From “What If” to “What Now” Perspectives on ARVs and the Future of Treatment and Prevention Mitchell Warren Executive Director, AVAC IAS 2011, Rome

Timing is Everything  2004  2007  2010  2011

1.No magic bullet; need smart combinations

Female Condoms Felblum P, AIDS 2001 Male Condoms Brody S, NEJM 1996 Note: PMTCT, Screening transfusions, Harm reduction, Universal precautions, etc. have not been included – this is focused on reducing sexual transmission Behavioural Intervention -Abstinence -Be Faithful HIV Counselling and Testing Coates T, Lancet 2000 Treatment of STIs Grosskurth H, Lancet 2000 Male circumcision Auvert B, PloS Med 2005 Gray R, Lancet 2007 Bailey R, Lancet 2007 Microbicides for women Abdool Karim Q, Science 2010 Treatment for prevention Donnell D, Lancet 2010 Cohen M, 2011 Positive prevention - behavioral Fisher J, JAIDS 2004 Grant R, NEJM 2010 Pre-Exposure prophylaxis Oral PrEP for MSM Post Exposure prophylaxis (PEP) Scheckter M, 2002 Vaccines Rerks-Ngarm S, NEJM 2009 COMBINATION HIV PREVENTION

Study Effect size (CI) Medical male circumcision (Orange Farm, Rakai, Kisumu) 57% (42, 68) Prime-boost Vaccine (Thai RV144) 31% (1, 51) Efficacy 0% % TDF/FTC oral-PrEP (iPrEx, Grant et al 2010) 44% (15, 63) 1% tenofovir gel (CAPRISA 004) 39% (6, 60) Immediate ART for positive partners (HPTN052) 96% (82, 99) TDF/FTC oral-PrEP (TDF2, CDC) TDF oral-PrEP (Partners PrEP) 63% (22, 83) TDF/FTC oral-PrEP (Partners PrEP) 62% (34, 78) 73% (49, 85)

History Lessons A vaccine [or condom, or microbicide or tablet] that sits on the shelf is useless. Albert Sabin

0% 20% 40%60%80%100% 10-12% Adults with access to HIV testing in Africa 8% Harm reduction for injection drug users 33% Prevention of mother-to-child transmission 9% Condom access 11% Behavior change programs for men who have sex with men 16% Behavior change programs for commercial sex workers And an Old Challenge  Can we deliver on the promise?  Global access to existing prevention options Source: UNICEF/UNAIDS/WHO 2009

1.No magic bullet; need smart combinations a)Corollary: Need smart researchers, policy makers, funders and advocates!

1.No magic bullet; need smart combinations 2.It’s behaviour

1.No magic bullet; need smart combinations 2.It’s behaviour 3.Adherence, adherence, adherence

1.No magic bullet; need smart combinations 2.It’s behaviour 3.Adherence, adherence, adherence 4.Embrace the niche

1.No magic bullet; need smart combinations 2.It’s behaviour 3.Adherence, adherence, adherence 4.Embrace the niche 5.Strategize the sequence

Pathway to Reversing the Epidemic Male & Female Condoms ARV microbicide Partially effective vaccine highly effective vaccine Time HIV incidence ARV PrEP Medical Male Circumcision ARV Tx as Px Deliver today Deliver soon Develop for tomorrow Demonstrate today

1.No magic bullet; need smart combinations 2.It’s behaviour, stupid! 3.Adherence, adherence, adherence 4.Embrace the niche 5.Strategize the sequence 6.Testing, testing, testing

1.No magic bullet; need smart combinations 2.It’s behaviour, stupid! 3.Adherence, adherence, adherence 4.Embrace the niche 5.Strategize the sequence 6.Testing, testing, testing 7.Watch our language

An Evolving Lexicon  ART  ARV  Oral PrEP  PEP  Topical PrEP  Microbicides  Long-acting methods  TasP  TisP  T4P  TnT  TLC+

1.No magic bullet; need smart combinations 2.It’s behaviour, stupid! 3.Adherence, adherence, adherence 4.Embrace the niche 5.Strategize the sequence 6.Testing, testing, testing 7.Watch our language 8.Four questions

Four Questions  Who needs what?  Who wants what?  Who gets what?  Who pays?

1.No magic bullet; need smart combinations 2.It’s behaviour, stupid! 3.Adherence, adherence, adherence 4.Embrace the niche 5.Strategize the sequence 6.Testing, testing, testing 7.Watch our language 8.Four questions 9.Money, money, money

Money, Money, Money  “Science of Prioritization and the Primacy of Targeting” Ward Cates, personal communication, the day before yesterday  “Substantial changes are needed to achieve a more targeted and strategic approach to investment in the response to the HIV/AIDS epidemic that will yield long-term dividends.” Towards an improved investment approach for an effective response to HIV/AIDS, Schwartländer B et al, Lancet, 3 June 2011  “If one accepts the tenet that science should inform policy, then the scientific data are speaking loud and clear. Global policy- makers must seriously consider these new data in their priority- setting and decision-making.” AIDS: Let Science Inform Policy, Fauci AS, Science, 1 July 2011

1.No magic bullet; need smart combinations 2.It’s behaviour, stupid! 3.Adherence, adherence, adherence 4.Embrace the niche 5.Strategize the sequence 6.Testing, testing, testing 7.Watch our language 8.Money, money, money 9.Four questions 10.Scientific data do not change the world— programmes and policies backed by civil society, donors, implementers and governments do

Reading List, July 2011  AIDS: Let Science Inform Policy, Fauci AS, Science, 1 July 2011  Antiretroviral Prophylaxis: A Defining Moment in HIV Control, Abdool Karim SA and Abdool Karim Q, Lancet, 15 July 2011  Towards an improved investment approach for an effective response to HIV/AIDS, Schwartländer B et al, Lancet, 3 June 2011  We CAN End The Epidemic,

WITH URGENCY