Gilead HIV clinical trials
Gilead Sciences Inc.'s Truvada was approved in 2012 as a way to prevent the spread of the AIDS virus.
People at high risk of contracting HIV should pop Gilead Sciences Inc.'s Truvada pill once a day to decrease their chances of contracting the AIDS virus, the Centers for Disease Control and Prevention said Wednesday.
Recommendations from the CDC, which in August 2012 recommended PrEP as a way to prevent the spread of the virus among heterosexuals, are used by doctors as they treat patients.
Truvada, a combination of the drugs emtricitabine and tenofovir that blocks pathways HIV taps to set up an infection, costs about $14, 000 a year and had sales of more than $3 billion last year. It was initially approved in 2004 as a treatment for people already infected with HIV.
The CDC said Wednesday that people with HIV-infected partners, those who sometimes have sex without using a condo and those who use illicit injectable drugs or share equipment should take Truvada each day to reduce their chances of contracting the virus. It also recommended use if unsure if a sexual partner has an HIV infection but that the partner is at risk.
"PrEP is not for everyone, " the CDC said in its guidelines.
Studies have shown that Truvada as a preventative can cut infection by more than 90 percent, if the drug is taken consistently. The CDC said PrEP's efficacy was in addition to repeated condom use, sexual risk-reduction counseling and the diagnosis and treatment of sexually transmitted infection.
About 50, 000 people a year or diagnosed with HIV.
The use of Truvada as a way to prevent HIV is somewhat controversial. The AIDS Healthcare Foundation, which operates a pharmacy as well as the Out of the Closet second-hand clothing shops, has long opposed pill popping instead of condom use as a way to prevent new infections. What's more, the Los Angeles-based nonprofit said people are unlikely to continue regular, daily use of Truvada.
"This is a position I fear the CDC will come to regret, " AHF President Michael Weinstein said in a press release. "By recommending widespread use of PrEP for HIV prevention despite research studies amply chronicling the inability to take it as directed, and showing a limited preventive effect at best, the CDC has abandoned a science-driven, public health approach to disease prevention — a move that will likely have catastrophic consequences in the right against AIDS in this country."
No health risks were found in HIV-uninfected clinical trial participants when followed up one to four years later, according to the CDC, but the long-term safety of PrEP use hasn't been determined.
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BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.