Once-a-Day HIV Quad Drug Stribild Gets FDA Approval
Add one more medication to the HIV treatment arsenal: The quad-drug Stribild, geared specifically for people who haven’t yet been treated for the infection, just got the OK from the Food and Drug Administration.
Stribild, from California-based Gilead Sciences, combines four drugs into a once-a-day pill: elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The first two drugs are new, according to an FDA release. Elvitegravir is an integrase inhibitor and stops the HIV virus from replicating by preventing HIV DNA from going into healthy cells. Cobicistat enhances the effects of elvitegravir.
Emtricitabine and tenofovir disoproxil fumarate also stop viral replication and are better known as Truvada. Truvada, which has been used to treat HIV, was also approved in July by the FDA as a preventive treatment for high-risk people.
Stribild drug is seen as a welcome alternative to “cocktail” drugs, or multiple drug regimens.
“Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” Dr. Edward Cox said in a news release. Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, added, “New combination HIV drugs like Stribild help simplify treatment regimens.”
Last month the FDA also approved an over-the-counter at-home test for HIV that has a 92 percent to 99 percent accuracy rate and is geared to people who want privacy and quick results.
In two double-blind trials on Stribild, between 88 percent and 90 percent of patients had an unnoticeable amount of HIV in their blood after about a year. The results were slightly better than other existing HIV medications.
But Stribild does not come without warnings and side effects. A boxed warning advises patients that the drug carries the risk of severe liver problems as well as a build-up of lactic acid in the blood.
Side effects noticed in clinical trials included nausea and diarrhea, plus lower bone mineral density, kidney problems and changes in the immune system.
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