US-based pharmaceutical company Merck has reported positive results from its ongoing Phase III pivotal trial ONCEMRK of Isentress (raltegravir) to treat adults with HIV-1 infection.
Isentress inhibits integrase for the treatment of HIV-1 infection in adult and pediatric patients aged four weeks and older and weighing at least 3kg as part of combination HIV therapy.
It blocks the integrase enzyme from inserting HIV-1DNA into human DNA thereby demonstrating a rapid anti-viral activity.
The blockage of integrase limits the ability of the virus to replicate and infect new cells.
The multicentre, double-blind, randomised, active comparator-controlled ONCEMRK trial is designed to evaluate the safety and efficacy of combination of raltegravir, Isentress each in combination with Truvada in previously untreated HIV-1 infected adult patients.
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 is 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 approved dosage of Isentress, both of which is in combination with Truvada.
Juan A. Fernandez Hospital, Buenos Aires, Argentina infectious disease unit chief Dr Pedro Cahn said: “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."
Based on the findings of the trial, the European Medicines Agency (EMA) has approved the file for the investigational once-daily formulation of Isentress for review.