Real-World Virological Efficacy and Safety of Ledipasvir and Sofosbuvir in Patients with Chronic Hepatitis C Virus Genotype 2 Infection: A Multicenter Study

Overview

Journal Infect Dis Ther

Specialty Infectious Diseases

Date 2020 Nov 3

PMID 33141401

Authors

Toshifumi Tada

Takashi Kumada

Hiroaki Okushin

Joji Tani

Koichi Takaguchi

Akemi Tsutsui

Hidenori Toyoda

Satoshi Yasuda

Kazufumi Dohmen

Atsushi Hiraoka

Kojiro Michitaka

Kazuhiro Nouso

Kazuya Kariyama

Soo Ryang Kim

Soo Ki Kim

Shinichi Fujioka

Shigeru Mikami

Yuto Watanabe

Tsutomu Tamai

Masanori Atsukawa

Norio Itokawa

Hironori Tanaka

Kunihiko Tsuji

Toru Ishikawa

Michitaka Imai

Ei Itobayashi

Hiroshi Shibata

Noritomo Shimada

Affiliations

Soon will be listed here.

Abstract

Introduction: The real-world virological efficacy and safety of interferon-free direct-acting antiviral (DAA) therapy with ledipasvir (LDV) plus sofosbuvir (SOF) were assessed in patients who were chronically infected with hepatitis C virus (HCV) genotype 2.

Methods: A total of 126 patients with chronic hepatitis C due to HCV genotype 2 infection who were treated with the LDV/SOF regimen were enrolled. The sustained virological response (SVR) rate and safety were analyzed. SVR was assessed in the intention-to-treat (ITT) population as well as in the modified intention-to-treat (mITT) population, which excluded patients with non-virological failure, including those who dropped out before the SVR assessment.

Results: The overall SVR rates of the ITT and mITT populations were 87.3% (95% confidence interval [CI] 80.2-92.6) (110/126) and 97.3% (95% CI 92.4-99.4) (110/113), respectively. In the mITT population, the percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 92.9% (95% CI 86.5-96.9) (105/113), 99.1% (95% CI 95.2-100.0) (112/113), and 100.0% (95% CI 97.4-100.0) (113/113), respectively. Subgroup analyses of the mITT population showed no significant differences in SVR rates according to age, sex, HCV genotype (subtype), history of interferon-based therapy, baseline FIB-4 index, or baseline estimated glomerular filtration rate. In all subpopulations, the SVR rates were > 90%. There were no severe adverse events associated with the treatment.

Conclusion: The LDV/SOF regimen showed high virological efficacy and acceptable safety in patients with HCV genotype 2 infection.

Trial Registration: UMIN registration no. 000038604.

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