Dolutegravir: Phase III data

The open-label, international Phase III VIKING-3 trial in 183 HIV-1 infected, antiretroviral therapy (ART)-experienced patients with current or historical failure on an integrase inhibitor-containing regimen showed that the addition of twice-daily 50 mg dolutegravir to the current failing regimen significantly reduced mean HIV-1 RNA levels from baseline to day 8, a co-primary endpoint, by 1.4 log10 copies/mL (p<0.001). Additionally, 63% of patients achieved HIV-1 RNA levels <50 copies/mL, a co-primary endpoint, at week 24 with an optimized background ART regimen substituted for the failing integrase inhibitor-regimen after day 7. Overall, 6 (3%) patients discontinued due to adverse events. The most common treatment-related adverse events were diarrhea, nausea and headache. Data were presented at the Drug Therapy in HIV Infection meeting in Glasgow. ...