A new direct-acting antiviral (DAA) oral regimen for the treatment of hepatitis C, glecaprevir + pibrentasvir (Maviret)
will be subsidised without restriction from 1 February, 2019 and will replace Viekira Pak* regimens, which are being delisted.1 General
practitioners have been able to prescribe Viekira Pak and Viekira Pak-RBV since 1 October, 2016, to treat patients infected
with HCV genotypes 1a and 1b (approved indications) and genotype 4 (unapproved indication). Glecaprevir + pibrentasvir
can be prescribed to patients with hepatitis C virus (HCV) infection due to any of the HCV genotypes.
* Viekira Pak (paritaprevir, ritonavir and ombitasvir with dasabuvir); Viekira Pak-RBV (the same combination with the
addition of ribavirin)
More patients can now benefit from treatment
There are approximately 50,000 people with chronic HCV infection in New Zealand who could benefit from subsidised treatment
with glecaprevir + pibrentasvir.2
In New Zealand, approximately 56% of HCV infections are caused by genotype 1, approximately 35% due to genotype 3 and
8% due to genotype 2.3 Genotypes 4 and 6 together account for less than 2% of HCV infections, and genotype
5 does not appear to be present in New Zealand.3 All patients with HCV infection without evidence of cirrhosis
can now be treated in primary care with subsidised glecaprevir + pibrentasvir, including patients with less severe disease
due to genotypes 2, 3, and 6, who were previously ineligible for subsidised treatment.
Treatment with glecaprevir + pibrentasvir is shorter and simpler for clinicians and patients than Viekira Pak regimens
Glecaprevir + pibrentasvir is taken as a once daily regimen of three tablets, for eight weeks, regardless of HCV genotype.
Viekira Pak regimens required patients to take six to ten tablets per day, with morning and evening dosing, for eight
to twelve weeks, depending on patient characteristics and HCV genotype.
HCV genotype testing is no longer required
Glecaprevir + pibrentasvir can be prescribed to patients infected with any HCV genotype, therefore genotype testing
prior to initiating treatment is no longer required.
Treatment with ribavirin is no longer required
Patients with genotype 1a infection previously required the addition of ribavirin to their treatment regimen (Viekira
Pak-RBV). The use of ribavirin is associated with adverse effects such as anaemia and requires strict use of two forms
of contraception during and for six months following treatment due to its teratogenic potential. Ribavirin is not required
for patients with genotype 1a infection receiving glecaprevir + pibrentasvir treatment.
Patients should present prescriptions for glecaprevir + pibrentasvir to an enrolled pharmacy
Prescriptions for glecaprevir + pibrentasvir should be given to the patient to present to a pharmacy, as is typically
the case for most medicines subsidised in the community. Similar to the arrangements that have been in place for Viekira
Pak regimens, glecaprevir + pibrentasvir will be available at enrolled pharmacies.4 There is no co-payment
required from patients for glecaprevir + pibrentasvir prescriptions. For patients prescribed Viekira Pak regimens or Harvoni,
prescriptions need to be sent directly to PHARMAC.
From 1 February, 2019, a list of pharmacies enrolled to dispense glecaprevir + pibrentasvir will be available at:
www.maviret.co.nz
An online training module for pharmacies who wish to enrol is available at:
www.abbviecarepharmacy.co.nz
From 1 February, 2019, Viekira Pak and Viekira Pak-RBV will no longer be subsidised.4 Patients who have
already begun treatment with these regimens before this date can continue treatment and finish their prescribed course
of medicines.1 Patients who have already been prescribed a Viekira Pak regimen, but have not presented to
an enrolled pharmacy to start their course of treatment, will be able to present to an accredited
pharmacy between 1 February, 2019 and 30 April, 2019 to start treatment and receive their prescribed course of Viekira
Pak regimen.4 Patients
who have previously been treated with Viekira Pak regimens and have no evidence of HCV viral activity after treatment
do not need to be re-treated with glecaprevir + pibrentasvir.
Patients initiating HCV treatment on or after 1 February, 2019 should be prescribed glecaprevir + pibrentasvir.1
Ledipasvir + sofosbuvir is subsidised for patients who meet Special Authority criteria, including patients with advanced liver complications, e.g.
decompensated cirrhosis or awaiting a liver transplant. Applications for subsidised ledipasvir + sofosbuvir are likely to be made in secondary
care and will be reviewed by the PHARMAC Hepatitis C Treatments Panel.
This resource provides prescribers in primary care with comprehensive guidance on the management of patients with hepatitis C (Figure 1).
It is not intended to cover patients treated in secondary care who may have advanced disease and/or concurrent
viral infections. Patients in secondary care are managed according to the New Zealand Society of Gastroenterology HCV
treatment guidelines.
To safely manage patients with hepatitis C in primary care, general practitioners need to:
- Test patients at high risk of infection
- Conduct pre-treatment assessments
- Monitor and follow-up patients prescribed glecaprevir + pibrentasvir
Further information for patients and clinicians:
HCV testing
- HCV serology
- HCV RNA assay or HCV core antigen assay*
*It is anticipated that HCV core antigen assays will become available for routine testing at some stage
during 2019. HCV core antigen assays can be used as an alternative to HCV RNA assays to test for current chronic HCV infection.
When they become available, HCV core antigen assays will be performed as reflex tests in patients with positive HCV serology
If treatment in primary care is appropriate
Prescribe glecaprevir + pibrentasvir
- Patients will need to collect their medicine from an enrolled pharmacy
- Alternative arrangements can be made if collection from an enrolled pharmacy is not possible
Treatment lasts eight weeks
Follow-up patients after four weeks of treatment to assess adverse effects
After treatment has finished
- Test for cure with an HCV RNA assay or HCV antigen assay conducted four weeks after treatment has finished. Order liver
function tests at the same time (may also need to check at 12 weeks post-treatment as these can take longer to normalise).
- Refer patients to a gastroenterologist if test results are positive four weeks after treatment has finished
- Patients with cirrhosis require long-term monitoring for the development of hepatocellular carcinoma
- No further follow-up for HCV complications is required for patients without cirrhosis and with normal liver function
tests after treatment
- If patients have ongoing abnormal liver function tests, consider other possible causes
- Annual HCV RNA assays or HCV core antigen assays are recommended for patients with ongoing risk factors, e.g. people
who inject drugs. Previous infection does not confer immunity.
Figure 1: Diagnosis and management of HCV infection in primary care
Acknowledgement:
Thank you to Dr Ed Gane, Professor of Medicine, University of Auckland, Chief Hepatologist and Deputy
Director of the New Zealand Liver Transplant Unit for expert review of this article.
References
