From the Guidelines
For patients with a positive hepatitis C antibody test, the next step is to confirm active infection with an HCV RNA test, and if HCV RNA is detected, treatment with direct-acting antivirals (DAAs) is recommended, as stated in the 2016 guidelines 1. The treatment choice depends on several factors, including HCV genotype, presence of cirrhosis, prior treatment history, and comorbidities.
- Before starting treatment, patients should undergo baseline laboratory testing, including:
- Complete blood count
- Liver function tests
- Renal function
- HCV genotype testing
- During treatment, patients should avoid alcohol and certain medications that interact with DAAs, and be monitored for side effects. Some of the recommended DAA regimens include:
- Epclusa (sofosbuvir/velpatasvir) 400mg/100mg once daily for 12 weeks
- Mavyret (glecaprevir/pibrentasvir) 300mg/120mg once daily with food for 8-12 weeks, depending on cirrhosis status
- Harvoni (ledipasvir/sofosbuvir) 90mg/400mg once daily for 8-12 weeks These modern DAA regimens are highly effective, with cure rates exceeding 95%, and work by directly inhibiting viral replication proteins, preventing the virus from multiplying, as noted in the 2015 guidelines 1. Treatment success is confirmed by undetectable HCV RNA 12 weeks after completing therapy (SVR12), as defined in the 2014 guidelines 1. It is essential to prioritize treatment for patients with advanced fibrosis, significant hepatic fibrosis, or those at high risk of cirrhotic complications and hepatocellular carcinoma, as recommended in the 2016 guidelines 1. Additionally, 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 the 2016 guidelines 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Positive Hepatitis C Antibody Test Treatment
- A positive hepatitis C antibody test indicates that a person has been exposed to the hepatitis C virus (HCV) at some point in their lives 2.
- The management of a patient with a positive HCV antibody test includes determining whether the patient has a false positive test, identifying asymptomatic carriers, and deciding which patients are candidates for interferon therapy 2.
- Reflex HCV viral load testing following an initial positive HCV antibody test can help increase the uptake of HCV RNA viral load testing and improve linkage to care among people with a positive HCV RNA test 3.
- Laboratory-based reflex viral load testing has been shown to increase HCV viral load test uptake compared to non-reflex testing, with a relative risk of 1.35 (95% CI: 1.16-1.58) 3.
- The use of direct-acting antiviral therapies, such as sofosbuvir and ledipasvir, has been shown to be effective in treating HCV genotype 1-infected patients, with a positive predictive value of 98% for sustained virologic response (SVR12) 4.
Treatment Outcomes
- The predictive ability of HCV RNA levels at the end of treatment for SVR12 has been evaluated, and it was found that low levels of quantifiable HCV RNA at the end of treatment do not preclude treatment success 4.
- Among patients treated with sofosbuvir and ledipasvir, 100% had HCV RNA less than the lower limit of quantification at the end of treatment, and only 1 patient relapsed 4.
- Reflex viral load testing can reduce the time to HCV viral load testing, with a median time of less than 1 day for laboratory-based reflex testing and 0-5 days for clinic-based reflex testing 3.