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Gilead Four-In-One HIV Drug Wins FDA Approval

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According to California-based Gilead Sciences, the U.S. Food and Drug Administration (FDA) has approved Genvoya, the biotechnology company's combination tablet for HIV in patients 12 years old and older.

The fixed-dose cocktail contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide and targets previously untreated HIV patients weighing at least 77 pounds, and adults whose HIV-1 infection is suppressed at present because of antiretroviral therapy.

According to a statement, the FDA said that Genvoya is not recommended for patients with severe kidney disease, but can be taken by those with moderate kidney problems.

The drug also carries a boxed warning alerting doctors and patients that it can cause lactic acid buildup in the blood and severe liver issues – both potentially fatal. The label adds that Genvoya is not approved for treating chronic hepatitis-B virus infection.

The FDA approval was based on four clinical trials that evaluated 3,171 patients, with Genvoya showing it can reduce viral loads comparable to other treatment options.

The HIV drug contains a type of tenofovir that has not been approved previously – a new form said to provide lower levels of the medication in the bloodstream but higher amounts within cells where the virus replicates.

"Today's approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection," said Dr. Edward Cox, director of the Office of Antimicrobial Products at the FDA Center for Drug Evaluation and Research.

According to estimates from the U.S. Centers for Disease Control and Prevention, 1.2 million individuals ages 14 and above have the HIV infection, with another 150,000 or so unaware they are living with the infection.

The daily combination pills are estimated to help patients stick to their HIV treatment, as early regimens required taking a dozen or more pills on a precise everyday schedule.

Gilead announced the annual list price for Genvoya to be $31,362. The cost is about the same as the one for its earlier developed four-in-one HIV treatment, Stribild, which according to a regulatory filing earned about $803 million in the first half of 2015.

Photo: Joe Rawlinson | Flickr

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