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Adherence to assigned dosing regimen and sustained virological response among chronic hepatitis C genotype 1 patients treated with boceprevir plus peginterferon alfa‐2b/ribavirin
Author(s) -
Gordon S. C.,
Yoshida E. M.,
Lawitz E. J.,
Bacon B. R.,
Sulkowski M. S.,
Davis M.,
Poordad F.,
Bronowicki J.P.,
Esteban R.,
Sniukiene V.,
Burroughs M. H.,
Deng W.,
Dutko F. J.,
Brass C. A.,
Albrecht J. K.,
Rajender Reddy K.
Publication year - 2013
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.12342
Subject(s) - medicine , dosing , boceprevir , ribavirin , regimen , gastroenterology , sofosbuvir , combination therapy , chronic hepatitis , immunology , virus
Summary Background Adherence to therapeutic regimens affects the efficacy of peginterferon alfa (P) and ribavirin (R) therapy in patients with chronic hepatitis C virus genotype 1. Aim To determine if medication adherence impacts efficacy [sustained virological response ( SVR )] with triple therapy that includes boceprevir (BOC) plus P/R. Methods Adherence was determined in two Phase 3 clinical studies with BOC: SPRINT ‐2 (previously untreated patients) and RESPOND ‐2 (patients who failed previous therapy with P/R). Adherence to the assigned duration of the dosing regimen and adherence to the three times a day (t.d.s.) dosing interval of 7–9 h for BOC were assessed by the recording of data from patients’ dosing diaries and by the amount of study drug dispensed and returned. Results Most patients (63–71%) adhered to ≥80% of their assigned treatment duration and achieved SVR rates of 86–90%. In contrast, patients who adhered to <80% of their assigned treatment duration achieved SVR rates of 8–32% ( P < 0.0001), particularly low in patients who failed previous therapy ( SVR = 8–15%). Different rates of adherence (<60% to >80%) to the t.d.s. dosing interval (7–9 h) with BOC did not influence the SVR rates ( SVR = 60–83%) with the exception of patients who failed previous treatment and adhered to <60% of the t.d.s. dosing interval with BOC ( SVR = 48–50%; P = 0.005). Conclusions The achievement of an SVR is more dependent on adherence to the assigned duration of treatment than adherence to the t.d.s. dosing interval with boceprevir. Adherence to >60% of t.d.s. dosing with boceprevir is important in patients who failed previous therapy.