30 May 2017 - Merck today announced that the U.S. FDA has approved Isentress HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, Isentress (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other anti-retroviral agents, for the treatment of HIV-1 infection in adults, and paediatric patients weighing at least 40 kg, who are treatment naïve or whose virus has been suppressed on an initial regimen of Isentress 400 mg given twice daily.

The FDA approval of once-daily Isentress HD (raltegravir) is supported by data from the pivotal Phase 3 ONCEMRK trial. At Week 48, 89% (N=531) of treatment-naïve HIV-1 infected patients receiving Isentress HD 1200 mg (2 x 600 mg) once a day achieved viral suppression of HIV-1 RNA <40 copies/mL compared to 88 percent (N=266) of patients receiving Isentress 400 mg twice a day, each in combination therapy with emtricitabine + tenofovir disoproxil fumarate, with a treatment difference of 0.5%, and a 95% confidence interval of -4.2, 5.2. This was consistent across demographic groups at initiation of therapy and a variety of patient populations, including those with high viral load (HIV-1 RNA >100,000 copies/mL).

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