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Analysis of Long-Term Vicriviroc Data Provides Evidence of Sustained Viral Suppression, Increased CD4 Cell Counts and Tolerability in Treatment-Experienced HIV-Infected Patients
Date:10/26/2008

rse events observed were consistent with expectations for the treatment-experienced HIV-infected population. Importantly, the incidence of malignancy seen across the vicriviroc clinical program has not increased over time even as the cumulative exposure to vicriviroc has increased by numbers of patients and duration of treatment.

"These long-term results demonstrate that vicriviroc added to an optimized background therapy may provide durable viral suppression and sustained elevated CD4 counts in treatment-experienced HIV-infected patients," said Jihad Slim, M.D., division of infectious diseases, Saint Michael's Medical Center, Newark, N.J., and an investigator for the vicriviroc clinical program. "Importantly, vicriviroc was well tolerated, with some patients continuing on treatment for up to four years, and it was not associated with increased liver, CNS or cardiovascular adverse events or with an increased incidence of malignancy in this patient population."

About the Data Analysis

Patients enrolled in the Phase II vicriviroc VICTOR-E1 study(3) (including patients in the placebo arm) and the ACTG 5211 study(4) were eligible to continue on open-label vicriviroc with optimized background therapy at the completion of 48 weeks of treatment in an extension for each study. The vicriviroc dose for all patients was escalated to 30 mg once daily during the open-label treatment period. As there were no dose-related differences in the safety profile, data for all patients receiving vicriviroc were pooled for analysis regardless of the original starting vicriviroc dose. The mean duration of vicriviroc treatment for all patients (N=205) was 96 weeks (range 1-216 weeks).

Analyses were performed on data from all patients who completed at least 12 weeks of vicriviroc treatment (N=196). Virologic response to regimens containing vicriviroc was evidenced within 12 weeks by a significant decrease in virus (HIV RNA) detectable in the blood and was sustained
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SOURCE Schering-Plough Corporation
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