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Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study

Antonio Craxì1, Felice Piccinino, Alessia Ciancio

  • 1aDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, University of Palermo, Palermo bDepartment of Public Medicine, Section of Infectious Diseases, Second University of Naples, Naples cDepartment of Gastroenterology and Hepatology, University of Torino, Torino dSPARC Consulting, Milan eRoche SpA, Monza fDepartment of Medicine, Centre for Liver Disease, Fatebenefratelli Hospital, Napoli, Italy.

European Journal of Gastroenterology & Hepatology
|February 27, 2014
PubMed

Insights

This study evaluated chronic hepatitis C (CHC) treatment in a diverse Italian population, finding a 56.6% overall sustained virological response rate. Peginterferon alfa-2a was associated with better outcomes in real-world clinical practice.

Area of Science:

  • Hepatology
  • Virology
  • Clinical Practice

Background:

  • Chronic hepatitis C (CHC) treatment outcomes in real-world clinical practice remain an area for improved understanding.
  • Peginterferon-based therapies were standard, but data on diverse patient populations were limited.

Purpose of the Study:

  • To assess the efficacy and predictors of sustained virological response (SVR) in a large, diverse cohort of CHC patients treated in routine clinical settings.
  • To evaluate treatment outcomes in patients with comorbidities or special populations (CSP) often excluded from clinical trials.

Main Methods:

  • A prospective, multicentre cohort study involving 5399 treatment-naive adult patients with CHC.
  • Patients received peginterferon alfa-2a or alfa-2b plus ribavirin, based on investigator discretion.
  • Data collection included patient demographics, comorbidities, laboratory values, and treatment adherence.

Main Results:

  • An overall SVR rate of 56.6% was observed across the cohort.
  • Patients without comorbidities or special populations (CSP) had a higher SVR rate (59.7%) compared to those with CSP (53.1%).
  • Key predictors of SVR included HCV genotype 2/3, absence of cirrhosis, viral load, liver enzyme levels, age, BMI, and receipt of peginterferon alfa-2a.

Conclusions:

  • Real-world CHC treatment in a diverse Italian population yielded a 56.6% SVR, demonstrating the generalizability of findings beyond randomized trials.
  • Peginterferon alfa-2a showed a trend towards better outcomes compared to alfa-2b in this population.
  • The study provides valuable insights into CHC treatment effectiveness in a broad patient spectrum, including those with CSP.
Abstract

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