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Advancing HIV-Prevention Options for Women

Advancing HIV-Prevention Options for Women Parliamentary Seminar on New HIV-Prevention Technologies Dr. Zeda Rosenberg Helsinki, 24 October 2007. The Face of HIV is Increasingly…. Female Young Married and monogamous A mother. What is a Microbicide?.

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Advancing HIV-Prevention Options for Women

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  1. Advancing HIV-Prevention Options for Women Parliamentary Seminar on New HIV-Prevention Technologies Dr. Zeda Rosenberg Helsinki, 24 October 2007

  2. The Face of HIV is Increasingly… • Female • Young • Married and monogamous • A mother

  3. What is a Microbicide? • Vaginal products to prevent or reduce HIV • Could be delivered in many forms: transmission • gel • intravaginal ring • softgel capsule • vaginal film • vaginal tablet • sponge Vaginal applicator Vaginal ring

  4. Microbicides in Product Development Lactin-V Invisible Condom Free virus BufferGel Carraguard PRO2000 SPL7013 (VivaGel) Monoclonal antibodies DS003 (BMS) DS001 (Merck) DS006 (Maraviroc) SCHs (Schering-Plough) Attachment Locus small molecules Fusion S-DABO Dapivirine (TMC120) UC781 Tenofovir (PMPA) PC815 (MIV150 + Carraguard) Pyrimidinediones (Samjin) Replication (RT) Integration Protein synthesis and assembly Budding IPM compounds Maturation IPM-supported compounds

  5. Microbicide Development Process Site Development Research & Development Launch & Access Regulatory Approval Clinical Trials • Clinical Trials • Licensure • Post-licensure studies • Manufacturing • Service delivery • Marketing • Pharmacokinetic • Safety • Efficacy • Acceptability • Community engagement • Site selection • Site preparation • Site monitoring • Incidence studies • Pipeline • Basic research • Pre-clinical studies • Lead selection

  6. Early Generation Microbicides • Products that non-specifically block HIV from interacting with target cells • In efficacy trials • Partial, low or no effectiveness • Short-acting (used near time of sex)

  7. Early Generation Efficacy Trials

  8. Next Generation Microbicides • Based on antiretroviral drugs used to treat HIV • IPM’s microbicide candidates fall in this category • Highly potent and HIV-specific • Delivery mechanism for sustained protection • Once a day or less • Gels, intravaginal rings, vaginal tablets and others • Developed as single drugs and in combination • Trial of tenofovir gel initiated May 2007 • South Africa (CAPRISA, CONRAD, USAID) • Coitally dependent

  9. IPM Mission & Donors • Established in 2002 as a non-profit product development partnership (PDP). • IPM’s 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 Belgium, Canada, Denmark, France, Germany, Ireland, Norway, Netherlands, Sweden, United Kingdom, United States, European Commission, World Bank, UNFPA, Bill & Melinda Gates Foundation, Rockefeller Foundation

  10. Partnerships with Industry IPM Licenses with Industry IPM Material Transfer Agreements with Industry

  11. Research and Development GMP Manufacture Pennsylvania, US Applicator Filling Line

  12. IPM Clinical Studies of Dapivirine PK PK/Feasibility Safety/ Feasibility Safety 2007 2008 2009 2004-05 2005-06 Safety Safety Male tolerance PK Seroconverter protocol PK Efficacy trial Studies in Belgium, Kenya, Rwanda, South Africa, Tanzania

  13. IPM Site Development in Africa Early stage site development (cross-sectional incidence studies) Advanced stage site development (cohort incidence studies)

  14. Why Test Microbicides in Developing Countries? • Countries in greatest need of new HIV prevention options • Communities with high HIV incidence • Test microbicides in contexts in which they will be used • Clinical and regulatory implications • Building understanding and support

  15. IPM Research Center Partners Stanza Bopape Community Trust Ladysmith Hospice Association Afrimesh Research and Care

  16. Ethical Guidelines for Clinical Trials • Community engagement • Informed consent process • Counseling • Pre- and post-HIV testing • Condom education and provision • Family planning • Referrals • Those who initially screen HIV-positive • Pregnancy • Social harms • Treatment • Sexually transmitted infections • Adverse reactions • Antiretrovirals for HIV infections

  17. Product Acceptability Studies • Placebo gel formulations • Market research in Kenya, Zambia, South Africa (500 volunteers), 2006 • Assess women’s preferences • Supported acceptability of a daily product • Placebo vaginal ring • Study launched February 2007 (200 volunteers) • Four sites in South Africa, Tanzania, Kenya • Collect early safety and acceptability data • Vaginal tablet and film: initiated Q4 2007

  18. IPM Access Principles • Availability • Accessibility • Acceptability • Affordability

  19. Sample Access Activities • Intellectual property agreements • Community mobilisation for trials • Market research • Mapping regulatory pathways • Surveying manufacturing capacity • Modelling introduction scenarios • Assessing health system capacity • Lessons learned from other health technologies

  20. European Activities • Europrise: European Vaccines & Microbicides Initiative • Int’l research network of 33 partners from 10 countries • Chair of IPM’s SAB is coordinator & IPM Belgium is affiliate member • EMPRO: European Microbicides Project • Int’l research network of 25 partners in Europe & Africa • IPM has advisory role & is planning a joint Phase IIVR trial • EDCTP: European and Developing Countries Clinical Trials Partnership • Partnership of 14 EU countries, Norway & Switzerland to develop clinical interventions in cooperation with 18 African countries • IPM provides proposal review and expertise and supports bridge funding for sites, as requested

  21. IPM Support of Global Development Efforts • Improvement in health • Reduction in new HIV infections • Increased community education and mobilization • Regulatory path for new prevention technologies • Capacity building • Infrastructure and equipment • Income and skills generation (jobs and training) • Access to medical care and support • Women’s rights

  22. Contribution to MDGs “Microbicides are a development priority. I can think of no other technology that has the potential to dramatically improve the health of women in developing countries. Moreover, I do not see how we can meet the MDGs without safe and effective microbicides.” STEPHEN LEWIS, 2005 Former UN Special Envoy for HIV/AIDS in Africa

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