Sofosbuvir-based therapies associated with regression of liver fibrosis in patients with hepatitis C virus infection: A prospective observational study.

Abstract

ABSTRACT:

Oral direct-acting antiviral (DAA) treatment leads to >95% sustained virological response (SVR) and could be clinically useful in regression of liver fibrosis in chronic hepatitis C virus (HCV) infection. We evaluated if ledipasvir/sofosbuvir or sofosbuvir + ribavirin is associated with regression of fibrosis in HCV patients who achieved SVR.In this prospective cohort study performed at 3 sites in Japan, patients with genotype 1 and genotype 2 were given standard treatment of ledipasvir 90 mg/sofosbuvir 400 mg and sofosbuvir 400 mg + 200-1000 mg/day ribavirin, respectively, for 12 weeks. Liver fibrosis was assessed using Mac-2-binding protein glycosylation isomer (M2BPGi) and other fibrosis markers (platelet count, Fib-4 index, liver stiffness measurement [LSM]) in patients who achieved SVR.A total of 98.1% of (n = 101/103) patients in genotype 1 cohort and 100% (n = 16/16) in the genotype 2 cohort achieved SVR12. Based on per-protocol analysis, M2BPGi levels showed a significant decrease (-2.2  cut-off index [COI], P < .0001) at week 48 after treatment initiation. Forty-three patients showed a significant decrease in Fib-4 index (-1.2, P < .0001), and 44 patients showed improvement in LSM (-5.9 kPa, P < .0001).Achievement of SVR after antiviral therapy was associated with fibrosis regression. M2BPGi correlated well with LSM at week 48 after treatment initiation, supporting the sustainable benefit of HCV therapy.

• Authors: Akito Nozaki, Makoto Chuma, Koji Hara, Satoshi Moriya, Hiroyuki Fukuda, Kazushi Numata, Katsuaki Tanaka, Manabu Morimoto, Kentaro Sakamaki, Takeharu Yamanaka, Masaaki Kondo, Shin Maeda
• Journal: Medicine (Medicine (Baltimore)) Vol. 100 Issue 12 Pg. e25110 (Mar 26 2021) ISSN: 1536-5964 [Electronic] United States
• PMID: 33761674 (Publication Type: Journal Article, Observational Study)
• Copyright: Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Benzimidazoles
• Fluorenes
• ledipasvir, sofosbuvir drug combination
• Ribavirin
• Sofosbuvir

Topics

• Adult
• Aged
• Aged, 80 and over
• Benzimidazoles (administration & dosage)
• Drug Therapy, Combination
• Female
• Fluorenes (administration & dosage)
• Hepacivirus (drug effects)
• Hepatitis C, Chronic (complications, drug therapy)
• Humans
• Liver (drug effects, virology)
• Liver Cirrhosis (drug therapy, virology)
• Male
• Middle Aged
• Prospective Studies
• Ribavirin (administration & dosage)
• Sofosbuvir (administration & dosage)
• Sustained Virologic Response
• Treatment Outcome