First FDA approved dual-agent combination therapy for the initial treatment of HIV patients

29 Jul 2019

US FDA have announced that it has approved the listing of the antiviral therapy Dovato (dolutegravir and lamivudine) developed by ViiV Healthcare as a complete treatment Program for HIV-infected patients who have never received antiviral therapy.

Dovato is a compound tablet developed by ViiV Healthcare consisting of a fixed dose of dolutegravir and lamivudine. Dolutegravir (DTG) is a new generation of HIV integrase inhibitors. It has the advantage of not only excellent antiviral efficacy, but also good safety and tolerability, and the chance of interaction with other drugs is small. Lamivudine is a nucleoside reverse transcriptase inhibitor.

First FDA approved dual-agent combination therapy for the initial treatment of HIV patients

The efficacy and safety of Dovato in a total of 1433 HIV-infected patients randomized double-blind,

Validating in clinical trials containing active controls. The results of the trial showed that the combination therapy consisting of two drugs, DTG and lamivudine, had a similar effect in reducing the number of HIV viruses in the blood compared with the combination therapy consisting of DTG, emtricitabine, and tenofovir.

Currently, the standard therapy for patients who have never received treatment is a 3-drug combination therapy. This approval gives these patients the option of using a combination tablet of two drugs. It can help eliminate the side effects and potential drug interactions associated with the third drug," said Dr. Debra Birnkrant, Director of the FDA Antiviral Products Division. "The ability to reduce the use of one drug can benefit some patients who have concerns about long-term use of multiple drugs. “