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New Agent TMC125 Effective in Patients with HIV and NNRTI and PI Resistance: Presented at EACS
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By Ted Bosworth
DUBLIN, IRELAND --December 9, 2005 -- A new non-nucleoside reverse transcriptase inhibitor (NNRTI) has passed a major hurdle en route to clinical development. TMC125, the first NNRTI developed for use in treatment experienced patients showed substantial antiretroviral activity and good tolerability at 24 weeks in a controlled dose-ranging study.
In a late-breaker presentation here at the European AIDS Conference (EACS), researchers discussed findings from a study conducted in heavily pre-treated patients with HIV who had documented NNRTI resistance and had least 3 primary protease inhibitor mutations.
"Against a standard of care regimen, TMC125 showed a significantly greater reduction in viral load and immune reconstitution at 24 weeks with an acceptable tolerability profile," reported Jeffrey P. Nadler, MD, Director of Clinical Research, Division of Infectious Diseases, University of South Florida College of Medicine, Tampa, Florida, United States, on November 18th.
"These data contribute to the evidence that TMC125 may be used to rescue patients with prior NNRTI failure," he said.
This C223 study randomized 199 treatment-experienced patients with NNRTI resistance to a standard-of-care (SOC) regimen or one of two TMC125 regimens -- 400 mg or 800 mg -- given twice daily, combined with an investigator-selected background regimen.
At 24 weeks, the SOC regimen had produced a viral load reduction of 0.19 log10 RNA copies/mL. In contrast, the reduction was 1.04 log10 for the 400 mg bid TMC125 dose and 1.18 log10 for the 800 bid mg dose.
The rates of patients who achieved a viral load <50 copies/mL were 21%, 18%, and 8%, respectively. At 24 weeks of treatment, 95% of the SOC patients had discontinued therapy for virologic failure, compared to 6% and 7% of the 400 mg and 800 mg bid subjects in the two TMC125 arms, respectively.
Grade 3 or 4 adverse events were reported in 17% of patients receiving TMC125. Rash was among the most common adverse effects, observed in 15% of patients. A total of 14% of patients discontinued therapy due to adverse events, 3% for rash.
Based on favorable potency and tolerability in a highly treatment experienced population resistant to other NNRTIs, "further clinical studies with TMC125 are warranted," Dr. Nadler concluded.
This study was funded by Tibotec, Mechelen, Belgium, the company developing TMC125.
[Presentation title: Efficacy and Tolerability of TMC125 in HIV Patients with NNRTI and PI Resistance at 24 Weeks. Abstract LSPS3/7A]
NATAP Reports from European Conference:
TMC-125: efficacy & safety in highly resistant patients (11/18/05)
TMC-125, new NNRTI for Resistance (11/18/05)
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