ViiV’s two-drug regimen proves non-inferior in treatment-naive HIV-1
pharmafile | October 5, 2020 | News story | Research and Development, Sales and Marketing | HIV-1, ViiV Healthcare, pharma
ViiV Healthcare has taken the opportunity at the HIV Glasgow 2020 Virtual Congress to unveil three-year Phase 3 data from two studies examining the efficacy of dolutegravir in combination with lamivudine for the treatment of HIV-1 in adult patients who have not received prior therapy.
The company said that it’s two-drug combo had proved non-inferior to the three-drug regimen of dolutegravir in combination with two nucleoside reverse transcriptase inhibitors (NRTIs): tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
It was found that 82% of the 716 trialed participants receiving the two-drug regimen showed less than 50 copies of HIV-1 RNA per millilitre after 144 weeks, compared to 84% of those receiving dolutegravir/TDF/FTC.
ViiV’s combo therapy “continued to demonstrate a high genetic barrier to treatment-emergent resistance”, with 1.7% of recipients displaying protocol-defined confirmed virologic withdrawal (CVW) compared to 1.3% of those receiving dolutegravir/TDF/FTC. None of these patients developed treatment-emergent resistance mutations.
“These long-term data confirm that dolutegravir-based two-drug regimens have a rightful place in the HIV treatment compendium,” explained Dr Pedro Cahn, principle investigator on the study programme, Scientific Director of Fundación Huésped and Professor of Infectious Diseases at Buenos Aires University Medical School. “Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression. 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-naïve adults with HIV now have evidence to show that it does.”
Matt Fellows
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