Adverse Events (AE) and Laboratory Changes in a Real-World Population of Hepatitis C Virus (HCV)-Infected Patients With Chronic Kidney Disease (CKD) Treated With Sofosbuvir (SOF)-Based Therapy
Year: 2015
Type: article
Study design: Observational Study
Abstract: Background. There is limited safety data available for patients with CKD treated with direct-acting antiviral therapy. Although no dosage adjustment of SOF is required for patients with mild to moderate renal impairment (CrCl 30 mL/min to 80 mL/min), SOF area under the curve (AUC) is increased in these individuals. Methods. Data from 72 patients with CKD who began SOF-based therapy for chronic HCV infection between November 2013 and December 2014 were evaluated retrospectively for safety and tolerability. CKD was defined by the presence of albuminuria >30 mg/g or glomerular filtration rate <60 mL/min. Ribavirin (RBV)-containing regimens were compared to those without RBV. Results. Median age was 61 ± 8 years, 60% were white, 45% were transplant recipients, and 7% were HIV coinfected. At baseline, 41 (57%) had stage 3 CKD, and 31 (43%) had stage 1-2 CKD. RBV-containing regimens were used in 26 (36%) of patients, 36 (50%) received SOF and simeprevir. Transient creatinine rise ≥0.3 mg/dL during treatment was noted in 63 patients, but on-treatment average eGFR did not differ significantly from baseline [mean (95% CI): 57 mL/min (52-62) versus 58 mL/min (53-63), respectively, P = 0.26]. 55 (76%) patients experienced an AE with 5 patients discontinuing due to AEs (table). The sustained viral response rate (SVR12) was 75%. Change in hemoglobin at 8 weeks was greater in patients receiving RBV compared to those on a RBV-free regimen [median (Q1-Q3): −1.8 g/dL −3.6 to −1.0) versus −0.4 g/dL (−1.4 to 0.1), respectively; p = 0.005]. Mean total bilirubin increased by 0.52 mg/dL (p = 0.01) from baseline to week 4 but post-treatment week 4 levels were on average 0.19 mg/dL below baseline (p = 0.015). *Prompted discontinuation in ≥1 Conclusion. We identified higher than expected rates of side effects associated with SOF-based therapy in CKD patients, but few led to treatment discontinuation and significant nephrotoxicity was not noted. Disclosures. R. Chung, Gilead: Investigator, Research grant; M. Sise, Gilead: Investigator, Research grant
Source: Open Forum Infectious Diseases
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,053
OpenAlex ID: W2337979309