Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced final results from a Phase II clinical study, extending out to 240 weeks, of its integrase inhibitor ISENTRESS® (raltegravir) Tablets in combination therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients. The regimen containing ISENTRESS showed efficacy similar to the regimen containing efavirenz at suppressing HIV-1 viral load to undetectable levels (less than 50 copies/mL) and at improving CD4 counts in treatment-naïve adult patients. Data also showed that ISENTRESS in combination therapy resulted in fewer reported drug-related adverse events (AEs) than efavirenz, and showed a modest impact on low-density lipoprotein (LDL) cholesterol and triglycerides. These 240-week results will be presented on July 20th at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Rome.
“In this Phase II study, ISENTRESS demonstrated comparable efficacy and tolerability to efavirenz at 240 weeks in treatment-naïve adult patients with HIV-1”
"In this Phase II study, ISENTRESS demonstrated comparable efficacy and tolerability to efavirenz at 240 weeks in treatment-naïve adult patients with HIV-1," said primary investigator Dr. Eduardo Gotuzzo, professor of medicine, infectious diseases and tropical medicine, Universidad Peruana Cayetano Heredia, Lima, Peru, who presented the data. "Because physicians consider many factors when selecting antiretroviral therapy for adult HIV-1 patients new to treatment, the results seen in this Phase II study with ISENTRESS in combination therapy showing a modest impact on LDL and triglycerides provide important insights."
ISENTRESS is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults. The label for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 96 weeks in three double-blind controlled Phase III clinical studies of ISENTRESS. Two of these studies were conducted in clinically advanced, three-class ARV [non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI)] treatment-experienced adults and one was conducted in treatment-naïve adults. The safety and efficacy of ISENTRESS have not been established in pediatric patients. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.