Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
Los Angeles Times - July 6, 2007
Jia-Rui Chong, Times Staff Writer, jia-rui.chong@latimes.com
The studies reported that up to 18% more drug-resistant patients saw the amount of virus in their blood drop to undetectable levels after 24 weeks compared with those taking a standard drug regimen.
The results with the experimental drug etravirine give a much-needed boost in the fight against drug resistance among HIV patients, particularly those resistant to the workhorse class of drugs known as non-nucleoside reverse transcriptase inhibitors, or NNRTIs.
"There are a lot of patients out there who need salvage therapy with a new NNRTI, and it looks like we'll have one," said Dr. Mark Wainberg, director of the McGill University AIDS Centre in Montreal, who was not involved in the study.
About half of patients on antiviral medications develop resistance to a drug in this class, said Wainberg, who has consulted for the maker of etravirine, Tibotec Pharmaceuticals of Yardley, Pa.
Tibotec plans to seek Food and Drug Administration approval for etravirine in the next few months.
The drug, previously known as TMC125, blocks one of the enzymes needed for replication by the human immunodeficiency virus, which causes AIDS.
The two studies, funded by Tibotec, followed 1,203 HIV patients in 19 countries. The patients had severely compromised immune systems and were resistant to NNRTIs and another commonly used class of drugs known as protease inhibitors.
Roughly half the patients were given etravirine and a protease inhibitor from Tibotec called Prezista, which the FDA approved last year. The remainder were given Prezista and a placebo.
Patients in both groups were also given other AIDS drugs depending on the recommendation of their doctors.
Dr. William Towner, one of the study's authors and medical director for Kaiser Permanente's HIV/AIDS Research Trials Program in Southern California, said using several drugs at once had proved to be an effective strategy against the quickly mutating AIDS virus.
"Adding only one active agent to a patient experiencing drug failure usually results in the rapid, predictable development of resistance to that agent," he said.
One of the studies found that 62% of patients on the etravirine regimen suppressed the virus to undetectable levels, compared with 44% in the placebo group. The other study reported successful viral suppression in 56% of the etravirine group, compared with 39% in the placebo group.
Most side effects were mild or moderate and occurred at about the same rate in the experimental and control groups. Rash, however, occurred slightly more often in the etravirine groups.
Results from this study suggest that etravirine is best used in combination with other drugs that retain a strong ability to control the virus, said Dr. W. David Hardy, director of infectious diseases at Cedars-Sinai Medical Center.
"It will not perform by itself," said Hardy, who was not involved in this study but has consulted for Tibotec and other pharmaceutical companies.
According to an editorial accompanying the studies, etravirine did not help a group of patients who were taking a drug called Fuzeon for the first time. Fuzeon is part of a relatively new class of drugs known as fusion inhibitors.
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