You are here

First Once-Daily, Single-Tablet Treatment for HIV-1

Dovato Achieved Non-inferior Efficacy Compared to Traditional Regimen; No Cases of Resistance

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

Recent Headlines

Statistically Significant Improvement in Excessive Daytime Sleepiness
Researcher Made Himself Guinea Pig to Test the Drug
Treatment Shorter, Less Complicated Than Typical Regimen
Zip Device Faster to Apply, Minimizes Scarring
Finding Could Spur New Targeted Treatments
But a ‘Serendipitous’ Finding Could Provide a Solution
New Drug Could Make Ears “Young” Again
DNA Changes May Help Predict Women at Risk