ViiV reports HIV data for dolutegravir vs. darunavir

ViiV Healthcare Ltd. said once-daily Tivicay dolutegravir met the primary endpoint of non-interiority to Prezista darunavir from Johnson & Johnson (NYSE:JNJ) boosted with ritonavir in the Phase IIIb/IV FLAMINGO (ING114915) trial to treat HIV-1 infection in treatment-naïve patients. Tivicay was non-inferior to darunavir in the proportion of patients with HIV-1 RNA levels below 50 copies/mL at week 48 (90% vs. 83%). A subsequent pre-specified analysis showed Tivicay was also superior to the darunavir regimen (p=0.025). The open-label, international trial enrolled 484 treatment-naïve adults with HIV-1 infection. All patients also received investigator-selected dual nucleoside analog reverse transcriptase inhibitors (NRTIs). Data were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Denver.

Last month, FDA approved an NDA for Tivicay to treat HIV infection in combination with other antiretroviral agents in treatment-naïve and treatment-experienced patients ages 12 years and older. The HIV integrase inhibitor was the first product from ViiV's pipeline to be approved. ViiV is a JV between GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Pfizer Inc. (NYSE:PFE). ...