Dolutegravir/lamivudine, sold under the brand name Dovato, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. It contains dolutegravir, as the salt, an integrase strand transfer inhibitor (INSTI), and lamivudine, a nucleoside analogue reverse transcriptase inhibitor (NRTI).^[4][5] It is taken by mouth.^[4][5]

It was approved for use in the United States in April 2019,^[4][6][7] and in the European Union in July 2019,^[5] and again with revisions in June 2022.^[5][8]

The most common side effects are headache, diarrhea, nausea, and difficulty sleeping.^[5] The most common serious side effects are allergic reactions, including rash and severe liver problems.^[5]

Dolutegravir/lamivudine is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.^[7]

Medical uses

In the EU, dolutegravir/lamivudine is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kilograms (88 lb), with no known or suspected resistance to the integrase inhibitor class, or lamivudine.^[5]

In the US, it is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.^[4][7]

History

The efficacy and safety of dolutegravir/lamivudine were demonstrated in two identical, randomized, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no prior antiretroviral treatment history.^[7] The 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.^[7] The treatment was considered successful if the participant maintained low-levels (less than 50 copies/mL) of HIV RNA in their blood for at least 48 weeks.^[7][5] In these studies, 91% of subjects with HIV-1 who took the dolutegravir/lamivudine combination no longer had detectable levels of HIV (i.e. they had fewer than 50 copies per ml) after 48 weeks compared with 93% of those who were taking the triple combination. In neither study was there a case of resistance to treatment after 48 weeks.^[5]