New HIV Drug Intelence Approved
FDA Approves Intelence for Use in Adults Not Helped by Other Antiretroviral Drugs
Jan. 25, 2008 -- The FDA has approved a new HIV drug called Intelence.
Intelence is approved for use with other HIV drugs in adults who haven't been helped by other antiretroviral drugs.
Intelence belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It helps to block an enzyme that HIV needs to multiply.
Intelence was developed based on its ability to counter HIV strains that resist NNRTI Â treatment.
"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," Debra Birnkrant, MD, director of the FDA's antiviral products division, says in a news release.
The FDA fast-tracked its review of Intelence and approved the drug based mainly on data from two studies.
Together, the studies included 599 adult HIV patients. Half of the patients got Intelence in addition to their other HIV drugs. The other half of the group got a placebo pill along with their other HIV drugs.
After six months of treatment, more patients in the Intelence group had a drop in their blood level of HIV than patients in the placebo group.
Rash and nausea were the most commonly reported side effects in the two Intelence studies reviewed by the FDA.
The FDA also notes that while Intelence was being developed, there were rare cases of skin reactions, such as Stevens-Johnson syndrome (a severe skin disorder) and erythema multiforme (which is usually less severe than Stevens-Johnson syndrome).
Patients taking Intelence may develop infections, including opportunistic infections or other conditions that may develop in people living with HIV.
The long-term effects of Intelence aren't known, and the drug's safety and effectiveness haven't been studied in children younger than 16 or in pregnant women.
The FDA has this advice for people taking Intelence:
- Contact your doctor if you develop a rash while taking Intelence.
- Tell your doctor and pharmacist about all the medications you take, in order to avoid drug interactions.
- Women who become pregnant while taking Intelence or other HIV drugs should consult a doctor.
Intelence is a product of Tibotec Therapeutics, a division of Ortho Biotech Products of Bridgewater, N.J.