Etravirine Approved to Treat Drug-Resistant HIV

By Michael Smith
ROCKVILLE, Md., Jan. 21 -- The FDA has approved etravirine (Intelence) as adjunct therapy for HIV patients who have failed to respond to other treatments.
A novel non-nucleoside reverse transcriptase inhibitor (NNRTI), etravirine was shown to be effective against strains resistant to other NNRTIs.
The drug, also known as TMC125, had been given priority review by the FDA.
The approval is based mainly on data from 599 highly treatment-experienced adults in two international, randomized, double-blind, placebo-controlled trials, DUET-1 and DUET-2. In those trials, researchers tested the protease inhibitor darunavir (Prezista) against the combination of darunavir and etravirine and found that the proportion of patients reaching an undetectable level of HIV -- defined as fewer than 50 copies of HIV RNA per milliliter of blood -- was 17% higher for patients on the combination in DUET-1 and 18% higher in DUET-2.
Typically, patients in the two trials had been treated with up to a dozen HIV drugs, had suffered one or more AIDS-defining illnesses, and had a CD4 cell count of about 100 per microliter of blood.
Their HIV also tended to be highly resistant to treatment -- two-thirds of the patients had two or more mutations that caused NNRTI resistance and half had four or more mutations that generated resistance to protease inhibitors.
The most common adverse events with etravirine were rash and nausea and the FDA said patients developing a rash while on the drug should contact a doctor.
During the development of the drug, some patients also developed serious skin reactions, such as Stevens-Johnson syndrome and erythema multiforme, but such cases were rare.
The FDA noted that the long-term effects of etravirine are not known, and its safety and effectiveness in children ages 16 or younger has not been studied.
Nor has the drug been studied in pregnant women.
Etravirine is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products.

FDA approves HIV drug etravirine


Tablets of the drug etravirine were approved Friday by the Food and Drug Administration for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.
Sold under the trade name Intelence, etravirine is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, that helps to block an enzyme that the human immunodeficiency virus needs to multiply, the FDA said. It was approved for use in combination with other anti-HIV medications.
Etravirine can reduce the amount of HIV in the blood and increase white blood cells that help fight off other infections, the FDA said. It also may reduce the risk of death or infections that can occur with a weakened immune system.
The government gave etravirine a priority review, a status granted to medications aimed at treating serious or life-threatening conditions. Tibotec Pharmaceuticals Ltd., a unit of Johnson & Johnson, said last July that it had requested etravirine be placed on a fast track for review.
"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 Dr. Debra B. Birnkrant, director of the FDA's Division of Antiviral Products.
The drug is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., a Johnson & Johnson company based in Bridgewater, N.J.

FDA: New Merck HIV-fighting drug is safe

By MATTHEW PERRONE, AP Business WriterFri Aug 31, 4:42 PM ET
A new HIV-fighting drug from Merck & Co. appears superior to options for patients who have stopped responding to available drugs, federal regulators said Friday.
The Food and Drug Administration said Merck's studies of Isentress show the drug is safe and effective to treat HIV patients who have developed a resistance to other medications.
Roughly 1 million people in the U.S. are HIV positive, according to the Centers for Disease Control. FDA has cleared 30 different HIV treatments since 1987, and they are typically prescribed in combination to suppress the virus, which cripples the immune system and causes death if not treated.
The agency posted its review of the drug to the FDA Web site ahead of a Wednesday meeting, where outside experts are scheduled to vote on the drug's safety and effectiveness. FDA is not required to follow the experts' recommendations, though it usually does.
The agency granted the drug priority review status earlier this year, meaning staffers would finish the review in six months, four months earlier than usual. A decision is expected mid-October.
If approved, Isentress would be the first in a new class of HIV treatments called integrase inhibitors that block the virus from infecting cells and reproducing.
Government scientists said Isentress has a favorable safety profile, with rash and elevated levels of creatine in the blood reported as the most common side effects.
Merck reported 13 deaths among 900 patients who took Isentress in a clinical study although the FDA said the deaths were not related to the drug.
Isentress would compete with Pfizer's Selzentry, another novel HIV treatment the FDA approved last month for drug-resistant HIV patients. Merck's drug could be more attractive to doctors and patients because it appears to have fewer side effects.
Selzentry's label carries a warning that the drug can cause liver damage and advises patients to see a doctor immediately if they develop an allergic reaction. FDA cleared the drug on the condition that the company conduct follow-up studies to look at the effects of long-term use.
On Wednesday, the FDA will ask its outside experts whether Merck should be required to conduct post-marketing studies on Isentress.