FDA Clears Once-Daily Raltegravir (Isentress HD) for HIV

Megan Brooks

May 31, 2017

The US Food and Drug Administration (FDA) has approved a new 1200-mg once-daily version of the integrase inhibitor raltegravir (Isentress HD, Merck), the company has announced.

Isentress HD is given in two 600-mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and children weighing at least 40 kg who are treatment-naive or whose virus has been suppressed on an initial regimen of raltegravir 400 mg twice daily, the company said in a news release.

"Isentress has been used as a component of treatment regimens for patients diagnosed with HIV-1 for almost a decade," Michael S. Saag, MD, director of the Center for AIDS Research at the University of Alabama at Birmingham School of Medicine, said in the release.

"The addition of a convenient once-daily version with a comparable efficacy and safety profile at 48 weeks to the existing twice-daily version of Isentress provides physicians with a new therapeutic option for some patients with HIV-1 infection," he added.

The FDA approved the 1200-mg once-daily raltegravir dose on the basis of data from the phase 3 ONCEMRK trial. At week 48, 89% of treatment-naive HIV-1-infected patients receiving once-daily raltegravir achieved viral suppression of HIV-1 RNA <40 copies/mL compared to 88% of patients receiving raltegravir 400 mg twice a day, each in combination therapy with emtricitabine plus tenofovir disoproxil fumarate (treatment difference, 0.5; 95% confidence interval, -4.2 to 5.2).

The finding 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), the company said.

The rate of discontinuance of therapy due to adverse events was low (1% in patients receiving raltegravir 1200 mg once daily and 2% in those receiving 400 mg twice daily), the company said.

No drug-related clinical adverse reactions of moderate to severe intensity occurred in 2% or more of patients in either treatment group. Clinical adverse reactions of all intensities (mild, moderate, and severe) occurring in 2% or more of patients taking once-daily or twice-daily raltegravir included abdominal pain, diarrhea, vomiting, and decreased appetite. Treatment-emergent viral mutations leading to any drug resistance were detected in fewer than 1% of patients taking raltegravir once daily.

Merck said the price of once-daily Isentress HD will be the same as twice-daily Isentress. They expect Isentress HD to be available in US pharmacies in about 4 weeks.

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