Hepatitis C Virus Survival Curve Analysis in Naïve Patients
Treated with PegInterferon a-2b Plus Ribavirin.
A Randomized Controlled Trial for Induction with High Doses
of PegInterferon and Predictability of Sustained Viral Response
from Early Virologic Data
Konstantinos Mimidis1, Vassilios P Papadopoulos1,
Ioannis Elefsiniotis2, Dimitrios Koliouskas3,
Ioannis Ketikoglou4, Eleftherios Paraskevas5,
Spyridon Kanatakis6, Dimitrios Chrysagis7,
Georgios N Dalekos8, Christos Tzathas9,
Athanasios Protopapas10, Eleni Gigi11,
Eleftherios Tsianos12, Georgios Kartalis1
of Medicine, Democritus University of Thrace, Alexandroupolis.
2) Helena Venizelou
Maternal Hospital, Athens.
Hospital, Aristotelion University of Thessaloniki, Thessaloniki.
4) Hippokration Hospital,
5) Savvas Hospital,
6) Red Cross Hospital,
7) Loimodon Hospital,
8) Department of
Medicine, Academic Liver Unit, University of Thessaly,
9) Attikon University
10) Giannitsa General
University of Thessaloniki, Thessaloniki.
12) Department of
Medicine, University of Ionnina, Ioannina
Aim. To evaluate the significance of induction with high doses of pegylated
interferon a-2b (Peg-IFNa-2b) and the predictability of sustained virologic response (SVR) in
naïve patients with chronic hepatitis C.
Methods. 188 consecutive naïve patients with chronic
hepatitis C were enrolled in a randomised controlled clinical
trial. Patients were randomised to receive either Peg-IFNa-2b 3.0 mcg/kg
QW x 12 weeks followed by 1.5 mcg/kg QW x 36 weeks plus
800-1200 mg ribavirin (Arm A) or Peg-IFNa-2b 1.5 mcg/kg QW x 48 weeks plus 800-1200 mg ribavirin (Arm B). HCV-RNA
was obtained at 0, 4, 8, 12, 16, 24, 48 and 72 weeks. Differences
between schemes were evaluated by Kaplan-Meier curves. Predictability
of SVR was assessed by two-way contingency table analysis
and ROC curve analysis.
Results. From 176 patients, 75 had genotype 1, 15 genotype
2, 75 genotype 3 and 11 genotype 4. No statistical significance
emerged in HCV-RNA positivity, side effects and withdrawals
between schemes. Patients with genotype 1 achieved lower
SVR (46.6%) in comparison to patients with genotypes 2/3
(94.1%, p<0.001) and 4 (90.9%, p=0.002).
The most appropriate time for estimation of SVR for genotype
1 is week 8 (accuracy= 0.84, AUC=0.90) while predictability
increases with time in genotypes 2/3, reaching maximum accuracy=0.93
and AUC=0.76 at week 16.
Conclusion. Induction with high doses of Peg-IFNa-2b does not preclude
better outcome and rapid virologic response at 4 weeks of
treatment sufficiently predicts SVR. These findings might
be useful in an attempt to gain supportive evidence for
decision making in difficult-to-treat patients.
Chronic hepatitis C - pegylated interferon a-2b - ribavirin - sustained virologic response
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Apology for wrong name of authors :
Emmanouil Paraskevas5, Stylianos Kanatakis6,
Charalambos Tzathas9, Andreas Protopapas10, Epameinondas Tsianos12