Real-world effectiveness of direct-acting antiviral agents for chronic hepatitis C in Taiwan: Real-world data

Abstract

Background/purpose: Treatment of chronic hepatitis C (CHC) has entered a new era since the introduction of direct-acting antiviral agents (DAAs). Numerous clinical trials have shown that treatment response as well as tolerability of DAAs are superior to those of conventional therapy with pegylated interferon and ribavirin. However, the results of clinical trials may not be directly applied to real-world practice. Therefore our study tried to investigate the effectiveness of various DAA regimens in Taiwanese patients with chronic hepatitis C. Methods: We performed a retrospective study on 400 CHC patients. The primary endpoint was undetectable HCV RNA (an HCV RNA level of <25 IU/mL) at 12 weeks posttreatment (SVR12). The results were stratified by different DAAs and HCV genotypes. Results: Genotype 1b was the major genotype (297, 74.3%), followed by genotype 2 (65, 16.3%). The patients were treated according to HCV genotype, clinical practice and reimbursement guidelines. The SVR12 rates of 57 patients treated with sofosbuvir and ribavirin, 107 treated with ledipasvir/sofosbuvir with or without ribavirin, 60 treated with daclatasvir/asunaprevir with or without ribavirin, 129 treated with ombitasvir/paritaprevir/ritonavir/dasabuvir with or without ribavirin, 12 treated with sofosbuvir/daclatasvir with or without ribavirin, and 35 treated with elbasvir/grazoprevir were 98.2%, 97.2%, 85.0%, 97.7%, 100.0%, and 100.0%, respectively. Conclusions: The overall SVR12 rates in our study were comparable with those in previous pivotal trials. DAAs are generally safe. The interaction of HBV and HCV during DAA therapy and the observation of de novo HCC development and HCC recurrence during or after DAAs warrants additional studies.

Keywords

• Chronic hepatitis C
• Direct-acting antiviral agents
• Real-world data