Adil Hassan, Ubedullah Bughio, Rehmatullah Bhatti, Mashooque Ali, Laraib Jamali, Muhammad Sadik
Asian Institute of Medical Sciences, Hyderabad, Sindh, Pakistan
Introduction: The combination of Sofosbuvir plus Ribavirin and Sofosbuvir plus Ledipasvir are recommended by American Association for the study of Liver Disease for treatment of Chronic Hepatitis C Virus (HCV) infection in adolescents; however, there is no clear recommendations for its use in children age < 12 years. The purpose of this study is to evaluate use of Sofosbuvir plus Ribavirin and Sofosbuvir plus Daclatasvir with or without Ribavirin in children and adolescents with Chronic HCV infection.
Methods: An observational (off-label), single-centre study was conducted from January 2016 to December 2018. All Chronic HCV RNA detected, aged between 3 to 17 years of either gender were included. Patients were offered one of two regimes; Sofosbuvir plus Ribavirin for 24 weeks (Regime 1) and Sofosbuvir plus Daclatasvir with or without Ribavirin for 12 weeks (Regime 2), according to their weight i.e. standard dose for patients >34kg, half of standard dose for patients weight between 17 to 34 kg and half of standard dose on alternate day for patients < 17 kg. Patients were closely monitored for any drug related adverse effects and very Rapid Virological Response (vRVR) i.e. undetectable serum HCV RNA by week 2 of treatment, then accordingly till Sustained Virological Response (SVR12) i.e. undetectable serum HCV RNA at 12 weeks after completion of treatment.
Results: Total 14 patients were included with mean age of 12.36 ± 5.43 years with 6 (42.9%) patients were less than 12 years and 8 (57.1%) were 12 years. Among these 9 (64.3%) were boys and 5 (35.7%) were girls. 13 (92.9%) patients were non-cirrhotic and 1 (7.1%) patient was compensated cirrhotic. 5 (35.7%) patients treated with Sofosbuvir plus Ribavirin (Regime 1) and 9 (64.7%) patients treated with Sofosbuvir plus Daclatasvir with or without Ribavirin (Regime 2). 13 (92.9%) patients achieved vRVR except 1 (7.1%) patient who achieved partial response in Regime 1. SVR12 achieved by all 14 (100%) patients. No any significant adverse effect was observed and normal growth was assessed with CDC Growth Charts.
Discussion: The combination of Sofosbuvir plus Daclatasvir with or without Ribavirin is not approved by the FDA or EMA for paediatric use, however, it is highly safe and effective in children and adolescents while Sofosbuvir plus Ribavirin combination showed good efficacy and comparable safety profile in age < 12 years.
Citation: Adil Hassan, Ubedullah Bughio, Rehmatullah Bhatti, Mashooque Ali, Laraib Jamali, Muhammad Sadik. P1544 - SAFETY AND EFFICACY OF SOFOSBUVIR PLUS RIBAVIRIN AND SOFOSBUVIR PLUS DACLATASVIR WITH OR WITHOUT RIBAVIRIN COMBINATIONS IN CHILDREN AND ADOLESCENTS WITH CHRONIC HEPATITIS C. Program No. P1544. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.