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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataSecondary 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.
