FDA Approves First 2-Drug Regimen for HIV-1

The US Food and Drug Administration has approved Dovato (dolutegravir and lamivudine), the first 2-drug complete regimen for adults with HIV-1 who have no history of antiretroviral treatment and have no known or suspected substitutions associated with resistance to individual components of Dovato.

Dovato is a once-daily oral tablet that was approved after 2 randomized clinical trials found that dolutegravir + lamivudine reduced the levels of HIV RNA similarly to dolutegravir + emtricitabine + tenofovir after 48 weeks.

The most commonly reported adverse reactions included headache, diarrhea, nausea, insomnia, and fatigue.

“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 Debra Birnkrant, MD, director of the Division of Antiviral Products. “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.”


—Amanda Balbi


FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment [press release]. Silver Spring, MD: US Food and Drug Administration; April 8, 2019. Accessed April 9, 2019.