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Response-Guided Therapy with Boceprevir + Peginterferon alfa-2b/Ribavirin for Treatment-Naïve Patientswith Hepatitis C Virus Genotype 1 Was Similar to a 48-Wk Fixed-Duration Regimen with Boceprevir + Peginterferon alfa-2b/Ribavirin in SPRINT-2
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Reported by Jules Levin
AASLD Nov 1 2010 Boston
Jean-Pierre Bronowicki1, Jonathan McCone2, Bruce R. Bacon3, Savino Bruno4, Michael P. Manns5, Mark S. Sulkowski6, Ira M. Jacobson7, K. Rajender Reddy8, Navdeep Boparai9, Vilma Sniukiene9, Clifford A. Brass9, Janice K. Albrecht9, Fred Poordad10
1Centre Hospitalier Universitaire de Nancy-Brabois, Vandoeuvre-les-Nancy, France; 2Gastroenterology/Hepatology/Certified Endoscopy Centers, Alexandria, VA, United States; 3Saint Louis University School of Medicine, St. Louis, MO, United States; 4University of Milan, Milan, Italy; 5Medical School of Hannover, Hannover, Germany; 6Johns Hopkins University School of Medicine, Baltimore, MD, United States; 7The Joan Sanford I. Weill Medical College of Cornell University, New York, NY, United States; 8University of Pennsylvania, Philadelphia, PA, United States; 9Merck, Whitehouse Station, NJ, United States; 10Cedars-Sinai Medical Center, Los Angeles, CA, United States.
ABSTRACT
Background: In SPRINT-2, BOC added to P/R given for 44 wks or as RGT after a 4-wk lead-in (LI) treatment period with P/R significantly improved the sustained virologic response (SVR) in treatment-naïve G1 patients compared to standard of care. We examined whether RGT based on the HCV RNA response during Wks 8-24 for a total duration of 28 or 48 wks (but including only 24 wks of BOC from Wks 4 to Wk 28 regardless of the Wk 8-24 HCV RNA response) produced similar results to the 4-wk LI & then BOC/P/R for 44 wks.
Methods:SPRINT-2 compared a LI treatment period with P/R, followed by (1) P/R plus placebo for 44 wks (48P/R); (2) RGT: BOC/P/R for 24 wks, with an additional 20 wks of P/R alone only if HCV RNA was detected during Wks 8-24 (LI+24BOC/P/R+/-20P/R); or (3) BOC/P/R for 44 wks (LI+44BOC/P/R). Study therapy was stopped for futility in patients with detectable HCV RNA at Wk 24. The primary efficacy endpoint was the SVR in all randomized patients treated with ≥1 dose of any study medication. Non-black (Cohort 1) & black (Cohort 2) patients were enrolled & analyzed separately per protocol.
Results: In Cohort 1, the overall SVR [95%CI] was similar for RGT (66.8%) & LI+44BOC/P/R (68.5%), with a Δ=1.7% [-5.6%, 9.0%]. For the 47% of subjects in RGT arm who achieved persistently undetectable HCV RNA during Wks 8-24, the SVR was 97% after LI+24/BOC/P/R & similar to the 96% SVR for the corresponding patients receiving LI+44BOC/P/R (Table). 31% of patients in the RGT arm discontinued treatment by 28 weeks (mostly due to the 24-wk futility rule or adverse events) & were not assigned a treatment duration. For the 22% of patients in the RGT arm with detectable HCV RNA during Wks 8-24 who received >28 wks of therapy, the SVR was 74% after LI+24BOC/P/R+20P/R & matched the 74% SVR for the corresponding patients given LI+44BOC/P/R. Generally comparable results were seen in the much smaller Cohort 2.
Conclusions: RGT with LI+24BOC/P/R+/-20P/R based upon on-treatment HCV RNA response produced SVR similar to LI+44BOC/P/R. Non-black patients achieving undetectable HCV RNA on LI+BOC/P/R from Wk 8 through Wk 24 can have their treatment duration shortened from 48 wks to 28 wks.
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