International Partnership for Microbicides

Transcription

1 International Partnership for Microbicides New Directions in Microbicide Research Accelerating an HIV Prevention Revolution: A Roadmap Zeda F. Rosenberg, ScD, Chief Executive Officer Washington, DC, March 9, 2011

2 The Face of HIV/AIDS In the United States 27% of US AIDS cases are in women 90% of new infections in girls due to high-risk heterosexual contact 1 in 30 African-American women HIV+ In Africa Women: 60% of those living with HIV Risk of infection highest among women years old Many are mothers, married and monogamous

3 Women s s Vulnerability to HIV Biological, economic and socio-cultural factors: Male-to-female transmission higher Young women at even greater risk Financial dependence on male partners Inequality of women (exploitation and violence) Cultural practices such as early marriages, intergenerational sex and concurrent partnerships

4 The Global Response

5 From AIDS Treatment to HIV Prevention First AIDS case reported in the US ARV mono- therapy approved for use 2-drug therapy available 3-drug therapy: HAART Global Fund launched Thai vaccine efficacy HIV virus identified UNAIDS launched PMTCT guidelines issued Call for universal access to treatment PEPFAR & 33 by 5 5 initiative launched ARVs in gel and pill reduce risk of infection 30+ ARV drugs available for treatment

6 The Current Generation of Microbicides Based on ARV drugs used successfully for AIDS treatment & prevention of mother-to-child transmission Proof of concept that an ARV is also able to prevent infection in adults Microbicides are being developed as single drugs and in combination Could offer long-term protection, more convenience, more choices Use around the time of sex; once daily; monthly or longer Option to also develop as a contraceptive

7 Investment from Pharmaceutical Industry Non-exclusive, royalty-free licenses to develop, manufacture and distribute compounds as microbicides in developing countries

8 Promise of ARV-based Microbicides CAPRISA 004 efficacy trial: 889 women participants Rural & urban site in South Africa Gel used twice, within 12 hrs before & after sex (BAT24) Proof of concept: tenofovir gel Protection for women 39% efficacy against HIV 51% efficacy against HSV-2

9 Next Steps with Tenofovir Gel Confirmatory studies: MTN-003 (VOICE): Ongoing, results in early 2013 FACTS 001: Planned July 2011, results late 2013 Follow-up studies: CAPRISA 008: HIV-negative participants CAPRISA 009: HIV-positive participants Approvals and access: Possible marketing approvals

10 Need for Multiple Products & Formulations Different women, different preferences More product choices, more options for protection Adherence impacts efficacy product will not help if women do not use it Vaginal gels, rings, films, tablets, soft gel capsules all found to be acceptable in IPM studies in Africa

11 A Ring To Protect Against HIV Phase III efficacy trials starting in 2011 Will test if dapivirine ring effective in reducing risk of infection for women 6,000 women; 10+ research centers in multiple countries in Africa; over 3 years Long-acting, monthly ring: more consistent use could lead to better protection Low cost: suitable for developing world Potential for drug combinations

12 Current Resource Environment

13 Funding for Microbicide Research US government Source: NIH OAR Trans-NIH AIDS Research Budget FY 2011 FY05 FY06 FY07 FY08 FY09 FY10 FY11 Pres. Budget NIH 65,826 85,693 96, , , , ,855 CDC 5,185 3,435 3, USAID 29,760 39,600 39,600 44,636 45,000 45,000 45,000 Total 100, , , , , , ,855 Many funders: European and other governments (including South Africa), Gates Foundation, World Bank

14 Funding, not Science, Is the Obstacle Global Investment in Microbicide Development

15 Conclusion

16 Summary New Era for microbicides began in July 2010 Tenofovir gel proof of concept Dapivirine ring is a potentially new innovative option for women Could address adherence challenges Declining funding will jeopardize development and availability of potentially life-saving tools Together we can save millions of lives

17 Women Urgently Need Microbicides Now we must build upon the CAPRISA trial results and optimize a highly effective and acceptable microbicide for women and others at high risk of HIV infection which could be deployed by PEPFAR and other programs. Anthony S. Fauci, MD, Director NIAID September 29, 2010