title: 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: Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.
authors: Eiichi
authors: E
authors: Ogawa
authors: Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.
authors: Norihiro
authors: N
authors: Furusyo
authors: The Center for Liver Disease, Shin-Kokura Hospital, Kitakyushu, Japan.
authors: Hideyuki
authors: H
authors: Nomura
authors: Department of Medicine, Hamanomachi Hospital, Fukuoka, Japan.
authors: Kazuhiro
authors: K
authors: Takahashi
authors: Department of Hepatology, Steel Memorial Yawata Hospital, Kitakyushu, Japan.
authors: Nobuhiko
authors: N
authors: Higashi
authors: Department of Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
authors: Akira
authors: A
authors: Kawano
authors: Department of Internal Medicine, Chihaya Hospital, Fukuoka, Japan.
authors: Kazufumi
authors: K
authors: Dohmen
authors: Center for Liver Disease, National Hospital Organization Kokura Medical Center, Kitakyushu, Japan.
authors: Takeaki
authors: T
authors: Satoh
authors: Department of Medicine, Kyushu Central Hospital, Fukuoka, Japan.
authors: Koichi
authors: K
authors: Azuma
authors: Department of Gastroenterology, Kyushu Medical Center, National Hospital Organization, Fukuoka, Japan.
authors: Makoto
authors: M
authors: Nakamuta
authors: Department of Medicine, Fukuoka City Hospital, Fukuoka, Japan.
authors: Toshimasa
authors: T
authors: Koyanagi
authors: Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors: Masaki
authors: M
authors: Kato
authors: Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors: Shinji
authors: S
authors: Shimoda
authors: Kajiwara Clinic, Kitakyushu, Japan.
authors: Eiji
authors: E
authors: Kajiwara
authors: Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan. Electronic address: hayashij1949@haradoi-hospital.com.
authors: Jun
authors: J
authors: Hayashi
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: Cirrhosis; DAA; Gerontology; Hepatitis C virus; Ribavirin; Sofosbuvir