Key practice points:
- The treatment of hepatitis C virus (HCV) infection is a changing area of medicine and it is likely that patients
will increasingly be managed in primary care
- Newer direct-acting antiviral (DAA) medicines result in high rates of cure (>95%) with fewer adverse effects than
previous treatment regimens. This has the potential to substantially reduce the incidence of long-term complications,
reduce transmission and decrease the stigma of HCV infection.
- More testing in primary care is required for people with HCV infection to benefit from DAA treatments: it is estimated
that 50,000 people are infected with HCV in New Zealand and approximately half are undiagnosed.
- Patients with risk factors for HCV should undergo testing; a blood sample for HCV serology is the first step for
In 2016, bpacnz published a comprehensive article on the management of HCV infection after newly subsidised
direct-acting antiviral (DAA) medicines became available. This represented a major change in practice, with many patients
with HCV infection now able to be managed in primary care.
Targeted testing for HCV infection is now required in order for people in New Zealand to gain the maximum possible benefit
from these medicines, and other treatments which may become available in the future.
Further information on testing and managing treatment in patients with HCV is available from: “Treatment
of hepatitis C (HCV) has changed”
Approximately 50,000 people in New Zealand are infected with hepatitis C virus (HCV).1 Only a minority
of patients are symptomatic when they first acquire the virus and most progress to a chronic infection which can go undetected
for many years (see: “Symptoms and signs of HCV infection”).2 The majority of HCV diagnoses in New Zealand
are in people aged in their 40s and 50s who are likely to have been infected earlier in their life.1, 3 The
prevalence of chronic HCV infection is higher in males than females; in a pilot programme in the Bay of Plenty and Wellington
which aimed to increase rates of testing, two-thirds of those diagnosed were male, and the average age of diagnosis was
52 years.1, 3
It is estimated that approximately half of people with HCV in New Zealand are undiagnosed.1 Many
patients in New Zealand have their HCV infection first identified only after they present with complications from long-term
infection. For example, from 2003 to 2013, only half of patients with HCV-related hepatocellular carcinoma had their HCV
infection detected prior to developing cancer.1
Many patients with HCV infection can now be treated in primary care. The DAA medicines Viekira Pak and
Viekira Pak with ribavirin (Viekira Pak-RBV)* were subsidised in July, 2016 and can be prescribed by general
practitioners. These have fewer adverse effects than previous HCV treatments and patients can now be responsible for self-administering
their medicines in the community, with monitoring by their general practitioner. Another DAA medicine, Harvoni,* can
also be prescribed by general practitioners, but patients eligible for this medicine are likely to be treated in secondary
A diagnosis of HCV infection no longer carries the same prognosis for patients. Previously, infection with
HCV was largely a life-long and difficult to treat condition. The high success rates of newer medicines has important
ramifications which can change the way HCV infection is managed and perceived by both clinicians and patients.
Treatment can reduce the risk of long-term complications and improve a patient’s quality of life. Chronic
HCV infection increases the risk of liver disease and can cause other symptoms such as fatigue and depression, as well
as increase the risk developing type 2 diabetes and cardiovascular disease.4 Earlier diagnosis and treatment
may help prevent cancer and other HCV complications, as well as reduce transmission.5
* Viekira-Pak contains four medicines: dasabuvir sodium & paritaprevir + ritonavir + ombitasvir. Viekira-Pak-RBV
contains the same medicines with the addition or ribavirin. Harvoni contains two medicines: ledipasvir and sofosbuvir.
For simplicity, the brand names are used in this article.
Symptoms and signs of HCV infection
The majority of patients with HCV infection are asymptomatic or have non-specific symptoms.6, 7 Diagnosis
of HCV infection is based on laboratory testing.
Acute HCV infection
Acute infection generally refers to the first six months after acquisition of the virus.2 Up to 80% of
people are asymptomatic at this stage.2 As a result, few people have cause to seek medical attention and
acute HCV infection is an uncommon diagnosis. In New Zealand, acute HCV infection is a notifiable disease and approximately
30–40 cases are reported per year.8 Patients who seek medical attention during acute infection may have symptoms
of acute hepatitis, such as jaundice, dyspepsia, a loss of appetite and lack of energy.9 Marked elevations
of alanine aminotransferase (ALT) levels, to over five to ten times the upper limit of normal, occur during acute infection.2 Patients
with clinical findings suggestive of acute HCV infection should undergo testing.
Chronic HCV infection
Approximately three-quarters of people who acquire HCV infection develop a chronic infection, which can also go undetected
as many remain asymptomatic.2 Fatigue is a non-specific symptom of chronic HCV infection, reported by approximately
50% of patients.7 Approximately 16% of people with chronic HCV infection develop cirrhosis after 20 years,
increasing to 41% after 30 years.10 Patients with chronic HCV infection may have symptoms and signs consistent
with liver disease, such as a spider naevi, oedema, ascites or bruising.2 Patients with non-specific symptoms
such as unexplained fatigue can be asked about risk factors to assess whether testing is appropriate.
Injectable drug use is the most common risk factor for HCV infection (based on people diagnosed during acute infection).11 The
risk of sexual transmission of HCV is low and occurs mainly in people who are infected with HIV.2, 6
It is recommended that all patients with risk factors for chronic HCV infection undergo testing.2 This
includes people who:2, 6, 12
- Have used injectable drugs
- Received a blood transfusion or organ transplant in New Zealand, or another developed country, prior to July, 1992*
- Have migrated from or received a medical or dental intervention in a region with high HCV prevalence. This includes
Eastern Europe, the Middle East, North Africa, Western and Central Sub-Saharan Africa, Central Asia and the
- Have spent time in prison, which can be associated with injectable drug use and unsafe tattooing practices
- Have a tattoo, body piercing or alteration, e.g. scarification, which was performed in an unsafe environment, e.g.
in prison or in a country with a high prevalence of HCV (see above)
- Have a history of acute hepatitis, jaundice or persistently elevated ALT level
- Were born to an HCV infected mother; mother to infant transmission occurs in approximately 5% of cases 13
It may be possible to use the practice’s patient management system to identify patients who should be tested for HCV,
but it is likely that in many cases risk factors will not be recorded in the patient’s clinical record, e.g. injectable
drug use or unsafe tattooing.
* Screening for HCV in blood transfusions and organ transplants began in July 1992 in New Zealand and at approximately
the same time in other developed countries; screening in less developed countries may have occurred at a later date.
Ideally, patients should feel comfortable discussing HCV and disclosing any risk factors, however, this will not always
be the case. Some patients may need more time and additional consultations to allow them to develop sufficient confidence
and trust to discuss risk factors, and therefore allow the clinician to assess whether testing is appropriate.
Understanding the reasons why people may be reluctant to discuss HCV can help clinicians to frame discussion. This may
- Lack of awareness about HCV:
- The low level of publicity about HCV; people who use injectable drugs may be more concerned about contracting HIV
although HCV prevalence is much higher
- Believing HCV is not a concern, since it is a long-term condition which develops over many years
- Not understanding that HCV can cause serious complications
- Lack of obvious symptoms:
- People may believe that since they are asymptomatic and their potential exposure was some time in the past that
they did not contract the virus or it did not have any consequences.
- Knowing other people who are infected who appear well
- Lack of awareness of the new treatments available and high chance of cure
- Confusing hepatitis C with hepatitis A or B and believing they have been vaccinated
- Embarrassment and perceived stigma of:
- Having HCV
- Risk factors for HCV such as drug use (drug users may also have associated fears such as difficulty having blood
- Concerns from anecdotes about other hepatitis C treatments and procedures, such as:
- Undergoing liver biopsy and the associated risks of bleeding and death
- Having interferon treatment and the associated adverse effects and poor chance of cure
- Preferring not to know if they are infected
Create a safe space for patients to open up about risk behaviours
Establish open communication. Risky behaviours can be difficult for patients to disclose. Reiterate
confidentiality; people using injectable drugs may fear repercussions such as problems with the police, employment or
removal of children from their care.16
Try asking the same question in different ways. For example, patients may reply with a “no” when asked
if they have used injectable drugs, but may respond differently to a follow-up question of “not even once?”.17
Minimise questioning if the patient is reluctant to reveal details. In order to decide whether testing
for HCV is necessary, it just needs to be established whether a risk behaviour occurred; further details about the incident
do not have to be revealed. N.B. In some cases, clinicians will want to ascertain if the risk is ongoing in order to provide
appropriate advice, e.g. using a needle exchange facility for current drug use.
Give people time to consider. Some patients may require time to process the information discussed before
revealing risk behaviours or agreeing to undergo testing. Make a note in the patient’s record to revisit the discussion
at their next appointment.
Instead of asking about risk behaviours, ask if patients would like to undergo a hepatitis C test
An alternative approach to asking patients directly about topics such as injectable drug use is to discuss risk factors
for HCV infection and then let them decide if they should undergo testing, without them having to reveal why. This may
also be achieved with the use of posters or handouts in the clinic waiting room which explain risk factors for HCV infection
and encourage patients to discuss testing when they see the doctor.
Printable handouts are available from:
A positive diagnosis and initiation of treatment for HCV requires three laboratory tests: HCV serology, an HCV RNA assay
and HCV genotyping (Figure 1).
In the first instance, a blood sample should be taken for HCV serology, which is ordered as per standard practice on
a community laboratory testing form. If this test is positive, an HCV RNA assay should be ordered, and if this is positive,
HCV genotyping should follow. Some laboratories will do these tests automatically if initial serology is positive in a
previously undiagnosed patient.
HCV serology detects the presence of anti-HCV antibodies:
- A positive result indicates current infection, previous infection or a false positive; further testing is required
- A negative result indicates a patient is unlikely to have an HCV infection unless their exposure occurred within the
last six months
Antibodies to HCV can take up to six months to develop and only 50% of patients are likely to have positive serology
during the acute stage of infection.18 If patients have negative HCV serology within the first six months
of an exposure, a repeat test should be performed after the six month period.
It is estimated that one-quarter of people who contract HCV infection are able to clear the virus without medical intervention,
and these people are likely to test positive for anti-HCV antibodies for a number of years following the infection.2,
19 A positive result could therefore indicate previous infection which has now resolved.
HCV serology is highly specific; false positives do, however, occur. The rate of false positives to true positives depends
on the background prevalence of HCV; in populations with a low prevalence of HCV, such as New Zealand, up to 35% of positive
serology results may be false positives.20
HCV RNA assay
Positive serology should be followed by an HCV RNA assay:
- A negative result indicates the patient does not have an active infection and does not require treatment.18
- A positive result indicates the patient has an active infection
Patients found to have active infection can then be assessed for suitability of different treatment options. If the
patient’s exposure to HCV was recent, a conservative watch and wait approach is generally recommended before commencing
treatment, as one-quarter of patients spontaneously clear the virus without intervention.2
After current infection is confirmed, HCV genotyping is required to identify the type of HCV and therefore the most
suitable treatment option. Viekira-Pak regimens can be used for the treatment of patients infected with genotype 1 (approved
indication) or genotype 4 (unapproved indication), with expected cure rates of over 95%.2, 21 Harvoni can
be initiated, with subsidy subject to Special Authority approval, for patients with decompensated cirrhosis or extra-hepatic
complications of HCV infection who are infected with any HCV genotype.
If patients are not currently eligible for subsidised treatment with the above medicines, guidelines from the New Zealand
Society of Gastroenterology recommend they should wait until they can access a DAA regimen rather than undergo treatment
with a pegylated interferon regimen (the previous standard treatment for HCV).22 Some patients may wish to
import unapproved generic DAA medicines.
For further information on importing generic medicines, see:
Figure 1: Testing for active HCV infection.
The development, testing and approval of DAA medicines for the treatment of HCV infection is a rapidly evolving area
of medicine. Viekira-Pak and Harvoni treatment regimens were subsidised in July, 2016, with Special Authority criteria
for Harvoni altered in June, 2017.23, 24 In 2016, four additional DAA medicines were approved for use in
New Zealand by Medsafe.25 Additional subsidised DAA medicines may become available in the future.
Further information for clinicians:
Information for patients: