[Pegylated interferon-alfa 2a with ribavirin in chronic viral hepatitis C (final report)].
We evaluated the efficacy and safety of peginterferon alfa-2a [40KD] (Peg-IFNalpha-2a) plus ribavirin in patients with chronic hepatitis C in an open-label programme in a routine clinical setting in Poland. Patients received Peg-IFNalpha-2a 180mg/week plus ribavirin 800-1200 mg/d for 48 weeks. Sustained virological response (SVR) was defined as undetectable HCV RNA (<50IU/mL) at the end of follow-up (week 72). 466 adults were enrolled. Most patients (87.3%) had genotype 1 infection. 440 subjects (94,4%) completed treatment. The overall SVR rate was 55.7%. A higher SVR rate was obtained in treatment-naïve patients (58.7%) than in relapsers (47.8%; p=0,048). SVR rates in genotype 1 and non-1 patients were 51.1% and 88.5%, respectively (p<0.001). There were significant higher SVR rates in patients with lower baseline fibrosis (p=0,01). There were no differences in SVRs by gender or viral load. Hemoglobin, leukocyte and neutrophil levels decreased significantly during treatment, but returned to baseline after the end of treatment. ALT levels decreased significantly during treatment in patients with and without an SVR. 38.4% of patients experienced adverse events like neutropenia, anemia, thrombocytopenia, and other. There was one death (severe thrombocytopenia).


CONCLUSIONS
The overall SVR achieved in this predominantly genotype 1 population was 55.7%. SVR rates were significantly higher in treatment-naïve patients, those with non-1 genotypes, and in patients with lower baseline fibrosis scores.
Juszczyk
Jacek
J
Katedra i Oddział Kliniczny Chorób Zakaźnych, SLAM, Katowice. juszczyk@post.pl
Baka-Cwierz
Barbara
B
Beniowski
Marek
M
Berak
Hanna
H
Bolewska
Beata
B
Boroń-Kaczmarska
Anna
A
Cianciara
Janusz
J
Cieśla
Andrzej
A
Dziambor
Andrzej
A
Gasiorowski
Jacek
J
Gietka
Andrzej
A
Gliwińska
Ewa
E
Gładysz
Andrzej
A
Gonciarz
Zbigniew
Z
Halota
Waldemar
W
Horban
Andrzej
A
Inglot
Małgorzata
M
Janas-Skulina
Urszula
U
Janczewska-Kazek
Ewa
E
Jaskowska
Jolanta
J
Jurczyk
Krzysztof
K
Knysz
Brygida
B
Kryczka
Wiesław
W
Kuydowicz
Jan
J
Lakomy
Elzbieta A
EA
Logiewa-Bazger
Beata
B
Lyczak
Anna
A
Mach
Tomasz
T
Mazur
Włodzimierz
W
Michalska
Zofia
Z
Modrzewska
Roma
R
Nazzal
Khalil
K
Pabjan
Paweł
P
Piekarska
Anna
A
Piszko
Paweł
P
Sikorska
Katarzyna
K
Szamotulska
Katarzyna
K
Sliwińska
Magdalena
M
Swietek
Katarzyna
K
Tomasiewicz
Krzysztof
K
Topczewska-Staubach
Ewa
E
Trocha
Hanna
H
Wasilewski
Marek
M
Wawrzynowicz-Syczewska
Marta
M
Wrodycki
Witold
W
Zarebska-Michaluk
Dorota
D
Zejc-Bajsarowicz
Małgorzata
M
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004337:Drug Carriers / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome
D000998:Antiviral Agents; D004337:Drug Carriers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b