Treatment of chronic hepatitis C with pegylated interferon and ribavirin in treatment-naive patients in 'true life': a plea in favor of independent postmarketing evaluations.
BACKGROUND
Results of treatments for chronic hepatitis C virus are only estimated and disclosed from pivotal trials.


OBJECTIVE
To report the 'true life' results of pegylated interferon and ribavirin in treatment-naive patients.


METHODS
A prospective, multicenter observatory in 22 general hospitals.


RESULTS
Five-hundred and one patients were included, with 309 men (62%), aged 46 ± 11 years, weighting 70 ± 13 kg, infected with the following hepatitis C virus genotypes: 1 (50%), 2 (12%), 3 (28%), 4 (7.5%), 5 (0.6%). Liver biopsy, available in 436 patients showed stage F3 fibrosis in 24% and F4 in 13%. Two-hundred and seven patients had a comorbid condition. Treatment consisted of interferon alpha 2b in 340 patients and interferon alpha 2a in 161 patients. Dose reductions were necessary in 145 patients (29%). Treatment was prematurely interrupted in 145 patients (29%) owing to lack of efficacy (n =72) or side-effects (n =73). Sustained virological response (SVR) rates were 50% for all patients, and 37.1, 70.5, and 71% for patients with genotype 1, 2 and 3, respectively. At multivariate analysis, age, genotype, and fibrosis severity were the only independent factors of SVR.


CONCLUSIONS
In true life, patients are older and more severe, and SVR is about 10% lower than in pivotal trials.
Pariente
Alexandre
A
Unité d'hépatogastroentérologie, Centre Hospitalier, Pau Cedex, France. alex.pariente@free.fr
Lahmek
Pierre
P
Duprat
Christel
C
Denis
Jacques
J
Faroux
Roger
R
Renou
Christophe
C
Nalet
Bernard
B
Morin
Thierry
T
Cadranel
Jean-François
JF
D000328:Adult; D000367:Age Factors; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D019317:Evidence-Based Medicine; D005260:Female; D005602:France; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006769:Hospitals, General; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a