FDA Approves HIV Combo Tablet

The US Food and Drug Administration (FDA) approved a fixed dose combination tablet (Genova/Gilead) for HIV-1 infection. It contains elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide and is approved for adults and children 12 and older.

The tablet is meant to be a complete treatment regimen that can be taken once a day. It is for patients who have never had HIV therapy and for those whose HIV-1 virus is currently suppressed.

The tablet is not recommended for patients with severe renal impairment, but is safe for patients with moderate renal impairment. The drug carries a boxed warning that it can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal. It is not approved for patients with chronic hepatitis B infection.

The drug has been shown to be effective in reducing viral loads and to be comparable to other approved treatment regimens.

The tablet contains a new form of tenofovir that provides lower levels of the drug in the bloodstream, but higher levels with the cells where HIV-1 replicates, the FDA said.

It appears to be safer for the kidneys and to cause less bone loss than other versions of tenofovir. Patients who took the drug in clinical trials also showed greater increases in serum lipds than patients receiving other treatment regimens.

The drug should not be given with other antiretrovirals and may have drug interactions with other commonly used medications.