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ICAAC: Long-Acting HIV Drug Matches Original Version

An extended-release formulation of nevirapine (Viramune) -- intended for once-daily dosing -- had similar efficacy in treatment-naïve HIV patients to the twice-a-day version commonly used, a researcher said here.

At the end of 48 weeks of therapy, 81% of patients treated with the extended-release drug had a sustained virologic response, defined as fewer than 50 copies of HIV RNA per milliliter of serum without rebound or change of therapy, according to Joseph Gathe, MD, an HIV specialist in private practice in Houston.

Those taking the immediate-release version -- given twice daily -- had a response rate of 76%, which met preset conditions for non-inferiority, Gathe said during an oral presentation here at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

At the same time, he said, the trial -- which included 1,011 patients -- did not produce any new or unexpected adverse events, and the rate of such events was roughly the same between the two arms.

Nevirapine, a non-nucleoside reverse transcriptase inhibitor, is widely used in the developing world, but less so in North America and Europe.

The development of the extended-release formulation is intended to bring nevirapine into line with the increasing emphasis on once-daily dosing for HIV patients, Gathe said. If it is approved, he said, it would allow "dosing symmetry" with guideline-preferred nucleoside reverse transcriptase inhibitors, which are given once a day.

Patients in the study had a 14-day lead-in with the immediate-release formulation, at 200 milligrams given once a day. Then they were randomly assigned -- in a double-blind, double-dummy fashion -- to get either the extended-release drug (at 400 milligrams once daily) or the immediate-release version (at 200 milligrams twice a day).

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