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Beyond the ABCs

Beyond the ABCs. The New World of HIV Prevention Mitchell Warren Executive Director AIDS Vaccine Advocacy Coalition (AVAC) 19 June 2008 Grand Rounds at Columbia. Why New Prevention Tools? Do the Math!. We’re losing our fight against HIV

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Beyond the ABCs

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  1. Beyond the ABCs The New World of HIV Prevention Mitchell Warren Executive Director AIDS Vaccine Advocacy Coalition (AVAC) 19 June 2008 Grand Rounds at Columbia

  2. Why New Prevention Tools? Do the Math! • We’re losing our fight against HIV • Estimated 45 million people are currently living with HIV • In many countries, AIDS is single-handedly reversing hard-won development gains of the last 50 years • More than 90% of people (even in sub-Saharan Africa) urgently need help remaining HIV-free, particularly young people and women • Major success in treatment access – 1.65 million on treatment, BUT… • 2.5 million new HIV infections each year

  3. An expanded alphabet soup of prevention: ABC (male & female), clean needles, male circumcision, VCT Prevention & Testing Deliver today Develop for tomorrow Treatment Trials Towards universal access Diaphragm, vaginal and rectal microbicides, PrEP, vaccines… A comprehensive, integrated & sustained response

  4. Prior to exposure Point of transmission After infection • Education & Behavior change • Male and female condoms • Anti-retroviral therapy (mother-to-child) • Post-exposure prophylaxis (PEP) • Anti-retroviral therapy • Care • Education & Behavioral change • Male circumcision • Preventive Vaccines • Pre-exposure prophylaxis (PrEP) • HSV2 suppression • TherapeuticVaccines • Vaginal and Rectal Microbicides • Diaphragm, cervical barriers & new FCs HIV/AIDS Toolkit

  5. Female Barrier - Diaphragm HSV-2 Treatment - Infectiousness Microbicides - Carraguard Oral PrEP - IDU Vaccines - Adenovirus1 Adenovirus 2 Male Circumcision - Susceptibility Community VCT and HIV Support Vaccines - Prime/Boost • Microbicides • BG/Pro2000 • CS – 1 • CS – 2 • Pro2000 • TDF Male Circumcision - Infectiousness HSV-2 Treatment – Susceptibility • Oral PrEP • MSM • Heterosexual Index Partner Treatment Oral PrEP - West Africa 2012 2010 2006 2008 2009 2007 Research that Could Re-define Prevention, 9/06 See also http://www.avac.org/timeline-website/index.htm

  6. Research That Is Re-defining Prevention, 6/08 Vaccine – Merck Adeno x2 STEP/Phambili • Oral PrEP • Heterosexual (FemPrEP & Partners) Female Barrier Diaphragm ` Vaccines – Thai Prime/Boost Microbicides – Carraguard Vaginal & Oral PrEP (VOICE) HSV-2 Treatment – Infectiousness • Microbicides • TDF/PMPA (CAPRISA) Microbicides – CS-1 CS-2 Community VCT and HIV Support Male Circumcision – Susceptibility ? Vaccine – VRC PAVE 100 Oral PrEP – IDU/Thai • Oral PrEP • MSM (iPrEx) • Heterosexual (Botswana) Male Circumcision – Infectiousness HSV-2 Treatment – Susceptibility Index Partner Treatment • Microbicides • BG/Pro2000 • Pro2000 Oral PrEP – West Africa 2011++ 2010 2006 2008 2009 2007 See also http://www.avac.org/timeline-website/index.htm

  7. Success is… • A clinical trial that produces a scientifically accurate result. • It may not be the result we had hoped for, but it answers questions that help the field move forward. • These trials need to be designed so that whether or not any particular trial finds efficacy, it at least produces clear results. • At the very least we will know what doesn't work, and perhaps be able to analyze results to understand why. • Caveat – no trial will answer all the questions (duh)

  8. “Failure” is/can be of the… • Candidate – MRK-Ad5 • Class – Adenovirus vaccine candidates • Concept – CMI-based vaccines • Trial – no result • Field – not learning and applying results • Communications – “In place of defending volunteers from the virus, the vaccine infected numerous participants…” • (“Moments of failure are the best occasions to refocus and move on.”)

  9. Issues for prevention trials • Right now all of the prevention trials that are being conducted ask more or less the same question: Does this strategy decrease the risk of HIV infection more than the standard prevention package provided by the study (condoms, clean needles – sometimes!, risk reduction counseling)?

  10. Issues for prevention trials But As we learn more about new, additional strategies, we will have to decide when to add these to the “standard of care” provided to trial volunteers. And We will need to develop even better ways to talk about partial efficacy (since none of these strategies is likely to be 100%)

  11. New promises, new challenges • How good is good enough? • Who will get new prevention tools – and when? • Who will pay for them? • How will people behave with these new tools? • What will the new standard of care be generally and in the context of other clinical trials? • Will we still be able to develop a vaccine?

  12. 0.6% HIV testing 4% Harm reduction for injection drug users 9% Prevention of mother-to-child transmission1 9% Condom access 11% Men who have sex with men 16% Commercial sex workers 0% 40% 60% 80% 100% 20% And one old challenge • Can we deliver on the promise – old or new? • % at Risk Globally with Access to Prevention Source: UNAIDS, 2006; USAID et al., 2004

  13. Knowing what we know… • We won’t prevent or treat or research our way out of this epidemic • The best approach to prevention is one which provides the most options • Break the false dichotomies • Not prevention OR treatment • Not deliver today OR develop from tomorrow • Not implementation OR research • Not vaccines OR microbicides OR female condoms • Not AIDS OR the rest of health and development • Not National OR international; local OR global

  14. In the midst of a plague • “...Dr Rieux resolved to compile this chronicle, so that he should not be one of those who hold their peace but should bear witness in favor of those plague-stricken people; so that some memorial of the injustice and outrage done them might endure; and to state quite simply what we learn in a time of pestilence: that there are more things to admire in men than to despise.” Albert Camus, The Plague

  15. Conclusions Ring the bells that still can ring; Forget your perfect offering. There is a crack in everything; That's how the light gets in. Leonard Cohen

  16. About AVAC • AVAC is a non-profit, community-based organization that uses education, policy analysis, advocacy and community mobilization to accelerate the ethical development and eventual global delivery of AIDS vaccines and other HIV prevention tools. • We accept no government or pharmaceutical funding. • www.avac.org

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