT , PMTCT preventive therapy (OIs, TB) preventive therapy (OIs, TB) Psychosocial Support palliative care, nutritionalSocioeconomic Support support
antiretroviral therapy counseling management of STIs and OIs Socioeconomic Support Psychosocial Support material orphan care palliative care, nutritional support support
VCT , PMTCT
management of STIs and OIs
communityorphan care services support economic security Affected by antiretroviral therapy economic security community support services food security HIV/AIDS spiritual support spiritual support Human Rights & Legal Support p food security
stigma & discrimination reduction
counseling
Adults and Children
material support
n o
r e
Human Rights & Legal Support
stigma & discrimination reduction succession planning PLHA participation PLHA participation
succession planning
i
v
e
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t
Antiretroviral Drugs
Antiretroviral Medications
NRTIs
Zidovudine(AZT) Stavudine(d4T) Lamivudine(3TC) Emtricitabine(FTC) Abacavir Didanosine(ddI) Zalcitabine(ddC) Tenofovir Combivir Trizivir Truvada
NNRTIs
Nevirapine Delavirdine Efavirenz Fusion Inhibitor Enfuvirtide (Fuzeon)
Protease Inhibitors
Indinavir Fortovase Ritonavir Nelfinavir Amprenavir Fosamprenavir Kaletra Atazanavir Tipranavir
Three drug cocktail
Goals of Antiretroviral Therapy
• Prevent Clinical Progression • Prevent Resistance
Goals of Therapy
• Increase CD4 cell counts. • Decrease HIV viral load levels: serum, CSF, testes. • Improve quality of life. • Decrease mortality. • Key to success: ADHERENCE
Factors to consider in selecting an initial regimen
• • • • • •
Tolerability Convenience Pill burden Long-term toxicities Potential future therapeutic options Drug interactions
Common Side Effects of ARVs
• Gastrointestinal complaints: nausea, vomiting, abdominal pain, diarrhea. • Loss of appetite. • Fatigue, loss of energy. • Headache. • Rash.
Other Side Effects
• • • • • •
Hyperglycemia/diabetes. Hyperlipidemia. Lipoatrophy. Lipohypertrophy. Lactic acidosis. Osteopenia, avascular necrosis.
Limitations of Current Anti-HIV Drugs
• Quality of life issues, example frequency of dosing, number of pills, side effects, interactions with food and other medications. • Toxicities. • Inability to completely suppress virus replication. • Persistence of viral reservoirs. • Emergence of resistance. • Cost/access.
Essential Elements of Antiretroviral Drug Therapy Programs 1
• Political commitment • Access to HIV counseling and testing services – VCT within a facility – Stand alone VCT center – Integrated in other medical settings, example TB and STI clinics • Trained providers who can diagnose and treat common HIV-related illnesses and manage ART
Essential Elements of Antiretroviral Drug Therapy Programs 2
• Basic medical records systems • Access to laboratory services capable of performing routine laboratory tests • Secure and consistent supply of affordable ARV drugs, drugs for HIV-related illnesses • Palliation, and prophylaxis of certain Opportunistic Infections.
Critical Elements of Comprehensive Care
• Involve PLWHA and community groups throughout the process • Develop standard operating procedures and/or clinical guidelines for HIV care and treatment at the facility level • Create or expand a functional referral system between clinical care and community support services to link PLWHA to a continuum of services
Critical Elements of Comprehensive Care 2
• Use initial assessments to strengthen capacity of the health care system – Data management – Health commodity management – Upgrading infrastructure • Develop and implement a monitoring and evaluation plan • Build capacity and support staff through training, monitoring and mentoring
HIV/TB Co-infection
• Strengthen the capacity of TB programs – Strengthen TB case detection and case finding capability of national TB programs • Establishing HIV services at TB service points • Introducing TB control activities at HIV service delivery points • Managing HIV related TB through training and capacity building
Lessons Learned
•
•
•
Country preparedness: – gather policy makers to crystallize a vision for ART services – Review national ART guidelines, including recommended drug regimens as a first order of business Community preparedness: – Work with local stakeholders and community members, including PLHA groups to design, support and evaluate clinic and community services – Manage expectations of the community The private sector has a key role to play
Lessons Learned
• Adherence: – Educate communities about who needs and qualifies for ART to provide adherence and a sense of equity – Tailor counseling and advice to individual patient needs • Clinical services: – Take steps to minimize attrition of health staff – Consider space as well as services – Provide continuing mentoring and supervision to health workers
Lessons Learned
Laboratory Services: – Forecast ART program scale up and prepare lab capacity accordingly – Do not underestimate the complexity of the laboratory function – As part of the ART program implementation plan to strengthen laboratory services
Lessons Learned
Pharmacy services: – Take steps very early to ensure a secure and consistent supply of antiretroviral drugs – Involve pharmacy staff at the site and national levels in identifying system strengths and weaknesses – Develop a commodity management plan
Challenges
• Limited health infrastructure both physical and human resources • Building the technical capacity of both the public and private sectors • Community preparedness • Cost to patients and cost recovery issues • Overcoming stigma • The need for non-judgmental, skilled providers • Integrating prevention with treatment
Remaining Issues
• Going to scale:
– Building capacity in very poor health systems
• Making existing technology more suitable to resource poor settings • Treatment is for a lifetime but projects have end dates; can decades-long financial support be sustained?
Thank You
Any Questions?
Strategies to Improve Adherence
• • • •
Inform patient, anticipate, and treat side effects. Simplify food requirements. Avoid adverse drug interactions. If possible, reduce dose frequency and number of pills. • Negotiate a treatment plan, which the patient understands and to which he/she commits.
Improve Adherence
• Take time, multiple encounters to educate and explain goals of therapy and need for adherence. • Establish readiness to take medications before the first prescription is written. • Recruit family and friends to support the treatment plan. • Develop a concrete plan for specific regimen, relation to meals, daily schedule, side effects.
Improve Adherence
• Provide written schedule and pictures of medications, daily or weekly pill boxes, alarm clocks, pagers, other mechanical aids to adherence. • Develop adherence support groups or add adherence issues to regular agenda of support groups. • Develop linkages with local community-based organizations.
Improve Adherence: Clinician and Health Team Related
• Establish trust. • Serve as educator, source of information, ongoing support and monitoring. • Provide access between visits for questions or problems. • Monitor on going adherence; intensify management in periods of low adherence. • Utilize health team for all patients, for difficult patients with special needs.
Improve Adherence: Clinician and Health Team Related
• Consider new diagnoses on adherence. • Utilize nurses, pharmacists, peer educators, volunteers, case managers, drug counselors, PAs, NPs, research nurses. • Provide training to support team related to antiretroviral therapy and adherence.
Palliative Care
• • • • • •
Palliative care is a core component of comprehensive HIV/AIDS care provide physical, psychosocial, spiritual comfort palliative rather than curative approach emotional support and guidance, bereavement counseling for family members/caregivers focus on patient and family maximize comfort and function despite disease progression
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