What are the next steps for a patient with positive Hepatitis C (Hep C) antibody results via Enzyme-Linked Immunosorbent Assay (ELISA) and Radioimmunoblot Assay (RIBA), and normal transaminase levels?

From the Guidelines

The next step for a patient with positive Hepatitis C antibody tests (both ELISA and confirmatory RIBA) and normal transaminases is to order HCV RNA testing to confirm active infection. This is because the patient's normal transaminase levels do not rule out the possibility of chronic hepatitis C, and HCV RNA testing is necessary to determine if the patient has an active infection requiring treatment versus a resolved infection with persistent antibodies 1.

Key Considerations

• The patient's positive Hepatitis C antibody tests indicate exposure to the virus, but do not confirm active infection.
• Normal transaminase levels do not exclude the possibility of chronic hepatitis C, as some patients with chronic infection may have normal liver enzyme levels.
• HCV RNA testing is essential to confirm active infection and guide treatment decisions.

Recommended Testing

• HCV RNA testing to confirm active infection
• Genotype testing if HCV RNA is detected to guide treatment selection
• Additional baseline testing, including complete blood count, comprehensive metabolic panel, coagulation studies, and assessment of liver fibrosis through non-invasive methods like FibroScan or serum biomarkers.

Treatment Considerations

• If HCV RNA is detected, direct-acting antiviral (DAA) therapy is indicated, with regimens like sofosbuvir/velpatasvir (Epclusa) 400/100 mg daily for 12 weeks being a common pan-genotypic option.
• Treatment decisions should consider the viral genotype, prior treatment history, presence of cirrhosis, and potential drug interactions.
• Early treatment is important as chronic HCV can lead to progressive liver fibrosis, cirrhosis, and hepatocellular carcinoma if left untreated, as noted in the 2014 guidelines 1.

Prioritizing Patient Care

The primary goal is to prioritize the patient's morbidity, mortality, and quality of life by confirming active infection and guiding treatment decisions with the most recent and highest quality evidence, as recommended by the 2015 AASLD-IDSA guidelines 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Hepatitis C Diagnosis and Next Steps

• The patient has tested positive for Hep C antibody (ELISA) and Hep C antibody (RIBA), indicating a high likelihood of Hepatitis C infection 2, 3.
• The patient has normal transaminase levels, which may not necessarily indicate the severity of liver disease 2.
• According to the studies, the next steps for a patient with positive ELISA and RIBA results would be to test for HCV RNA using PCR assay to confirm the diagnosis of HCV infection 2, 4, 5.
• The PCR assay is considered the gold standard for diagnosing HCV infection, and it can help determine the presence of viral RNA in the serum 2, 5.
• Additionally, liver histology may be considered to assess the severity of liver disease, as quantitative tests for serum HCV RNA levels do not provide information on disease severity 2.

Testing Algorithm

• The testing algorithm for Hepatitis C infection involves initial screening with ELISA, followed by confirmatory testing with RIBA or PCR assay 3, 4, 5.
• The signal-to-cutoff (S/Co) ratio of the ELISA test can help determine the need for further testing, with an S/Co ratio <3.0 indicating a low likelihood of active HCV infection and an S/Co ratio ≥20.0 indicating a high likelihood of HCV infection 4.
• Samples with an S/Co ratio between 3.0 and 19.9 should be followed up with RIBA or PCR testing to confirm HCV exposure 4.