Aabha Nagral1,2,3, Smita Sawant1, Nishtha Nagral1,4, Pathik Parikh2, Priya Malde1,2, Rashid Merchant5. 1. Children's Liver Foundation, Mumbai, India. 2. Department of Gastroenterology, Apollo Hospitals, Navi Mumbai, India. 3. Department of Gastroenterology, Bhatia Hospital, Mumbai, India. 4. Department of Medicine, BYL Nair Medical College, Mumbai, India. 5. Department of Pediatrics, Nanavati Hospital, Mumbai, India.
Abstract
BACKGROUND: There is no published data of treating hepatitis C in thalassemia major patients with any sofosbuvir based direct acting antivirals (DAAs). This study was performed to determine the efficacy and safety of these regimes using generic drugs in the thalassemia major population. METHODS: In this observational study, 902 patients of thalassemia major from five transfusion centres in Mumbai were screened for HCV antibody. Of the 120 positive patients, HCV RNA was detected in 50%. The first 29 patients were enrolled for evaluating the efficacy and safety of generic sofosbuvir based DAAs. RESULTS: The 29 patients' had a mean age of 24 years with genotype 1 in 17, genotype 3 in 11patients, while 1 patient's genotype could not be classified. Six patients had compensated cirrhosis and 8 patients were treatment experienced. SVR 12 was achieved in 100% of patients. There was significant increase in PRC (packed red cell) requirements (P = 0.0003) during treatment. At 12 weeks post-treatment, PRC requirements returned to baseline with a significant fall in serum ferritin (P = 0.03). Headache, fatigue and diarrhoea were the most common side effects. The difference in side effects including anaemia between patients who received ribavirin (19/29) and those who did not receive ribavirin (10/29) was not significant. Presence of diabetes, splenectomy, high ferritin or liver or heart iron overload on MRI T2* did not affect the efficacy of treatment. CONCLUSION: Generic DAAs are safe in thalassemia major patients with hepatitis C with efficacy of 100%. Serum ferritin falls significantly after treatment despite an increase in transfusion requirements during treatment.
BACKGROUND: There is no published data of treating hepatitis C in thalassemia major patients with any sofosbuvir based direct acting antivirals (DAAs). This study was performed to determine the efficacy and safety of these regimes using generic drugs in the thalassemia major population. METHODS: In this observational study, 902 patients of thalassemia major from five transfusion centres in Mumbai were screened for HCV antibody. Of the 120 positive patients, HCV RNA was detected in 50%. The first 29 patients were enrolled for evaluating the efficacy and safety of generic sofosbuvir based DAAs. RESULTS: The 29 patients' had a mean age of 24 years with genotype 1 in 17, genotype 3 in 11patients, while 1 patient's genotype could not be classified. Six patients had compensated cirrhosis and 8 patients were treatment experienced. SVR 12 was achieved in 100% of patients. There was significant increase in PRC (packed red cell) requirements (P = 0.0003) during treatment. At 12 weeks post-treatment, PRC requirements returned to baseline with a significant fall in serum ferritin (P = 0.03). Headache, fatigue and diarrhoea were the most common side effects. The difference in side effects including anaemia between patients who received ribavirin (19/29) and those who did not receive ribavirin (10/29) was not significant. Presence of diabetes, splenectomy, high ferritin or liver or heart iron overload on MRI T2* did not affect the efficacy of treatment. CONCLUSION: Generic DAAs are safe in thalassemia major patients with hepatitis C with efficacy of 100%. Serum ferritin falls significantly after treatment despite an increase in transfusion requirements during treatment.
Entities:
Keywords:
ALP, alkaline phosphatase; ALT, alanine aminotransferases; AST, aspartate amonotransferase; DAAs, direct acting antivirals; EBR, elbasvir; ETR, end of treatment response; GZR, grazoprevir; HIV, human immunodeficiency virus; Hb, haemoglobin; India; PRC, packed red blood cells; RNA, ribonucleic acid; RVR, rapid virological response; SD, standard deviation; SVR, sustained virological response; VAS, visual analogue scale; WCC, white cell count; daclatasvir; haemoglobinopathy; ledipasvir; sofosbuvir
Authors: Pankaj Puri; Anil C Anand; Vivek A Saraswat; Subrat K Acharya; Radha K Dhiman; Rakesh Aggarwal; Shivram P Singh; Deepak Amarapurkar; Anil Arora; Mohinish Chhabra; Kamal Chetri; Gourdas Choudhuri; Vinod K Dixit; Ajay Duseja; Ajay K Jain; Dharmesh Kapoorz; Premashis Kar; Abraham Koshy; Ashish Kumar; Kaushal Madan; Sri P Misra; Mohan V G Prasad; Aabha Nagral; Amarendra S Puri; R Jeyamani; Sanjiv Saigal; Shiv K Sarin; Samir Shah; P K Sharma; Ajit Sood; Sandeep Thareja; Manav Wadhawan Journal: J Clin Exp Hepatol Date: 2014-06-09
Authors: Hugo Perazzo; Rodolfo Castro; Paula M Luz; Mariana Banholi; Rafaela V Goldenzon; Sandra W Cardoso; Beatriz Grinsztejn; Valdilea G Veloso Journal: Bull World Health Organ Date: 2019-11-08 Impact factor: 9.408