ABSTRACT FINAL ID: 2005
TITLE: Efficacy and safety of sofosbuvir-based therapy for aged patients with chronic hepatitis C
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Background and Aim: Sofosbuvir (SOF)-based therapy has achieved high rates of sustained virologic response (SVR) in patients with chronic hepatitis C virus (HCV) genotype (GT)1 and GT2 infections. Additionally, it has been available for aged patients who are intolerant to interferon therapy. We investigated the efficacy and safety of SOF-based therapy for aged patients with chronic HCV infection.
Patients and Methods: This prospective study was conducted at our hospital and related institutions. A total of 726 patients including 536 patients with GT1 treated with SOF/ledipasvir (LDV) and 248 patients with GT2 treated with SOF/ ribavirin (RBV) were analyzed. The proportion of aged patients ≥65 years old (y.o.) was 63% and 53%, in the GT1 and GT2 groups, respectively. The SVR rate was evaluated by using the intention-to-treat analysis. We performed subgroup analysis in three groups that were classified based on age (< 65, 65-74, and ≥ 75 y.o.).
Results: In the SOF/LDV-treated patients with GT1, the older the patients were, the higher the discontinuance rates were with 0% (0/101), 1% (1/117), and 4% (3/86) in patients who were < 65, 65-74, ≥ 75 y.o., respectively (p = 0.04). Furthermore, the older the patients were, the more the SVR rates decreased with values of 100% (86/86), 99% (96/97), and 96% (70/73) in patients who were < 65, 65-74, and ≥ 75 y.o., respectively (p = 0.04). In the SOF/RBV-treated patients with GT2, the discontinuance and SVR rates did not differ among the three groups. However, the discontinuance rate was significantly higher in patients ≥ 80 y.o. at 8% (2/24) than it was in those < 70 and 70-79 y.o. at 0 and 3% (0/128 and 2/72), respectively (p = 0.011). The adverse events related to discontinuance were as follows; renal dysfunction, hyperkalemia, pneumonia, and unexpected death in SOF/LDV therapy and vomiting, dysphagia, dizziness, and malaise with SOF/RBV therapy. Patients ≥ 75 y.o. treated with SOF/RBV tended to show a steeper decrease in serum hemoglobin level (-1.8 g/dL) than the other two groups (-1.5 g/dL in each group). Additionally, both of mean serum creatinine level and mean eGFR level were not significantly decreased among all groups in SOF-based therapy.
Conclusion: Although the proportion of aged patients increased in SOF-based therapy, and high SVR rates were achieved even in aged patients, the discontinuance rate was significantly higher in super-aged patients. Therefore, we should pay attention to those aged patients by closely monitoring their therapeutic regimens.