Raltegravir Maintains Efficacy, Tolerability at 96 Weeks: Presented at AIDS 2008

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Title: Raltegravir Maintains Efficacy, Tolerability at 96 Weeks: Presented at AIDS 2008
URL: http://www.pslgroup.com/dg/22743A.htm
Doctor's Guide
August 6, 2008

By Ed Susman

MEXICO CITY -- August 6, 2008 -- Raltegravir, the only integrase inhibitor currently on the market for treating human immunodeficiency virus (HIV), maintains its effectiveness in suppressing HIV over a course of at least 96 weeks, according to trial research presented here at the 17th International AIDS Conference (AIDS 2008).

The impact of raltegravir in suppressing HIV appears to be similar to standard-of-care treatment with the non-nucleoside reverse transcriptase inhibitor efavirenz, reported Martin Markowitz, MD, Aaron Diamond AIDS Research Center, Rockefeller University, New York, New York, speaking here at an oral poster presentation on August 5.

Dr. Markowitz's study enrolled 198 treatment-naïve patients and randomised 160 patients in a blinded fashion to 1 of 4 doses of raltegravir (100, 200, 400, and 600 mg twice a day) and 38 patients to efavirenz 600 mg/day. At week 48, the raltegravir patients were all switched to 400 mg/day.

"At 96 weeks, 83% of the 160 treatment-naïve patients on raltegravir had sustained antiretroviral effects in lowering [the] HIV viral load to undetectable levels using the 50-copy/mL assay," said Dr. Markowitz. "About 84% of [the] 38 patients on efavirenz also had undetectable virus."

"No new raltegravir mutations were identified after 96 weeks," Dr. Markowitz noted.

Dr. Markowitz said that this finding extends earlier data from the company-sponsored phase 2 randomised trial.

"Drug-related adverse events appeared to be [fewer] among the raltegravir patients than among those taking efavirenz," Dr. Markowitz added. Overall, he said, adverse events were generally similar between the 2 medications, but drug-related adverse events -- mainly neuropsychiatric issues -- were reported by 74% of the patients on efavirenz compared with 51% of patients on raltegravir.

Funding for this study was provided by Merck & Co., Inc.

[Presentation title: Sustained Antiretroviral Efficacy of Raltegravir as Part of Combination ART in Treatment-Naïve HIV-1 Infected Patients: 96-Week Data. Abstract TUAB0102]

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