This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.
CADTH. Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). Rapid Response. 2015
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.
Subject indexing assigned by CRD
Hepatitis C; Hepatitiss; Ritonavir
Country of organisation
An English language summary is available.
Address for correspondence
Canadian Agency for Drugs and Technologies in Health (CADTH), 865 Carling Avenue, Suite 600, Ottawa, Ontario Canada, K1S 5S8 Email: email@example.com
Date abstract record published