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
dc.creator | Mimidis, K. | en |
dc.creator | Papadopoulos, V. P. | en |
dc.creator | Elefsiniotis, I. | en |
dc.creator | Koliouskas, D. | en |
dc.creator | Ketikoglou, I. | en |
dc.creator | Paraskevas, E. | en |
dc.creator | Kanatakis, S. | en |
dc.creator | Chrysagis, D. | en |
dc.creator | Dalekos, G. N. | en |
dc.creator | Tzathas, C. | en |
dc.creator | Protopapas, A. | en |
dc.creator | Gigi, E. | en |
dc.creator | Tsianos, E. | en |
dc.creator | Kartalis, G. | en |
dc.date.accessioned | 2015-11-23T10:39:39Z | |
dc.date.available | 2015-11-23T10:39:39Z | |
dc.date.issued | 2006 | |
dc.identifier.issn | 18418724 | |
dc.identifier.uri | http://hdl.handle.net/11615/31030 | |
dc.description.abstract | 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. | en |
dc.source.uri | http://www.scopus.com/inward/record.url?eid=2-s2.0-33749263381&partnerID=40&md5=3b92f473238e31a002d0556d52db9e91 | |
dc.subject | Chronic hepatitis C | en |
dc.subject | Pegylated interferon α-2b | en |
dc.subject | Ribavirin | en |
dc.subject | Sustained virologic response | en |
dc.subject | peginterferon alpha2b | en |
dc.subject | virus RNA | en |
dc.subject | adult | en |
dc.subject | alopecia | en |
dc.subject | anemia | en |
dc.subject | anxiety | en |
dc.subject | article | en |
dc.subject | bone marrow toxicity | en |
dc.subject | clinical trial | en |
dc.subject | controlled clinical trial | en |
dc.subject | controlled study | en |
dc.subject | depression | en |
dc.subject | dose response | en |
dc.subject | drug megadose | en |
dc.subject | drug response | en |
dc.subject | female | en |
dc.subject | genotype | en |
dc.subject | heart arrhythmia | en |
dc.subject | hepatitis C | en |
dc.subject | Hepatitis C virus | en |
dc.subject | human | en |
dc.subject | hypothyroidism | en |
dc.subject | low back pain | en |
dc.subject | major clinical study | en |
dc.subject | male | en |
dc.subject | medical decision making | en |
dc.subject | myopathy | en |
dc.subject | prediction | en |
dc.subject | psychosis | en |
dc.subject | randomized controlled trial | en |
dc.subject | rash | en |
dc.subject | side effect | en |
dc.subject | survival | en |
dc.subject | treatment outcome | en |
dc.subject | treatment withdrawal | en |
dc.subject | weakness | en |
dc.subject | weight reduction | en |
dc.subject | Antiviral Agents | en |
dc.subject | Drug Therapy, Combination | en |
dc.subject | Hepatitis C, Chronic | en |
dc.subject | Humans | en |
dc.subject | Interferon Alfa-2b | en |
dc.subject | Polyethylene Glycols | en |
dc.subject | Survival Analysis | en |
dc.title | 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 | en |
dc.type | journalArticle | en |
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