Mapping Pathways is a multi-national project to develop and nurture a research-driven, community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based prevention strategies to end the HIV/AIDS epidemic. The evidence base is more than results from clinical trials - it must include stakeholder and community perspectives as well.

29 December 2011

Gilead has submitted application for FDA approval of PrEP

via Bay Area Reporter, by Liz Highleyman

The company, which made the announcement December 15, has asked for priority review, meaning a decision could come as early as June. Clinicians can currently prescribe drugs "off label" as they see fit, but official approval of Truvada PrEP would have implications for public health programs and insurance coverage.

"The data from clinical trials clearly show that taking Truvada every day and using condoms can be very effective in preventing HIV for people at highest risk for infection," said Project Inform Executive Director Dana Van Gorder. "We believe in the right of HIV-negative people to choose the evidence-based prevention methods that best support their efforts to remain negative, and we urge quick FDA approval of Truvada for prevention."

PrEP trial results

Gilead's request is based on findings from a series of large international trials of oral PrEP using Truvada or the medications it contains, tenofovir (sold separately as Viread) and emtricitabine (Emtriva). Overall, results have been promising but several questions remain unanswered.

The large iPrEX trial, which enrolled nearly 2,500 gay and bisexual men and transgender women in six countries (including San Francisco and Boston in the U.S.), found that daily Truvada reduced the risk of acquiring HIV by 44 percent overall, with 36 new infections among men receiving PrEP compared with 64 among men taking a placebo pill.

Further data presented at the International AIDS Society conference this summer in Rome showed that risk reduction exceeded 90 percent for participants who had detectable drug levels in their blood, indicating good adherence.

"With 2.6 million new HIV infections occurring each year, and fewer than half of people with HIV receiving treatment, the world needs new and effective HIV prevention strategies," said iPrEx protocol chair Dr. Robert Grant from the Gladstone Institutes and UCSF. "Men who have sex with men have borne an enormous burden in this epidemic, and have also been consistently at the head of efforts to help reverse it."

Two other trials discussed in Rome – Partners PrEP and TDF2 – showed that the drugs in Truvada reduced the risk of HIV infection among heterosexual men and women in Africa by 60 percent to 75 percent.

In contrast, however, two studies of heterosexual African women have not seen a similar effect. The Fem-PrEP study of daily Truvada was halted earlier this year due to lack of effectiveness, as was an arm of the VOICE trial testing oral tenofovir alone (the tenofovir/emtricitabine combination is still being evaluated.)

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

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