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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

long-term. Median change from baseline viral load (HIV RNA) was -2.1, -2.2, -2.3, -2.3 (log10) at weeks 48, 96, 144 and 168, respectively. Mean change from baseline CD4 (cells/microliter) count was +121, +144, +158 and +143 at the same time points.

Key Safety Findings

Safety analyses were performed on data from all patients who received any vicriviroc treatment (N=205). AIDS-associated opportunistic infections and conditions were observed infrequently and sporadically. Infections involving the upper and lower respiratory tract were the only other infections or adverse events that occurred in 5 percent or more of patients. Elevations of liver enzymes and bilirubin were noted, but were not characteristic of drug-induced liver injury and were judged to be not related to vicriviroc. These infections and other adverse events observed in these patients were generally consistent with expectations for patients with advanced HIV infection and with the multiple drugs being administered.

Status of Vicriviroc Phase III Studies in Treatment-Experienced Patients

Schering-Plough has completed patient enrollment in two large Phase III clinical studies, known as VICTOR-E3 and VICTOR-E4 (Vicriviroc in Combination Treatment with an Optimized Antiretroviral Therapy Regimen in HIV-Infected Treatment-Experienced Subjects), evaluating vicriviroc 30 mg once daily in combination with an optimized background antiretroviral regimen containing a ritonavir-boosted protease inhibitor compared to a control group receiving new optimized background therapy alone. The optimized background therapy must include at least two drugs to which the patient's HIV is susceptible. Patients coinfected with hepatitis B or C may be included in these studies and there are few exclusions of commonly prescribed drugs or need for dose adjustments based on the known vicriviroc drug-drug interaction profile. The two studies involve a total of more than 850 patients and are currently ongoing
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SOURCE Schering-Plough Corporation
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