Profile Of Viiv’s Unboosted Dolutegravir Emerges With First Phase III Results

03 Apr 2012

• By Emily Hayes

Viiv Healthcare/Shionogi’s once-daily, unboosted integrase inhibitor dolutegravir is efficacious and well-tolerated in the first of four Phase III HIV trials to report, a study of treatment-naïve patients. Drug poses a competitive threat to Merck’s blockbuster Isentress and Gilead’s elvitegravir, part of the four-in-one “Quad” pill.

ViiV Healthcare/Shionogi Inc.’s eagerly awaited once-daily dolutegravir was efficacious and well-tolerated in the large Phase III SPRING-2 non-inferiority trial in treatment-naïve HIV patients – the first of four late-stage studies to report – setting the stage for a commercial battle against rival integrase inhibitors down the line.

In the randomized study of 822 patients taking two non-nucleoside reverse transcriptase inhibitors (NNRTIs), the drug was as efficacious as...