Holkira (ombitasvir/paritaprevir/ ritonavir with dasabuvir) and Harvoni (ledipasvir/sofosbuvir) for chronic hepatitis C: a review of the clinical evidence
CADTH
Record ID 32016000129
English
Authors' recommendations:
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.
Details
Project Status:
Completed
Year Published:
2015
URL for published report:
http://www.cadth.ca/sites/default/files/pdf/htis/jan-2015/RC0632%20Holkira%20and%20Harvoni%20Final.pdf
English language abstract:
An English language summary is available
Publication Type:
Rapid Review
Country:
Canada
MeSH Terms
- Ritonavir
- Hepatitis C
- Antiviral Agents
- Drug Therapy, Combination
Contact
Organisation Name:
Canadian Agency for Drugs and Technologies in Health
Contact Address:
600-865 Carling Avenue, Ottawa, ON K1S 5S8 Canada. Tel: +1 613 226 2553; Fax: +1 613 226 5392;
Contact Name:
requests@cadth.ca
Contact Email:
requests@cadth.ca
Copyright:
Canadian Agency for Drugs and Technologies in Health (CADTH)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.