Revision history
The Series of National Guidelines (‘the Guidelines’) have been developed by the Communicable Diseases Network Australia (CDNA) and endorsed by the Australian Health Protection Principal Committee (AHPPC). Their purpose is to provide nationally consistent guidance to public health units (PHUs) in responding to a notifiable disease event.These guidelines capture the knowledge of experienced professionals and provide guidance on best practice based upon the best available evidence at the time of completion.
Readers should not rely solely on the information contained within these guidelines. Guideline information is not intended to be a substitute for advice from other relevant sources including, but not limited to, the advice from a health professional. Clinical judgement and discretion may be required in the interpretation and application of these guidelines.
The membership of CDNA and AHPPC, and the Commonwealth of Australia as represented by the Department of Health (‘Health’), do not warrant or represent that the information contained in the Guidelines is accurate, current or complete. CDNA, AHPPC and Health do not accept any legal liability or responsibility for any loss, damages, costs or expenses incurred by the use of, or reliance on, or interpretation of, the information contained in the guidelines.
Endorsed by CDNA: 21 May 2015Endorsed by AHPPC: 18 August 2015Released by Health: 1 September 2015
This guideline is based on the Hepatitis C – CDNA National Guidelines for Public Health Units. NSW specific hepatitis C guidance is included within these call-out boxes throughout the document. Some sections of the CDNA SoNG content have been replaced by more recent NSW specific information in the call-out boxes.
Routine
Individual case management is the responsibility of the treating clinician. Determine if the case is newly acquired and whether associated with injecting illicit drugs or may be another source of exposure
Counselling and offer of testing may be arranged for contacts by the treating clinician and/or the jurisdictional or regional public health unit (PHU) if indicated. This would apply where a person had known, relevant contact with the case or if any other aspects of a case’s history indicated likely exposure of the contact.
The hepatitis C virus (HCV) is a positive strand RNA virus and a member of the flavivirus family of ribonucleic acid (RNA) viruses. At least six HCV genotypes and a large number of subtypes have been described. Each genotype contains numerous subtypes, labelled a, b, or c. Genotypes 1 and 3 are the most common genotypes in Australia [1]. The virus mutates frequently so that many variants may coexist in a single patient [2].
Humans are the only known natural host. People with chronic infection, as defined by persistent serum HCV RNA, are the major reservoir of infection.
HCV is transmitted primarily through blood-to-blood contact, predominantly through the following modes of infection:
+Other routes of exposure are also associated with HCV transmission:
HCV RNA is detectable within 2 weeks following exposure/infection [8] with anti-HCV antibody detectable from 20 to 150 days [9]. The majority of people with newly acquired HCV infection are asymptomatic or mildly symptomatic. When present, acute HCV symptoms and peak elevations in liver enzymes occur at around 6 weeks following infection [10]. As noted below, most people will progress to chronic infection, and a minority will spontaneously clear infection.
People infected with HCV become infectious very early in the course of infection and certainly from the time that RNA is detectable in the blood. Those who clear infection spontaneously are no longer infectious, but are not immunologically protected, so may be re-infected through subsequent HCV exposure. Those who progress to chronic HCV infection remain infectious unless they successfully clear the infection through treatment. Infectiousness is thought to be influenced by HCV RNA level (viral load), but the viral load range is relatively narrow among people with chronic HCV infection (5 to 7 logIU/mL) [9]. There is limited variation in the viral load of an individual case over time.
Approximately 55 to 85% of those with acute infection will develop chronic HCV infection [7] with persistent viraemia and HCV-related liver disease [8]. Liver disease progression, through stages of inflammation, fibrosis (mild, moderate, severe) and cirrhosis, occurs in a proportion of those with chronic infection but is not inevitable and is generally slow with a highly variable course. An estimated one-third of those who become chronically infected will develop liver cirrhosis or hepatocellular carcinoma in the long term [7,12].
Factors that have been associated in observational studies with higher rates of disease progression include older age at infection, heavy alcohol intake [13], regular marijuana smoking, HIV or chronic HBV co-infection, obesity and diabetes [14-16]. Among people with HCV-related cirrhosis, the risk of hepatocellular carcinoma is 2-3% per annum [7] with a similar risk of progression to liver failure.
In addition to liver disease, HCV has been associated with several extra-hepatic manifestations or syndromes, including autoimmune disorders, mild cognitive impairment and chronic fatigue.
Successful HCV treatment, defined by viral eradication, alters the natural history of the infection. Liver disease regression is generally seen, with reductions in the extent of fibrosis or cirrhosis, even if advanced disease is present pre-treatment. Viral eradication also improves quality of life, including improvements in lethargy and other nonspecific symptoms and cognitive impairment.
Population groups at increased risk are:
In Australia, most new and existing hepatitis C infections are amongst people with a history of injecting drug use.
Notifications of hepatitis C in Australia have declined since 2016 following the availability of direct-acting antiviral (DAA) therapy through the Pharmaceutical Benefits Scheme.
Nationally in 2023[i]:
In NSW in 2024 [ii]:
There is no vaccine.
Passive immunisationNone. Passive immunisation with NHIG (normal human immunoglobulin) is not recommended; there is no evidence that it is useful. Active immunisationNone.
The risk of transmission of HCV can be reduced by:
Surveillance of HCV aims to collect data to monitor epidemiological trends in HCV, with particular regard to time, place, population groups and risk factors. These data are used to identify and characterise clusters of cases; inform and evaluate policies, interventions and services to reduce the transmission and consequences of HCV infections; and contribute to reporting on the progress of national strategies.
Newly acquired cases should be entered onto the jurisdictional notifiable diseases database within 5 working days of notification (after evidence is obtained for a case being categorized as either newly acquired or unspecified). Core data and (for newly acquired cases) enhanced data sought from clinicians and laboratories should be entered as soon as information becomes available. Data from jurisdictions are collated in the National Notifiable Diseases Surveillance System (NNDSS) and further analysed by the Kirby Institute. Enhanced surveillance information for newly acquired HCV is collected from states and territories but not included in the core national dataset. Unspecified cases also need to be entered and reported to the NNDSS [a]. These data are defined in the national core and enhanced HCV datasets (NNDSS Dataset – Enhanced Hepatitis C (Newly Acquired) Surveillance Dataset Field Specifications). Appendix 3 has a sample case report form/data collection based on these specifications for use by PHUs.
[a] In practice, the majority of newly acquired cases will be entered as unspecified cases and then revised to the newly acquired category after information is collected that satisfies the case definition.
Hepatitis C is to be notified by:
Notifications received by fax/mail/email should be manually entered into NCIMS.
Data entry into NCIMS should include the following variables:
Laboratories performing HCV testing must notify the relevant state and territory health authorities of any new HCV-positive laboratory diagnosis in accordance with the relevant legislation/regulations. In some states and territories, medical practitioners and/or hospital CEOs must also notify the relevant State and Territory health authorities. On receipt of a notification, a state or territory PHU will contact the diagnosing clinician to obtain additional information to determine the appropriate category for the notification and the need for further case investigation.
HCV surveillance notifications are classified as either ‘newly acquired’ (infection acquired within 24 months prior to diagnosis) or ‘unspecified’ (infection acquired more than 24 months prior to diagnosis or duration not known).
CDNA updated hepatitis C case definitions in 2023; however, these have not yet been implemented in NSW. The definitions for use in NSW are below (as per current definitions from CDNA SoNG v1.0).
Only confirmed cases should be notified.
A confirmed case requires:
Detection of anti-hepatitis C antibody or hepatitis C virus by nucleic acid testing in a patient with no prior evidence of hepatitis C infection.
Clinical hepatitis within the past 24 months (where other causes of acute hepatitis have been excluded) defined as:
A confirmed case requires laboratory definitive evidence and the case does not meet any of the criteria for a newly acquired case and is aged more than 24 months.
In a person with no prior evidence of hepatitis C Infection:
Not applicable.
Updated case definitions can be found on the Department of Health.
As there is no specific test to determine recent infection with hepatitis C and most cases of HCV infection are asymptomatic, it can be very difficult to confirm whether a positive HCV antibody test represents new infection or is indicative of long-standing infection. A documented negative HCV antibody test within the past 24 months is required to meet the confirmed newly acquired case definition. In the absence of a recent negative HCV antibody test, a clinically compatible illness (without an alternate diagnosis) in the 24 months prior to testing is suggestive of a new infection.
Reinfection (where a person has a positive HCV RNA test following a previous HCV antibody test and negative HCV RNA test) is possible, but it is not currently considered in the surveillance definitions.
Two classes of assays are used in the diagnosis of HCV infection: serologic assays that detect specific antibody to HCV (anti-HCV), or HCV antigen; and molecular assays that detect viral nucleic acid.
HCV antigen assays are not available in Australia.
The National Hepatitis C Testing Policy can be found at ASHM Testing Portal.
Current tests are both sensitive and specific (the specificity of current immunoassays for anti-HCV is greater than 99%). However, false positive results may occur. A positive result is more likely to be a false positive when testing is performed among populations where the prevalence of HCV is low and/or where the reactivity of the assay is low. Therefore, a second immunoassay using an assay with a different antigen source or an immunoblot is routinely performed to confirm new positives. False negative results may occur with severe immunosuppression such as infection with HIV, solid organ transplant recipients, hypo- or agammaglobulinaemia or in patients on haemodialysis [21].
Anti-HCV IgG can be detected in the serum or plasma using a number of immunoassays. However, detection of specific antibody does not differentiate between acute and chronic infection, previous exposure, or passive antibody transfer. IgM tests, which usually indicate acute infection, are not clinically useful for HCV. Cases with spontaneous viral clearance will usually remain HCV antibody positive for life.
A nucleic acid test (e.g. PCR test) detects HCV RNA and is therefore a marker of viraemia and current infectivity. A single negative PCR does not rule out infection, as viraemia may be intermittent, particularly during acute infection. Currently available assays have excellent specificity (from 98 to 99%) [21]. Both qualitative and quantitative HCV PCR tests are available but only the former are registered as diagnostic tests. Quantitative HCV PCR tests are only registered for patient management.
Hepatitis C RNA reflex testing is performed by some laboratories in NSW (Appendix 4: Table of pathology laboratories performing HCV RNA reflex testing). Laboratories can perform reflex testing on antibody indeterminate and antibody reactive samples without the request of the ordering clinician. This is achieved by collecting two tubes at sample collection or splitting a single specimen into two aliquots at the sample processing stage. Reflex testing ensures single-visit sample collection to assess current or resolved infection.
Determining the specific HCV genotype can be useful in epidemiological studies and in clinical management because it is associated with treatment outcome [21].
The diagnosis of acute, chronic or cleared HCV infection requires testing of serum for both antibody to HCV (anti-HCV) and for HCV RNA. The differentiation of acute from chronic HCV infection may be difficult or impossible in the short-term and require individual assessment of clinical information, including history of symptoms and risk factors and previous test results, including any previous liver function tests.
After exposure, HCV RNA is usually detectable in serum before antibody; HCV RNA can be identified within two weeks following exposure [8] whereas anti-HCV is detectable between 20 to 150 days following exposure [9].
[b]After recent exposure viral loads can oscillate widely, and can fall below the limit of detection.
Detection of anti-HCV in a person with a negative test for HCV RNA usually represents past, cleared HCV infection. Rarely this result can indicate acute HCV infection during a period of transient clearance of HCV RNA, or a false positive or false negative result on the antibody and RNA results respectively. Re-testing for HCV RNA is recommended to confirm the resolution of HCV infection.
A negative anti-HCV test with a HCV RNA detection may represent:
Again, re-testing for anti-HCV and HCV RNA is recommended [21].
Public health action should commence within 3 working days of notification of a newly acquired confirmed case. Unspecified cases should be provided with information (refer Appendix 2 Sample HCV information sheet) and followed up at the discretion of the PHU director.
Within 5 working days of notification of a newly acquired case begin follow-up investigation.
For more detailed information on unspecified case follow-up, please refer to the NSW specific guidance in the Case investigation section.
Determining the source of infection for newly acquired cases may permit identification of other cases and interrupt infection transmission. Information regarding exposures during the period six weeks to six months before the onset of the illness should be sought. A PHU investigation checklist is provided in Appendix 1.
The response to a notification (newly acquired cases only) will normally be carried out in collaboration with the case's health care providers. Regardless of who does the follow-up, PHU staff should ensure that action has been taken to determine whether the case has any history of injecting illicit drugs in a time period relevant to the acquisition of HCV. If so, the case should be provided with information about the disease (refer Appendix 2 Sample HCV information sheet). If not, information should still be provided about the disease and an exposure investigation carried out.
The response to a notification will normally be carried out in collaboration with the case's healthcare providers. Each local health district should have their own local arrangements regarding the follow-up of cases; however, PHU staff should ensure that action has been taken to:
Only newly notified unspecified cases are to be followed-up. These cases include:
Each local health district must have clearly defined local protocols and processes for case follow up. Where unspecified cases have been tested in a speciality service or high case load GP clinic who are known to regularly treat and manage hepatitis C, the PHU director may choose not to follow-up these cases.
PHUs may make local arrangements for the LHD specialist service to follow-up the cases in line with this control guideline. Where a local arrangement with a specialist service is in place, they may refer cases to specialist services within 3 months to support linkage to care and treatment and collection of enhanced surveillance information or contact the referring doctor to facilitate treatment and collection of enhanced data.
Prior to commencing doctor/patient follow up, the PHU or specialist health service should check the district electronic medical record to determine if the patient has already been assessed at a district facility.
For cases that are RNA positive, PHUs may either:
For cases with incomplete testing, PHUs may either:
Cases with a positive HCV RNA result should be encouraged to commence curative treatment, either prescribed by their general practitioner or through referral to the liver clinic, hepatology or specialist services.
In the situation where a case has been diagnosed with current infection by a public hospital, it is appropriate for the liver clinic, hepatology or specialist services or the PHU to contact the patient directly if medical records do not indicate that treatment has been initiated.
For newly acquired cases not associated with injecting illicit drugs, the possible time period of acquisition should be defined. Information should then be sought regarding potential exposures during the period six months before the start of this period with the purpose of 1) ascertaining the source of the infection and 2) determining whether there might have been others exposed to the same source.
This should include information about history of:
If 2 or more cases are determined to be linked with the same putative source of exposure, then a search for additional cases is strongly indicated as part of the investigation (see Contact Management below).
For newly acquired cases only, information regarding exposures during the six months before onset of the illness (where known) should be sought. Particular emphasis should be placed on the 6 to 9 weeks before onset. If asymptomatic, investigations should be done according to risk history. This should include information about:
Identification of a specific source of infection may be difficult, if not impossible.
Exposures among health care workers should be managed as per the NSW Health Policy Directive (PD2017_010) HIV, Hepatitis B and Hepatitis C – Management of Health Care Workers Potentially Exposed.
For all newly acquired cases, notify CDB if surgical/medical, dental, skin penetration or cosmetic procedures (including are identified as the only possible source of transmission (i.e. no other risk factors have been identified). It is recommended that a case summary (see Appendix 5) is sent to CDB with information on these procedures for review and advice. If the case underwent these procedures interstate, provide CDB with the relevant information and CDB will contact interstate health authorities for further details.
Unspecified cases may need to be investigated on a case-by-case basis or at the discretion of the PHU director.
Discussing, offering and providing treatment are the responsibility of the case’s clinician. Curative therapies have been available for a number of years and can now cure more than 90% of HCV infections, even covering genotypes that were once poorly responsive to treatment [7].
The viral suppression and eradication achieved with treatment is important for the individual patient because it prevents disease progression, and for public health control because it eliminates the risk of viral transmission from that person. Reinfection following treatment can nevertheless occur in association with ongoing injecting illicit drug use [22] and sexual transmission in HIV infected MSM.
Effective new treatments, called direct acting antivirals (DAAs), are now subsidised on the Pharmaceutical Benefits Scheme (PBS) for the treatment of adults with chronic hepatitis C.
Refer to ‘Treatment’ section of the Australian recommendations for the management of hepatitis C virus infection: a consensus statement (2022).
Successful viral eradication is defined as undetectable plasma or whole-blood HCV RNA by PCR at least 12 weeks after DAA therapy is completed. HCV RNA PCR can be performed 4 weeks after completion of treatment. Refer to the ‘Monitoring’ and ‘Post-treatment’ sections of the Australian recommendations for the management of hepatitis C virus infection: a consensus statement (2022).
Following the introduction of DAAs on the PBS, NSW Health has set a goal for the elimination of hepatitis C by 2028 (see NSW Hepatitis C Strategy 2022-2025). People living with hepatitis C are strongly recommended to see their general practitioner or specialist about hepatitis C treatment.
The case (or care-provider as appropriate) should be informed of measures needed to prevent onward transmission while the case is infectious. Standard precautions include:
A fact sheet on HCV infection should be made available to the case and family and other potentially exposed individuals to provide information about the nature of the infection and the mode of transmission (refer Appendix 2 Sample HCV information sheet).
Cases should be advised that until they have an RNA-negative test their blood is infectious to others. An RNA-positive test for virus correlates with infectivity, but RNA positivity can vary over time in HCV antibody-positive individuals.
If the case has had a recent risk exposure and the initial HCV RNA test is negative, repeat testing should be performed. Reinforce standard precautions:
Some people with hepatitis C may be able to donate organs and tissues. Breast feeding by mothers with HCV is not contraindicated unless the nipple is cracked or bleeding.
Cases should be advised HCV is rarely transmitted through sexual contact, but it is possible. Condom use during penetrative sex is recommended with new partners. Cases with only one long-term sex partner are usually advised that there is little benefit in changing their sex practices.
There are a small number of situations in which individuals who have or ever had hepatitis C are advised to disclose their status. Refer to Hepatitis NSW.
HCV infection information sheets in different languages are available at Hepatitis Australia.
The risk of transmission of HCV through personal contact not involving blood is very low (except sexual contact if HIV co-infection is present). Hence, no specific precautions are required other than standard infection control measures.
There may be work restrictions if a case occurs in some occupational groups (see ‘special cases’ and jurisdictional specific requirements in appendices). Isolation and restrictions are otherwise generally not required.
Active case finding entails the encouragement of voluntary testing of populations at high risk of HCV infection (see page 4 of SoNG for populations).
None required, except when a cluster of cases is reported.
Contacts include all people who have had exposure to blood from a person with current HCV infection, including through the use of the same injecting equipment as the case subsequent to the date when infection was acquired in the case. Also included is a child born to a woman with HCV whose infection could have occurred prior to the birth of the child. Contacts may also include sexual partners with HIV infection. Other sexual partners may be considered if they are long-term.
For infections acquired through a procedure involving skin penetration in a medical or other setting, contacts are those who received the same procedure in the same setting, within the time period that the risk was considered, on the best available evidence, to be present.
Household contacts of a person with HCV are not at risk of person-to-person transmission. For cases where there is evidence that HCV acquisition occurred through medical or other skin penetration procedures (generally considered to be a very small minority of cases in the Australian setting), the public health response should include identification and notification of others who may have been exposed in the same setting and should be done in conjunction with the jurisdictional health authority.
Notification of those potentially exposed to HCV infection will alert them to the risk, and thereby enable counselling, testing, medical management as required and education regarding behavioural risk modification if indicated. The responsibilities for contact tracing and management vary between jurisdictions, and may include clinicians, sexual health centres and/or PHUs or Departments of Health. There are some situations in which it is important that relevant jurisdictional health authorities are informed (see Section 12 – Special Situations) even if contact tracing is managed at a local level. For cases acquired through a skin penetration procedure, contact tracing can serve the additional purposes of further investigating or determining the degree of contact with the source, and identifying and ultimately eliminating the risk of further exposure to the identified source of HCV - refer (Australian Contact Tracing Manual).
The extent of contact tracing will depend on an assessment of both the duration and likely source of infection. If the case is determined to be newly acquired and there is a history of injecting drug use in the relevant time period, the notifying doctor may discuss contact tracing of drug-use partners with the case; PHU support may be made available if requested by the doctor. The Australian Contact Tracing Manual provides guidance.
If the case is newly acquired and the source of infection has been determined (or assessed as likely) to be a medical or other skin penetration procedure, trace back using medical or other records to identify others potentially exposed in the same setting up to 6 months prior to onset of acute symptoms in the index case. Depending on the nature of the source, this process can be complex and involve significant logistical and resource challenges and should occur in conjunction with the jurisdictional health authority. It may require a public announcement to alert potentially exposed people if appropriate records are not available. It may also require resources additional to those available routinely. For cases with an unspecified duration of infection, or those for which the procedure took place many years ago, trace back of this kind may not be feasible.
The management of contacts is usually the responsibility of the treating doctor. PHU staff should support treating clinicians in the identification and follow up of contacts of newly acquired cases where required. The Australasian Contact Tracing Guidelines – Hepatitis C recommends tracing back 6 months prior to onset of acute symptoms. If the case is asymptomatic, trace back should be according to risk history.The guidelines recommend the following groups for contact tracing priority:
Sex or injecting partners of people with hepatitis C infection should be encouraged to be tested.
If there is suspicion of acquisition from a skin penetration procedure in a healthcare setting and there is a risk of transmission, the PHU should refer the matter to the NSW Health Blood Borne Viruses Advisory Panel for advice regarding a lookback. It is recommended that a case summary (see Appendix 5) is sent to CDB with information on the skin penetration procedure/s for review and advice.
Nil.
Encourage case to advise contacts about the risk of infection.
If the case occurs is a health care worker who performs exposure prone procedures, it should be assessed and monitored in accordance with Australian National Guidelines for the Healthcare workers who live with blood borne viruses, perform exposure prone procedures, or are at risk of exposure to blood borne viruses.
If the case is a health care worker who performs exposure prone procedures, the case should be assessed and monitored in accordance with the NSW Health Policy Directive (PD2019_026) Management of health care workers with a blood borne virus and those doing exposure prone procedures. HCV status must be ascertained, and if RNA-positive the case should not perform exposure prone procedures. Health care workers should be aware of the need for compliance with standard infection prevention and control precautions as per the NSW Health Policy Directive (PD2023_025) Infection Prevention and Control in Healthcare Settings.
If more than one case occurs among patients of the same health care provider or facility, or tattooist or other skin penetration service provider, or in other circumstances which might suggest the possibility of iatrogenic infection, initiate an investigation and notify the relevant state/territory communicable diseases branch immediately.
For all newly acquired cases, notify CDB if surgical/medical, dental, skin penetration or cosmetic procedures are identified as the only possible source of transmission (i.e. no other risk factors have been identified). The PHU should send a case summary (see Appendix 5) to CDB with information on these procedures for review and advice. If the case underwent these procedures interstate, provide CDB with the relevant information and CDB will contact interstate health authorities for further details.
The Australian Red Cross Blood Service and relevant jurisdictional office should be notified immediately if a person with acute or chronic HCV infection has donated blood or plasma, or if transfused blood or blood products are suspected as the possible source of infection in a newly diagnosed case of HCV.
Notify CDB of any newly acquired cases if:
Appendix 5 should be completed and sent to CDB with information on the transfusions, blood products, and/or organ transplants as required. CDB will notify the Australian Red Cross Lifeblood and the Organ and Tissue Authority as relevant.
Additional actions may be required where a cluster of cases in place or time is detected through analysis of case exposure history. The goal of these actions would be is to identify the source of infection and potential risk factors, thereby informing public health action.
Universal HCV screening is recommended at the first antenatal visit.
Guidelines on whom to offer screening to can be found in the National HCV Testing Policy . People at risk of contracting HCV through ongoing injecting drug use should be offered testing on a regular basis but there are no formal guidelines recommending frequency of testing.
Some jurisdictions offer regular HCV screening for people in custodial settings.
Children under 18 months of age who test positive for anti-HCV antibody should be followed up with either:
to determine whether or not the child is a confirmed newly acquired case.