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. 2016 Apr 20;39:589–611. doi: 10.1007/s40264-016-0420-2

Table 2.

Dosage recommendations for patients with mild, moderate, or severe renal insufficiency or end-stage renal disease

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)