New and Noteworthy
- Canadian Hep C research network receives $4.5 million grant
- B.C., Saskatchewan, Manitoba and Yukon add Holkira Pak to formularies
- FDA approves new interferon-free Hep C treatments for genotypes 3 and 4 virus
Canadian Hep C research network receives $4.5 million grant
The new National Collaborative Hepatitis C Network received a 5-year, $4.5 million dollar grant from the Public Health Agency of Canada and the Canadian Institutes for Heath Research.
The network includes over 60 researchers, health professionals and partners from across Canada. Projects undertaken by the network will aim to:
- improve prevention strategies
- enhance access and adherence to treatment
- better understand the health challenges of Canadians living with hepatitis C
(crchum.chumontreal.qc.ca, July 2015, in English and French)
B.C., Saskatchewan, Manitoba and Yukon add Holkira Pak to formularies
Holkira Pak has been added to B.C., Saskatchewan, Manitoba and the Yukon’s formularies for people with genotype 1 Hep C virus.
Holkira Pak is a combination of three direct-acting antivirals (DAAs). DAAs attack the ability of the Hep C virus to make copies of itself. Holkira Pak consists of:
- paritaprevir, a protease inhibitor, which is boosted with ritonavir
- ombitasvir, an NS5A inhibitor
- dasabuvir, an NS5B inhibitor
Paritaprevir/ritonavir and ombitasvir are co-formulated into one tablet. Dasabuvir is its own tablet. Holkira Pak may also be taken with ribavirin.
In clinical trials of Holkira Pak, the cure rates ranged from 90% to 100%.
For more information on Holkira Pak, see the Holkira Pak factsheet and TreatmentUpdate 207.
FDA approves new interferon-free Hep C treatments for genotypes 3 and 4 virus
The U.S. Food and Drug Administration (FDA) has approved daclatasvir (also known by the brand name Daklinza in the U.S.) taken with sofosbuvir for treatment of people with genotype 3 Hep C virus.
This is the first approved Hep C treatment for genotype 3 virus that does not include peg-interferon or ribavirin, medications that can cause difficult side effects.
In clinical trials of daclatasvir and sofosbuvir for 12 weeks, cure rates were higher in participants who did not have severe liver injury or cirrhosis (98% and 92%) than people who had cirrhosis (58% and 69%).
Daclatasvir is not approved in Canada.
The FDA has also approved a co-formulation of ombitasvir and paritaprevir boosted with ritonavir for people with genotype 4 virus who do not have severe liver injury (cirrhosis). This combination is one of the tablets included in the Holkira Pak combination and is called Technivie in the U.S. It is approved to be taken with ribavirin for treatment of people with genotype 4 virus.
This is the first approved treatment for genotype 4 that does not include peg-interferon.
In a clinical trial of Technivie with and without ribavirin for 12 weeks in people with genotype 4 virus, 100% of the 91 participants who took Technivie with ribavirin were cured. Of the 44 people who took Technivie without ribavirin, 91% were cured.
Ombitasvir and paritaprevir boosted with ritonavir has not been approved in Canada for genotype 4 virus.
(fda.gov, July 2015, in English)