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Microbicides: Developing HIV-Prevention Options for Women World Bank Briefing Dr. Zeda Rosenberg 5 December 2006

Microbicides: Developing HIV-Prevention Options for Women World Bank Briefing Dr. Zeda Rosenberg 5 December 2006. The Face of HIV Globally. Increasingly female, young In Sub-Saharan Africa, 74% of young adults (aged 15-24 years) living with HIV are female

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Microbicides: Developing HIV-Prevention Options for Women World Bank Briefing Dr. Zeda Rosenberg 5 December 2006

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  1. Microbicides: Developing HIV-Prevention Options for Women World Bank Briefing Dr. Zeda Rosenberg 5 December 2006

  2. The Face of HIV Globally • Increasingly female, young • In Sub-Saharan Africa, 74% of young adults (aged 15-24 years) living with HIV are female • In South Africa: 1 in 4 women infected by age 22 • HIV infections also on the rise in women and girls in Eastern Europe, Asia, Latin America and the Caribbean • Married, monogamous • In India: 22% of cases in housewives with single partner • Mothers • In Swaziland: 56% of pregnant women from ages 25 to 29 are HIV positive – highest prevalence in 5 years World Bank Photos

  3. Women’s Vulnerability • Women’s susceptibility to HIV infection results from a combination of biological, economic and socio-cultural factors • Male-to-female transmission higher • Young women at even higher risk • Financial dependence on male partners • Inequality of women (exploitation and violence) • Cultural practices such as early marriages, intergenerational sex and marital infidelity

  4. Microbicides: A Human Rights Issue for Women • Microbicides would provide women with a prevention tool consistent with their right to self-protection and personal autonomy • Over time, microbicides could be developed with both contraceptive and non-contraceptive properties

  5. Comprehensive Approaches to HIV/AIDS Prevention Treatment and Care Prior to Exposure Time of Exposure • Behavior change • STI treatment • Male circumcision • Pre-exposure prophylaxis • HIV vaccines • Male and female condoms • Cervical barriers • Antiretroviral rx (mother-to-child) • Post-exposure prophylaxis • Antiretroviral therapies • Opportunistic infection therapies • Basic care Microbicides Microbicides would offer a woman-initiated method to reduce HIV transmission

  6. What is a Microbicide? • Vaginally applied substance that prevents or reduces transmission of HIV • Could potentially be delivered in many forms: – gel or cream – sponge – film, tablet – suppository – diaphragm – intravaginal ring Vaginal applicator Vaginal ring • Ideally, safe, effective, low cost and user-friendly

  7. Mechanisms of Action C31G SLS Buffer Gel Free virus BMS 793 Merck 167 CD4 mAbs PSC-rantes T1249 DC-SIGII CV-II Mannan Carragiard Cellulose sulfate PRO 2000 Dendrimers SPL Attachment Fusion Replication (reverse transcriptase) PMPA Dapivirine MIV 150 UC 781 DABO Protein synthesis and assembly Budding Maturation

  8. Current Clinical Efficacy Trials

  9. Next-Generation Microbicides • Antiretroviral-based • Future of microbicides likely in combinations – two or more mechanisms of action in one product to increase effectiveness • Advanced delivery mechanisms – non-coitally dependent • Long-acting gels • Intravaginal rings

  10. Realistic Expectations First generation of microbicides likely to be only partially effective Microbicide development path similar to that of AIDS therapeutics IPM hopes to condense the development process and expedite access 1981 1997 1987 2003 1983 1995 2002 2006 Three-drug therapy: HAART Brazil offers free universal access to treatment Drug combinations/ reducing pill burden “3 by 5” initiative First AIDS case reported in the US AZT mono-therapy approved for use 26 FDA-approved drugs and research continues HIV virus identified Two-drug therapy becomes available Global Fund established

  11. IPM Mission & Donors IPM is a non-profit product development partnership (PDP) established in 2002 whose mission is to prevent HIV transmission by accelerating the development and availability of safe and effective microbicides for use by women in developing countries. Donors: World Bank, Belgium, Canada, Denmark, France, Ireland, Norway, Netherlands, Sweden, United Kingdom, United States, European Commission, Rockefeller Foundation, Bill & Melinda Gates Foundation

  12. IPM Infrastructure • Formulation • GMP Manufacturing Phase I/II • Animal Models • Screening

  13. IPM Clinical Trials

  14. Delivery: Manufacture of Semi-Solid Formulations GMP Manufacture Pennsylvania, US Applicator Filling Line

  15. Partnership with Industry • IPM has acquired non-exclusive royalty-free licenses to develop, manufacture and distribute antiviral compounds as microbicides in developing countries from several major drug companies • TMC 120: NNRTI licensed from Tibotec • M 167: CCR5 blocker licensed from Merck • BMS 793: gp120 binder licensed from Bristol- Meyers Squibb • PMPA: NRTI, license pending from Gilead

  16. Product Attribute Study • Gel acceptability study - completed Sept. 2006 • 3 country market research study of gel preferences among 543 women in Kenya, South Africa and Zambia • Supported by the World Bank • Primary conclusions: • Participants and male partners liked using gels (focus groups) • Suggest less viscous formulation than current IPM gel BUT also that viscosity is not a primary driver of decision to use • Publication strategy for 1st/2nd quarter 2007

  17. Site Development • Identify promising new sites (dependent on incidence) • At least 10 sites needed for pivotal phase III trials • Build research capacity • Establish links for community-based HIV/AIDS care and support services • Conduct site preparedness studies • Community participation and advisory process

  18. IPM Approach to Site Development Non SA:8 countries11 sitesSA: 12 sites

  19. Site Development Trial Locations & Partners

  20. Kigali, RwandaProjet Ubuzima Premises IPM visit to Kigali Clinic and lab Offices and reception Counseling rooms The Laboratory Makeover Community Advisory Group

  21. Moshi, TanzaniaKCMC - HSPH The Laboratory

  22. Informed consent Family planning counseling Pre/Post HIV-testing counseling Referrals for women becoming pregnant Referrals for those screening HIV positive Treatment of STIs Treatment of those who become HIV-infected during the trial Treatment of adverse reactions Resistance Ethics of HIV Prevention Trials

  23. Urgency and Access • Historically, it can take decades for benefits of scientific innovation to reach the developing world • Microbicide field committed to expediting widespread availability of any effective product, reaching those most in need first • Microbicides must be widely available and affordable

  24. Access Objectives • Maximize health impact of microbicides for women in developing countries • Situate microbicides as part of comprehensive response to HIV • Address components of access: availability, acceptability, accessibility and affordability • Mobilize partnerships

  25. Demand Forecasting & Production Planning Mobilization of Scale-Up Financing Access Timeline Safety Trials Efficacy Trials Regulatory Approval Post-Licensure Studies Clinical & Regulatory Community Trial Engagement & Participation Manufacturing Pilot Manufacturing Efficacy Trial Manufacturing Commercial Scale Production Behavioral Research Trial Support & Acceptability Research Introduction Support Research SCALE UP Launch and Pilot Delivery Research Operations Research Service Delivery Mechanisms Impact Modeling Policy & Advocacy Mobilization of Political Support Marketing Market Research Branding Advertising

  26. IPM Access-Related Efforts

  27. Post-Trial Access “IPM is committed to the principle that all participants in an IPM-sponsored trial will have access to the product studied if the product has been proven to be safe and effective, and has been approved for domestic use in the country.” (Guidelines for the Conduct of IPM Clinical Trials, IPM, April 2006)

  28. World Bank Contribution to Microbicides • Donor to IPM since 2002 through the Population and Reproductive Health Capacity Building Program • Political leadership, including support for access to microbicides, once licensed • Grants supported: • Launch of IPM in Europe • Two IPM Access Advisory Committee meetings • Country preparedness/capacity building in South Africa & Zambia • Product attribute study to determine gel preferences

  29. With leadership, sufficient financial resources, collaborative efforts and product development expertise, women in developing countries could have access to effective microbicides within the next five to seven years. Conclusion

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