Hepatitis C

Includes non-perinatal acute hepatitis C and chronic hepatitis C.

Reporting Information

Class B

Report a case, suspected case, and/or positive laboratory result to the local public health department in which the patient resides by the close of the next business day. If patient residence is unknown, report to the local public health department in which the reporting healthcare provider or laboratory is located.

Reporting Form(s) and/or Mechanism

The Ohio Disease Reporting System (ODRS) should be used to report cases and lab findings to the Ohio Department of Health (ODH). For healthcare providers without access to ODRS, the Ohio Confidential Reportable Disease Form (HEA 3334) may be used.

The Positive Laboratory Findings for Reportable Disease Form (HEA 3333) may be used for laboratories without access to ODRS or electronic laboratory reporting (ELR) to report positive results.

The Viral Hepatitis Case Report (CDC OMB 0920-0728) is available for use by the local public health department when following up with cases. Do not send this form to ODH unless otherwise requested; information collected from the form should be entered into ODRS where fields are available.

Key Fields for ODRS Reporting

• Patient demographics:
  • First and last name.
  • Date of birth or age (including age type).
  • Sex at birth.
  • Race and ethnicity.
  • Pregnancy status.
• Laboratory information:
  • Test name (selected from drop-down menu).
  • Result (qualitative).
  • Numeric results (quantitative).
  • Reference range for numeric test results.
  • Do not enter Organism if the test is anti-HCV, HCV RNA, or ALT as these tests do not identify the organism.
• Clinical information:
  • Was patient jaundiced?
  • Jaundice onset date.
  • Elevated alanine aminotransferase (ALT) (enter in Laboratory information).
• Epidemiology information: pay special attention to questions related to healthcare associated transmission (e.g., transfusion, dental work), drug use, incarceration, tattooing, and piercing.

Agent

Hepatitis C virus (HCV) is classified in the genus Hepacivirus in the Flaviviridae family. Hepatitis C virus is a single-stranded RNA virus, 55-65 nm in diameter. There are seven distinct genotypes and more than 67 subtypes of the HCV virus.

Case Definition

Clinical Criteria

Cases under the age of 36 months should be classified under the Perinatal HCV Position Statement (17-ID-08) unless the exposure mode is not perinatal (e.g., healthcare acquired).

Acute

A new acute case is an incident case that is over the age of 36 months and has not previously been reported meeting case criteria for chronic hepatitis C or for whom there is laboratory evidence of re-infection AND

• Jaundice OR
• A peak elevated serum alanine aminotransferase (ALT) level greater than 200 IU/L OR
• Peak elevated total bilirubin levels ≥3.0 mg/dL during the period of acute illness.

Symptoms are not required for acute cases.

Chronic

No available evidence of clinical or relevant laboratory information indicative of acute infection. Most hepatitis C virus-infected persons are asymptomatic; however, many have chronic liver disease, which can range from mild to severe.

Laboratory Criteria for Diagnosis

• A positive test for antibodies to hepatitis C virus (anti-HCV) positive OR
• Hepatitis C virus detection test:
  • Nucleic acid test (NAT) for HCV RNA positive (including qualitative, quantitative or genotype testing).
  • A positive test indicating presence of hepatitis C viral antigen(s) (HCV antigen – when and if a test is approved by FDA and available).

Case Classification

Acute, Probable

• A case that meets clinical criteria and has a positive anti-HCV antibody test, but has no reports of a positive HCV NAT for HCV RNA or HCV antigen in the absence of a more likely diagnosis AND
• Does not have test conversion within 12 months or has no report of test conversion.

Acute, Confirmed

• A case that meets clinical criteria and has a positive hepatitis C virus detection test (NAT or HCV antigen) in the absence of a more likely diagnosis OR
• A documented negative HCV antibody OR negative hepatitis C virus detection test (in someone without a prior diagnosis of HCV infection) followed within 12 months by a positive hepatitis C virus detection test (HCV RNA test conversion).

Chronic, Probable

• A case that does not meet clinical criteria or has no report of clinical criteria AND
• Does not have a test conversion within 12 months or has no report of test conversion AND
• Has a positive anti-HCV antibody test, but no report of a positive HCV NAT or positive HCV antigen test.

Chronic, Confirmed

• A case that does not meet clinical criteria or has no report of clinical criteria AND
• Does not have test conversion within 12 months or has no report of test conversion AND
• Has a positive NAT or HCV antigen test.
• Once a person has met the confirmed case definition, their classification should not be changed upon receiving new negative or undetectable HC NAT results.

Chronic, Not a Case

• Has a negative HCV NAT within 6 months of a first positive anti-HCV antibody test.

Criteria to Distinguish a New Case from an Existing Case

A new case is an incident case (new acute or newly diagnosed chronic) that has not previously been reported meeting case criteria for hepatitis C. A new probable acute case may be reclassified as confirmed acute case if a positive NAT for HCV RNA or a positive HCV antigen(s) test is reported within the same reporting year. A confirmed acute case may be classified as a confirmed chronic case if a positive NAT for HCV RNA or a positive HCV antigen is reported one year or longer after acute case onset. A confirmed acute case may not be reported as a probable chronic case (i.e., HCV antibody positive, but with an unknown HCV RNA NAT or antigen status). States and territories may choose to track resolved hepatitis C cases in which spontaneous clearance of infection or sustained virologic response to treatment are suspected to have occurred before national notification or are known to have occurred after national notification as a confirmed or probable case to CDC.

For Probable Acute HCV

If the initial tests (ordered the same day) include both a positive anti-HCV and a negative HCV RNA, the case will be classified as "Not a Case" since the person does not have current infection. If the person has a positive anti-HCV, followed by a negative HCV RNA that was collected more than 30 days after the collection date of a positive anti-HCV along with the presence of jaundice, ALT >200 IU/L, or total bilirubin ≥3.0 mg/dL, the cases will remain probable acute.

For Probable Chronic HCV

If a positive anti-HCV is followed by a negative HCV RNA within 6 months, the case will be classified as "Not a Case." If a positive anti-HCV is followed by a negative HCV RNA after six months, the case will remain a probable chronic case (per guidance from CDC).

Evidence for Reinfection

Evidence for re-infection may include a case of confirmed chronic HCV infection that has at least two sequential negative HCV viral detection tests reported, indicative of treatment initiation and sustained virologic response, followed by a positive HCV viral detection test. Under current treatment recommendations, those two negative tests should be at least three months apart, however, the timing may change as standard of care for HCV treatment evolves. Other evidence of reinfection should be considered, including a report of a new genotype on a case that has previously cleared a different genotype. Jurisdictions are encouraged to ensure that cases of HCV treatment failure are not classified as new cases of HCV infection to the extent that it can be determined. Jurisdictions tracking re-infection should also consider collecting data on prior treatment completion (when relevant and possible to document), treatment failure, change in reported genotype if that applies, and the known time frame for reinfection. If there is evidence of reinfection (two negative HCV viral detection tests ≥3 months apart, followed by a positive HCV viral detection test), then a new chronic case should be created.

Signs and Symptoms

Acute hepatitis C is defined as the first 12 months after an individual is infected with hepatitis C. Acute infection is usually asymptomatic. Symptomatic infection is generally mild, with malaise being the most common manifestation. Fulminant disease is rare. When symptoms do occur, they can include fever, fatigue, dark urine, clay-colored stools, abdominal pain, loss of appetite, nausea, vomiting, joint pain, and jaundice. However, the above-mentioned symptoms are not required to meet the acute case definition. After acute infection, approximately 15-25% of persons resolve their infection without sequelae as defined by sustained absence of HCV RNA in serum and normalization of ALT levels.

Chronic hepatitis C is defined as infection with hepatitis C virus that continues beyond the acute phase (or 12 months). Chronic infection develops in 75-85% of those infected. Chronic liver disease develops in 60-70% of chronically infected persons and is accompanied by persistent or fluctuating ALT levels; the progression of disease is usually slow and without symptoms or physical signs during the first two or more decades after infection. Cirrhosis develops in 5-20% of the chronically infected over a period of 20-30 years, and hepatocellular carcinoma develops in 1-5%.

A small percentage of persons with chronic HCV infection develop medical conditions due to HCV that are not limited to the liver. Such conditions can include:

• Fatigue.
• Diabetes mellitus.
• Glomerulonephritis.
• Essential mixed cryoglobulinemia.
• Porphyria cutanea tarda.
• Non-Hodgkin's lymphoma.

Diagnosis

Testing for hepatitis C begins with either a rapid or a laboratory-conducted assay for hepatitis C virus antibody in blood.

A nonreactive hepatitis C virus antibody result indicates no hepatitis C virus antibody was detected.

A reactive result indicates one of three things:

• Current hepatitis C infection.
• Past hepatitis C infection that has resolved.
• False positivity.

A reactive result should be followed by a nucleic acid test (NAT) for hepatitis C RNA.

• If hepatitis C RNA is detected, that indicates current hepatitis C infection.
• If hepatitis C RNA is not detected, that indicates either resolved hepatitis C infection or false hepatitis C antibody positivity.

The table below summarizes interpretation of laboratory findings:

* If the person tested is suspected of having hepatitis C exposure within the past year, has clinical evidence of hepatitis C, or if there is concern regarding the handling or storage of the test specimen.

Test Name Abbreviations

Epidemiology

Source

Hepatitis C virus (HCV) is found in human blood and blood products.

Occurrence

Hepatitis C infection is prevalent throughout the world and is the most common chronic bloodborne infection in the United States. Each year since 2013, there has been an increase in new hepatitis C cases in the United States, from 29,700 to 93,805 estimated cases in 2022 with an estimated 2.4 million adults in the United States living with hepatitis C during 2017-2020. Nationally, the peak prevalence is in persons born between approximately 1945 and 1965, the majority of whom were likely infected during the 1970s and 1980s when rates for hepatitis C were the highest.

Concurrent with the nation's opioid crisis in more recent years, new HCV infections have occurred primarily among young adults, including persons of reproductive age. In 2016, Ohio peak prevalence occurred in persons 20-29 years of age. Individuals that are chronically infected serve as a source of transmission to others and are at risk for chronic liver disease or other hepatitis C-related sequelae.

Mode of Transmission

Hepatitis C is transmitted through exposure to infectious blood or body fluids that contain blood. Currently, the most common mode of transmission in the U.S occurs due to injection drug use, through transfer of infected blood by sharing needles or other drug paraphernalia.

Hepatitis C is rarely transmitted by blood transfusion (less than one chance per two million units transfused) or organ transplantation; however, prior to donor screening, both blood transfusion and organ transplantation carried a high risk for transmission of hepatitis C. With recent advancements in the development of direct acting antivirals to treat and effectively cure hepatitis C infections, there has been an increase in the intentional transplantation of HCV viremic donor organs in HCV-negative recipients, thus increasing the number of available organs for transplantation.

Healthcare-associated transmission of hepatitis C is possible if infection control techniques or disinfection procedures are inadequate and contaminated equipment is shared among patients. Healthcare, emergency medical, and public safety workers who are exposed to blood in the workplace are at risk of being infected with blood borne pathogens, including hepatitis C.

Sexual transmission of hepatitis C appears to occur, but the virus is inefficiently spread in this manner. Having a sexually transmitted disease (STD) or HIV, sex with multiple partners, or rough sex appears to increase a person's risk for hepatitis C.

Hepatitis C transmission to non-sexual household contacts, presumably through direct or inapparent percutaneous or permucosal exposure to infectious blood or body fluids containing blood, is uncommon.

Approximately 6% of infants born to HCV-infected mothers become infected with the virus. As perinatal transmission of hepatitis C can occur at the time of birth, there is no prophylaxis available to prevent it. The risk is increased by the presence of maternal HCV viremia at delivery and is two to three times greater if mother is co-infected with HIV.

A person may become infected with a different strain of hepatitis C after clearing the initial infection. Prior infection with HCV does not protect against later infection with the same or different genotypes of the virus. This is because persons infected with HCV typically have an ineffective immune response due to changes in the virus during infection. For the same reason, no effective pre- or post-exposure prophylaxis (i.e., immune globulin) is available.

At-Risk Groups

Groups at high risk of acquiring this infection are:

• Current or former injection drug users, including those who injected only once many years ago.
• Recipients of clotting factor concentrates made before 1987, when more advanced methods for manufacturing those products were developed.
• Recipients of blood or blood component transfusions or solid organ transplants before July 1992, when better testing of blood donors became available.
• Persons who have ever received maintenance hemodialysis and those with persistently abnormal ALT levels.
• Persons who were notified that they received blood from a donor who later tested positive for HCV infection.
• Persons with known exposures to HCV, such as:
  • Healthcare, emergency medical, or public safety worker after needle sticks involving HCV-positive blood.
  • Recipients of blood or organs from a donor who tested HCV-positive.
• Persons with HIV infection.
• Children born to HCV-positive mothers.

Period of Communicability

Communicability lasts from one or more weeks before onset of first symptoms through the acute clinical course of the disease and indefinitely in the chronic stage.

Incubation Period

The incubation period averages 6-9 weeks with a range of 2-6 months. The time from exposure to the development of viremia (the presence of virus in the blood) is 1-3 weeks.

Public Health Management

Case

Investigation

Determine through the patient's physician if the patient is/was acutely ill (symptoms, symptom onset date, has jaundice, an elevated ALT >200 IU/mL or total bilirubin ≥3.0mg/dL).

Treatment

For information regarding treatment of hepatitis C, please refer to the Infectious Disease Society of America's hepatitis C treatment guidelines. The goal of hepatitis C treatment is a sustained virologic response (SVR), which can be considered a cure and is expected to benefit nearly all chronically infected persons. Only those with short life expectancy that cannot be remediated by HCV therapy, liver transplantations, or another directed therapy should not receive treatment. The treatment regimen depends on the HCV genotype. Treatment will reduce liver-related adverse consequences of long-term HCV infection, such as end-stage liver disease, liver cancer, and death. Reduction in HCV transmission will also occur with treatment. New treatment guidelines recommend no treatment of acute HCV. Patients with acute HCV infection should be followed and only considered for treatment if HCV RNA persists after six months.

All persons with chronic hepatitis C should be vaccinated against hepatitis A and B because of the high rate of severe hepatitis in those with chronic liver disease from hepatitis C who become coinfected with one of these infections.

Isolation

Use Universal Precautions. Persons diagnosed with hepatitis C should not donate blood, tissue, or semen.

Contacts

The value of prophylactic immunoglobulin (IG), however, is not clear. Current data suggest that post-exposure prophylaxis with IG is not effective in preventing hepatitis C infection. No assessments have been made of post-exposure use of antiviral agents. There is no vaccine available.

Prevention and Control

General control measures against hepatitis B virus infection apply for hepatitis C virus infection as well (see also the Hepatitis B Infectious Disease Control Manual (IDCM) chapter).

Vaccination

There is no vaccine available.

Children Born to Mothers with Hepatitis C Infection

Refer to the Hepatitis C, Perinatal Infection Infectious Disease Control Manual (IDCM) chapter.

Special Information

Questions about reporting, surveillance, and epidemiology for acute or chronic hepatitis C or requests for data should be directed to the ODH Hepatitis Surveillance Program at: hepatitis@odh.ohio.gov.

Questions about the testing, prevention, and control of acute or chronic hepatitis C should be directed to the ODH Hepatitis Prevention Program at: hepatitis@odh.ohio.gov.

Many excellent fact sheets and other resources are available at the Centers for Disease Control and Prevention (CDC) Hepatitis website.