The FDA has approved ViiV Healthcare’s Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection in adults without prior antiretroviral (ARV) treatment and no known resistance to DTG or 3TC.
Dolutegravir/lamivudine’s approval heralds a pivotal moment in HIV-1 treatment. People living with the HIV-1 virus who are treatment-naïve now have a powerful option that will enable them to take fewer ARVs and achieve and maintain suppression.
The approval is based on results of the phase 3, randomized, double-blind, multicenter, parallel group, non-inferiority GEMINI 1 (204861) and GEMINI 2 (205543) studies involving more than 1,400 adults with HIV-1. At Week 48, DTG + 3TC demonstrated non-inferiority when compared to a three-drug regimen of DTG and two nucleoside reverse transcriptase inhibitors in treatment-naïve, HIV-1 infected adults.
Dolutegravir/lamivudine is a once-daily, single-tablet, two-drug regimen combining the integrase strand transfer inhibitor dolutegravir (Tivicay, 50 mg) with the nucleoside analogue reverse transcriptase inhibitor lamivudine (Epivir, 300 mg).
All patients with HIV-1 should be tested for hepatitis B virus (HBV) prior to or when initiating dolutegravir/lamivudine. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing ARV regimens has been reported. Dolutegravir/lamivudine is not recommended in patients with creatinine clearance <50 mL/min, or in patients with severe hepatic impairment.
The most common adverse reactions observed in study participants receiving dolutegravir/lamivudine were headache, diarrhea, nausea, insomnia, and fatigue.
Source: Viiv Healthcare, April 8, 2019