Aabha Nagral1,2,3, Ajay Jhaveri4, Smita Sawant5, Nirzar Samir Parikh4, Nishtha Nagral6, Rashid Merchant7, Mihir Gandhi8,9,10. 1. Department of Gastroenterology, Jaslok Hospital & Research Centre, Mumbai, India. aabhanagral@gmail.com. 2. Department of Gastroenterology, Apollo Hospital, Mumbai, India. aabhanagral@gmail.com. 3. Department of Gastroenterology, Bhatia Hospital, Mumbai, India. aabhanagral@gmail.com. 4. Department of Gastroenterology, Jaslok Hospital & Research Centre, Mumbai, India. 5. Medical Officer, Nagral Clinic, Mumbai, India. 6. Topiwala National Medical College & BYL Nair Charitable Hospital, Mumbai, India. 7. Department of Pediatrics, Dr. Balabhai Nanavati Hospital, Mumbai, India. 8. Department of Biostatistics, Singapore Clinical Research Institute, Singapore, Singapore. 9. Quantitative Services & Collaborations, Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore, Singapore. 10. Global Health Group, Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.
Abstract
OBJECTIVES: To assess the efficacy and safety of sofosbuvir based generic Direct Acting Antivirals (DAAs) in treatment of Hepatitis C virus (HCV) in adolescents with thalassemia major (TM). METHODS: In this prospective single-arm study, 18 TM adolescents with Chronic Hepatitis C received sofosbuvir based generic DAAs. Patients with genotype 1 and genotype 3 received ledipasvir and daclatasvir respectively. Two cirrhotic patients with genotype 3 also received ribavirin. RESULTS: The mean age of patients was 15.1 y, of which 12 had genotype 1, 5 had genotype 3 and 1 had an undetermined genotype. Six patients had cirrhosis and 1 was treatment experienced. Sixteen of 18 patients (89%; 95% confidence interval 74 to 100%) achieved sustained virological response at 3 mo post completion of treatment with DAAs. There was a significant reduction in alanine aminotransferase levels (p < 0.001), HCV RNA load (p < 0.001) and ferritin levels (p < 0.026) at 3 mo post completion of treatment. There were no major adverse events associated with the use of DAAs. CONCLUSIONS: Generic DAAs are effective and safe in TM adolescents with HCV.
OBJECTIVES: To assess the efficacy and safety of sofosbuvir based generic Direct Acting Antivirals (DAAs) in treatment of Hepatitis C virus (HCV) in adolescents with thalassemia major (TM). METHODS: In this prospective single-arm study, 18 TM adolescents with Chronic Hepatitis C received sofosbuvir based generic DAAs. Patients with genotype 1 and genotype 3 received ledipasvir and daclatasvir respectively. Two cirrhotic patients with genotype 3 also received ribavirin. RESULTS: The mean age of patients was 15.1 y, of which 12 had genotype 1, 5 had genotype 3 and 1 had an undetermined genotype. Six patients had cirrhosis and 1 was treatment experienced. Sixteen of 18 patients (89%; 95% confidence interval 74 to 100%) achieved sustained virological response at 3 mo post completion of treatment with DAAs. There was a significant reduction in alanine aminotransferase levels (p < 0.001), HCV RNA load (p < 0.001) and ferritin levels (p < 0.026) at 3 mo post completion of treatment. There were no major adverse events associated with the use of DAAs. CONCLUSIONS: Generic DAAs are effective and safe in TM adolescents with HCV.
Entities:
Keywords:
Daclatasvir; Hemoglobinopathy; Iron overload; Ledipasvir; Sofosbuvir
Authors: Neal R Barshes; Ian W Udell; Timothy C Lee; Christine A O'Mahony; Saul J Karpen; Beth A Carter; John A Goss Journal: Liver Transpl Date: 2006-07 Impact factor: 5.799
Authors: Edoardo G Giannini; Nezam H Afdhal; Samuel H Sigal; Andrew J Muir; K Rajender Reddy; Shanthi Vijayaraghavan; Magdy Elkashab; Manuel Romero-Gómez; Geoffrey M Dusheiko; Malini Iyengar; Sandra Y Vasey; Fiona M Campbell; Dickens Theodore Journal: J Gastroenterol Hepatol Date: 2015-08 Impact factor: 4.029
Authors: V Di Marco; O Lo Iacono; M Capra; S Grutta; C Ciaccio; C Gerardi; A Maggio; D Renda; P Almasio; R Pisa Journal: Haematologica Date: 1992 Nov-Dec Impact factor: 9.941