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

Abstract

BACKGROUND:

This large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice.

METHODS:

A diverse population of adults with CHC including patients with comorbid conditions, laboratory abnormalities and demographic features [comorbidities or special populations (CSP)] who were under-represented or excluded from peginterferon registration studies was treated with peginterferon α-2a (40 kDa) or α-2b (12 kDa) plus ribavirin at the investigator's discretion.

RESULTS:

During the study, 5399 treatment-naive patients [2527 (46.8%) with CSP] received peginterferon α-2a (n=3513, 65.1%) or peginterferon α-2b (n=1886, 34.9%). The sustained virological response rate was 56.6% (3057/5399) overall, 59.7% (1716/2872) in patients without CSP and 53.1% (1341/2527) in patients with CSP. Significant predictors of sustained virological response included hepatitis C virus genotype 2 or 3 infection, absence of cirrhosis, hepatitis C virus RNA≤500 000 IU/ml, alanine transaminase quotient >3× the upper limit of normal, age ≤65 years, BMI<25 kg/m, at least 80% of the planned exposure to peginterferon and ribavirin and prescription of peginterferon α-2a.

CONCLUSION:

The results provide detailed information on the outcome of therapy for CHC in a diverse Italian population that included a large number of patients with CSP and provides an insight into the generalizability of the results obtained in the more restricted setting of randomized registration trials.

• Authors: Antonio Craxì, Felice Piccinino, Alessia Ciancio, Claudio Iannacone, Barbara Deodato, Caterina Golotta, Antonio Ascione
• Journal: European journal of gastroenterology & hepatology (Eur J Gastroenterol Hepatol) Vol. 26 Issue 4 Pg. 388-95 (Apr 2014) ISSN: 1473-5687 [Electronic] England
• PMID: 24569819 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• peginterferon alfa-2b
• peginterferon alfa-2a

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antiviral Agents (adverse effects, therapeutic use)
• Comorbidity
• Drug Therapy, Combination
• Female
• Genotype
• Hepacivirus (drug effects, genetics)
• Hepatitis C, Chronic (diagnosis, drug therapy, epidemiology)
• Humans
• Interferon alpha-2
• Interferon-alpha (adverse effects, therapeutic use)
• Italy (epidemiology)
• Male
• Middle Aged
• Polyethylene Glycols (adverse effects, therapeutic use)
• Prospective Studies
• RNA, Viral (blood)
• Recombinant Proteins (adverse effects, therapeutic use)
• Recurrence
• Remission Induction
• Ribavirin (adverse effects, therapeutic use)
• Time Factors
• Treatment Outcome
• Viral Load
• Young Adult