New Dosage for HIV Drug Approved

The US Food and Drug Administration has recently approved a new 1200 mg daily dosage of Isentress HD (raltegravir) for the treatment of HIV-1 infection in adults, and pediatric patients who weigh at least 40 kg and are treatment-naïve or whose virus has been suppressed on an initial regimen of 400 mg twice-daily dose of Isentress HD.

Isentress HD is administered as two 600 mg film-coated oral tablet in combination with other antiretroviral agents, and can be taken with or without food. Co-administration of Isentress HD can include a wide range of antiretroviral agents and non-antiretroviral agents, however aluminum and/or magnesium-containing antacids, calcium carbonate antacids, rifampin, tipranavir/ritonavir, etravirine, and other strong inducers of drug metabolizing enzymes are not recommended to be combined with Isentress HD. Health care providers should consider the potential for drug-drug interactions prior to and during treatment with Isentress HD and any other recommended agents.
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The efficacy of Isentress HD was based on data from the ONCEMRK phase 3 trial that included 531 treatment-naïve patients with HIV-1 infection who received 1200 mg of Isentress HD and 266 patients with HIV-1 infection who received 400 mg of Isentress HD. Of the patients who received Isentress HD at 1200 mg, 89% achieved viral suppression at 48 weeks compared with 88% of patients in the 400-mg group.

Adverse effects associated with treatment included abdominal pain, diarrhea, vomiting and decreased appetite. In addition, severe, potentially life-threatening and fatal skin reactions can occur, including Stevens-Johnson syndrome, hypersensitivity reaction, and toxic epidermal necrolysis. Treatment should be immediately discontinued if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develop.

—Melissa Weiss

Reference:

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: Merck; May 30, 2017. http://investors.merck.com/news/press-release-details/2017/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/default.aspx