According to Xinhua News Agency, the U.S. Food and Drug Administration (FDA) has recently approved a new anti-HIV drug for market launch, which can be used to treat adult HIV-infected patients who have not received antiretroviral therapy.
Dovato, a newly approved medication, is a single-tablet regimen comprising fixed-dose dolutegravir and lamivudine, administered once daily.
Dolutegravir is an HIV integrase inhibitor, and lamivudine is a nucleoside reverse transcriptase inhibitor. This medication was developed by GlaxoSmithKline PLC in the United Kingdom for the treatment of individuals with HIV who are antiretroviral-naïve and have not demonstrated resistance to these two active ingredients.
Debra Birnkrant, Director of the Division of Antiviral Products at the U.S. Food and Drug Administration (FDA), stated that the current standard therapy for HIV/AIDS involves a combination of three drugs. The approval of this new medication provides an additional option for treatment-naïve patients. This two-drug fixed-dose combination tablet eliminates the need for a third agent, thereby reducing toxicity, side effects, and potential drug interactions.
Researchers conducted a randomized, double-blind clinical trial involving a total of 1,433 individuals living with HIV. The results demonstrated that the new combination therapy was comparable in efficacy to the triple-drug regimen consisting of dolutegravir, emtricitabine, and tenofovir in reducing HIV viral load in the blood, while requiring patients to take fewer pills.
The drug label warns that HIV-infected patients co-infected with hepatitis B virus need to take additional hepatitis B treatment medications or consider other treatment options.