Effectiveness and safety of sofosbuvir plus ribavirin for HCV genotype 2 patients 65 and over with or without cirrhosis.

Abstract

Older patients with chronic hepatitis C virus (HCV) infection have historically been designated difficult-to-treat. We evaluated the efficacy and safety of sofosbuvir (nucleotide NS5B polymerase inhibitor) plus ribavirin for patients with HCV genotype 2 infection in a real-world clinical setting, with the focus on elderly patients aged ≥ 65. This large, multicenter study consisted of 446 Japanese HCV genotype 2 patients (303 treatment-naïve and 143 treatment-experienced), including 190 (42.6%) aged ≥ 65 and 90 (20.2%) with compensated cirrhosis. Efficacy was assessed by the sustained virological response 12 weeks post-treatment (SVR12). The overall SVR12 rate was 95.7% (427/446), and the SVR12 rate of patients aged ≥ 65 was 95.3% (181/190). For treatment-naïve patients, almost all with compensated cirrhosis (95.6%, 43/45) achieved SVR12, irrespective of age. For treatment-experienced patients, cirrhosis undermined the treatment outcome, both for the aged ≥65 (SVR12: 80.0%, 20/25) and <65 (85.0%, 17/20) patient groups when compared to non-cirrhosis patients (≥65: 95.7%, 45/47 and < 65: 96.2%, 50/52). The most common adverse effect was anemia (hemoglobin <10 g/dL), especially for patients aged ≥ 65 with the inosine triphosphate pyrophosphatase CC genotype at rs1127354 (26.2%, 33/126). Notably, ribavirin reduction was not related to treatment failure. Only three (0.7%) patients, all aged ≥ 65, discontinued treatment, but all achieved SVR12. Sofosbuvir plus ribavirin for HCV genotype 2 was effective for patients aged ≥65, especially those who were treatment-naïve or treatment-experienced/non-cirrhosis.

• Authors: Eiichi Ogawa, Norihiro Furusyo, Hideyuki Nomura, Kazuhiro Takahashi, Nobuhiko Higashi, Akira Kawano, Kazufumi Dohmen, Takeaki Satoh, Koichi Azuma, Makoto Nakamuta, Toshimasa Koyanagi, Masaki Kato, Shinji Shimoda, Eiji Kajiwara, Jun Hayashi, Kyushu University Liver Disease Study (KULDS) Group
• Journal: Antiviral research (Antiviral Res) Vol. 136 Pg. 37-44 (12 2016) ISSN: 1872-9096 [Electronic] Netherlands
• PMID: 27789224 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2016 Elsevier B.V. All rights reserved.

Chemical References

• Antiviral Agents
• RNA, Viral
• Ribavirin
• Sofosbuvir

Topics

• Age Factors
• Aged
• Aged, 80 and over
• Antiviral Agents (adverse effects, therapeutic use)
• Cohort Studies
• Drug Therapy, Combination
• Female
• Genotype
• Hepacivirus (drug effects)
• Hepatitis C, Chronic (drug therapy, virology)
• Humans
• Liver Cirrhosis (drug therapy, virology)
• Male
• Middle Aged
• RNA, Viral
• Ribavirin (adverse effects, therapeutic use)
• Sofosbuvir (adverse effects, therapeutic use)
• Treatment Failure
• Treatment Outcome