- Pangenotypic sofosbuvir/velpatasvir (SOF/VEL, Epclusa) safely achieves a 95% HCV clearance rate among patients undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD).
Why this matters
- The prescribing information does not offer dosing recommendations for patients with estimated glomerular filtration rate (eGFR, in mL/minute/1.73 m2)
- Multinational phase 2 open-label study of 59 patients (mean age, 60 years; 60% male) with HCV genotypes (GT) 1-6 undergoing hemodialysis (92%, mean, 7 years) or peritoneal dialysis and receiving 12 weeks of standard-dose SOF/VEL.
- 78% were treatment-naive; 29% had cirrhosis.
- Sustained virologic response was measured at 12 weeks posttreatment (SVR12).
- Funding: Gilead Sciences.
- GT1 was most common (42%: 1a, 25%; 1b, 19%), followed by GT3 (32%), GT2 (12%), GT4 (7%), and GT6 (3%); GT was undetermined in 9%.
- SVR12 rate was 95% (56/59; 95% CI, 86%-99%).
- Of 3 non-SVR12 patients, 2 relapsed at week 4 posttreatment (1 nonadherent, 1 with treatment-experienced HCV-3a); 1 patient committed suicide.
- SOF, SOF metabolite, and VEL exposures were 81%, 1719%, and 41% higher, respectively, than that observed with normal renal function.
- Adverse events (incidence >10%): headache (17%), fatigue/nausea/vomiting (14% each); no serious events were related to SOF/VEL.
- Single-arm design.