BACKGROUND: Treatment of HCV infection in patients with thalassemia major (TM) is limited by the lack of large clinical trials and concerns about ribavirin-induced hemolysis. METHODS: We conducted a prospective, randomized, open-label study to determine efficacy and tolerability of pegylated-interferon alfa 2b (1.5 microg/kg/week) alone (group A) or with ribavirin (12-15 mg/kg/day; group B) in patients with TM and chronic HCV infection. Patients with genotype 1 or 4 HCV were treated for 48 weeks and those with genotype 3 or 2 HCV for 24 weeks. Early viral response (EVR; after 12 weeks of treatment), end-of-treatment virological response (ETR) and sustained virological response (SVR; 6 months after stopping therapy) were assessed. RESULTS:Of 40 patients, 20 each were allocated to the two treatment groups. EVR rates in group A and B were 15 (75%) and 18 (90%), respectively. ETR occurred in 17/20 (85%) patients in each group. SVR occurred in 8 (40%) patients in group A and 14 (70%) in group B. Blood transfusion requirements increased in one patient in group A and four patients in group B. One patient in group A had severe sepsis and one in group B had nephrotic syndrome. Two patients in each group required reduction in drug dose. CONCLUSIONS: In patients with TM and chronic HCV infection, pegylated interferon alfa 2b and ribavirin combination therapy achieves a higher SVR rate than pegylated interferon alone, and is well tolerated except for an increase in blood transfusion requirement.
RCT Entities:
BACKGROUND: Treatment of HCV infection in patients with thalassemia major (TM) is limited by the lack of large clinical trials and concerns about ribavirin-induced hemolysis. METHODS: We conducted a prospective, randomized, open-label study to determine efficacy and tolerability of pegylated-interferon alfa 2b (1.5 microg/kg/week) alone (group A) or with ribavirin (12-15 mg/kg/day; group B) in patients with TM and chronic HCV infection. Patients with genotype 1 or 4 HCV were treated for 48 weeks and those with genotype 3 or 2 HCV for 24 weeks. Early viral response (EVR; after 12 weeks of treatment), end-of-treatment virological response (ETR) and sustained virological response (SVR; 6 months after stopping therapy) were assessed. RESULTS: Of 40 patients, 20 each were allocated to the two treatment groups. EVR rates in group A and B were 15 (75%) and 18 (90%), respectively. ETR occurred in 17/20 (85%) patients in each group. SVR occurred in 8 (40%) patients in group A and 14 (70%) in group B. Blood transfusion requirements increased in one patient in group A and four patients in group B. One patient in group A had severe sepsis and one in group B had nephrotic syndrome. Two patients in each group required reduction in drug dose. CONCLUSIONS: In patients with TM and chronic HCV infection, pegylated interferon alfa 2b and ribavirin combination therapy achieves a higher SVR rate than pegylated interferon alone, and is well tolerated except for an increase in blood transfusion requirement.
Authors: Caterina Borgna-Pignatti; Maria Domenica Cappellini; Piero De Stefano; Giovanni Carlo Del Vecchio; Gian Luca Forni; Maria Rita Gamberini; Roberta Ghilardi; Antonio Piga; Maria Antonietta Romeo; Huaqing Zhao; Avital Cnaan Journal: Blood Date: 2005-12-22 Impact factor: 22.113
Authors: Caterina Borgna-Pignatti; Simone Rugolotto; Piero De Stefano; Huaqing Zhao; Maria Domenica Cappellini; Giovanni Carlo Del Vecchio; Maria Antonietta Romeo; Gian Luca Forni; Maria Rita Gamberini; Roberta Ghilardi; Antonio Piga; Avital Cnaan Journal: Haematologica Date: 2004-10 Impact factor: 9.941
Authors: Vito Di Marco; Marcello Capra; Francesco Gagliardotto; Zelia Borsellino; Daniela Cabibi; Francesco Barbaria; Donatella Ferraro; Liana Cuccia; Giovanni Battista Ruffo; Fabrizio Bronte; Rosa Di Stefano; Piero L Almasio; Antonio Craxì Journal: Haematologica Date: 2008-06-12 Impact factor: 9.941
Authors: Pankaj Puri; Anil C Anand; Vivek A Saraswat; Subrat K Acharya; Shiv K Sarin; Radha K Dhiman; Rakesh Aggarwal; Shivaram P Singh; Deepak Amarapurkar; Anil Arora; Mohinish Chhabra; Kamal Chetri; Gourdas Choudhuri; Vinod K Dixit; Ajay Duseja; Ajay K Jain; Dharmesh Kapoor; Premashis Kar; Abraham Koshy; Ashish Kumar; Kaushal Madan; Sri P Misra; Mohan V G Prasad; Aabha Nagral; Amarendra S Puri; R Jeyamani; Sanjiv Saigal; Samir Shah; Praveen K Sharma; Ajit Sood; Sandeep Thareja; Manav Wadhawan Journal: J Clin Exp Hepatol Date: 2014-06-24