Viva La Rectum! Revolutionizing Sex in the New Millennium LGBTI Health Summit 2007 Philadelphia

Transcription

1 Revolutionizing Sex in the New Millennium LGBTI Health Summit 2007 Philadelphia Viva La Rectum! Jim Pickett International Rectal Microbicide Working Group AIDS Foundation of Chicago

2 Viva La Rectum! What we ll cover/uncover today What is a rectal microbicide? Who needs one and why? What is going on with the research? Funding? Advocacy Your BOOTY Your SELF

3 Viva La Rectum! A microbicide is A product applied in the vagina or the rectum that can offer protection against HIV and perhaps other STDs Formulated as a gel, lubricant or cream A rectal microbicide might be delivered via suppository or an enema THEY DON T EXIST IN DEVELOPMENT

4 How would a microbicide work? Kill/inactivate/immobilize the virus Prohibit viral entry Inhibit viral replication Block infection by creating barrier between virus and cells Strengthen the body s own natural defenses Ideally, a microbicide brought to market would combine these mechanisms for greater effectiveness

5 Viva La Rectum! Rectal microbicide = a new tool in our prevention toolbox

6 Are we really happy playing the ABC s?

7 An act of unprotected anal intercourse is times more likely to result in HIV transmission than an act of unprotected vaginal intercourse.

8 Viva La Rectum! Who needs a rectal microbicide? Who is having anal intercourse?

9 Hetero anal intercourse (AI) Prevalence, incidence among het not well defined Varies regionally by age, population, co-risk factors AI relatively common globally, 5 10% in gen pop and up to 30-50% of women with other HIV risks 7,794 HIV testing clients in Brazil 40% AI CSW between Durban and Jo burg 43% AI for clients South African het men 2x as likely as male counterparts reporting only vaginal sex to be HIV+ Pop.-based study of 2,547 N. CA women age 19 to % Volume unprotected AI (UAI) est. 7x higher in het compared to gay/msm

10 Viva La Rectum! AI - where the boys are Gay and MSM still make up the bulk of HIV infections in the West, Latin America, South America. Among U.S. gay and MSM, most report practicing AI: 76-90%. U.K.: 48.8% UAI (Gay Men s Sex Survey 2002) U.S.: 48-54% UAI among 4,295 men (EXPLORE Study 2003) STD rates confirm high prevalence of UAI Higher prevalence of HIV compared to heterosexual pop = more risk per act of UAI *9% of MSM in 2006 received any type of prev (global)

11 Viva La Rectum! Rectal microbicide research biological challenges Vagina Rectum Most of the epithelium is 40 cell layers thick Very fragile epithelium, 1 cell layer thick. Fewer CD4 cells than rectum Acidic ph More inflammatory cells under surface (CD4 receptors) Alkaline, rather than acidic ph Enclosed pouch Open-ended tube

12 Anatomy 101

13 Rectal microbicide research sociocultural/political challenges Significant challenges to developing a safe and effective rectal microbicide for the men and women who need them Homophobia, stigma, taboo, denial Civil society and policy makers have unwillingness to acknowledge AI Incomplete data around prevalence, mechanics, where infection occurs Researchers scrub abstracts Need to be on and off the radar

14 in brief The research Pre-clinical cell lines, explants Rhesus macaques 1% tenofovir gel 6/9 protected (Martin Cranage M2006) 1% Cyanovirin gel 7/7 protected E.coli - C peptide 2/4 protected (Dean Hamer M2006) Phase 0 trials, or baseline studies measure the baseline levels of injury, inflammation that occur in the rectum during typical AI

15 in brief The research Distribution studies look at how a microbicide might travel, be distributed during, after sex Acceptability/behavioral studies to learn what kinds of products people might be willing, able, want to use, anal hygiene and AI sexual behaviors How much is too much? Delivery method?

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17 in brief The research Phase 1 clinical trial - safety UC-781 (replication inhibitor) for rectal use, using vaginal microbicide gel formulation Has begun at UCLA, first enrollee 1/07 18 mos 36 participants, men&women with history RAI Another Phase 1, of VivaGel (rectal safety of vaginal microbicide -entry/fusion inhibitor) starting sometime this year There are no safety trials yet planned for the vaginal products in Phase 3 - Carraguard, BufferGel or PRO2000

18 A word about safety Rectal safety of vaginal products We must have rectal safety data on vaginal microbicides We won t know if the first vaginal microbicides are effective for rectal use. Likely they won t be But we MUST know if they are safe to put in the rectum. If they are not safe, we must communicate The 10 minute hypothesis

19 in brief The research NIH U19 5-Year Microbicide Development Project (MDP) UCLA and other sites $17.4 million, ends 09 Flagship for rectal microbicide r&d NIH Johns Hopkins, St. Georges, Health Protection Agency, NIH, University of Washington, MTN Dr. Peter Anton PI Preclinical (Dr. Ian McGowan et. al) Behavioral/acceptability (Dr. Pamina Gorbach et. al) Phase 1 (Dr. Peter Anton) Formulation (Dr. Craig Hendrix)

20 in brief The research amfar The Foundation for AIDS Research $1 million over two years funding began 07 AI who, prevalence who do we hope to protect, modeling impact on epidemic, AI practices? AI who, prevalence who do we hope to protect, modeling impact on epidemic, AI practices? Circumstances in which AI is practiced, interpersonal factors that may influence HIV risk? Damage done to colon/rectum during AI? What happens at cellular level of infection? Role of microbicides? Animal models for studies between test tubes and humans Safe, effective delivery device

21 Viva La Rectum! Bottom line A rectal microbicide MUST BE 1. Safe 2. Effective 3. Easy to use 4. Inexpensive, over the counter 5. Desirable

22 Advocacy International Rectal Microbicide Working Group Jim Pickett Formed June 2005 by AFC, CHAMP, CAS, GCM Currently nearly 400 members from 35 countries advocates, scientists, policy makers (and you?) Global listserv, teleconferences Mission: support the development of safe, effective, inexpensive, easy to use rectal microbicides for all that need them Published Rectal Microbicides: Investments and Advocacy in April 2006, M2006 conference in Cape Town BOOKMARK this site ---

23 Advocacy Mission IRMWG.org Jim Pickett To promote, facilitate research and development of safe, effective rectal microbicides for all those that need them To promote rectal safety studies on all Phase III vaginal microbicide candidates To support research of other new prev tech, such as vaccines and oral prevention (PrEP) To promote and disseminate lubricant safety research To place rectal microbicides within sexual harm reduction To serve as a central forum for exchange, debate, networking on these ideas To convene diverse perspectives and scientific disciplines to improve understanding and action

24 Rectal investments Total = $34M 2000 = $2M and 2006 = $7.2M (est)

25 Public Sector U.S. = $33.1M, 00-06, 97.4% NIH = $30.8M, = $6.6M.023% of overall budget 07 = $5.5M (projected) CDC = $2.3m, The Evaluation of Topical Microbicides in Men Who Have Sex With Men CDC vaginal - $2.4M, cents per capita Rectal investments Total = $34M 2000 = $2M and 2006 = $7.2M (est) Europe? Funds not apportioned specifically, VM $?, Britain s Microbicide Development Programme - Phase 1 rectal safety study in 06 but investment totals could not be confirmed, other spending too elusive to track

26 Rectal investments Total = $34M 2000 = $2M and 2006 = $7.2M (est) Philanthropic Sector $739, Approx. 2.2% total funds Trend from = $337, = $268, = $99, = $0 04 = $10, = $0 06 = $25,000 amfar primary investor No dedicated RM stream, funding levels fluctuate. *New funding released this year $1million* Direct research support, meeting support, rectal support growing Commercial sector $100, Most support in-kind Time spent, pipeline compounds, infrastructure. Likely waiting for proof of concept before fiscal risk. Biosyn 06 $100,000 in kind Gilead no figure given

27 Viva La Rectum! Needs estimate Conservatively, rectal field probably needs 5 candidates over years Will require minimum $350M, or at least $35M/year for 10 years Therefore, annual rectal spending needs to increase 5-fold

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30 Viva La Rectum! Advocacy your booty your self *Join the listserv/membership of the International Rectal Microbicide Working Group -Visit IRMWG.org to learn more about the working group and for extensive resources - Jim Pickett *Fill out the IRMWG survey on lubricants used for anal sex -Visit LifeLube.oprg a new gay men s health site, or IRMWG.org -Encourage friends/colleagues/networks to fill it out as well. -Survey currently avail in English, Spanish, French, Portuguese, German and Turkish.

31 Viva La Rectum! Advocacy your booty your self Microbicide Development Act *Introduced in both Senate and House March 8, 2007 *Overall, the goal of the bill is to achieve better coordination and expanded resources for microbicide research and development activities at the NIH, CDC and USAID. **Urge your Members to support

32 Viva La Rectum! Microbicide Development Act In the Senate, S.823 was introduced by Senator Barack Obama [D-IL] and Senator Olympia Snowe [R-ME]. Cosponsors include: Barbara Boxer [D-CA] Christopher J. Dodd [D-CT] Richard J. Durbin [D-IL] Barack Obama [D-IL] John F. Kerry [D-MA] Olympia Snowe [R-ME] Hillary R. Clinton [D-NY] Charles Schumer [D-NY]

33 Microbicide Development Act In the House of *Shays, Christopher CT Representatives, H.R. *Bean, Melissa L. - IL 1420 was introduced by Rep. Jan Schakowsky (D-IL) *Davis, Danny K. - IL and Rep. Chris Shays (R- *Emanuel, Rahm - IL CT). Cosponsors include: *Kirk, Mark Steven - IL Grijalva, Raul M. - AZ *Schakowsky, Janice D. - IL Berman, Howard L. - CA *McDermott, James - WA Capps, Lois - CA Lee, Barbara - CA *McNulty, Michael R. - NY Matsui, Doris O. - CA *Schwartz, Allyson Y. - PA

34 Viva La Rectum! Resources International Rectal Microbicide Working Group LifeLube Global Campaign for Microbicides Alliance for Microbicide Development amfar-the Foundation for AIDS Research Microbicide Trials Networks International Partnership for Microbicides

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36 Viva La Rectum! Thank you, thank you Jim Pickett Chair, IRMWG Policy Director, AIDS Foundation of Chicago