Isentress gains indication for use in treatment-naïve HIV patients
The FDA has approved an expanded indication for Isentress (raltegravir tablets, from Merck), a HIV-1 integrase strand transfer inhibitor, in combination with other antiretrovirals for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients, including treatment-naïve patients. Isentress was previously indicated for use only in treatment-experienced adults with evidence of viral replication and HIV-1 strains resistant to multiple antiretrovirals. The expanded indication is based on results from a 48-week, randomized, double-blind, active control trial in treatment-naïve patients that evaluated the safety and efficacy of Isentress plus emtricitabine plus tenofovir versus Sustiva (efavirenz, from Bristol-Myers Squibb) plus emtricitabine plus tenofovir. The proportion of patients with HIV RNA <50 copies/mL was 87% for patients treated with Isentress compared to 82% of patients treated with Sustiva. The difference between Isentress and Sustiva with respect to HIV RNA <50 copies/mL is 4.7% (95% confidence interval: -1.3%, 10.6%).
Isentress is available in a 400mg dosage strength.