Merck Sharp & Dohme Limited (MSD) announced today that ISENTRESS® (raltegravir) has been granted an expanded licence from the European Union Commission (Commission) for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as treatment-experienced adult patients. The safety and efficacy of ISENTRESS has not been established in patients below 16 years of age. The Commission's decision is applicable to the 27 Member States of the European Union (EU), including France, Germany, Italy, Spain and the United Kingdom as well as to Iceland and Norway.
The Commission’s decision, reflecting the positive opinion of the Committee for Medicinal Products for Human Use (CHMP), was based on data from three double-blind controlled Phase III studies. Two of these studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve adults. In the study with treatment-naïve patients (STARTMRK), raltegravir was found to be as effective as efavirenz (one of the standard antiretrovirals prescribed for treatment-naïve patients) at suppressing viral load and restoring immune system function through 48 weeks in treatment-naïve patients. Both medicines were administered in combination with tenofovir and emtricitabine.