Direct‐acting antiviral agents in the treatment of chronic hepatitis C—Real‐life experience from clinical practices in Pakistan. Issue 12 (13th March 2020)

• Record Type: Journal Article
• Authors: Mushtaq, Saima; Mansoor, Atika; Umar, Muhammad; Khan, Amjad; Siddiqi, Saima; Manzoor, Sobia
• Is Part Of: Journal of medical virology. Volume 92:Issue 12(2020)
• Page Start: 3475
• Page End: 3487
• Publication Date: 2020-03-13
• Subjects: direct‐acting antiviral agents -- genotype 3 -- hepatitis C -- sustained virological response; Virology -- Periodicals; 616
• DOI: 10.1002/jmv.25745
• Languages: English
• ISSNs: 0146-6615

Abstract

Abstract: This study aims to evaluate the clinical effectiveness in terms of sustained virological response (SVR), predictors of SVR and safety of available second‐generation generic direct‐acting antivirals in Pakistani chronic hepatitis C patients. This is a retrospective study conducted in multiple centers of Pakistan from January 2015 to January 2019. The samples include patients infected with chronic hepatitis C virus, regardless of virus genotype, cirrhosis, or prior treatment. A total of 993 patients were included in the present study, with the majority receiving sofosbuvir with daclatasvir (95%), sofosbuvir with daclatasvir and ribavirin (4%), and sofosbuvir with ribavirin (1%). There were 96% cases of chronic hepatitis, 3% cases compensated cirrhosis, and 1% cases of decompensated cirrhosis. Genotype 3 (99.6%) was the most common genotype. Overall SVR after 12 weeks was 98% for all treatment regimens. High SVR12 was observed with sofosbuvir in combination with daclatasvir (98.5%), then sofosbuvir in combination with daclatasvir and ribavirin (90.2%) and sofosbuvir in combination with ribavirin (75%). SVR rates were high in chronic hepatitis C patients (98.2%) as compared with cirrhotic patients (92.1%) and it was high in treatment‐naive (98.8%) then interferon experienced patients (90.1%). In multivariate binary logistic regression analysis, patients' education status, treatment strategy, viral load, and alanine aminotransferase had a statistically significant association with SVR at 12 weeks. No major adverse events occurred which required treatment discontinuation. Generic oral direct acting antiviralss (sofosbuvir with daclatasvir) achieved higher SVR12 rates and were well tolerated in this large real‐world cohort of genotype 3 infected patients. Highlights: In this study we have analyzed the clinical effectiveness, predictors and safety profile of available second generation generic direct‐acting antivirals in Pakistani chronic Hepatitis C patients. Generic sofosbuvir with daclatasvir achieved 98% SVR rate after 12 weeks in this large real‐world cohort of genotype 3 infected patients. The predictors of low SVR12 were poor education status, high viral load and elevated level of ALT.