Former employee of Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA.
Adherence to assigned dosing regimen and sustained virological response among chronic hepatitis C genotype 1 patients treated with boceprevir plus peginterferon alfa-2b/ribavirin
Article first published online: 26 MAY 2013
© 2013 John Wiley & Sons Ltd
Alimentary Pharmacology & Therapeutics
Volume 38, Issue 1, pages 16–27, July 2013
How to Cite
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. and Rajender Reddy, K. (2013), Adherence to assigned dosing regimen and sustained virological response among chronic hepatitis C genotype 1 patients treated with boceprevir plus peginterferon alfa-2b/ribavirin. Alimentary Pharmacology & Therapeutics, 38: 16–27. doi: 10.1111/apt.12342
- Issue published online: 6 JUN 2013
- Article first published online: 26 MAY 2013
- Manuscript Accepted: 1 MAY 2013
- Manuscript Revised: 29 APR 2013
- Manuscript Revised: 27 JAN 2013
- Manuscript Received: 10 JAN 2013
Adherence to therapeutic regimens affects the efficacy of peginterferon alfa (P) and ribavirin (R) therapy in patients with chronic hepatitis C virus genotype 1.
To determine if medication adherence impacts efficacy [sustained virological response (SVR)] with triple therapy that includes boceprevir (BOC) plus P/R.
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.
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).
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.