FDA Approves Gilead's HIV Drug Genvoya

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By Bronwyn Mixter

Nov. 5 — The FDA Nov. 5 approved Genvoya as a complete regimen for treating HIV-1 infection in adults and pediatric patients who are at least 12 years old.

Genvoya is a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

The product, which is marketed by Gilead Sciences Inc., is approved for HIV-infected adults and children who are at least 12 years old and weigh at least 77 pounds (35 kilograms) and who have never taken HIV therapy, and HIV-infected adults whose HIV-1 virus is currently suppressed, the Food and Drug Administration said. While Genvoya isn't recommended for patients with severe renal impairment, those with moderate renal impairment may take it.

The FDA said the product contains a new form of tenofovir that hasn't been approved before. This new form provides lower levels of drug in the bloodstream, but higher levels within the cells where HIV-1 replicates, the agency said.

The product was developed to help reduce some drug side effects, the agency said. Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved regimens including tenofovir, based on laboratory measures.

“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 Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Clinical Trials 

Genvoya’s safety and effectiveness in adults were evaluated in 3,171 participants enrolled in four clinical trials, the FDA said. Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA-approved HIV treatment.

Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens, the agency said.

Boxed Warning 

Patients receiving Genvoya experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the clinical studies, the FDA said.

Genvoya carries a boxed warning alerting patients and health-care providers that the drug can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal, the agency said. The boxed warning also says that Genvoya isn't approved to treat chronic hepatitis B virus infection.

The most common side effect is nausea, the FDA said. Serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system (immune reconstitution syndrome).

Health-care providers are advised to monitor patients for kidney and bone side effects, the agency said. Genvoya shouldn't be given with other antiretroviral products and may have drug interactions with a number of commonly used medications.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com