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Briefing on the American AIDS Epidemic Innovations in HIV Treatment May 28, 2009. Mark Feinberg, MD, PhD Merck Vaccines and Infectious Diseases. Key Messages. More potent, better tolerated and simpler treatments have transformed HIV infection from a commonly fatal to a chronic condition
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Briefing on the American AIDS EpidemicInnovations in HIV TreatmentMay 28, 2009 Mark Feinberg, MD, PhD Merck Vaccines and Infectious Diseases
Key Messages • More potent, better tolerated and simpler treatments have transformed HIV infection from a commonly fatal to a chronic condition • New treatments will need to be continually developed • Earlier treatment of infected individuals saves lives and treatment may decrease the risk of HIV spread • However- not all HIV-infected people receive the benefits of early diagnosis and improved care • We need to plan for increased numbers of people being treated for and living with HIV infection
Factors affecting HIV treatment success • Drug potency • Genetic barrier to resistance • Targeting multiple stages in the virus life cycle • Drug tolerability • Drug regimen simplicity
Development of HIV therapies targeting several steps in the HIV life cycle • Over 30 drugs total in 6 different classes • Combinations therapies suppress but do not eradicate HIV infection Protease Integration
Trends in Annual HIV Death Rates and Benefit of Combination Antiretroviral Therapy Introduction of combination therapy
Improvements in HIV Therapies AZT 1980 1990 2000 2010 • Earlier Therapy • Limited treatment options of variable potency • Considerable side effects • Toxicities • Large pill burdens • Current Therapy • More choices (drug classes) • More potent • Improved tolerability • Fewer toxicities • Smaller pill burdens
Regimen Simplification:From Individual Agents to Combinations Fixed-dose combinations ZDV/3TC 3TC ABC/3TC FTC TDF/FTC EFV/TDF/FTC LPV/RTV RTV Individual Agents = + ZDV = ABC + TDF = + + FTC EFV TDF + = LPV
Simpler, better tolerated & very effective therapies have transformed HIV to a manageable chronic condition (for those with access to care) 1980 1990 2000 2010
New treatments will need to be continually developed • Individuals with multi-drug resistant viruses will need new drugs with novel mechanisms of action • There is also a need for: • more therapies with fewer side effects & fewer drug-drug interactions • longer-acting formulations with even simpler dosing
Earlier treatment appears to be associated with a lower risk of death Current Guidelines reflect a balance between the demonstrated benefits and potential adverse effects of therapy. DHHS (11/08) Initiate therapy in patients with CD4<350 or with history of AIDS. IAS (9/08) Therapy recommended for symptomatic HIV disease or for asymptomatic disease with CD4<350. Recent data: Deferral of treatment to CD4<500 is associated with a 94% increased risk of death Kitahata et al, New Engl J Med. 2009. CD4 count at therapy initiation
Asymptomatic Infection Acute Infection AIDS Treatment is hypothesized to be associated with a decreased risk of HIV transmission • HIV transmission is associated with the level of viremia in an infected person • By reducing viremia, HIV treatment may lead to a decreased risk of transmission* Risk of sexual transmission 1/30-1/200 HIV RNA Level 1/100-1/1000 1/1000-1/10,000 *CDC Expert Consult on Effect of Antiretroviral Therapy on Risk of Sexual Transmission of HIV Infection, Oct. 2008
The need to identifymore HIV-infected people earlier • 1.2 million infected • over 25% of new infections are in women • Half receive late diagnosis • miss life-extending benefits of therapy • 20-50% of infected individuals are unaware of their infection • these individuals are estimated to lead to 75% of new infections 56,300 new infections/yr
The Challenge of Universal HIV Diagnosis and Treatment • Routine opt-out HIV screening is now recommended for all individuals 13-64 yrs (CDC, ACP) • routine screening removes the stigma associated with risk-based testing • cost-effective • However- • Slow uptake of the new testing recommendations • Recommendations will only be effective with routine access to health care for all
Enabling Access and Benefits of HIV Therapy Moving Forward • Early diagnosis • Ready access to informed health care providers • Access to most effective antiretroviral therapies • Drug regimen simplicity and tolerability • Availability of essential supportive services (e.g. mental health, substance abuse treatment) • Continuing innovation in HIV care and treatment
New AIDS Cases, Deaths, and People Living with AIDS in the U.S. People Living with AIDS New AIDS Cases People Living with AIDS Deaths and New AIDS Diagnoses Deaths among People with AIDS 2004 Note: Data are estimates. Source: CDC, Data Request, 2006.
With effective treatment, more people will be living with HIV • HIV diagnosis, care and treatment programs need to be adequately funded to ensure the greatest individual and public health benefit. • Progress in preventing HIV infection will be essential for long-term success.