FDA Approves First Single-Tablet, Two-Drug Treatment for Untreated HIV

The first single-tablet, two-drug regimen for treatment of adults with the HIV virus who have never taken antiretroviral drugs has been approved by the U.S. Food and Drug Administration.

"Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug," said Dr. Debra Birnkrant, director of the FDA's Division of Antiviral Products.

The approval of Dovato (dolutegravir and lamivudine) is based on two clinical trials of more than 1,400 HIV-infected adults with no prior antiretroviral treatment.

The trials found that a regimen of dolutegravir and lamivudine was similarly effective in reducing the amount of HIV in the blood as treatment with dolutegravir, emtricitabine and tenofovir, according to the FDA.

"Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time," Birnkrant said in an FDA news release.

The Dovato labeling includes a boxed warning that patients infected with both HIV and hepatitis B should add treatment for their hepatitis B or consider a different drug regimen, due to the risk of liver damage.

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