On April 11, 2016, Health Canada approved Holkira Pak to treat patients who are HCV/HIV-1 co-infected and those with hep C (HCV) who have had liver transplants.
The efficacy and safety of Holkira Pak to treat patients with hep C genotype 1 co-infected with HIV-1 has been established. The efficacy and safety of Holkira Pak with ribavirin has also been proven when used to treat liver transplant recipients with normal hepatic function and a Metavir fibrosis score of ≤ 2, regardless of whether the virus is hepatitis C genotype 1a or 1b.
Holkira Pak is a treatment for patients with chronic genotype 1 hepatitis C without severe liver damage. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.
In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of those with genotype 1 hep C and was found to be well tolerated by patients. 98% of clinical trial participates completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to side effects were low (0.2%).
Holkira Pak for Patients HCV/HIV-1 Co-Infected
In the clinical trial Turquoise-I, 94% of patients who were HCV/HIV-1 co-infected were cured of hep C, achieved a sustained virologic response, with Holkira Pak and ribavirin.
Holkira Pak for Liver Transplant Recipients
Holkira Pak cured 97% of liver transplant recipients in clinical trial. Those clinical trial results and additional information about the trial can be found in The New England Journal of Medicine.
For more information about Holkira Pak, hep C treatments for those HCV/HIV co-infected, or for those who have had liver transplants, please visit PHCN’s Hepatitis C Treatment Information Project or email.