The US Food And Drug Administration has approved etravirine tablets for the treatment of HIV patients. Etravirine, which will be sold under the trade name Intelence, was developed by Tibotec Pharmaceuticals, Ltd

The drug is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply and it was approved to be used in combination with other anti-HIV medications.

Development of etravirine was triggered by the observations of in vitro anti-HIV activity of etravirine against mutant, NNRTI-resistant HIV strains.

"NNRTIs have been used in HIV combination therapy for more than a decade, but their use has been limited by cross-resistance within the class. Resistance to one NNRTI generally meant resistance to all NNRTIs," explained Richard Haubrich, M.D., Professor of Medicine, Division of Infectious Diseases, University of California, San Diego, and investigator in the INTELENCE Phase 3 DUET studies. "Etravirine breaks new ground in the NNRTI class, and provides a new option to thousands of treatment-experienced patients with NNRTI-resistant HIV."

FDA said the approval of Intelence was granted after it has studied data from 599 adults who received etravirine in two randomized, double-blind, placebo-controlled trials.

After 24 weeks of treatment, more of the patients who received etravirine along with background therapy experienced reductions in the level of HIV in their blood than did those who received a placebo and background therapy.

"This is another significant new product for many HIV-infected patients who are NNRTI –resistant and whose infections are not responding to currently available medications," said Debra B. Birnkrant, M.D., director of the FDA's Division of Antiviral Products.

FDA warned also that the drug could have side effects such as rash and nausea, and

rare cases of serious skin reactions such as Stevens-Johnson syndrome and erythema multiforme were reported.

According to latest statistics released by WHO, 33 million people around the world are diagnosed to be living with HIV. The number seemed to have leveled off from 40 million worldwide which sounds promising but it still is a matter of great concern. Another 2.5 million people contracted the virus this year, which means a 40 percent lower than the estimate for 2006. Two million people more have died from AIDS in 2007.