Hepatitis C virus survival curve analysis in naïve patients treated with PegInterferon α-2b plus ribavirin. A randomized controlled trial for induction with high doses of PegInterferon and predictability of sustained viral response from early virologic data
AuthorMimidis, K.; Papadopoulos, V. P.; Elefsiniotis, I.; Koliouskas, D.; Ketikoglou, I.; Paraskevas, E.; Kanatakis, S.; Chrysagis, D.; Dalekos, G. N.; Tzathas, C.; Protopapas, A.; Gigi, E.; Tsianos, E.; Kartalis, G.
Aim. To evaluate the significance of induction with high doses of pegylated interferon α-2b (Peg-IFNα-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-IFNα-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-IFNα-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-IFNα-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.
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