US-based pharmaceutical company, Merck & Co Inc., (known as MSD outside the US and Canada) presented data assessing efficacy and safety at the end of 48 weeks of therapy as a late-breaking abstract at the 21st International AIDS Conference.
The study 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 Phase III study known as ONCEMRK.
The trial was primarily focused on limiting the number of HIV RNA achieved by the patients at week 48 of the study, while the secondary objective was to determine the change from baseline in CD4 cell counts and tolerability at week 48.
After 48 weeks of the therapy, data suggested a non-inferior safety and efficacy of raltegravir when compared to the marketed formulation approved dose of raltegravir 400 mg twice-daily, both of which is in combination with Truvada.
Furthermore, the study showed comparable rates of reported drug-related clinical adverse events and rates of discontinuation between the two treatment groups.
Raltegravir is indicated twice-daily in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients two years of age and older. The use of other active agents with raltegravir is associated with a greater likelihood of treatment response.
“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,” said the lead author of the study and Chief of the Infectious Disease Unit at Juan A Fernandez Hospital, Dr Pedro Cahn.
“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,” continued Dr Cahn.
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.
However, based on results from week 48 of the study, the European Medicines Agency (EMA) has accepted the file for the investigational once-daily formulation of raltegravir for review. MSD says it plans to submit applications for licensure in several countries, including the US later this year.