The Food and Drug Administration announced today its approval of tenofovir-emtricitabine (aka Truvada) for HIV prevention. Truvada, which has been approved since 2004 for use in HIV treatment, is now approved for use as preexposure prophylaxis (“PrEP”)–a strategy in which an HIV-negative person uses an antiretroviral drug (in this case a daily pill) to reduce the risk of acquiring HIV from behaviors such as unprotected sex. [More info on this strategy from CDC and AVAC.]
Although the approval had been anticipated–an advisory committee recommended approval in May–there had remained questions about the parameters of the approval:
(1) Populations: clinical trials have demonstrated clear (albeit partial) efficacy of Truvada among men who have sex with men and heterosexual couples in which one partner is HIV positive and the other is negative, leading the advisory committee to vote overwhelmingly to approve for these populations. However, the data among heterosexual women are more mixed. As a result, the advisory committee’s vote on whether to approve for “other individuals at risk for acquiring HIV through sexual activity” was a close call at 12-8. Today, FDA announced that Truvada would be approved for anyone “at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners”–a win for women’s health advocates who supported broader access, citing the vulnerability of many women to HIV exposure from male partners who refuse to use condoms.
(2) Risk mitigation: the FDA‘s decision was originally fast-tracked with a target date of June 15, but pushed back with the announcement that the FDA would be considering new materials on the Risk Evaluation Management Strategy (REMS) from the drug’s manufacturer. This topic had received extensive discussion among the advisory committee, and for those skeptical of PrEP as a public health intervention, it was key: concerns about the drug’s safety (risks of kidney damage and bone density loss) and drug resistance (among those who become HIV infected and continue taking Truvada instead of full-on ARV therapy) had led some to suggest strict limitations to control access, e.g. only to patients who could show a negative HIV test. Instead, the FDA‘s announcement described a REMS based on education for providers and patients, explaining that stricter limits would have added “unnecessary burdens to health care professionals and patients.”
Less strict requirements may be important for patients with less consistent access to health systems, many of whom may face elevated HIV risk. The CDC is expected to issue new clinical practice guidelines for PrEP, and the debate over how best to roll out this intervention–safely, effectively, and equitably–will certainly continue.
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.