Efficacy and Safety of Sofosbuvir and Ribavirin for Treating Chronic Hepatitis C, Genotype 3: Experience of a Tertiary Care Hospital at Karachi, Pakistan

Abstract

Background It is estimated that approximately 10 million individuals in Pakistan are infected with hepatitis C virus (HCV). Historically, it was very difficult not just to cure but even treat HCV as available options did not have desirable outcomes. However, the approval of directly acting antiviral (DAA) drugs has revolutionized treatment and management. These are specific proteases and polymerase inhibitors with profound capability for accomplishing elimination and overtime eradication of the virus. Objective The aim of this study was to evaluate the efficacy and safety of sofosbuvir (SOF) in combination with ribavirin (RIB) for the treatment of chronic hepatitis C virus with genotype 3. Materials and methods This prospective observational study was conducted at the gastroenterology section of Medical Unit IV, Jinnah Post-graduate Medical Center, Karachi and Medical Unit II, Dow University of Health Sciences, Ojha Campus, Karachi from January 2016 to December 2016. Patients aged 18 years or older of either gender having chronic active HCV infection as demonstrated by a positive Anti-HCV (ELISA) test and a qualitative polymerase chain reaction (PCR) analysis along with genotype analysis showing only type 3 were inducted into the study. Treatment was initiated with either 12-week or 24-week regimen of SOF 400 mg once daily along with weight-adjusted RIB orally. Successful treatment was indicated by the elimination of the virus, i.e., undetectable viral load/levels by PCR qualitative analysis. Rapid virological response (RVR), end of treatment response (ETR), and sustained virological response (SVR) were defined as the undetectable viral load at four, 12, and 24 weeks, respectively. Results A total of 300 patients were inducted into the study, predominantly female (57%). The mean age of presentation was 41.14 ± 11.48, and most (70.33%) were treatment naïve. The mean alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) levels at presentation were 41.89 ± 46.23 IU/l, 68.57 ± 83.62 IU/l, and 54.52 ± 77.57 IU/l, respectively. ALT, AST, and GGT levels at 24 weeks were 33.84 ± 13.60 IU/l, 32.44 ± 16.16 IU/l, and 37.59 ± 22.41 IU/l, respectively, showing significant improvement. ETR was achieved in 99.1% (209) treatment-naïve patients and 98.9% (88) treatment-experienced patients. SVR rates were almost similar with 98% (208) achieving it in the treatment-naïve group and 96.6% (86) achieving it in the treatment-experienced group. Conclusion SOF in combination with RIB is safe and remarkably efficacious in the treatment of chronic HCV, genotype 3. Not only is this regimen associated with the elimination of viral replication but it also improved transaminase levels. Outcomes are rarely, if ever, affected by previous use of antiviral medications.

Effectiveness and Safety of Direct Acting Antiviral Agents in Thalassaemic Patients With Chronic Hepatitis C

“…Mainly there are adults' studies and in paediatrics Hashmi MA et al reported mean age of 10years and Alvi MA et al reported 14± 2.5years. 12,17,18 Male to female ratio in our study was 1.3, male were predominant same as reported by Hashmi et al 1.7 times male and Alvi MA et al 1.6 times male, even higher ratio of males in their studies as compared to our study. 12,17 Nine patients in our study were less than 6 years of age and youngest one was 3 years old.…”

Patterns of Hepatocellular Carcinoma After Direct Antiviral Agents and Pegylated-Interferon Therapy

“…Hepatitis C Virus (HCV) which is a leading cause of chronic liver disease (CLD) and decompensated liver disease (DCLD) affects about 170-200 million individuals worldwide [ 1 ]. In Pakistan, approximately 10 million individuals are infected with HCV and this burden is expected to grow in the coming years [ 2 ]. Several efforts are being done by the officials in Pakistan to control the spread of disease as well as to timely manage all those suffering from it.…”

Efficacy and safety of sofosbuvir plus ribavirin in treatment-naive chronic hepatitis c genotype 3 patients of South Punjab, Pakistan

“…SOF plus RIB therapy has been depicted to be safest antiviral therapy in local as well as international studies in the recent years. 1,4,12,13,14 All the side effects with this regimen are manageable and possess low threat as compared to previously available treatments. 25…”

“…More than 200 million people are estimated to be affected by hepatitis C virus (HCV) around the globe and it is considered to be the leading cause of chronic liver disease and decompensated liver disease especially in developing countries. 1,2 Amongst various genotypes globally, genotype 1 has an overall share of 46% while genotype 3 accounts for nearly 22% of the cases. In Pakistan, the burden of HCV seems to involve more than 10 million individuals and the numbers are growing every day.…”