DGDispatch

AIDS 2004: Patients on Enfurvitide (Fuzeon) Keep HIV Undetectable at 96 Weeks

By Ed Susman

BANGKOK, THAILAND -- July 12, 2004 -- Patients who can establish a routine of injecting themselves with enfurvitide subcutaneously twice a day are rewarded with control of HIV for at least 2 years.

"After 2 years, twice as many patients [taking enfurvitide] have achieved virological success than people on their optimal regimes," said Calvin Cohen, MD, Medical Director, Harvard Vanguard Medical Associates, Boston, Massachusetts.

Dr. Cohen, one of the myriad investigators involved in the long-running "T-20 vs. Optimized Regimen Only" (TORO) studies, presented the findings in a press briefing here July 12th at the XV International AIDS Conference said that contrary to clinician and patient belief. He said the need for twice-daily injections is not seen as a major problem once patients start using the drug and become aware if its benefits.

"The patients taking enfurvitide find it much easier to inject themselves than do most people who haven't tried it," he said.

He noted that after 2 year, 26% of patients on enfurvitide -- once known as T-20 -- had undetectable virus loads compared to 13% of patients who were taking the most effective background antiretroviral therapy. The original study compared outcomes of patients on best optimal background therapy versus those taking enfurvitide in addition to the background therapy.

Dr. Cohen said that about half the patients who are offered Fuzeon refuse the drug because of "needle phobia," and added, "A perceiver fear of needles drives about 90% of the decision to reject use of Fuzeon." Needle phobia occurs on both sides of the consultation desk, he said, with about 4 of 10 doctors not offering the medicine because they see a problem with the mode of delivery.

Richard Apodaca of San Francisco, California, USA, a patient who has been taking enfurvitide for more than 4 years, said he was originally troubled by development of nodules at the injection sites, but a gentle massage of the area avoided that adverse effect. He said travel with his injection kits has been without incident in airports.

"Four years ago, HIV had decimated my immune system," he said in an interview. "After beginning treatment with Fuzeon along with other drugs -- I think I have tried almost everything starting with zidovudine monotherapy in the 1980s -- my viral load became undetectable and my CD4 count increased dramatically."

The TORO trials enrolled about 1,000 patients who had been treated with numerous antiretroviral medications. Researchers reported viral load drops of about 1.1 log10 in patients on optimized therapy alone compared with a 2.1 log10 fall in patients who added enfurvitide to their regimen, said Keikawus Arasteh, MD, a clinician at Vivantes Auguste-Viktoria-Klinikum, II, Berlin, Germany, who presented the data in an oral report.

Corklin Steinhart, MD, Senior Attending Physician, Mercy Hospital, Miami, Florida, who also participated in the study, said, "The new data show that the significant virological and immunological benefits of Fuzeon seen in earlier analyses are extended to 96 weeks, an especially notable achievement given the extensive prior exposure of patients enrolled in the TORO studies. It is particularly exciting that more than half of the patients who began treatment with Fuzeon continued on the drug for 96 weeks."

Dr. Helene Gayle, Director of HIV, Tuberculosis and Reproductive Health, Bill and Melinda Gates Foundation, Seattle, Washington, said that presently enfurvitide is still for use in salvage cases in which patients have failed all other treatments.

"When a person's life is on the line, self-injection with drugs such as enfurvitide can become an acceptable therapy," she said.

Enfurvitide is marketed by Roche, Nutley, New Jersey, and Trimeris of Durham, North Carolina.


[Presentation title: "TORO: 96 week virological and immunological response and safety evaluation of enfurvitide with an optimized background regimen. Abstract MoOrB1058]