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PMID: 16083709 Published · ppublish English Clinical Trial Clinical Trial, Phase III Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Peginterferon-alpha-2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C.

Gastroenterology ·Vol. 129 ·No. 2 ·2005-08-00 ·Pages 522-7

von Wagner M, Huber M, Berg T, Hinrichsen H, Rasenack J, Heintges T, Bergk A, Bernsmeier C, Häussinger D, Herrmann E, Zeuzem S

Abstract

Standard therapy of patients with chronic hepatitis C virus (HCV) infected with HCV genotype-2 or -3 is the combination of pegylated interferon-alpha and ribavirin for 24 weeks. Whether shorter treatment durations are possible for these patients without compromising sustained virologic response rates is unknown. Patients chronically infected with HCV-2 (n = 39), HCV-2/3 (n = 1), or HCV-3 (n = 113) were treated with peginterferon-alpha-2a (180 microg/wk) plus ribavirin 800-1200 mg/day. HCV RNA was quantitatively assessed after 4 weeks. Patients with a rapid virologic response (HCV RNA below 600 IU/mL) were randomized for a total treatment duration of 16 (group A) or 24 weeks (group B). All patients with HCV RNA > or =600 IU/mL at week 4 (group C) were treated for 24 weeks. End-of-treatment and sustained virologic response were assessed by qualitative RT-PCR (sensitivity 50 IU/mL). Only 11 of 153 patients (7%) were allocated to group C. End-of-treatment and sustained virologic response rates were 94% and 82%, (group A), 85% and 80% (group B), and 73% and 36% (group C), respectively. In patients infected with genotype HCV-3 and high viral load (>800,000 IU/mL), a significant lower sustained virologic response rate was found than in patients infected with HCV-3 and a viral load lower or equal to 800,000 IU/mL (59% vs 85%, respectively; P = .003). In HCV-2 and -3 (low viral load)-infected patients who have a rapid virologic response, treatment for 16 weeks with peginterferon-alpha-2a and ribavirin is sufficient. In patients infected by HCV-3 (high viral load), longer treatment may be necessary.

MeSH Terms
Adult Dose-Response Relationship, Drug Drug Administration Schedule Drug Therapy, Combination Female Follow-Up Studies Genotype Hepacivirus/drug effects,genetics Hepatitis C, Chronic/diagnosis,drug therapy,genetics Humans Interferon alpha-2 Interferon-alpha/administration & dosage Liver Function Tests Logistic Models Male Middle Aged Multivariate Analysis Polyethylene Glycols/administration & dosage Probability RNA, Viral/genetics Recombinant Proteins Reference Values Ribavirin/administration & dosage Risk Assessment Severity of Illness Index Treatment Outcome Viral Load
Chemicals
Interferon alpha-2 Interferon-alpha RNA, Viral Recombinant Proteins Polyethylene Glycols Ribavirin peginterferon alfa-2a
Authors & Affiliations
11 authors, click to expand affiliations / ORCID
von Wagner Michael
Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.
Huber Miriam
Berg Thomas
Hinrichsen Holger
Rasenack Jens
Heintges Tobias
Bergk Alexandra
Bernsmeier Christine
Häussinger Dieter
Herrmann Eva
Zeuzem Stefan
Article Info
Journal
Gastroenterology
Abbr.
Gastroenterology
ISSN
0016-5085
Published
2005-08-00
Pages
522-7
Language
English
Region
United States
NLM ID
0374630
Subset
IM
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