Effectiveness and safety of sofosbuvir/velpatasvir with or without ribavirin for patients with chronic hepatitis C and chronic kidney disease

Objective:To evaluate the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) with or without ribavirin in the treatment of patients diagnosed with chronic hepatitis C (CHC) and chronic kidney disease (CKD).Methods:From June 2018 to May 2022, a total of 75 patients with CHC and CKD, and treated with SOF/VEL±ribavirin at the Kunming Third People′s Hospital were enrolled in this study. The basic information of patients were collected. Assessments of renal function, liver function, virologic response rate and adverse events were conducted at baseline, four weeks and 12 weeks of treatment and 12 weeks after treatment withdrawal. Wilcoxon rank sum test and Kruskal-Wallis rank sum test were used for statistical analysis.Results:Among the 75 patients, 51 cases(68.0%) were classified as CKD stage 2, 12 cases (16.0%) as CKD stage 3, four cases (5.3%) as CKD stage 4, eight cases (10.7%) as CKD stage 5. Additionally, 26 cases (34.7%) were classified as HCV type 3a, while 37 cases (49.3%) were classified as type 3b. Among the patients, 51 cases (68.0%) had cirrhosis, including 15(20.0%) compensated cirrhosis and 36(48.0%) decompensated cirrhosis. Twelve weeks after treatment withdrawal, there was a statistically significant improvement in the estimated glomerular filtration rate (eGFR) compared to baseline (81.76(60.94, 94.34) mL/(min·1.73 m 2) vs 70.99(52.86, 82.38) mL/(min·1.73 m 2), Z=8.12, P=0.040). From baseline to 12 weeks after treatment withdrawal, eGFR of patients with CKD stage 2 and stage 3 were both gradually increased, with statistical significance ( H=8.91 and 8.03, respectively, both P<0.05). For CKD stage 2 patients, eGFR increased from 78.82(70.98, 84.80) mL/(min·1.73 m 2) to 86.94 (75.91, 96.01) mL/(min·1.73 m 2), while CKD stage 3 patients had an increased from 51.24 (45.92, 53.37) mL/(min·1.73 m 2) to 64.58 (44.54, 74.34) mL/(min·1.73 m 2). Renal function was improved to CKD stage 1 in 21 patients (28.0%). Compared to baseline, CKD stage 2 patients exhibited a decrease of aspartate aminotransferase to platelet ratio index 12 weeks after treatment withdrawal, and alanine aminotransferase and aspartate aminotransferase levels were also significantly improved with statistical significance ( Z=8.03, 21.57 and 43.74, respectively, all P<0.05). The rate of sustained virological response (SVR)12 at 12 weeks after treatment withdrawal was 98.7%(74/75). Among these cases, 51 patients in CKD stage 2, 11 patients in CKD stage 3, 12 patients in CKD stage 4 and stage 5 reached SVR12. Adverse events occurred in 32 patients (42.7%), including 18 cases of mild hemolytic anemia, four cases of skin itching, three cases of rash, two cases of chest tightness, and five cases of fatigue. Conclusions:SOF/VEL with or without ribavirin for the treatment of patients with CHC and CKD has good effectiveness and safety. The renal function, liver function and liver fibrosis degree have been improved after antiviral treatment.