Real-world effectiveness and safety of sofosbuvir and ledipasvir with or without ribavirin for patients with hepatitis C virus genotype 1 infection in Taiwan.

Chen-Hua Liu,Tai-Chung Tseng,Ding-Shinn Chen,Jia-Horng Kao,Pei-Jer Chen,Tung-Hung Su,Chun-Jen Liu,Hung-Chih Yang,Chun-Ming Hong

doi:10.1371/journal.pone.0209299

Abstract

BackgroundThe real-world data for the effectiveness and safety of sofosbuvir/ledipasvir (SOF/LDV) with or without ribavirin (RBV) in patients with hepatitis C virus genotype 1 (HCV-1) infection remain limited in Taiwan.MethodsA total of 273 chronic HCV-1 patients receiving 8, 12, or 24 weeks of SOF/LDV with or without RBV were enrolled. The sustained virologic response rate at week 12 off-therapy (SVR12) by evaluable population (EP) and per-protocol population (PP) were assessed for effectiveness. The treatment discontinuation rate due to adverse events (AEs) and serious AE rate were assessed for safety. Baseline patient characteristics and on-treatment HCV viral kinetics associated with SVR12 were analyzed.ResultsThe SVR12 rates by EP and PP analyses were 96.7% (95% confidence interval [CI]: 93.9%-98.3%) and 97.5% (95% CI: 94.8%-98.8%), respectively. The rates of treatment discontinuation due to AE and serious AE were 0.4% and 4.4%, respectively. Seven patients with true virologic failure were relapsers. In 2 patients who were lost-to follow-up, one expired at treatment week 3 due to pneumonia which was considered not related to treatment, and one declined follow-up at off-therapy week 4. The SVR12 rates were comparable in terms of baseline patient characteristics and viral decline at week 4 of treatment.ConclusionsSOF/LDV with or without RBV for 8–24 weeks is well tolerated and achieves a high SVR12 rate in patients with HCV-1 infection in Taiwan.

Highlights

Hepatitis C virus (HCV) infection is a challenging health problem which affects approximately 71.1 million people worldwide [1]
The SVR12 rates by evaluable population (EP) and PP analyses were 96.7% (95% confidence interval [CI]: 93.9%98.3%) and 97.5%, respectively
Over a period of 20–30 years, about 20% of chronic HCVinfected patients will evolve to cirrhosis which may progress to hepatic decompensation and hepatocellular carcinoma (HCC) [2,3]

Summary

Introduction

Hepatitis C virus (HCV) infection is a challenging health problem which affects approximately 71.1 million people worldwide [1]. Over a period of 20–30 years, about 20% of chronic HCVinfected patients will evolve to cirrhosis which may progress to hepatic decompensation and hepatocellular carcinoma (HCC) [2,3]. HCV genotype 1 (HCV-1) infection is predominant around the world [9]. Compared to patients with non-HCV-1 infection, those with HCV-1 infection have an increased risk of cirrhosis and HCC [10,11]. An effective and safe HCV treatment strategy, for patients with HCV-1infection, is mandatory. The real-world data for the effectiveness and safety of sofosbuvir/ledipasvir (SOF/LDV) with or without ribavirin (RBV) in patients with hepatitis C virus genotype 1 (HCV-1) infection remain limited in Taiwan

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