Dovato, comprised of two compounds dolutegravir and lamivudine, is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.
The FDA granted approval of Dovato to ViiV Healthcare, whose parent is British drugmaker GSK.
"Currently, the standard of care for patients who have never been treated is a three-drug regimen," said Debra Birnkrant, director of the Division of Antiviral Products with FDA.
"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 Birnkrant.
Two randomized clinical trials showed that a drug regimen containing dolutegravir and lamivudine had a similar effect of reducing the amount of HIV in the blood compared to another drug regimen, which included dolutegravir, emtricitabine, and tenofovir.
The treatment was considered successful as the patient maintained low-levels of HIV RNA in their blood for at least 48 weeks.
Approximately 1.1 million people in the United States are living with HIV, according to the U.S. Centers for Disease Control and Prevention.