Merck & Co, Inc announced that Isentress (raltegravir) has been recommended, in combination therapy, as a preferred regimen for treatment- naïve, non-pregnant patients living with HIV-1, according to new HIV treatment guidelines issued by the United States Department of Health & Human Services (HHS). The new guidelines recommend the use of Isentress in combination therapy with two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir and emtricitabine, for patients beginning treatment for the first time (treatment-naïve). The 'Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents' were developed by the HHS Panel on Antiretroviral Guidelines for Adults and Adolescents, a working group of the Office of AIDS Research Advisory Council, and were updated today on World AIDS Day.

The US Food and Drug Administration (FDA) approved an expanded indication for Isentress on July 8, 2009, to include the treatment of adult patients starting HIV-1 therapy for the first time, as well as treatment-experienced adult patients, in combination with other antiretroviral (ARV) medicines. The expanded indication for Isentress was based on analyses of plasma HIV-1 RNA levels through 48 weeks in three double-blind controlled phas-III studies. Two of these studies were conducted in clinically advanced, three-class antiretroviral [nonnucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI)] treatment-experienced adults, and one was conducted in treatment-naïve patients.

Isentress is used in combination with other ARV medicines for the treatment of HIV-1 infection in adult patients. The safety and efficacy of Isentress have not been established in paediatric patients. The use of other active agents with Isentress is associated with a greater likelihood of treatment response.

“These Guidelines play an integral role in guiding the way physicians in the U.S. treat HIV,” said Robin Isaacs, vice president, Clinical Research, Merck Research Laboratories. “As the only approved integrase inhibitor, Isentress targets the HIV-1 virus in a unique way and offers physicians another option to help patients effectively lower viral loads while increasing CD4 cell counts.”

Isentress is the first medicine to be approved in a class of ARV drugs called integrase inhibitors.