Virological response of Tunisians patients treated by peginterferon plus ribavirin for chronic hepatitis C: a preliminary study.
BACKGROUND
Peginterferon plus ribavirin is actually the most effective therapy for chronic hepatitis C.


OBJECTIVE
This study was designed to evaluate the efficacy and safety of peginterferon and ribavirin combination therapy in Tunisian patients with chronic hepatitis C and to identify predictors of response to treatment.


METHODS
Fifty patients with chronic HCV infection recruited from the gastroenterology department of Habib Thameur hospital between January 2003 and March 2006 were prospectively included. All patients received peginterferon alpha 2a or alpha 2b subcutaneously respectively at a dose of 180 microg or 1.5 microg/Kg once weekly plus oral ribavirin given in two divided doses per day at a dose of 1000 mg/day for patients weighing 75 Kg or less and 1200 mg/day for those weighing more than 75 Kg. The clinical endpoints were the end of treatment response (EOT) and the sustained virological response (SVR) defined as an undetected serum HCV RNA 6 months after the end of treatment (< 600 IU/ml). Items associated with the main dependant variable (virological response (EOT and SVR) such us sex, age, body mass index, pretreatment viral load, pretreatment ALT quotient, pretreatment histologic degree of fibrosis, activity, steatosis, and HCV genotype (1 vs. non-1) were studied in an unvaried analysis.


RESULTS
A total of 50 patients were included in the study. The mean age of patients was 47.64 +/- 8.54 years. Thirty three patients were infected by HCV genotype 1 (66%) and 15 patients by HCV genotype 2 (30%). Forty five patients (90%) had normal ALT values at the end of treatment. At the end-of-treatment 82% of patient had virologic responses. Seventy three percent of patients with HCV genotype 1 had an end-of-treatment (EOT) virologic response and 52% had sustained virologic response (SVR). In patients with HCV genotypes 2 or 3, EOT and SVR were obtained respectively in 100%and 81% of patients. Only one patient infected by HCV genotype 4 was included in this study, she achieved an EOT virologic response whereas the SVR wasn't assessed. Among the 41 patients with EOT virologic response, 3 patients (7.31%) relapses during the 6 months after the end of therapy. Nine patients didn't achieve virologic response. Treatment was well-tolerated for 80% of patients. Laboratory abnormalities were observed in 12 of the 50 included patients (24%) and 7 patients experienced severe adverse events during the treatment period.


CONCLUSIONS
Combination therapy with peginterferon plus ribavirin for HCV infection was effective and safe. Careful monitoring of treatment-associated adverse events is necessary to avoid withdrew of therapy and to maintains a reasonable quality of life.
Belhadj
Najet
N
Department of Gastroenterology and Hepatology, Habib Thameur hospital, Tunis, Tunisia.
Houissa
Fatma
F
Elloumi
Hela
H
Ouakaa
Asma
A
Gargouri
Dalila
D
Romani
Malika
M
Kilani
Afef
A
Kochlef
Asma
A
Kharrat
Jamel
J
Ghorbel
Abdeljabbar
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins; D014416:Tunisia; D055815:Young Adult
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a