FDA Approves Gilead’s New HIV Drug, Could Prevent Serious Side Effects

The U.S. Food and Drug Administration announced their approval of Gilead’s new HIV medication, Genvoya, which is the first complete regime that uses a new form of tenofovir (tenofovir alafenamide) to receive FDA approval. Genoya was developed particularly for people with HIV who have experienced side effects like bone loss and kidney problems on other HIV meds, or poz people who had those issues prior to starting HIV treatment

A fixed-dose combination tablet, Genvoya also contains some previously approved HIV medications (elvitegravir, cobicistat, emtricitabine). The new form of tenofovir in Genvoya works in such a way that it results in lower levels of the drug in a patient’s bloodstream, but higher levels within the cells (where HIV-1 replicates).

Genvoya’s safety and effectiveness were evaluated in 3,171 participants enrolled in four clinical trials. Participants were randomly assigned to receive Genvoya or another FDA-approved HIV treatment. Results showed Genvoya was comparable to the other treatment regimens in reducing viral loads but was also associated with less kidney toxicity and fewer decreases in bone density.

Genvoya carries a warning that the drug can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal. Genvoya is not approved to treat chronic hepatitis B virus infection. The most common side effect associated with the drug was nausea. Serious side effects included new or worsening kidney problems, decreased bone mineral density, fat redistribution, and immune reconstitution syndrome, a disorder in which a rare number of people who start antiretroviral therapy get other health problems even though their HIV is under control. Health care providers are advised to especially monitor patients for kidney and bone side effects.

Patients receiving Genvoya had a greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies. Those with moderate renal impairment can take Genvoya but the drug is not recommended for patients with severe renal impairment.