WHITEHOUSE STATION (dpa-AFX) - Merck & Co. (MRK) announced Friday efficacy and safety data in previously untreated adults with HIV-1 infection for the company's investigational once-daily formulation of ISENTRESS (raltegravir), known as raltegravir 600 mg, from the ongoing Phase 3 pivotal trial called ONCEMRK.
The study found that after 48 weeks of treatment, 1200 mg raltegravir was statistically non-inferior to the marketed formulation approved dose of ISENTRESS 400 mg twice-daily, each in combination therapy with TRUVADA (emtricitabine/tenofovir disoproxil fumarate); with a treatment difference of 0.5, as assessed by the proportion of patients achieving less than 40 copies/mL of HIV RNA.
Based on these results from Week 48 of the ONCEMRK study, the European Medicines Agency has accepted the file for the investigational once-daily formulation of ISENTRESS for review. Merck plans to submit applications for licensure in several countries, including the United States later this year.
ISENTRESS is indicated twice-daily in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 4 weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
The study showed comparable rates of reported drug-related clinical adverse events and rates of discontinuation between the two treatment groups.
The data evaluating efficacy and safety at 48 weeks of therapy were presented at the 21st International AIDS Conference being held in Durban, South Africa, from July 18-22.
The company noted that ISENTRESS (raltegravir) does not cure HIV-1 infection or AIDS.
The newly formulated 600 mg tablet for once-daily use, used in the ONCEMRK study, is not currently approved for use and this formulation is not interchangeable with the currently marketed 400 mg tablet.
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