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Response-Guided Therapy for Boceprevir Combination Treatment?
Results from HCV SPRINT-1
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Reported by jules Levin
AASLD Nov 2009
Paul Y. Kwo,1 Eric Lawitz,2 Jonathan McCone,3 Eugene R. Schiff,4 John M. Vierling,5 David Pound,6 Mitchell Davis,7 Joseph S. Galati,8 Stuart C. Gordon,9 Nataranjan Ravendhran,10 Lorenzo Rossaro,11 Frank H. Anderson,12
Ira M. Jacobson,13 Raymond Rubin,14 Kenneth Koury,15 Navdeep Boparai,15 Eirum I. Chaudhri,15 Clifford A. Brass,15 Janice K. Albrecht15
1Medicine, Division of Gastroenterology/ Hepatology, Indiana University School of Medicine, Indianapolis, IN, USA; 2Alamo Medical Research, San Antonio, TX, USA; 3Mount Vernon Endoscopy Center, Alexandria, VA, USA; 4University of Miami Center for Liver Diseases, Miami, FL, USA; 5Baylor College of Medicine,
Houston, TX, USA; 6Indianapolis Gastroenterology Research Foundation, Indianapolis, IN, USA; 7South Florida Center for Gastroenterology, Wellington, FL, USA; 8Liver Specialists of Texas, Houston, TX, USA; 9Henry Ford Hospital, Detroit, MI, USA; 10Digestive Disease Associates, Baltimore, MD, USA; 11University of
California-Davis, Sacramento, CA, USA; 12The Liver & Intestinal Research Center, Galveston, TX, USA; 13Weill Medical College of Cornell University, New York, NY, USA; 14Digestive Healthcare of Georgia, Atlanta, GA, USA; 15Schering-Plough Research Institute, Kenilworth, NJ, USA
ABSTRACT
Background: HCV SPRINT-1 investigated a 4-week lead-in of PegIntron (P;1.5 µg/kg/QW) plus Ribavirin (R;800-1400 mg/day) prior to the addition of Boc (800 mg TID) for 24 or 44 weeks. Analysis of this data may lead to RGT paradigms.
Methods: Viral response was assessed by Roche TaqMan (LLD=15 IU/mL) at multiple time points including treatment weeks 4, 8, 12, 24, and 24 weeks post-treatment (sustained virologic response; SVR).
Results: Patients were all G1 (1a>1b) with 15% African- Americans, 7% cirrhotics, and 90% high viral load. W8 virology was available for all 103 patients in each arm. The majority of patients (64%) became negative by week 8 and SVR rates were similar for the long (94%) and short (82%) treatment arms
(p=NS). In contrast, patients who first became negative between week 8 and 16, benefited from longer therapy (SVR 79% vs 21%; p=0.004) but represented only 18% of the population. A third group never achieved undetectable HCV RNA by W16; this group primarily comprises null responders (11/18 in 48W arm) at week 4.
Conclusions: The majority of patients (64%) had undetectable HCV RNA after 4 weeks of triple therapy following the lead-in and had a high rate of SVR (82%) following a shortened 28-week treatment duration. Only 18% of patients first achieving undetectable HCV RNA after week 8 and before week 16 of therapy benefited from a longer treatment regimen of 48 weeks. These data suggest that only a minority of treatment-naïve G1 patients will require more than 28 weeks of therapy, and response-guided therapy based on week-8 viral response may be a powerful predictive tool to individualize therapy. The SPRINT-2 trial is designed to prospectively confirm this treatment paradigm.
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