FDA To Decide By June 15th Fate Of First-Ever HIV Prevention Drug

The FDA is expected to decide by June 15, 2012 whether the first-ever HIV prevention drug will be approved after the FDA Antiviral Drugs Advisory Committee voted overwhelmingly on May 10, 2012 in favor of Truvada PrEP (emtricitabine/tenofovir disoproxil fumarate) for HIV-uninfected men who have sex with men, for HIV-uninfected partners of those with HIV, and for others at risk for acquiring HIV through sexual activity. The Committee also recommended monthly testing for HIV and regular monitoring of kidney function while on Truvada PrEP.

What Are Some Of The Statistics Regarding New HIV Infections In The U.S.?

New HIV infections in the United States have remained at about 50,000 per year for the past decade. Men represent 75% of new HIV infections. The highest incidence of new HIV infections is in black men (8 times higher than in the white population). Hispanics and Latinos have an incidence rate 3 times higher than in the white population. Men having anal sex with men represent between 56% and 61% of new HIV infections in the United States. The increase in the number of new HIV infections was 38% between 2006 and 2009 for men who had sex with men in the 13 to 29-year-old age group, mainly due to a 48% increase among young black men who had sex with men in that age group. Condoms, when used correctly, are more than 90% effective in preventing HIV infection.

The manufacturer of Truvada, Gilead Science, had provided data from trials that found that men who had sex with men who took Truvada daily had a 44% reduction in the incidence of HIV over 1.2 years of follow-up when compared with placebo. However, almost 50% of the study participants had no detectable level of Truvada when tested, which may mean that they were not taking Truvada regularly.

The Committee expressed the following concerns regarding Truvada use in prevention of new HIV infections: that healthy people who take Truvada for prevention of HIV will suffer harm if they do become infected with HIV but do not change from the single-dose regimen for prevention to a three-drug combination of antiretroviral medications for treatment; that people who continue to use the single-dose regimen after acquiring HIV will lead to the development of Truvada-resistant viral strains; and, the increased risk for adverse effects such as kidney damage resulting from the Truvada regimen.

In light of its concerns, the Committee made recommendations regarding Gilead Science’s proposed risk evaluation and mitigation strategy (REMS) that usually only occur when the FDA has concerns regarding a drug’s toxicity. The proposed REMS includes mailings to approximately 200,000 health care providers; a medication guide for uninfected people; voluntary training for primary care prescribers, infectious disease specialists, emergency medicine physicians, obstetricians and gynecologists, and addiction specialists regarding the importance of strictly adhering to the daily dosing regimen and regular HIV testing; safety brochures for both prescribers and individuals; and, a wallet card for individuals taking Truvada for HIV prevention. However, the REMS does not require participation in the educational program by the prescriber or patient before taking Truvada and it does not require a negative HIV test before a patient receives a 30-day supply of Truvada.

The cost of the daily Truvada regimen would be $13,000 per year.


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This entry was posted on Sunday, May 13th, 2012 at 12:48 pm. Both comments and pings are currently closed.


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