COMBINING laboratory and pharmacy data provided the most rigorous measure of hepatitis C care outcomes in a US cohort study, although incomplete follow-up RNA testing meant this approach could underestimate cure. When only one data source was available, laboratory-confirmed viral clearance or pharmacy-recorded treatment initiation could serve as reasonable surrogate measures of viral clearance after treatment initiation.
Hepatitis C is a viral infection that can lead to advanced liver disease, liver cancer and death if left untreated. Direct-acting antivirals (DAAs) cure more than 95% of infections, with sustained virologic response (SVR), defined as undetectable hepatitis C virus (HCV) RNA at least 12 weeks after treatment completion, considered evidence of cure.
Healthcare systems often rely on laboratory results, pharmacy records or a combination of both to monitor treatment outcomes, making accurate measurement important for tracking progress towards hepatitis C elimination.
Researchers analysed longitudinal laboratory results, pharmacy claims and insurance enrolment data from the HealthVerity database. The study included US adults aged 18 years or older who underwent HCV antibody, RNA or genotype testing between 30 January 2019 and 30 June 2022. Participants had evidence of HCV infection between 30 January 2019 and 30 June 2021, maintained continuous insurance enrolment and had no record of DAA treatment before their index infection.
Among 4,515,568 adults who underwent at least one HCV test, 91,491 had evidence of HCV infection. Most (90.1%) received at least one HCV RNA test. Among those, 62.0% had an initial HCV infection. Of these, 39.9% had viral clearance, 35.7% initiated DAA treatment within 360 days and 26.1% had viral clearance after treatment initiation. Similar patterns were observed across age groups and insurance payer categories, although the magnitude of outcomes differed.
Among patients with an initial HCV infection, 38.3% did not undergo a subsequent RNA test to assess viral clearance, while 78.4% had no evidence of treatment initiation.
Of the 18,246 individuals who initiated treatment, 73.2% later had a negative HCV RNA result, 3.7% had a positive RNA result and 23.2% had no subsequent RNA testing. Most patients in the latter group had been prescribed at least 56 days of DAA therapy. Among those without recorded treatment initiation, 21.3% later had a negative RNA result, 32.1% remained RNA positive and 46.7% had no follow-up testing.
The researchers noted that laboratory-based measures of viral clearance may underestimate cure because many patients who complete treatment do not return for follow-up RNA testing. Conversely, laboratory-confirmed viral clearance did not necessarily indicate treatment success because some patients may have cleared HCV spontaneously or received treatment that was not captured in the database.
The authors said viral clearance after treatment initiation, which requires both laboratory and pharmacy data, was the most rigorous outcome and aligned most closely with the definition of SVR. However, they noted that this measure was also likely to underestimate cure because of incomplete follow-up RNA testing.
The study had several limitations, including the possibility that treatments outside insurance claims were not captured, changes in HCV testing recommendations during the study period, the exclusion of people without continuous insurance coverage and potential misclassification arising from incomplete laboratory data.
The researchers concluded that improving follow-up RNA testing and integrating laboratory and pharmacy data would enhance the accuracy of hepatitis C care monitoring and help identify gaps in testing and treatment.
Reference
Symum H et al. Comparison of care cascade outcome measures for hepatitis C among insured US adults. JAMA Netw Open. 2026;10.1001/jamanetworkopen.2026.21736.
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