Schering-Plough reports encouraging results from Phase IIa hepatitis study
SGP | Quote | Chart | News | PowerRating -- Schering-Plough has reported that interim results from an ongoing Phase IIa study of narlaprevir, its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus, or HCV genotype 1.
In the lead-in arms of the study, in which patients received a four-week lead-in of Pegintron and Rebetol followed by the addition of narlaprevir, 85-87% of patients achieved rapid virologic response (RVR), compared to 58-75% of patients in the no lead-in narlaprevir arms and no patients in the Pegintron and Rebetol control arm.
RVR, defined in this study as undetectable virus (HCV RNA) at week four of narlaprevir treatment, is recognized as an important predictor for achieving sustained virologic response. These interim results are from the Next-1 study.
Importantly, patients in the lead-in narlaprevir arms also achieved improved rates of early virologic response, defined as undetectable virus at week 12 of treatment, with 85-87% of patients having undetectable virus at week 12 of narlaprevir treatment compared to 17% of patients at week 12 in the control arm, Schering-Plough said.
The Next-1 study evaluates 12 weeks of narlaprevir 200mg or 400mg once-daily or 100mg twice daily with low-dose ritonavir (100mg) in combination with Pegintron (1.5mcg/kg once weekly) and Rebetol (600-1400mg daily), followed by Pegintron and Rebetol alone for an additional 12 or 36 weeks.
The study includes two treatment arms in which patients receive a four-week lead-in of Pegintron and Rebetol prior to receiving narlaprevir 200mg or 400mg once-daily in the above regimen. All patients in the narlaprevir arms have completed narlaprevir dosing. The control arm is Pegintron and Rebetol alone for 48 weeks.
John Vierling, lead investigator of the study, said: "These interim results, while preliminary, are very encouraging, and showed that narlaprevir has potent antiviral activity in hepatitis C. In this study, once-daily narlaprevir greatly improved viral clearance at week four of treatment in genotype 1 hepatitis C infection compared to the control group. We look forward to further results from this ongoing study."
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