FDA Approves New Therapeutic Option for HIV-1

The U.S. Food and Drug Administration (FDA) has approved ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS® (raltegravir).

According to the medicine’s manufacturer, “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 and ISENTRESS HD do not cure HIV-1 infection or AIDS.

ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.

This new HIV medication is to be administered orally as 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 pediatric 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.

“ISENTRESS has been used as a component of treatment regimens for patients diagnosed with HIV-1 for almost a decade,” said Dr. Michael S. Saag, associate dean for global health, and director of the Center for AIDS Research at the University of Alabama at Birmingham School of Medicine.

The FDA approval of ISENTRESS HD is supported by data from the pivotal Phase 3 ONCEMRK trial.

“Because of improvements in the effectiveness of antiretroviral therapies and with appropriate access to care, HIV infection can now be managed as a chronic disease,” said Carl Schmid, deputy executive director of the AIDS Institute.

“For people living with HIV, having a wide range of effective therapies is important because it provides options to fit patients’ individual needs and lifestyles.”

ISENTRESS HD can be co-administered with a wide range of antiretroviral agents and non-antiretroviral agents.

The price of ISENTRESS HD will be the same as ISENTRESS twice daily. Merck anticipates ISENTRESS HD to be available in pharmacies before July 2017.

ISENTRESS is approved as part of combination therapy in 112 countries for treatment of HIV-1 infection in adult patients. ISENTRESS, in combination therapy, for use in children and adolescents with HIV-1 aged two years and older has also been approved for use in 69 countries, and ISENTRESS oral suspension for infants at least four weeks of age is approved for use in 33 countries.

Women infected with HIV-1 should be instructed not to breastfeed if they are receiving ISENTRESS or ISENTRESS HD due to the potential for HIV transmission.

Please see Prescribing Information for ISENTRESS (raltegravir) and ISENTRESS HD (raltegravir).

Patient Information for ISENTRESS and ISENTRESS HD (raltegravir).

The instructions for use are available.