ViiV’s Dolutegravir Dual Therapy Works for Both First-Line & Maintenance Treatment



Findings from the GEMINI and TANGO studies, reported at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City, indicate that a two-drug combination (dolutegravir and lamivudine; brand name: Dovato) is just as effective at treating patients starting HIV treatment for the first time, achieving an undetectable viral load after ninety-six weeks, as a standard three-drug combination. The two-drug combination also was effective in maintaining viral suppression in those patients who switched to the two-drug regimen from a different one.

This is significant because lowering the number of medications people have to take can reduce both side-effects and cost. But two-drug antiretroviral therapy requires medications that are strong enough to keep viral load fully suppressed and prevent the development of drug resistance. ViiV Healthcare’s dolutegravir is a potent integrase inhibitor with a high barrier to resistance. Lamivudine is a well-tolerated and inexpensive nucleoside reverse transcriptase inhibitor (NRTI) widely available in generic versions. In April, the co-formulation was approved as Dovato in the U.S. and received a positive opinion from the European Medicines Agency.

Ongoing GEMINI 1 and 2 studies, Phase III clinical trials, enrolled 1433 people in Europe, the Americas, Asia, Australia, Russia and South Africa who were starting HIV treatment for the first time. Participants were randomly assigned to receive either dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate (TDF) and emtricitabine, the drugs found in Truvada. Dr. Pedro Cahn of Fundación Huésped in Buenos Aires presented ninety-six-week results, showing that 86.0% in the dolutegravir/lamivudine group and 89.5% in the dolutegravir/TDF/emtricitabine group had an undetectable viral load, indicating that the two-drug regimen was equally effective as the three-drug regimen.

Results from the TANGO study were also presented at IAS 2019. This ongoing Phase III trial compares the safety and efficacy of switching to the dolutegravir/lamivudine fixed-dose co-formulation versus staying on a three- or four-drug regimen containing tenofovir alafenamide fumarate (TAF), the newer version of tenofovir. TANGO enrolled 741 participants in Europe, North America, Australia, and Japan. Participants were randomly assigned either to the group to switch to dolutegravir/lamivudine or to the group to stay on their current TAF-containing regimen. At forty-eight weeks, 93.2% of people who switched to dolutegravir/lamivudine and 93.0% of those who stayed on their TAF regimen maintained viral suppression, meeting the criteria for non-inferiority.
—Reporting by Hank Trout
