- PEI was the first province in Canada to launch a province-wide model for hepatitis C care.
- 93 patients started treatment in the first year, compared to only four treatment initiations in the two previous years.
- 97.6% of patients who started treatment were cured.
The introduction of oral direct-acting antiviral (DAA) drugs for the treatment of hepatitis C has raised the possibility that hepatitis C can be eliminated. For this to happen, there needs to be improved and streamlined access to treatment and care programs.
In April 2015, Prince Edward Island was the first province in Canada to launch a province-wide model for hepatitis C care.
Key elements of the program included:
- centralized referral, triage and intake by a hepatitis C nurse care coordinator
- hepatitis C treatment specialists
- access to DAA treatment with no fibrosis restrictions
- patient education and individualized follow-up
A study of the program’s first year found that 123 patients were seen for intake assessment and 93 patients started treatment. This compares to only four treatment initiations in the two previous years.
Study details
Phase I of the PEI HCV Treatment Program ran from April 1, 2015 to April 1, 2016.
Key entry points into the program were through primary care providers, addiction services, methadone clinics, needle exchanges and emergency departments. Patients were referred to the provincial program after confirmation of hepatitis C infection and a positive viral load test.
Intake and assessment were performed by a nurse care coordinator followed by an appointment with a hepatitis C treatment specialist. Priority was given to patients with advanced fibrosis, co-existing liver disease or viral co-infection, followed by people with genotypes 1 or 4 without serious liver disease (because the available treatments were approved for these genotypes).
Genotype I patients were treated with Holkira Pak (ombitasvir/paritaprevir/ritonavir + dasabuvir) with or without ribavirin for 12 or 24 weeks. Genotype 4 patients were treated with Technivie (ombitasvir/paritaprevir/ritonavir) plus ribavirin for 12 weeks. All drugs were provided free of charge. Patients were given harm reduction support and no one was excluded from treatment solely based on recent substance use.
A nurse care coordinator provided individualized patient education and follow-up at scheduled visits under the oversight of treatment specialists. Patients were given information on hepatitis C transmission, liver health and the importance of adherence to treatment. Patients who were successfully treated and achieved a sustained virological response at 12 weeks post-treatment (SVR12) were given more counselling to reduce the chance of re-infection.
All patients who received at least one treatment dose were included in the analysis of treatment effectiveness. Patients who achieved an SVR12 were considered to be cured, and SVR12 rates were analyzed overall by genotype and cirrhosis status.
Results
There were 242 referrals to the program in its first year. The majority of people (157) had genotype 1, followed by genotype 3 (45 patients), genotype 2 (21 patients), genotype 4 (one patient), and 17 people spontaneously cleared the virus.
Of the 242 referrals, 123 patients (51%) had an initial assessment and education session with the nurse care coordinator. Of these patients, 120 had genotype 1 infection (98%), 17 had fibrosis stage 3 (14%), 29 had cirrhosis (24%), and 24 had previously been treated with interferon-based therapy (20%).
Following initial assessment, 93 patients started treatment, but 30 people were not started on treatment at this point. Of these, 16 (53%) were expected to start treatment after consulting with a hepatitis C treatment specialist. Reasons for not starting treatment included active injection drug use with perceived or reported non-adherence to medication, spontaneous virus clearance, moved out of province, incarceration, abusive behaviour, pregnancy, and exacerbation of Crohn’s disease.
Of the 93 patients who started treatment, 42 had fibrosis stage 3 or stage 4 (cirrhosis). The majority of genotype 1 patients (86, or 92.4%) were treated with Holkira Pak with or without ribavirin for 12 weeks. Six genotype 1 patients who had cirrhosis and had previously not responded to treatment were treated with Holkira Pak plus ribavirin for 24 weeks. The one genotype 4 patient was treated with Technivie plus ribavirin for 12 weeks.
At the time of the study analysis, 84 patients had been followed for 12 weeks post-treatment. The remaining nine patients were still on treatment or waiting for their SVR12 result. Of the 84 patients who had been followed, 82 (97.6%) had achieved an SVR12. Of the two who didn’t achieve an SVR12, one patient was lost to follow-up and one person died of an unrelated event.
Information was collected in a voluntary treatment registry to help gain a better understanding of the hepatitis C population and real-world experience of hepatitis C treatment. A total of 70 patients were enrolled in the registry from April 2015 to April 2016.
Sixty percent of patients in the registry reported no missed doses. The majority (74%) of those who reported missing doses reported missing less than five doses. All patients with an SVR12 result were cured despite this less-than-optimum adherence.
Adverse events
The majority of patients (82%) reported at least one adverse event. The most common reported adverse events were:
- fatigue – 38%
- nausea/vomiting – 22%
- pruritus (severe itchy skin) – 13%
A reduction in ribavirin dose was required in 7% of patients because of anemia or associated symptoms, but all of these patients achieved an SVR12.
Only one person stopped treatment because of an adverse event, which was unrelated to therapy. The patient stopped treatment at week seven but still achieved an SVR12.
A successful strategy
PEI was the first Canadian province to implement a multi-phase open-access hepatitis C elimination strategy. Treatment was very well tolerated and there were no treatment failures in this first stage. A significant number of people with advanced liver disease and other co-morbidities were treated and achieved positive outcomes.
At the time of this study, the program provided access for treatment of genotypes 1 and 4. Since the study was completed, there have been further advances in hepatitis C treatments and pan-genotypic treatments are now available. PEI is planning an expansion of the program to make treatment available to patients with other genotypes.
Resource
Hepatitis C drugs approved in Canada for adults
– Zak Knowles
Reference
Smyth D, Francheville JW, Rankin R, et al. Early successes in an open access, provincially funded Hepatitis C Treatment Program in Prince Edward Island. Annals of Hepatology. 2017 Sep-Oct;16(5):749–758.