What is the recommended testing and treatment protocol for hepatitis C?

From the Guidelines

The recommended protocol for hepatitis C testing and treatment begins with screening high-risk individuals and those born between 1945-1965 using an HCV antibody test, followed by HCV RNA testing to confirm active infection if antibodies are detected, as recommended by 1.

Hepatitis C Testing Protocol

• Screening for HCV infection should be considered in populations at risk as well as those over 40 years old with increasing prevalence of HCV infection, as stated in 1.
• Anti-HCV should be tested in patients suspected of having acute or chronic HCV infection, as recommended by 1 and 1.
• HCV RNA should be tested in patients with a positive anti-HCV test to confirm the diagnosis, as stated in 1 and 1.
• Even if anti-HCV is negative, HCV RNA testing is required when acute HCV infection is suspected or in the presence of unexplained liver disease in immunosuppressed patients, as recommended by 1 and 1.

Hepatitis C Treatment Protocol

• For treatment, direct-acting antivirals (DAAs) are the standard of care, with regimens typically lasting 8-12 weeks, as stated in 1 and 1.
• Common first-line options include Epclusa (sofosbuvir/velpatasvir) 400mg/100mg once daily for 12 weeks, Mavyret (glecaprevir/pibrentasvir) 300mg/120mg once daily for 8 weeks in treatment-naïve patients without cirrhosis, or Harvoni (ledipasvir/sofosbuvir) 90mg/400mg once daily for 12 weeks, as recommended by 1.
• Treatment selection depends on viral genotype, prior treatment history, presence of cirrhosis, and comorbidities, as stated in 1 and 1.
• During treatment, patients should be monitored for side effects and medication adherence, as recommended by 1.
• Post-treatment, HCV RNA testing is performed 12 weeks after completion to confirm sustained virologic response (SVR), which indicates cure, as stated in 1.

Prioritization of Treatment

• All HCV-infected patients with no contraindication to treatment should be considered for treatment, as recommended by 1.
• Patients with advanced fibrosis ≥F3 (including compensated and decompensated cirrhosis) should be given priority for treatment, as stated in 1.
• Treatment should be prioritized in the pre- and post-liver transplant setting, as recommended by 1.
• Treatment should be individualized taking into consideration the severity of liver disease, probability of treatment success, risks of severe adverse effects, accompanying diseases, and patients’ willingness to undergo treatment, as stated in 1.

From the FDA Drug Label

Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.

Recommended adult and pediatric dosage: One 400 mg tablet taken once daily with or without food.

The recommended testing protocol for hepatitis C includes:

• Testing all patients for HBV infection by measuring HBsAg and anti-HBc before initiating therapy 2
• The treatment regimen and duration may vary depending on the genotype of the hepatitis C virus, the presence of cirrhosis, and whether the patient is treatment-naïve or treatment-experienced
• The recommended treatment regimen for hepatitis C includes a combination of sofosbuvir and other medications, such as ribavirin and peginterferon alfa 2
• For patients with HCV/HIV-1 coinfection, the dosage recommendations should be followed as outlined in the tables in the full prescribing information 2 3

From the Research

Hepatitis C Testing and Treatment Protocol

• The recommended testing protocol for hepatitis C involves universal screening with an anti-HCV antibody test, followed by reflex HCV RNA polymerase chain reaction testing for positive results to confirm active disease 4.
• Screening is recommended at least once for all adults 18 years and older, and during each pregnancy, except in settings where the prevalence of HCV infection is <0.1% 5.
• People at the greatest risk of HCV infection, such as those between 18 and 39 years of age and those who use injection drugs, should be screened periodically as long as the at-risk behavior persists 4.
• 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 results in greater than 95% cure rates 4.

Diagnostic Accuracy of Hepatitis C Tests

• Rapid diagnostic tests (RDTs) and laboratory-based EIA assays have excellent sensitivity and specificity for detecting HCV antibodies, with pooled sensitivity and specificity of 98% and 100%, respectively 6.
• Oral HCV Ab RDTs also have good sensitivity and specificity compared to blood reference standards, with a pooled sensitivity of 94% and specificity of 100% 6.
• Reflex HCV RNA viral load testing following an initial positive HCV antibody test can increase HCV VL test uptake and improve linkage to care among people with a positive HCV RNA test 7.

Treatment and Follow-up

• A sustained virologic response is associated with lower all-cause mortality and improves hepatic and extrahepatic manifestations, cognitive function, physical health, work productivity, and quality of life 4.
• In patients with compensated cirrhosis, posttreatment surveillance for hepatocellular carcinoma and esophageal varices should include abdominal ultrasonography and upper endoscopy every two to three years 4.
• In the absence of cirrhosis, no liver-related follow-up is recommended 4.