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Late phase II trial results of HIV fusion inhibitor T-20 appear promising
By Anthony J. Brown, MD
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ATHENS, Greece (Reuters Health) - Phase II trial results at 48 weeks indicate
that the investigational antiretroviral drug T-20 achieves a sustained viral
response in more than half of heavily pre-treated HIV-infected patients,
according to data presented on Tuesday at the 8th European Conference on
Clinical Aspects and Treatment of HIV Infection.
T-20, developed jointly by Switzerland's Roche and US biotech firm Trimeris,
is a member of the class of antiretroviral agents known as HIV fusion
inhibitors.
Dr. Frank Duff, director at Roche Clinical Science, presented an update of
clinical trials evaluating T-20 and T-1249, a newer fusion inhibitor.
"The phase II trial data of T-20 at 48 weeks confirms the safety,
tolerability, and patient acceptability of the subcutaneous mode of delivery
that earlier results suggested," Dr. Duff told Reuters Health.
"The majority of patients had experience with all three antiretroviral drug
classes," Dr. Duff noted. All of the subjects had advanced disease, with a
median viral load of 100,000 HIV RNA copies/mL and a median CD4 count of 90
cells per microliter.
"More than half of the 41 patients who completed 48 weeks of T-20 therapy had
1 log or greater viral load suppression," Dr. Duff stated. In addition, 39%
of these patients achieved viral loads less than 400 copies/mL, he noted.
Dr. Duff also presented results from a phase II pediatric study of T-20 which
indicate it is well tolerated and causes rapid viral suppression in this
patient population (see Reuters Health report, January 29, 2001).
While more data have been generated for T-20, Dr. Duff said the early results
for T-1249 also appear promising. Results from a previous phase I/II
dose-escalation study indicate that T-1249 monotherapy confers dose-related
viral suppression (see Reuters Health report, February 6, 2001).
"In vitro studies have shown that T-1249 is active against the majority of
T-20-resistant isolates," Dr. Duff stated. "A key area for future
investigation will be studying the efficacy of T-1249 in patients with
T-20-resistant isolates," he noted. "We need to confirm the laboratory
findings in the clinical setting before we can truly say that T-1249 is
second generation."
T-20 is currently in phase III trials and Roche and Trimeris are hoping to
win rapid regulatory approval to allow for its launch in 2003.
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