What is the next step for a patient with a positive Hepatitis C (HCV) panel result?

From the Guidelines

The next step for a patient with a positive Hepatitis C (HCV) panel result is to confirm active infection with an HCV RNA test, which measures viral load. This is based on the most recent and highest quality study available, which emphasizes the importance of confirming active infection before proceeding with treatment 1.

Key Considerations

• If HCV RNA is detected, the patient should undergo genotype testing to determine the specific strain of the virus and complete liver function tests, fibrosis assessment (via FibroScan or FibroTest), and possibly liver imaging to assess disease severity.
• Patients with confirmed active infection should be referred to a hepatologist or infectious disease specialist for treatment evaluation.
• Current standard treatment involves direct-acting antivirals (DAAs) such as Epclusa (sofosbuvir/velpatasvir), Mavyret (glecaprevir/pibrentasvir), or Harvoni (ledipasvir/sofosbuvir), typically taken for 8-12 weeks with cure rates exceeding 95% 1.
• Treatment selection depends on viral genotype, liver function, prior treatment history, and comorbidities.
• During treatment, patients require monitoring of viral load, liver function, and potential side effects.

Rationale

The primary goal of HCV therapy is to cure the infection, i.e., to achieve a sustained virological response (SVR) defined as undetectable HCV RNA after treatment completion 1. An SVR corresponds to a cure of the HCV infection, as late relapse occurs in less than 0.2% of cases beyond 6 months of follow-up. This comprehensive approach is necessary because a positive antibody test alone doesn't distinguish between past infection and current active disease, and determining the extent of liver damage guides appropriate treatment decisions.

Additional Recommendations

• Patients should be educated about preventing further damage to their liver, including the prevention of the potential deleterious effect of alcohol, which may lead to more rapid progression of liver fibrosis and the development of hepatocellular carcinoma (HCC) 1.
• Annual HCV testing is recommended for persons who inject drugs and for HIV-seropositive men who have unprotected sex with men 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Next Steps for a Patient with a Positive Hepatitis C (HCV) Panel Result

• The patient should undergo further testing to confirm the diagnosis and assess the extent of liver damage, as recommended by 2.
• This may include HCV RNA polymerase chain reaction testing to confirm active disease, as well as liver function tests and other diagnostic procedures to evaluate the degree of liver fibrosis or cirrhosis.
• The patient's treatment options will depend on the severity of their liver disease, as well as other factors such as their overall health and medical history.
• For treatment-naive adults without cirrhosis or with compensated cirrhosis, a simplified treatment regimen consisting of eight weeks of glecaprevir/pibrentasvir or 12 weeks of sofosbuvir/velpatasvir may be recommended, as this has been shown to result in greater than 95% cure rates 2.
• In patients with compensated cirrhosis, posttreatment surveillance for hepatocellular carcinoma and esophageal varices should include abdominal ultrasonography and upper endoscopy, as recommended by 2.
• Transient elastography may be used as a non-invasive method to assess liver fibrosis, but its accuracy can be influenced by various factors, including biochemical activity of liver disease, and it should be used in conjunction with other diagnostic methods, as discussed in 3, 4, 5, and 6.

Assessment of Liver Fibrosis

• Liver biopsy is still considered the gold standard for assessing liver fibrosis, but it is an invasive procedure with associated risks and limitations, as noted in 4 and 5.
• Non-invasive methods, such as serum markers and transient elastography, have been developed to assess liver fibrosis, but they have their own limitations and should be used in an integrated approach with liver biopsy, as recommended by 5.
• Transient elastography has been shown to be a useful tool for assessing liver fibrosis, particularly in patients with hepatitis C virus infection or HIV-hepatitis C virus coinfection, as demonstrated in 6.

Treatment and Management

• The goal of treatment is to achieve a sustained virologic response, which is associated with lower all-cause mortality and improved hepatic and extrahepatic manifestations, as noted in 2.
• Treatment options should be individualized based on the patient's specific needs and circumstances, and may involve a combination of antiviral medications and other therapies, as recommended by 2.