What is the best test to perform after treatment in a patient with elevated Hepatitis C Virus (HCV) RNA quantitative levels?

From the Guidelines

For a patient with elevated HCV RNA quantitative levels after treatment, the best test to perform is HCV RNA or HCV core antigen detection at week 12 (SVR12) or 24 (SVR24) post-treatment to assess whether treatment has been successful. This is based on the most recent and highest quality study available, which recommends this approach for assessing treatment efficacy 1. The study suggests that HCV RNA or HCV core antigen detection should be performed at week 12 or 24 post-treatment to determine if the treatment has been successful.

Some key points to consider when interpreting the results of HCV RNA or HCV core antigen detection include:

• The high SVR12 rates expected with pangenotypic DAA-based regimens, which may make checking SVR dispensable in some cases, except in patients with high-risk behaviors and in patients at risk of reinfection 1
• The importance of using a real-time PCR-based assay with a lower limit of detection of ≤15 IU/ml to monitor HCV RNA levels during and after therapy, as recommended in previous studies 1
• The option to use HCV core antigen levels by EIA as an alternative to HCV RNA level measurement to monitor treatment efficacy during and after therapy when HCV RNA assays are not available or not affordable 1

It is also important to note that while resistance-associated substitution (RAS) testing may be useful in guiding retreatment decisions, the most recent and highest quality study available does not specifically recommend this test for patients with elevated HCV RNA quantitative levels after treatment. However, a comprehensive hepatic panel and a FibroScan or other fibrosis assessment may still be valuable in determining the current stage of liver disease and guiding further management.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Treatment Options for Patients with Elevated HCV RNA after Treatment

• Patients with elevated HCV RNA after treatment can be retreated with a combination of sofosbuvir/velpatasvir plus ribavirin for 24 weeks, as shown in a study published in 2021 2
• This treatment regimen has been found to be effective in achieving a sustained viral response (SVR) at 24 weeks after completing treatment
• The use of direct-acting antivirals (DAAs) has revolutionized the treatment of hepatitis C, with high efficacy and safety profiles, as reported in a 2017 study 3
• DAAs have made it possible to cure chronic hepatitis C infection in most patient groups, including those with historically difficult-to-treat categories such as HCV genotype 1 and advanced liver disease

Retreatment Options for Patients who have Failed Previous Treatment

• For patients who have failed previous treatment with a DAA regimen, sofosbuvir-velpatasvir-voxilaprevir taken for 12 weeks has been shown to provide high rates of sustained virologic response, as demonstrated in a 2017 study 4
• This treatment regimen has been found to be effective across HCV genotypes, including genotype 1,2, and 3
• The addition of ribavirin to sofosbuvir plus velpatasvir has been found to be beneficial in certain patient groups, such as those with genotype 3 infection, as reported in a 2018 study 5
• A 2017 study also found that sofosbuvir-velpatasvir with ribavirin for 24 weeks was effective in retreated patients who had previously failed a direct-acting antiviral regimen 6

Key Considerations for Treatment

• The choice of treatment regimen should be based on the patient's HCV genotype, stage of liver disease, and previous treatment history
• The use of DAAs has made it possible to treat patients who were previously considered difficult to treat, such as those with decompensated cirrhosis and solid organ transplant recipients
• Treatment regimens are still largely dependent on HCV genotype and stage of liver disease, with duration ranging between 12 weeks and 24 weeks, as reported in a 2017 study 3