ViiV Healthcare’s two-drug, single-tablet antiretroviral (ARV) regimen Dovato (dolutegravir/lamivudine) proved as effective at suppressing HIV after three years as Tivicay (dolutegravir) plus Truvada (tenofovir disoproxil fumarate/emtricitabine) among people treated for the first time in a major clinical trial.
Findings from the randomized, double-blind, multicenter parallel group Phase III GEMINI 1 and GEMINI 2 noninferiority trials were presented at the virtual Glasgow HIV Drug Therapy conference earlier this month.
The studies, which had the same design, included first-timers to HIV treatment who had viral loads between 1,000 and 500,000. The participants were randomized to receive Dovato or Tivicay plus Truvada.
A pooled analysis of the studies found a comparable rate of viral suppression after three years: 82% (584 of 716) of those in the Dovato arm had a viral load below 50 at that point, compared with 84% (599 of 717) of those in the Tivicay plus Truvada arm.
The safety and tolerability data at the three-year mark were consistent with previous reports.
Dovato boasted a high genetic barrier to the development of viral resistance to ARVs. A total of 1.7% (12 of 716) of those who received Dovato and 1.3% (9 of 717) of those who received Tivicay plus Truvada withdrew from the study due to virologic failure. None of these individuals developed viral mutations associated with resistance to ARVs during the study.
One participant who did not have virologic failure and who received Dovato reported not adhering to the daily regimen and developed the viral resistance mutations known as M184V and R263R/K before dropping out of the study.
The rate of adverse health events was similar between the study arms. However, those in the Dovato arm had a lower rate of drug-related adverse events, at 20% (146 of 716), compared with those in the Tivicay plus Truvada arm, at 27% (192 of 717).
Data suggested that Dovato was less toxic to the kidney and bones than Tivicay plus Truvada.
To read a press release about the study, click here.