From the Guidelines
For a patient with elevated HCV RNA quantitative levels, the next step is to initiate direct-acting antiviral (DAA) therapy after determining the HCV genotype and assessing liver fibrosis stage, as recommended by the American Association for the Study of Liver Diseases-Infectious Diseases Society of America 1. The current standard of care typically includes medications such as sofosbuvir/velpatasvir (Epclusa) for 12 weeks for most genotypes, or glecaprevir/pibrentasvir (Mavyret) for 8-12 weeks depending on cirrhosis status and treatment history. Before starting treatment, baseline laboratory tests should be obtained including:
- Complete blood count
- Liver function tests
- Renal function
- Assessment for hepatitis B coinfection Patients should also be evaluated for potential drug interactions with their current medications. Treatment is highly effective with cure rates exceeding 95% for most patients, as supported by the 2020 hepatitis C guidance update 1. The goal of treatment is to achieve sustained virologic response (SVR), defined as undetectable HCV RNA 12 weeks after completing therapy, which is considered a cure. Early treatment prevents progression to cirrhosis, liver failure, hepatocellular carcinoma, and reduces transmission risk. It's worth noting that HCV genotype testing may be considered for those in whom it may alter treatment recommendations, although pretreatment genotyping is not required for treatment-naive patients without cirrhosis if a pangenotypic regimen is used 1. Quantitative HCV-RNA testing is recommended prior to initiation of antiviral therapy to document the baseline level of viremia, which may affect treatment duration with certain regimens 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Next Steps for Patients with Elevated HCV RNA Quantitative
- For patients with elevated HCV RNA quantitative, the next step is to consider treatment with direct-acting antivirals (DAAs) such as sofosbuvir, daclatasvir, and ledipasvir 2, 3, 4, 5.
- The treatment duration and regimen may vary depending on the patient's HCV genotype, liver disease stage, and treatment history 2, 3, 4.
- For non-cirrhotic patients with HCV genotype 1, a 12-week treatment with sofosbuvir and ledipasvir or daclatasvir may be sufficient 2, 3.
- For cirrhotic patients or those with advanced liver disease, a longer treatment duration of 24 weeks may be necessary 2, 4.
- Monitoring of HCV RNA levels during treatment is not always predictive of treatment response, and some patients with quantifiable HCV RNA at the end of treatment may still achieve sustained virological response (SVR12) 6.
Treatment Options
- Sofosbuvir and ledipasvir for 8 or 12 weeks 3
- Daclatasvir and sofosbuvir for 12 or 24 weeks 2, 4
- Sofosbuvir, daclatasvir, and ribavirin for 12 or 16 weeks 4
- Ledipasvir and sofosbuvir for 12 weeks 5