FDA Approves New Dosing Option for Raltegravir in Treating HIV-1

Yellow medication in a blister pack.
Yellow medication in a blister pack.
The FDA approved higher dose of Isentress for the treatment of HIV-1 infection in adults and pediatric patients.

Merck announced that the Food and Drug Administration (FDA) has approved Isentress HD (raltegravir), a new higher dose of Isentress, for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and pediatric patients (weighing ≥40kg) who are treatment-naive or whose virus has been suppressed on an initial regimen of Isentress 400mg twice daily.

Isentress HD is a 1200mg once-daily dose that is given orally as two 600mg tablets with or without food. The approval was based on data from the Phase 3 ONCEMRK study. At Week 48, 89% of treatment-naive HIV-1 patients receiving Isentress HD 1200mg once daily achieved viral suppression of HIV-1 RNA <40 copies/mL vs. 88% of patients receiving Isentress 400mg twice daily; each regimen was in combination with emtricitabine + tenofovir disoproxil fumarate. 

The treatment difference was 0.5% (95% CI: –4.2, 5.2). The data was consistent across demographic groups at the start of therapy as well as for specific populations, including those with high viral load (HIV-1 RNA >100,000 copies/mL). 

Dr Michael Saag, from the University of Alabama at Birmingham School of Medicine added, “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.”

Isentress is already available as 25mg and 100mg chewable tablets, 400mg film-coated tablets, and as a 100mg/packet powder for oral suspension. Isentress HD is expected to launch in approximately 4 weeks.

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Merck receives FDA approval of ISENTRESS® HD (raltegravir), a new once-daily option, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in appropriate patients. [press release] Kenilworth, NJ. Merk & Co. Published May 30 2017. Accessed June 22, 2017.

This article originally appeared on MPR