Local Experience with Generic Sofosbuvir and Ribavirin With or Without Pegylated-IFN in Chronic Hepatitis C Predominantly Genotype 3 Patients

Maheshwary Neeta, Asad A Chaudhry, Rabeeya Arif, Bushra Ali, Anam Khalid, Shahid Majid, Ahson Siddiqi, Adnan Anwar
2017 Journal of Gastroenterology Pancreatology & Liver Disorders  
Objective: To study the efficacy and safety of generic Sofobuvir and ribavirin with or without pegylated IFN. Material and Methods: This was a prospective observational multicenter study with non-probability convenient sampling procedure and duration of 1 year from 31 January 2016 till 1st February 2017.The study was conducted after ethical approval by Ethics Committee of the Gujranwala Liver foundation. The patients infected with Hepatitis C Virus, belonging to both genders, and willing for
more » ... atment with sofosbuvir, pegylated interferon and ribavirin were enrolled for the study. The written consent was taken from all the patients with complete confidentiality of the data. The genotype of the patient was categorized through polymerase chain reaction (PCR). HCV RNA by PCR was done before treatment and at 12weeks after completion of the treatment classified as Sustained Virological Response(SVR12). The goal of the treatment was classified as achieved and not achieved. The therapy was categorized into dual containing Sofosbuvir and Ribavirin, and triple containing Sofosbuvir, Ribavirin and Pegylated Interferon. The patients were classified as non-cirrhotic or cirrhotic based on findings of fibroscan or APRI score. Patients were treated with Sofosbuvir 400 mg daily, weight based ribavirin in 2 or 3 divided doses and Pegylated Interferon 180 µcg weekly. All data was entered and analyzed on SPSS version 20. Results: Total 150 patients were selected with male to female ratio of 1:1. 97.4 % were GT3 and 3.4 % were non GT3. Overall SVR12 was achieved in 134 patients (89.3 %). 130 patients received dual therapy with sofosbuvir and ribavirin, of these 116 (89.2 %) achieved SVR12. 20 patients were treated with triple combination of pegylated interferon, sofosbuvir and ribavirin, 18 (90%) amongst these achieved SVR12. In the dual therapy group, Treatment naïve, non-cirrhotic patients showed 96 % (73/76) SVR12 while treatment experienced non-cirrhotic patients achieved 100 % (8/8) SVR12. Treatment naïve and treatment experienced cirrhotic patients in the same group achieved 87.5 % (35/40) and 100 % (6/6) SVR12 respectively. Amongst the 20 patients in the triple therapy category, SVR12 were 100 % (5/5) in treatment naïve non cirrhotic patients, 87.5 % (7/8) treatment experienced non-cirrhotic patients, 100 % (2/2) in treatment naïve cirrhotic group and 80 % (4/5) in treatment experienced cirrhotic category. The most frequently reported adverse events were fatigue followed by anemia, nausea, headache and insomnia with no report of serious adverse events. Conclusion: Treatment with generic Sofosbuvir and Ribavirin with or without pegylated Interferon has shown excellent sustained virological response in HCV genotype 3 infected non-cirrhotic and cirrhotic patients. The results are at par with the International studies and the therapy was well tolerated. Fesharaki M, et al. Combination of sofosbuvir, pegylated-interferon and ribavirin for treatment of hepatitis C virus genotype 1 infection: a systematic review and metaanalysis.
doi:10.15226/2374-815x/4/6/001104 fatcat:mt3blidufrcd3n6woggqlveyci