ViiV reports additional Phase III data for dolutegravir

ViiV Healthcare Ltd. reported that the addition of twice-daily 50 mg dolutegravir to patients' current failing integrase inhibitor-containing regimen significantly reduced mean HIV-1 RNA levels from baseline to day eight, a co-primary endpoint, by 1.4 log10 copies/mL (p<0.001) in the Phase III VIKING-3 trial to treat HIV-1 infection in treatment-experienced patients. Additionally, 63% of patients achieved HIV-1 RNA levels of less than 50 copies/mL, a co-primary endpoint, at week 24 with an optimized background antiretroviral therapy (ART) regimen substituted for the failing integrase inhibitor-regimen after day seven. Data were presented at the Drug Therapy in HIV Infection meeting in Glasgow. The open-label, international trial enrolled 183 HIV-1 infected, ART-experienced patients with current or historical failure on an integrase inhibitor-containing regimen.

Last month, ViiV acquired exclusive, worldwide rights to develop and commercialize a portfolio of HIV integrase inhibitors, including dolutegravir, from Shionogi-ViiV Healthcare LLC, a JV between ViiV and Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507) (see BioCentury Extra, Oct. 29). ...