Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C

R K Sterling1, A Kuo, V K Rustgi

  • 1Virginia Commonwealth University Health System, Richmond, VA, USA.

Insights

Direct-acting antiviral agents (DAAs) showed lower sustained virological response (SVR) rates in real-world HCV treatment compared to clinical trials. Patients without cirrhosis consistently achieved higher SVR rates, highlighting cirrhosis as a key factor influencing treatment outcomes.

Area of Science:

  • Hepatology
  • Virology
  • Clinical Pharmacology

Background:

  • The HCV-TARGET study is a longitudinal, observational research initiative involving a US consortium of 90 medical centers.
  • It focuses on patients with chronic hepatitis C virus (HCV) infection undergoing treatment with direct-acting antiviral agents (DAAs).

Purpose of the Study:

  • To evaluate the utilization of response-guided therapy (RGT).
  • To determine the sustained virological response (SVR) rates in a large cohort of HCV patients treated with early DAAs.

Main Methods:

  • Patients received a treatment regimen including peginterferon (PEG-IFN), ribavirin, and either telaprevir or boceprevir.
  • Demographical, clinical, and virological data were collected throughout treatment and follow-up periods.
  • Response-guided therapy (RGT) and treatment futility stopping rules were assessed at critical time points.

Main Results:

  • The study included 2084 patients; 38% had cirrhosis and 56% had prior HCV treatment.
  • SVR rates varied by DAA and cirrhosis status: Boceprevir (31% with cirrhosis, 50% without); Telaprevir (46% with cirrhosis, 60% without).
  • Predictors of SVR included early viral clearance, IL28B genotype, platelet count, and diabetes (boceprevir); and viral clearance, IL28B, cirrhosis, HCV subtype, age, hemoglobin, bilirubin, and albumin (telaprevir).

Conclusions:

  • Triple therapy with boceprevir or telaprevir yielded SVR rates lower than those reported in pivotal phase 3 clinical trials.
  • SVR rates were consistently higher in patients without cirrhosis compared to those with cirrhosis, irrespective of the DAA used or prior treatment history.
  • The study is registered at clinicaltrials.gov (NCT01474811).
Abstract

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