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.
Summary Triple therapy using boceprevir or telaprevir remains the reference treatment for genotype 1 chronic hepatitis C in countries where new interferon‐free regimens have not yet become available. Antiviral treatment is highly required in cirrhotic patients, but they represent a difficult‐to‐treat population. We aimed to develop a simple algorithm for the prediction of sustained viral response ( SVR ) in cirrhotic patients treated with triple therapy. A total of 484 cirrhotic patients from the ANRS CO 20 CUPIC cohort treated with triple therapy were randomly distributed into derivation and validation sets. A total of 52.1% of patients achieved SVR . In the derivation set, a D0 score for the prediction of SVR before treatment initiation included the following independent predictors collected at day 0: prior treatment response, gamma‐ GT , platelets, telaprevir treatment, viral load. To refine the prediction at the early phase of the treatment, a W4 score included as additional parameter the viral load collected at week 4. The D0 and W4 scores were combined in the CUPIC algorithm defining three subgroups: ‘no treatment initiation or early stop at week 4’, ‘undetermined’ and ‘ SVR highly probable’. In the validation set, the rates of SVR in these three subgroups were, respectively, 11.1%, 50.0% and 82.2% ( P < 0.001). By replacing the variable ‘prior treatment response’ with ‘ IL 28B genotype’, another algorithm was derived for treatment‐naïve patients with similar results. The CUPIC algorithm is an easy‐to‐use tool that helps physicians weigh their decision between immediately treating cirrhotic patients using boceprevir/telaprevir triple therapy or waiting for new drugs to become available in their country.
