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Retreatment, Switching and Extended Therapy with Boceprevir and Telaprevir for Chronic Hepatitis C Infection: A Review of the Clinical Effectiveness and Safety

Published on: March 8, 2012
Project Number: RC0327-001
Product Line: Rapid Response
Research Type: Devices and Systems
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical evidence for retreating a patient with chronic hepatitis C infection with a protease inhibitor?
  2. What is the clinical evidence for switching a patient with chronic hepatitis C infection to the other protease inhibitor midway through completion of the original PR-protease inhibitor therapy?
  3. What is the clinical evidence for adding boceprevir or telaprevir treatment for patients with chronic hepatitis C infection who are currently undergoing treatment with only PR?
  4. What is the clinical evidence regarding longer courses of treatment (of either PI-PR or PR alone) than approved in product monographs for patients with poor virological response on PI-PR or PR alone?

Key Message

There is currently no available evidence for retreatment of patients with CHC infection with protease inhibitors. There is currently no available evidence for switching a patient with CHC infection from one protease inhibitor to the other midway through completion of the original PR-protease inhibitor therapy. There is evidence that initiating boceprevir after a 4-week lead-in period with PR leads to a higher response rate than continuing on PR alone. There is also evidence that in treatment-experienced patients, initiating telaprevir 4 weeks into a PR regimen is as efficacious and safe as starting patients on telaprevir-PR. There is no evidence for initiating a protease inhibitor after four weeks of PR therapy. There is also no evidence comparing the addition of a PI to PR at 4 weeks with continuation of PR alone in patients who achieve rapid virological response (undetectable HCV at 4 weeks); such patients demonstrate high SVR rates with 24 weeks of PR alone, therefore the benefit of PI-PR therapy is uncertain. There is evidence that extending treatment duration with PR from 48 to 72 weeks leads to a statistically significant increase in the rate of sustained virologic response (SVR). However, given the availability of the protease inhibitors, it is perhaps unlikely that PR regimens longer than 48 weeks would be considered for most patients exhibiting slow virological response.

Tags

hepatitis, drug therapy, pharmacotherapy, oligopeptides, proline, chronic hepatitis c