ViiV Healthcare has announced that dolutegravir plus lamivudine demonstrated long-term viral suppression in Phase III GEMINI 1 and 2 trials involving treatment-naïve adults with human immunodeficiency virus-1 (HIV-1).
Named as Dovato, the two-drug regimen (2DR) is a combination of integrase strand transfer inhibitor (INI) dolutegravir 50mg and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine 300mg.
GEMINI 1 and 2 are duplicate, randomised, double-blind, multi-centre, parallel group and non-inferiority trials.
The studies evaluated the safety, tolerability and non-inferior efficacy of Dovato compared to a three-drug regimen in HIV-1 infected adults with viral loads between 1,000 and 500,000c/mL at baseline.
The three-drug regimen is a combination of dolutegravir plus two NRTIs, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
The primary endpoint of the studies was the proportion of participants with HIV-1 RNA plasma less than 50c/mL at week 48.
Secondary endpoints included the proportion of patients with HIV-1 RNA plasma less than 50c/mL at weeks 24, 96 and 144.
The combined three-year data from the trials showed that the 2DR demonstrated non-inferiority for viral suppression, with 82% of patients at week 144 having HIV-1 RNA copies less than 50c/mL versus 84% on the three-drug regimen.
In addition, Dovato continued to show a high genetic barrier to resistance emerging from the treatment.
Safety and tolerability profiles were consistent with previous studies, with Dovato demonstrating lesser drug-related adverse events.
ViiV Healthcare Research & Development head Kimberly Smith said: “The momentum behind 2DRs is growing: Dovato has now shown sustained efficacy and tolerability through three years of treatment, with people able to maintain viral suppression with fewer medicines than a three-drug regimen.”
The results of the three-year study were presented at the HIV Glasgow 2020 congress.