HCV : PE-136 ; Sustained virologic response (SVR) in prior peginterferon/ribavirin (PR) treatment failures after retreatment with boceprevir (BOC) + PR: The PROVIDE study interim results = HCV : PE-136 ; Sustained virologic response (SVR) in prior peginterferon/ribavirin (PR) treatment failures after retreatment with boceprevir (BOC) + PR: The PROVIDE study interim results

다국어 초록 (Multilingual Abstract)

Background: Patients in the PR control arms of BOC Phase 2/3 studies who did not achieve SVR could enroll in PROVIDE and receive BOC+PR. This interim analysis examines the preliminary efficacy and safety of BOC+PR in patients who failed prior treatment with PR. Methods: BOC (800 mg TID with food) was given with P 1.5 mcg/kg/week and weight-based R (600-1400 mg/day) BID for up to 44 weeks. If >2 weeks had elapsed since end of treatment in the previous study, PR was given for 4 weeks before adding BOC. Protocol specified analyses include patients who received at least one dose of BOC. Denominators for on-treatment response include patients who reached the specific time point or discontinued. The denominators for SVR include all patients who reached end of follow-up, discontinued, or were treatment failures. Results: Characteristics of 168 enrolled patients were: 67% male, 84% Caucasian, mean age 52 years, mean BMI 27.9 kg/m2, 77% high viral load (>800,000 IU/mL; mean log10 6.26); 10% cirrhotic; 61% subtype 1a. Table shows the proportion of BOC treated patients with undetectable HCV RNA at tested time points. SVR was achieved in 40% of prior null responders (<2 log10 decline in HCV RNA at TW12 in prior study) and 68% of prior partial responders/relapsers; 78% (38/49) of prior null responders and 24% (26/107) of prior partial responders/ relapsers had <1 log10 decline in HCV RNA after the PR lead in. Overall SVR was 47% in patients with <1 log10 decline with lower SVR rates in prior null responders (36%) vs. prior partial responders/relapsers (65%). 68% of patients with >1 log decline achieved SVR (55% prior null responders; 70% prior partial responders/relapsers). Seven percent of patients discontinued due to AEs, while 48% experienced anemia, 34% dysgeusia and 22% neutropenia. Conclusions: BOC+PR achieved high SVR rates regardless of prior response to PR. The degree of interferon responsiveness after PR lead in correlates with prior response and can help predict SVR for prior null responders. The safety profile is comparable to that previously reported for BOC+PR.