Srpski arhiv za celokupno lekarstvo 2012 Volume 140, Issue 7-8, Pages: 448-455
https://doi.org/10.2298/SARH1208448B
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Efficacy and safety of peginterferon alfa-2a and ribavirin treatment of chronic hepatitis C in the Republic of Serbia
Božić Milena (Klinika za infektivne i tropske bolesti, Klinički centar Srbije, Beograd + Medicinski fakultet, Beograd)
Bojović Ksenija (Klinika za infektivne i tropske bolesti, Klinički centar Srbije, Beograd)
Fabri Milotka (Klinika za infektivne bolesti, Klinički centar Vojvodine, Novi Sad + Medicinski fakultet, Novi Sad)
Nožić Darko (Klinika za infektivne bolesti, Vojnomedicinska akademija, Beograd)
Trkulja Bojan (Predstavništvo Hoffmann-La Roche, Beograd)
Milošević Ivana (Klinika za infektivne i tropske bolesti, Klinički centar Srbije, Beograd + Stomatološki fakultet, Beograd)
Introduction. Hepatitis C virus (HCV) infection is one of the main causes of
chronic liver disease worldwide. Pegylated interferon alfa-2a or 2b (PEG IFN
alfa-2a or 2b) and ribavirin (RBV) represent a standard treatment of chronic
hepatitis C (CHC). Sustained virological response (SVR), defined as continued
undetectable HCV RNA 24 weeks after completion of treatment, is universally
considered as an indicator of treatment efficacy. Objective. The aim of this
study was to determine efficacy and safety of PEG IFN alfa-2a and RBV
treatment in patients with CHC in Serbia. Methods. One hundred seventy-six
patients with CHC were included in this multicenter trial from 8 reference
centers in Serbia. The patients were treated with standard PEG IFN alfa- 2a
and RBV protocol. We performed the following virological testing: anti-HCV
(ELISA), HCV RNK (quantitative PCR), HCV genotype (type-specific PCR), HBsAg,
anti-HBs, anti-HBc and anti-HIV (ELISA). Histological activity and the degree
of fibrosis were determined according to the Metavir scoring system.
Potential predictors for achieving SVR were evaluated using multivariable
logistic regression analysis. Results. Of the treated patients with CHC 65.9%
were male, and 60.2% of them aged over 40 years. Of the treated patients
68.2% had infection over 5 years, 63% had HCV RNA >400.000 IU/mL, 76.1% had
HCV G1/4, and 60.1% had a mild to moderate liver fibrosis. SVR was achieved
in 78.9% of patients (G1/4 79.1%; G2/3 78.1%). The factors that indicated a
poorer efficacy of the treatment were age >40 (p<0.05), high basal viremia
(p=0.013), and the reduction of PEG IFN alfa-2a and RBV doses, with
interruption of therapy (p<0.001). Of the treated patients 45.9% had adverse
affects (G1/4 50.8%; G2/3 29.7%). Conclusion. Treatment of CHC with PEG IFN
alfa-2a and RBV was efficient in 78.9% of patients. The safety profile of
therapy was satisfactory. Longer therapy increases the possibility of the
development of adverse affects. No life-threatening adverse effects were
recorded in our patients.
Keywords: chronic hepatitis C, peginterferon alfa-2a, ribavirin, sustained virological response, adverse effects