PMID- 22239509 OWN - NLM STAT- MEDLINE DCOM- 20120504 LR - 20181201 IS - 1365-2893 (Electronic) IS - 1352-0504 (Linking) VI - 19 IP - 2 DP - 2012 Feb TI - Peginterferon alfa-2b plus weight-based ribavirin for 24 weeks in patients with chronic hepatitis C virus genotype 1 with low viral load who achieve rapid viral response. PG - e120-5 LID - 10.1111/j.1365-2893.2011.01515.x [doi] AB - In chronic hepatitis C (CHC), treatment duration may be individualized according to time to first undetectable hepatitis C virus (HCV) RNA, with patients who attain undetectable HCV RNA early in treatment being candidates for shorter regimens. The aim of this study was to determine the relapse rate in patients with CHC genotype (G) 1 infection and low baseline viral load who achieved undetectable HCV RNA by week 4 [rapid virologic response (RVR)] when treated for 24 weeks. This was an open-label, multicentre, noninterventional study. Adult patients with G1 CHC infection and baseline viral load <600,000 IU/mL who attained RVR were treated with peginterferon alfa-2b (1.5 mug/kg/week) plus ribavirin (800-1200 mg/day) for 24 weeks, then followed for a further 24 weeks. The primary endpoint was relapse rate, defined as the proportion of patients with undetectable HCV RNA at treatment week 24 and detectable HCV RNA at week 24 follow-up. The secondary efficacy endpoint was sustained virologic response (SVR). Overall, 170 patients were included in the efficacy-evaluable population. The relapse rate was 9.7% (16/165, 95% confidence interval: 0.06-0.15), and SVR was attained by 149 of 170 patients (87.6%). Virologic outcomes were consistent regardless of age, gender, body weight and genotype. Seven patients reported treatment-emergent serious adverse events (AEs), and four patients discontinued treatment because of an AE. This study further demonstrates that peginterferon alfa-2b plus weight-based ribavirin for 24 weeks is an effective treatment strategy for treatment-naive patients with G1 CHC and low viral load who attain RVR. CI - (c) 2011 Blackwell Publishing Ltd. FAU - Craxi, A AU - Craxi A AD - Sezione di Gastroenterologia & Epatologia, DiBiMIS, University of Palermo, Italy. craxanto@unipa.it FAU - Koutsounas, S AU - Koutsounas S FAU - Ogurtsov, P AU - Ogurtsov P FAU - Chemello, L AU - Chemello L FAU - Maticic, M AU - Maticic M FAU - Torras, J AU - Torras J FAU - Diago, M AU - Diago M FAU - Tartaglione, M T AU - Tartaglione MT FAU - Witthoeft, T AU - Witthoeft T FAU - Yu, X AU - Yu X FAU - Faruqi, R AU - Faruqi R FAU - Chaudhri, E AU - Chaudhri E FAU - Pedicone, L D AU - Pedicone LD FAU - Zuckerman, E AU - Zuckerman E LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20110919 PL - England TA - J Viral Hepat JT - Journal of viral hepatitis JID - 9435672 RN - 0 (Antiviral Agents) RN - 0 (Interferon alpha-2) RN - 0 (Interferon-alpha) RN - 0 (Recombinant Proteins) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 49717AWG6K (Ribavirin) RN - G8RGG88B68 (peginterferon alfa-2b) SB - IM MH - Adolescent MH - Adult MH - Antiviral Agents/*administration & dosage MH - Female MH - Genotype MH - Hepacivirus/*classification/genetics/*isolation & purification MH - Hepatitis C, Chronic/*drug therapy/virology MH - Humans MH - Interferon alpha-2 MH - Interferon-alpha/*administration & dosage MH - Male MH - Middle Aged MH - Polyethylene Glycols/*administration & dosage MH - Recombinant Proteins/administration & dosage MH - Recurrence MH - Ribavirin/*administration & dosage MH - Time Factors MH - Treatment Outcome MH - *Viral Load MH - Young Adult EDAT- 2012/01/14 06:00 MHDA- 2012/05/05 06:00 CRDT- 2012/01/14 06:00 PHST- 2012/01/14 06:00 [entrez] PHST- 2012/01/14 06:00 [pubmed] PHST- 2012/05/05 06:00 [medline] AID - 10.1111/j.1365-2893.2011.01515.x [doi] PST - ppublish SO - J Viral Hepat. 2012 Feb;19(2):e120-5. doi: 10.1111/j.1365-2893.2011.01515.x. Epub 2011 Sep 19.