The percentage of subjects withdrawing from the study because of adverse events was 4% in the DTG+3TC arm and less than 1% in the TAF-based treatment arm, according to reported data.
And with regard to safety there were similar outcomes between the two arms, with regard to overall adverse events, “but as expected in a switch study, we did see more treatment-related adverse events in the dolutegravir plus lamivudine arm, and that’s because the majority of patients were on two new agents in the form of dolutegravir plus lamivudine, so it’s completely expected,” Dr. van Wyk said.
The study met its primary endpoint for noninferiority at week 48, based on the Food and Drug Administration snapshot algorithm. Results showed that switching to DTG+3TC was noninferior to continuing the TAF-containing regimen at week 48, with virologic failure per snapshot criteria seen in less than 1% of subjects in either arm, according to reported data. The proportion of subjects with plasma HIV-1 RNA less than 50 c/mL was 93.2% and 93.0% for the DTG+3TC and TAF-based treatment arms, respectively.
Longer-term follow-up will be important to confirm the noninferiority of the two-drug approach, Dr. van Wyk and Dr. Cahn said in the press conference. The TANGO study of the switch strategy will continue through 148 weeks, while an additional year of follow-up is ongoing for the GEMINI studies of the initial therapy approach.
TANGO and both GEMINI 1 and GEMINI 2 were sponsored by ViiV Healthcare. Dr. van Wyk is an employee of ViiV Healthcare. Dr. Cahn has received research support grants, and fees as consultant and speaker from ViiV Healthcare.
SOURCE: Cahn P et al. IAS 2019, Abstract WEAB0404LB; van Wyk J et al. IAS 2019, Abstract WEAB0403LB.