Once-Daily Formulation of HIV Drug Passes Hurdle

A treatment for HIV met its primary efficacy endpoint during a recent trial for the investigational formulation of the once-daily drug for untreated patients with HIV-1.

The pivotal phase 3 ONCEMRK trial for Merck’s raltegravir (Isentress) administered 1200 mg of Isentress as 2 x 600 mg. This formulation was statistically non-inferior to the approved dose of Isentress (400 mg twice-daily) in combination with Truvada by the proportion of patients achieving HIV-1 RNA <40 copies/mL at Week 48.

Researchers found that the tolerability and immunologic efficacy were comparable in the secondary endpoints. These secondary endpoints included change from baseline in CD4 cell counts and tolerability at Week 48.

The ongoing multicenter, double-blind, randomized, active comparator-controlled clinical compared the 2 formulations of Isentress in combination with Truvada in previously untreated HIV-1 infected adult patients. The new 600 mg tablet has not yet been approved for use and is not interchangeable with the currently marketed 400 mg tablet.

The planned total treatment duration for the trial is 96 weeks.

“Merck has never wavered in our commitment to develop meaningful therapeutic options for people with HIV-1 infection,” said Vice President of clinical development at Merck Research Laboratories Eliav Barr. "We are pleased that this study has met its primary endpoint and look forward to presenting the data at a future congress.”