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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).
Background:
HCV-TARGET is a longitudinal observational study of chronic hepatitis C virus (HCV) patients treated with direct-acting anti-viral agents (DAAs) in a US consortium of 90 academic and community medical centres.
Aim:
To assess utilisation of response-guided therapy (RGT) and sustained virological response (SVR) of a large cohort of patients.
Methods:
Patients received peginterferon (PEG-IFN), ribavirin and either telaprevir or boceprevir. Demographical, clinical and virological data were collected during treatment and follow-up. RGT and treatment futility stopping rules was assessed at key time points.
Results:
Of 2084 patients, 38% had cirrhosis and 56% had received prior treatment for HCV. SVR rates were 31% (95% CI: 24-40) and 50% (95% CI: 44-56) in boceprevir patients with and without cirrhosis, respectively. SVR rates were 46% (95% CI: 42-50) and 60% (95% CI: 57-64) in telaprevir patients with and without cirrhosis, respectively. Early clearance of virus, IL28B genotype, platelet counts and diabetes were identified as predictors of SVR among boceprevir patients, while early clearance of virus, IL28B, cirrhosis, HCV subtype, age, haemoglobin, bilirubin and albumin levels were identified as predictors of SVR for telaprevir patients.
Conclusions:
In academic and community centres, triple therapy including boceprevir or telaprevir led to SVR rates somewhat lower than those noted in large phase 3 clinical trials. Response rates were consistently higher among patients without cirrhosis compared to those with cirrhosis regardless of DAA used and prior treatment response. Trial registration clinicaltrials.gov NCT01474811.
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