Gilead seeks approval of Truvada for HIV prevention

Gilead Sciences Inc. is seeking regulatory approval of its once-daily Truvada tablet as a way to prevent HIV.
The Foster City-based company (NASDAQ: GILD) said it submitted a supplemental application to the Food and Drug Administration. If successful, Gilead would be the first company to win FDA approval for a drug intended to prevent uninfected adults from getting infected with the AIDS virus, an approach known as pre-exposure prophylaxis, or PrEP.
But the move is controversial — even with some advocacy groups for AIDS patients — because opponents have said some gay men might engage in unprotected sex if they believe Truvada by itself protects them from getting the virus. Others have said that Truvada hasn’t proved that it can prevent transmission of HIV.

Big NIH grant awards show Bay Area still at center of HIV fight

The Bay Area continues to innovate at the center of the fight against HIV, winning a couple of major National Institutes of Health grants aimed at HIV reservoirs.
Dr. Steven Deeks and Dr. Mike McCune of the University of California, San Francisco , will work with Rafick-Pierre Sekaly of the Vaccine & Gene Therapy Institute of Florida to define the nature and location of reservoirs — cells where HIV may be undetectable for years — and how those reservoirs are created and maintained. What's more, researchers will develop and test targeted treatments that eliminate HIV reservoirs without broadly activating the immune system, which could activate the virus.
Sangamo BioSciences Inc. (NASDAQ: SGMO) of Richmond will work with the Fred Hutchinson Cancer Research Center in Seattle as part of a $20 million project to develop proteins that directly attack HIV reservoirs. Researchers also will study whether a patient’s immune cells can be made resistant to the virus.

Gilead, Tibotec to work on new HIV-fighting combos

Gilead Sciences Inc. will combine its experimental booster with a protease inhibitor from Tibotec Pharmaceuticals in a new HIV-fighting drug.
What’s more, Foster City-based Gilead (NASDAQ: GILD) and Johnson & Johnson unit Tibotec said they are negotiating terms for developing and commercializing another tablet that combines the same Tibotec protease inhibitor, Prezista, with the already-approved Gilead HIV drug Emtriva, the new booster, called cobicistat, and a Gilead investigational drug, known as GS-7340.

Gilead's Truvada fails HIV prevention trial in African women

A study testing Gilead Sciences Inc.’s Truvada as a way to prevent the AIDS virus in African women failed, according to a nonprofit group sponsoring the trial.
The 1,951-woman study, undertaken by FHI and enrolling patients in Kenya, South Africa and Tanzania, was designed to study whether HIV-negative women at a higher risk of being exposed to the virus could safely use a daily dose of Truvada to prevent infection. But half of the 56 new HIV infections occurred in women using Truvada, according to FHI.

Gladstone-led HIV prevention study tops Time list