Merck Presents Data On Its Investigational Once-Daily Formulation of ISENTRESS

Merck & Co., Inc.

revealed efficacy, as well as, safety data in previously untreated adults with HIV-1 infection for its investigational once-daily formulation of ISENTRESS from the ongoing final stage pivotal study known as ONCEMRK. It is also called as raltegravir 600 mg (to be given as 2 x 600 mg). Merck said that the data assessing efficacy and safety at the end of 48 weeks of therapy were presented as a late-breaking abstract at the 21st International AIDS Conference (AIDS 2016) being held in South Africa between July 18 and 22. The drug maker said that at the end of 48 weeks of treatment, the trial found that 1200 mg raltegravir (given as 2 x 600 mg once-daily) was statistically non-inferior, i.e. 88.9 percent, 472/531. This was in comparison to the marketed formulation approved dose of ISENTRESS 400 mg twice-daily, i.e. 88.3 percent, 235/266, each in combination therapy with TRUVADA; with a treatment difference of 0.5 (-4.2, 5.2). That meant 95 percent confidence interval as measured by the proportion of patients achieving less than 40 copies/mL of HIV RNA. Additionally, the trial showed comparable rates of reported drug-related clinical adverse events and rates of discontinuation among the two treatment groups. Merck quoted chief of the infectious disease unit at Juan A. Fernandez Hospital, Buenos Aires, Argentina, and lead study author, Pedro Cahn, as commenting: "It is important for patients living with HIV-1 to have additional therapeutic options for the treatment of HIV-1 infection to meet their diverse needs. This once-daily investigational formulation of raltegravir has the potential to simplify some HIV-1 infected patients' regimens, which may be beneficial to those patients as they continue to manage their disease." The company also indicated that based on these results, the European Medicines Agency (EMA) has accepted the file for the investigational once-daily formulation of ISENTRESS for review. As a result, it plans to submit applications for licensure in several countries. That included the United States later in the current year. On Friday, the stock traded 0.26 lower at the time of writing.