FDA Approves HIV-1 Treatment By Merck

January 8, 2014 - Merck announced  that the FDA has approved its ISENTRESS drug for oral suspension. ISENTRESS is a pediatric formulation used to treat patients above the age of four weeks who weigh more than 3 kg and less than 20 kg and are infected with HIV-1. Currently the safety and efficiency of the drug has not been disclosed for infants under the age of four weeks old and the drug is stated to have a higher possibility of treatment response if used with other active agents.  ISENTRESS is not a cure for HIV or AIDS. ISENTRESS is sold in the form of chewable tablets and film coded tablets.

Hedy Teppler, executive director of Clinical Research at Merck Research Laboratories stated "We are very pleased that ISENTRESS can now be a part of a treatment regimen for HIV–1 infected infants and children as young as four weeks of age." According to Merck, the HIV-1 treatment may be available for consumers in the United States during the third quarter of 2014.

The FDA warns that reports of skin reactions which can lead to life threatening conditions and even fatalities have been associated with ISENTRESS. Steven-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis are some additional reported side effects. Merck advises patients to discontinue further use of ISENTRESS if they experience severe hypersensitivity or rashes and advises medical professionals to monitor patients’ liver function.

The drug functions by preventing the integration of the HIV–1 DNA into the human DNA genome via the integrase enzyme. ISENTRESS is currently available and approved for use in 76 countries for use in treatment-naive adult patients suffering from HIV-1 and in more than 114 countries for use in treatment-experienced adult patients with HIV-1. With this FDA approval, ISENTRESS is now indicated as part of a combination therapy with other antiretroviral (ARV) agents.