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Data Supporting Boceprevir Response Guided Therapy Presented at American Association for the Study of Liver Diseases (AASLD) Annual Meeting
Date:11/1/2009

28 weeks or 36 weeks, respectively. Patients without RVR receive a 48-week boceprevir-based regimen. RVR in these studies is defined as undetectable virus (HCV RNA) in plasma at 4 weeks after the addition of boceprevir (treatment week 8).

Boceprevir Response Guided Therapy to Determine Treatment Duration

In a poster presentation at AASLD,(2) researchers reported that patients in the lead-in arms (4 weeks of PEGINTRON and REBETOL followed by the addition of boceprevir) of the Phase II HCV SPRINT-1 study who had RVR and were treated for 28 weeks achieved an 82 percent SVR (54/66). Patients in the lead-in arms who did not have RVR, but had undetectable virus by treatment week 16, and were treated for 48 weeks achieved a 79 percent SVR (15/19). These results doubled the 38 percent SVR (39/104) achieved by patients in the control group receiving 48 weeks of peginterferon and ribavirin alone. Overall, 64 percent of patients in the lead-in arms achieved RVR (132/206).

"These results are very exciting and provide important insights to help further define response guided therapy with boceprevir using a peginterferon and ribavirin lead-in strategy," Kwo said. "Building on the RVR rate seen in this Phase II study, the boceprevir Phase III study in treatment-naïve patients is designed to confirm whether the majority of patients can be treated with a 28-week boceprevir-based regimen."

SVR was the primary efficacy endpoint of the HCV SPRINT-1 study. Based on an intent-to-treat analysis (ITT), the 28-week and 48-week lead-in boceprevir arms had SVR rates of 56 percent (58/103) and 75 percent (77/103), respectively, and the no lead-in boceprevir arms had SVR rates of 54 percent (58/107) and 67 percent (69/103), respectively, compared to 38 percent SVR for the control group.(3-5)

In the HCV SPRINT-1 study, the most common adverse events reported in the boceprevir arms were fatigue, anemia, nausea and headache.
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SOURCE Schering-Plough Corporation
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