The US Food and Drug Administration has announced that it approves the expanded use of an important anti viral drug used to treat HIV infections. Isentress is an antiretroviral drug produced my Merck & Co. It was first approved in October 2007 and was the first of a new class of anti HIV drugs known as integrase inhibitors.

Known pharmaceutically as raltegravir, Isentress targets an HIV enzyme called integrase, which allows the virus to combine genetic code into human chromosomes. It is thought to be a critical step in breaking the secrets of the HIV virus.

Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research said :

“Many young children and adolescents are living with HIV and this approval provides an important additional option for their treatment.”

The drug is taken twice daily, with or without food, and has been seen to slow and inhibit the spread of the virus, thus, at least prolonging the time taken for full blown AIDS to affect the body.

The chewable form of the tablet is now approved for children from 2 to 11 years.

A single, multi-center clinical trial of 96 children and adolescents aged 2-18 years with HIV-1 infection evaluated the safety and effectiveness of Isentress. These patients previously received treatment for HIV-1 infection. After 24 weeks of treatment with Isentress, 53 percent of these patients had an undetectable amount of HIV in their blood.

Unfortunately, there are some side effects from the drug which can include insomnia and headache. It does appear though that adults and children are affected in similar proportions. One patient in the trial reported severe insomnia, while another had a skin rash caused by the drug.

It should be noted that Isentress does not cure HIV infection and patients must stay on a continuous anti HIV therapy to avoid the virus becoming full blown AIDS.

At the same time, Merck & Co. has announced that it will be providing additional discounts to low income patients who have limited or no insurance. The cuts will be effective Jan 1st and run through end 2013.

At minimum, Isentress must be taken with at least two other anti-HIV drugs as part of an effective antiretroviral treatment regimen, pushing the overall price of one Isentress patient’s yearly anti-HIV drugs to between $20,000 and $30,000.

Written by Rupert Shepherd