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Adherence To Assigned Dosing Regimen and Sustained Virologic Response Among Hepatitis C-Genotype 1 Previously Untreated and Peginterferon/Ribavirin Treatment-Failure Patients Treated With Boceprevir Plus Peginterferon Alfa-2b/Ribavirin (patients with >80% adherence to all dosing achieved 90% cure rates. My guess is if adherence is 100% SVR rates will be higher)
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Reported by Jules Levin
EASL 2011 Berlin Germany March 31-April 2
from Jules: patients with >80% adherence to all dosing achieved 90% cure rates. My guess is if adherence is 100% SVR rates will be higher. (see Tables 2, 3)
S.C. Gordon1*, E.J. Lawitz2, B.R. Bacon3, M.S. Sulkowski4, E.M. Yoshida5, M. Davis6, R. Jiang7, V. Sniukiene7, M. Burroughs7, C.A. Brass7, J.K. Albrecht7, K.R. Reddy8
1Henry Ford Hospital, Detroit, MI, USA, 2Alamo Medical Research, San Antonio, TX, USA, 3Saint Louis University School of Medicine, St. Louis, MO, USA, 4Johns Hopkins University School of Medicine, Baltimore, MD, USA, 5University of British Columbia and Vancouver General Hospital,
Vancouver, BC, Canada, 6South Florida Center of Gastroenterology, Wellington, FL, USA, 7Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA, 8University of Pennsylvania, Philadelphia, PA, USA, *SGordon3@hfhs.org
BACKGROUND
· Boceprevir (BOC) is an experimental NS3 protease inhibitor
· Addition of BOC to standard-of-care (SOC) peginterferon (P) ribavirin (R) therapy for hepatitis C virus genotype 1 (HCV-G1) significantly improves sustained virologic response (SVR) in previously untreated (SPRINT-2 study) and previous-treatment failure (RESPOND-2 study) patients
· BOC is administered orally, 800 mg TID
· Adherence to therapy dosage and duration is an important predictor
of SVR in HCV-G1 using P/R
OBJECTIVE
To examine the relationship between adherence to treatment dosage and duration and SVR in the SPRINT-2 and RESPOND-2 studies
Methods
Dosing and Adherence
· Calculated as cumulative number of doses divided by expected number of doses, based on actual treatment duration. Stopping for futility per protocol placed some patients in nonadherent status.
· Defined as number of BOC dosing intervals within 7-9 hours in patients ≥80% adherent to dose
· Dosing data collected from patient e-diaries and drug dispensed/returned at the study site
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