HepCInfo Updates

HepCInfoUpdate 7.19 

Welcome to CATIE's HepCInfo Update 7.19 for October 1 to October 14, 2016. Read on to learn more about new and updated scientific findings in hepatitis C prevention, care, treatment and support.

New and noteworthy

Access to DAAs limited in most Canadian provinces and territories

Most provinces and territories in Canada (85% to 92%) restrict coverage of direct acting antiviral medications to people with moderate or severe liver injury (F2), reported researchers in CMAJ Open.

The reimbursement criteria for four direct acting antiviral (DAA) drugs or combinations (simeprevir, sofosbuvir, Harvoni and Holkira Pak) were reviewed between April 2016 and June 2016 for 10 provinces and three territories.

The researchers examined:

  • Minimum fibrosis stage required
  • Drug and alcohol use restrictions
  • HIV co-infection restrictions
  • Prescriber related restrictions

PEI is the only province that does not limit access to DAA reimbursement (for Holkira Pak only) based on fibrosis stage. Quebec is taking a tiered approach, treating people with the most liver injury first, then eventually treating people with milder injury.

No province or territory had drug or alcohol use restrictions, but whether to treat people who are currently using injection drugs is left to the doctor.

No restrictions were placed on treating people with HIV co-infection for hepatitis C in any province or territory except Quebec, which does not reimburse simeprevir or sofosbuvir for this group.

In up to 42% (5 out of 13) provinces and territories, specialists were required to recommend people for treatment that would be reimbursed.

According to one of the researchers, “The treatment is effective, safe and economically viable. We should treat all people infected with hepatitis C.” (crchum.chumontreal.qc.ca, October 2016)

Holkira Pak for eight weeks cures almost all with genotype 1b virus

In a late-stage trial, Holkira Pak taken without ribavirin for eight weeks cured 98% of participants with genotype 1b virus, reported researchers at the European Association for the Study of the Liver special conference New Perspectives in Hepatitis C Virus Infection - The Roadmap for Cure.

Holkira Pak consists of two pills:

  • paritaprevir/ritonavir/ombitasvir
  • dasabuvir

The first pill is taken once per day and dasabuvir is taken twice per day.

The trial included 166 participants, the majority of whom had genotype 1b virus. Almost all participants were white and more than half (57%) were women. Most had absent to moderate fibrosis.

The cure rate was 99% for people with mild to moderate fibrosis (F0 to F2) but fell to 87% for people with advanced liver injury (F3).  A cure is also known as a sustained virological response (SVR).

Treatment was generally safe and well tolerated. The most common side effects were headache and fatigue.

According to the researchers “The 98% SVR rate demonstrated that treatment-naive genotype 1b patients without cirrhosis can be effectively treated with [Holkira Pak] for 8 weeks," (HIVandhepatitis.com, September 2016)

New treatment cures all participants with genotype 1 virus in six or eight weeks

A new direct acting anti-viral (DAA) combination containing simeprevir, odalasvir and AL-335 cured 100% of participants in six or eight weeks in a mid-stage trial, reported researchers at the European Association for the Study of the Liver special conference New Perspectives in Hepatitis C Virus Infection - The Roadmap for Cure.

Simeprevir is a protease inhibitor that is already approved in Canada. Oladasvir is an NS5A inhibitor. AL-335 is a polymerase inhibitor.

The trial included 80 participants with genotype 1 virus who had never been treated before. Most participants were white and two-thirds were men. About 80% had genotype 1a virus and the rest had genotype 1b virus. No participants had severe liver injury (cirrhosis).

Participants received AL-335 at doses of 400 or 800 mg once-daily, odalasvir at 50 mg once-daily or every-other-day (QOD), and simeprevir at 75 or 100 mg once-daily.

Treatment was generally safe and well tolerated. The main side effects were headache and fatigue.

There was one adverse event that was considered probably related to the study drugs, an atrioventricular block (a type of heart rhythm abnormality).

Further studies will examine this DAA combination with larger groups of people and a wider range of genotypes. (HIVandhepatitis.com, September 2016)

Straight to the source for new science

HCV post-exposure prophylaxis in the healthcare worker: Why DAAs don’t change a thing, Clinical Infectious Diseases, September 2016