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news.In a 48-week study 7% of HIV-1 infected patients who switched from a stable, protease inhibitor-based anti-HIV regimen to a regimen containing the Bristol-Myers Squibb once-daily protease inhibitor Reyataz experienced viral rebound, compared to 16% of patients who continued on their current protease inhibitor regimen.
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“Data such as these expand our understanding of the role Reyataz may play in anti-HIV regimens,” said Dr Jose Gatell, of the Hospital Clinic Provincial, Barcelona, Spain, and lead investigator of the study. Data from the study were presented at the tenth European AIDS Conference.
The study evaluated 419 HIV-1-infected patients who were virologically suppressed (HIV-RNA level of less than 50 copies per milliliter at screening) on stable, protease inhibitor based regimens. Patients were randomized in a two-to-one ratio either to change protease inhibitor to a Reyataz-based regimen or to continue their current therapy.
The primary endpoint of the study was to compare the proportion of patients experiencing viral rebound at or prior to 48 weeks. The secondary endpoints examined time to virologic rebound, magnitude of change from baseline count through week 48, frequency and severity of adverse events, discontinuations, and changes from baseline in lipids through week 48.
Rates of discontinuation from the study due to adverse events were 6% in the Reyataz arm and 6% in the comparator PI arm. Treatment-emergent gastrointestinal adverse events of any grade (diarrhea, nausea, vomiting or abdominal pain) were reported in 13% of patients in the comparator PI arm and 8% of patients in the Reyataz arm.