ViiV Healthcare announced 24-week data from the VIKING-3 Phase 3 study evaluating the investigational integrase inhibitor dolutegravir in HIV-1 infected adults with multiple class antiretroviral resistance. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of T-cells.
VIKING-3 (ING112574) was a Phase 3, multicenter, open-label, single arm study designed to assess the antiviral activity and safety of a dolutegravir-containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with historical or current evidence of resistance to integrase inhibitors (raltegravir [Isentress; Merck] and/or elvitegravir). Patients enrolled were required to have documented genotypic and/or phenotypic resistance to at least one drug in two or more of the other approved classes of ART but also be able to include at least one fully active drug in the optimized background regimen to be started Day 8.
In the study, mean HIV RNA levels declined by 1.4 log10 copies/mL after 7 days of dolutegravir 50mg twice-daily treatment was added to the current failing regimen [95% CI for the difference (1.3, 1.5; P<0.001)]. The proportion of study participants who were subsequently virologically suppressed (HIV-1 RNA <50 copies/mL) with optimized background regimen was 63% at Week 24.
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