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

- The SVR12 rate of patients aged ≥65 was 95.3% in sofosbuvir plus ribavirin for HCV genotype 2.
- For treatment-experienced patients, cirrhosis undermined the treatment outcome, both for the aged ≥65 and < 65 groups.
- Early virological response was associated with a low baseline HCV RNA level, but not with treatment outcome.
- The most common adverse effect was anemia, especially for older patients with the ITPA CC genotype at rs1127354.
- Ribavirin reduction and mean dosage of ribavirin had little impact on treatment failure.

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.