Schering-Plough has said that final results of vicriviroc Phase II clinical study has demonstrated potent and sustained viral suppression through 48 weeks of therapy in treatment- experienced HIV-infected patients, when administered once-daily as a single tablet in combination with an optimized ritonavir-boosted protease inhibitor containing antiretroviral regimen.
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In the study, significantly more patients who added vicriviroc 30mg once daily to a new optimized background therapy (OBT) had fully suppressed HIV-RNA (less than 50 copies/ml) at 48 weeks compared to patients receiving new OBT alone (56% vs. 14%, p=0.0002).
At 48 weeks, patients in the 30mg and 20mg vicriviroc treatment groups achieved mean decreases from baseline in viral load of -1.77 and -1.75 (log10 copies/mL), respectively, compared to -0.79 for the control group (p=0.0017 and p=0.0026, respectively). No clinically relevant differences in safety profile between the vicriviroc and control groups were observed in this study, including liver toxicity, opportunistic infections, malignancies or other conditions.
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