What is the treatment approach for a 37-year-old patient with positive Hepatitis C (HCV) Enzyme-Linked Immunosorbent Assay (ELISA) and Recombinant Immunoblot Assay (RIBA), negative HCV Ribonucleic Acid (RNA), and impaired liver function?

From the Guidelines

For a 37-year-old patient with positive HCV ELISA and RIBA but negative HCV RNA and impaired liver function, no antiviral treatment is indicated, as the negative RNA test confirms the absence of active viral replication. This serological pattern suggests past infection with spontaneous clearance of the virus, as indicated by the positive antibody tests (ELISA and RIBA) which signify previous exposure to HCV 1. The goal of therapy, as outlined in the EASL recommendations, is to cure HCV infection to prevent hepatic cirrhosis, decompensation of cirrhosis, HCC, severe extrahepatic manifestations, and death, but this is not applicable in the absence of active infection 1.

Key Considerations

• The patient's impaired liver function requires further evaluation to determine its cause, which could include comprehensive liver function tests, imaging studies such as ultrasound or fibroscan, and possibly liver biopsy if indicated.
• Other potential causes of liver dysfunction should be investigated, including alcohol use, non-alcoholic fatty liver disease, autoimmune hepatitis, hemochromatosis, and medication-induced liver injury.
• The patient should be monitored with periodic liver function tests and should receive counseling on liver health, including avoiding alcohol, maintaining a healthy weight, and vaccination against hepatitis A and B if not already immune.

Management Approach

• Assessment of liver disease severity is crucial, and non-invasive methods such as liver stiffness measurement or well-established panels of biomarkers of fibrosis can be used to assess liver fibrosis and the presence of portal hypertension 1.
• The combination of blood biomarkers or the combination of liver stiffness measurement and a blood test can improve accuracy and reduce the need for liver biopsy to resolve uncertainty 1.
• Despite the absence of active HCV infection, the patient should be informed about their HCV antibody status to avoid confusion in future medical encounters.

From the FDA Drug Label

The VALENCE trial evaluated SOVALDI in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis. Table 19 presents the SVR12 for the treatment groups of SOVALDI + ribavirin for 12 weeks and 24 weeks Table 20 presents the subgroup analysis by genotype for cirrhosis and prior HCV treatment experience

The treatment approach for a 37-year-old patient with positive Hepatitis C (HCV) Enzyme-Linked Immunosorbent Assay (ELISA) and Recombinant Immunoblot Assay (RIBA), negative HCV Ribonucleic Acid (RNA), and impaired liver function is not directly addressed in the provided drug label. Key points:

• The patient has a negative HCV RNA, which is not directly addressed in the provided studies.
• The provided studies discuss treatment approaches for patients with positive HCV RNA.
• No conclusion can be drawn from the provided information. 2

From the Research

Treatment Approach for Hepatitis C

The treatment approach for a 37-year-old patient with positive Hepatitis C (HCV) Enzyme-Linked Immunosorbent Assay (ELISA) and Recombinant Immunoblot Assay (RIBA), negative HCV Ribonucleic Acid (RNA), and impaired liver function is multifaceted. Key considerations include:

• The patient's age and risk factors, such as injection drug use 3
• The presence of impaired liver function, which may indicate chronic hepatitis or cirrhosis 4
• The negative HCV RNA result, which may suggest that the patient is not currently viremic, but this does not rule out the possibility of ongoing liver damage 5

Treatment Options

Treatment options for HCV infection have evolved significantly in recent years, with direct-acting antivirals (DAAs) offering high cure rates and improved safety profiles compared to traditional interferon-based therapies 6, 3. 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 is recommended, resulting in greater than 95% cure rates 3.

Monitoring and Follow-up

Monitoring of HCV RNA levels during treatment is not always predictive of treatment response, particularly with DAA therapies 5. However, achieving undetectable HCV RNA 12 weeks after completing therapy is considered a virologic cure (i.e., sustained virologic response) and is associated with improved outcomes, including lower all-cause mortality and improved hepatic and extrahepatic manifestations 3. Posttreatment surveillance for hepatocellular carcinoma and esophageal varices is recommended for patients with compensated cirrhosis, including abdominal ultrasonography and upper endoscopy at regular intervals 3.

Key Considerations

Key considerations in the treatment of this patient include:

• The need for prompt initiation of antiviral therapy to prevent further liver damage and improve outcomes 3
• The importance of monitoring for potential side effects and adjusting treatment as needed 6
• The need for ongoing surveillance and follow-up to monitor for hepatocellular carcinoma and esophageal varices in patients with cirrhosis 3