Gilead seeks sNDA for Truvada as HIV prevention

Gilead Sciences is stepping into some controversial waters involving the treatment of HIV.

The Foster City, CA, drug company ($GILD) wants adults without HIV to be able to use its antiretroviral drug Truvada before sex to reduce the risk of contracting the virus. Gilead has submitted a supplemental new drug application to the FDA to expand the once-daily blockbuster drug's indication so it can be used as a "pre-exposure prophylaxis" to reduce the risk of HIV-1 infection in uninfected adults.

If regulators sign off on the application, Truvada would be the first antiretroviral treatment approved to reduce the risk of HIV infection in adults. FDA approved Truvada to treat HIV-1 infection in 2004, reports

Gilead's data are promising. Two large Phase III trials helped support the submission, involving thousands of heterosexual couples in Africa, and thousands of HIV-negative men who have sex with men in the U.S., Africa, Asia and South America. In one, which tested about 2,500 high-risk HIV negative adult men, the drug helped reduce the risk of acquiring HIV overall 44%, and as much as 73% in men who took the drug at least 90% of the time, according to the company. The other trial involved 4,758 heterosexual couples in Kenya and Uganda in which one partner was HIV positive, and results were even more promising. The HIV-negative partners used the drug once per day and reduced the risk of HIV infection 73% versus placebo.

No doubt, the drug is a blockbuster. It generated $744.7 million in sales during Gilead's third quarter alone, RTTNews notes in coverage of the Gilead announcement.

But there are plenty of risks in taking the drug. Patients experienced nausea, weight loss and serum creatinine elevations when taking Truvada. Gilead says, however that these reactions are consistent with its safety and tolerability profile for HIV patients who take the drug. The national Centers for Disease Control and Prevention issued interim guidance in January on using Truvada as a drug to help prevent HIV transmissions in men who have sex with men.

Still, will the drug get a fair shake based on the science alone? Or will Congress step in, fearing that an expanded approval amounts to the government promoting risky sexual behavior?

- here's the story
- here's the release

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