Genvoya approved as complete regimen for HIV treatment

The US Food and Drug Administration (FDA) approved a fixed dose combination tablet (Genova/Gilead) for HIV-1 infection.

Patients receiving Genvoya had greater increases in serum lipids than those receiving other treatment regimens. The results of the trials showed Genvoya to be effective in reducing viral loads and comparable to other treatments, the FDA said.

Tenofovir alafenamide, or TAF for short, is becoming the backbone of Gilead's new HIV treatments.

Additionally, the approval is supported by a Phase III study evaluating Genvoya among virologically suppressed patients who switched from TDF-based regimens.

It is not recommended for patients with severe renal impairment but people with moderate impairment can take the combination.

Genvoya can also cause redistribution of fat in the body and changes in the immune system, and can interact with a number of commonly used medicines.

In addition, fatal side effects including severe liver problems and a unsafe buildup of lactic acid in the blood are possible, so the drug carries a so-called black box warning, the FDA's strongest.

Gilead's U.S. Advancing Access program provides assistance to patients in the United States who are uninsured, underinsured or who need financial assistance to pay for their medications, including Genvoya.

HIV-1 is the most common and pathogenic strain of the virus.

Genvoya - developed from Stribild, an older version of the four drug cocktail - was also given positive recommendation from European health regulators in September.

The CDC estimates that 1.2 million persons ages 13 years and older are living with HIV infection, and that more than another 150,000 persons in this age range have HIV but are unaware of their infection.