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Holkira (Ombitasvir/Paritaprevir/ Ritonavir with Dasabuvir) and Harvoni (Ledipasvir/Sofosbuvir) for Chronic Hepatitis C: A Review of the Clinical Evidence

Published on: January 19, 2015
Project Number: RC0632-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness and safety of Holkira Pak (ombitasvir/paritaprevir/ ritonavir plus dasabuvir) for the treatment of chronic hepatitis C genotype 1?
  2. What is the clinical effectiveness and safety of Harvoni (ledipsavir and sofosbuvir) for patients with chronic hepatitis C genotype 1?

Key Message

Six clinical trials demonstrated the superiority of Holkira Pak alone and with RBV over historical control rates for SVR12 (sustained virologic response 12 weeks after treatment). In patients with CHC genotype 1b, Holkira Pak alone was not within the pre-specified margin for non-inferiority to Holkira Pak with RBV. However, in patients with CHC genotype 1a, Holkira Pak alone was not non-inferior to the combination, indicating the need for RBV co-treatment in patients with genotype 1a. The available evidence from six open-label clinical trials on Harvoni indicates that SVR was achieved by more than 90% of patients who received Harvoni with or without ribavirin (RBV) for 8, 12 or 24 weeks. Serious adverse events and discontinuation due to adverse events were low, and anemia, rash and depression were low in patients who did not receive RBV.

Tags

ritonavir, hepatitis c, hepatitis, Holkira, Viekira Pak, Viekira, Viekirax, ombitasvir, paritaprevir, dasabuvir, Exviera