Two-drug dolutegravir regimen remains noninferior to three-drug regimen after 3 years
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A two-drug regimen of dolutegravir plus lamivudine remained noninferior to a three-drug regimen in treatment-naive adults with HIV, according to results from the GEMINI 1 and 2 studies.
“These long-term data confirm that dolutegravir-based two-drug regimens have a rightful place in the HIV treatment compendium,” Pedro Cahn, MD, scientific director for the Guest Foundation in Buenos Aires, professor of infectious diseases at Buenos Aires University Medical School and principal investigator for the GEMINI study program, said in a press release.
“Dolutegravir plus lamivudine continues to demonstrate long-term noninferior efficacy compared” with the three-drug regimen of dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) “with benefits beyond viral suppression,” Cahn said. “While overall adverse event rates were similar across the study arms, we saw fewer drug-related adverse events with dolutegravir plus lamivudine. Clinicians who wanted proof that a dolutegravir-based two-drug regimen works long term in treatment-naive adults with HIV now have evidence to show that it does.”
The regimen was approved by the FDA in 2019 for ART-naive patients. A two-drug regimen is also available for virally suppressed patients on ART.
According to the newly released study results, which also were presented at HIV Glasgow, 84% (599 of 717) of patients on the three-drug regimen of dolutegravir plus TDF/FTC and 82% (584 of 716) patients who took the two-drug regimen of dolutegravir and lamivudine had HIV-1 RNA levels of less than 50 copies/mL at week 144.
The percentage of patients with virologic withdrawal was 1.7% (12 of 716) in the two-drug regimen group and 1.3% (nine of 717) in the three-drug regimen group, suggesting dolutegravir plus lamivudine demonstrates a large genetic barrier to treatment-emergent resistance, ViiV Healthcare said.
“Globally, the number of people living with HIV aged 50 and over is increasing, and that’s testament to the success of antiretroviral therapy, which has transformed HIV into a chronic condition,” Kimberly Smith, MD, MPH, head of research and development for ViiV, said in the release. “However, living longer with HIV can mean taking multiple medications for many years, and we know that many people living with HIV have a preference to take as few medicines as possible, as long as their HIV remains under control.”
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Cahn P, et al. Abstract P018. Presented at: HIV Glasgow; Oct. 5-8, 2020; virtual.
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