Next steps with 1% tenofovir microbicide gel
Meeting report - Johannesburg, South Africa, 25–26 August 2010
Following results from a South African study (CAPRISA 004) showing that a vaginal microbicide gel containing the antiretroviral drug tenofovir was 39% effective in reducing a woman’s risk of becoming infected with HIV during sex, a meeting was held to develop consensus and plan for next steps with this tenofovir gel.
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Objectives of the meeting
- Identify gaps and develop consensus on priority research to confirm safety, effectiveness and acceptability of 1% tenofovir gel.
- Develop most efficient pathways for licensure and guideline development, including regulatory dossier development and submission
- Delineate priorities, next steps and lead responsibilities in clinical research, programmatic research, and regulatory submission, and other issues as identified.
- Agree on mechanisms for coordination and execution, and identify funding sources and gaps
Participants at the meeting proposed that further trials should determine whether different populations of women will have the same level of protection as seen in the CAPRISA trial. One study, which will take place in South Africa, will establish whether the CAPRISA results can be repeated in other settings. It will also evaluate whether the gel can be used safely by sexually active 16 and 17 year olds.
The second study, which is planned other high HIV incidence African countries, will examine whether a different dosing schedule is safe and effective. It will test whether a single application of the gel before sex, or failing that immediately after, is as effective and safe as the original two dose regimen. The single dose schedule would be less expensive and easier for women to use.
An ongoing trial in Malawi, South Africa, Uganda and Zimbabwe being conducted by the Microbicides Trial Network is studying the same gel but used every day, will generate important data on safety and effectiveness of the product. Results are expected in early 2013.
Research in the communities where the CAPRISA trial was carried out will also examine how to best promote, distribute, and monitor gel use through existing family planning facilities. This will allow former trial participants and others in their communities to have early access to the new gel, but within the context of programmatic research.
While participants agreed on research priorities, concerns were expressed over the limited funding committed thus far to carry forward the next phase of research, which is estimated to cost US$ 100 million. Only US$ 58 million is available. Further prioritization of the research needs to be done, as well as preparations for introducing the product into national HIV and reproductive health programmes, assuming that it is confirmed to be safe and effective.
Nearly 20 years of research have gone into microbicides. If confirmed, the tenofovir gel would empower women by adding significantly to the options they have to protect themselves from HIV without requiring the cooperation of their male partner.