Table 2.
HCV drug | Normal renal function | Degree of renal impairment | Removed by dialysis? | |||
---|---|---|---|---|---|---|
GFR >90 mL/min | Mild (GFR 50-89 mL/min)) | Moderate (GFR 30-49 mL/min) | Severe (GFR 15-29 mL/min) | ESRD (GFR <15 mLl/min) | ||
Simeprevir | 150 mg od [11] | 150 mg od [11] | 150 mg od[11] | 150 mg od[11]a | 150 mg od[11]a | No |
Asunaprevirb | 100 mg bid [17] | 100 mg bid [17] | 100 mg bid [17] | 100 mg od [17] | 100 mg bid [17, 70] | Unknown |
Daclatasvir | 60 mg od [18] | 60 mg od [18] | 60 mg od [18] | 60 mg od [18] or 30mg od in combination with asunaprevir [17] | 60 mg od[18] | No |
Sofosbuvir | 400 mg od [23] | 400 mg od [23] | 400 mg od [23] | 400 mg od [31, 32]c | 400mg QD [26, 31, 32] c | Yes, administer after dialysis |
Velpatasvir/sofosbuvirb | 100 mg od/400 mg od [37] | Unknown | Unknown | Unknown | Unknown | Unknown |
Sofosbuvir | 90 mg od/400 mg od [21] | 90 mg od/400 mg od [21] | 90 mg od/400 mg od [21] | Unknown | Unknown | Ledipasvir = no [21] GS-331007 = yes [23] |
Grazoprevir/elbasvir | 100 mg od/50 mg od [50] | 100 mg od/50 mg od [50] | 100 mg od/50 mg od [50] | 100 mg od/50 mg od [50] | 100 mg od/50 mg od [50] | Elbasvir = no Grazoprevir = negligible [32, 50] |
Ombitasvir/paritaprevir/ritonavir | 25 mg od/150 mg od/100 mg od [51] | 25 mg od/150 mg od/100 mg od [51] | 25 mg od/150 mg od/100 mg od [51] | 25 mg od/150 mg od/100 mg od [51] | 25 mg od/150 mg od/100 mg od [80] | Unknown |
Dasabuvir | 250 mg bid [53] | 250 mg bid [53] | 250 mg bid [53] | 250 mg bid [53] | 250 mg bid [80] | Unknown |
Ribavirin | <75 kg = 500 mg bid≥75 kg = 600 mg bid [56] | <75 kg = 500 mg bid≥75 kg = 600 mg bid [56] | Loading dose: <75 kg = 50 0mg bid for 1 day ≥75kg = 600 mg bid for 1 day. Followed by alternating 200 and 400 mg od [95] TDM ribavirind |
Loading dose: <75kg = 500mg bid for 1 day ≥75kg = 600mg bid for 1 day. Followed by 200mg od [95] TDM ribavirind |
Loading dose: <75kg = 500 mg bid, for 1 day ≥75kg = 600 mg bid for 1 day. Followed by 200 mg od [95] TDM ribavirind |
No [56] |
bid twice daily, Cl cr creatinine clearance, DAA direct-acting antiviral, eGFR estimated glomular filtration rate, ESRD end-stage renal disease, FDA Food and Drug Administration, GFR Glomerular filtration rate, HCV hepatitis C virus, SmPC summary of product characteristics
a The SmPC for OLYSIOTM states that exposure may be increased in HCV-infected patients with severe renal impairment, caution is recommended when prescribing OLYSIOTM to these patients
b No SmpC or FDA prescribing information was available at the time of publication
c The SmPC for Solvaldi® (Gilead Sciences, Inc, Foster City, CA, USA) stat that the safety and appropriate dose of Sovaldi® have not been established in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD requiring hemodialysis. These recommendations are made when no other DAA regimen is available
d The SmPC for Rebetol® (Merck & Co., Inc., Whitehouse Station, NJ, USA), states that patients with Clcr <50 mL/min must not be treated with Rebetol®. The prescribing information for Copegus® (Genentech USA, Inc., South San Francisco, CA, USA) states that the dose should be reduced in patients with Clcr <50 mL/min as described in the table. No loading dose is advised (expert opinion)