Efficacy and safety of sofosbuvir and daclatasvir in treatment of kidney transplantation recipients with hepatitis C virus infection

Table 1 Baseline clinical characteristics of patients after kidney transplantation treated with sofosbuvir and daclatasvir

Patient number	1	2	3	4	5	6
Age/gender	47/M	40/M	40/M	48/M	48/M	49/M
Pre-treatment serum HCV viral load (IU/mL)	3.2E+6	8.6E+5	1.4E+7	5.14E+5	2.95E+7	8.08E+5
HCV genotype	1b	1b	3a	1b	6a	1b
Anti-HCV	Negative	Positive	Positive	Positive	Negative	Positive
Cirrhosis	No	No	No	No	No	No
Number of kidney transplantations	Two	One	One	One	One	One
Prior antiviral therapy	No	No	No	No	No	No
Baseline serum Cr (μmol/L) (n = 53-115)	75.5	84.2	146.6	175.6	128	89.3
Baseline eGFR (mL/min)	63.63	80.04	42.86	30.94	48.29	61.85
Baseline Hgb (g/dL)	113	136	121	111	167	137
Baseline ALT (IU/L)	68	67	26	13	26	44
Baseline AST (IU/L)	161	143	42	27	42	54
Baseline γ-GT (IU/L)	162	621	55	25	60	54
Baseline TB (μmol/L)	30	29.2	9.6	8	18.7	12.5
Baseline (Hb g/L)	113	136	121	94	167	137
Complication	Hypertension	Hypertension	Hypertension	Hypertension	Hypertension/Diabetes	Hypertension
Antiviral regimen	Sofosbuvir 400 mg daily + daclatasvir 6 0mg daily	Sofosbuvir 400 mg daily + daclatasvir 60 mg daily	Sofosbuvir 400 mg daily + daclatasvir 60 mg daily + ribavirin 0.6 g daily	Sofosbuvir 400 mg daily + daclatasvir 60 mg daily	Sofosbuvir 400 mg daily + daclatasvir 60 mg daily	Sofosbuvir 400 mg daily + daclatasvir 60 mg daily
Treatment duration (wk)	12	12	12	12	12	12
Baseline immunosuppressive regimen	Mycophenolatemofetil 500 mg bid	Mycophenolate mofetil 540 mg bid	Mycophenolate mofetil 540 mg bid	Mycophenolate mofetil 750 mg bid	Cyclosporin A 75 mg bid	Mycophenolate mofetil 720 mg bid
	Tacrolimus (FK506) 0.5 mg bid	Tacrolimus (FK506)1.5 mg bid	Tacrolimus (FK506)2 mg bid	Tacrolimus 2 mg bid	Mycophenolate mofetil 540 mg bid	Tacrolimus (FK506) 0.5 mg bid
	Methylprednisolone 4 mg qd	Prednisone 5 mg qd	Prednisone 5mg qd	Prednisone 5 mg qd	Prednisone 5 mg qd	Methylprednisolone 4 mg qd
Baseline anti-hypertension regimen	Metoprolol 12.5 mg qd	Benazepril 10 mg	Benazepril 10 mg bid	Valsartan 80 mg bid	Irbesartan 150 mg bid	None
		qd
		Valsartan 80 mg qd
Other regimens	Benzbromarone tablets 12.5 mg bid			Recombinant human erythropoietin injection 10000 U, IH, biw

Cr: Creatinine; eGFR: Estimated glomerular filtration rate; HCV: Hepatitis C virus; HD: Hemodialysis; Hb: Hemoglobin; IU: International units; MMF: Mycophenolate mofitil; MPGN: Membranoproliferative glomerulonephritis; N/A: Not applicable; IH: Hypodermic injection; qd: Once daily; bid: Twice daily; biw: Twice weekly.

Table 2 Adverse events reported

	Event	Patients
Any adverse event leading to discontinuation	-	0
Serious adverse events	Gastrointestinal bleeding/Portal vein thrombosis and Streptococcus bacteremia/Sinus bradycardia and first degree A-V block with syncope	0
Common adverse events	Fatigue	2
	Diarrhea	1
	Tinnitus	1
	Elevation in serum creatinine	2
	Discomfort of abdomen	1
	Discomfort of transplanted kidney region	1
	Unstable blood pressure	3
	Rash	0
	Insomnia	0
	Headache	0

Table 3 Adjustment of immunosuppression regimen in patients after renal transplantation treated with sofosbuvir and daclatasvir

	KT patient 1	KT patient 2	KT patient 3	KT patient 4	KT patient 5	KT patient 6
Baseline immunosuppressive regimen	Prednisone 5 mg qd	Prednisone 5 mg qd	Prednisone 5 mg qd	Methylprednisolone 4 mg qd	Prednisone 5 mg qd	Methylprednisolone 4 mg qd
	Mycophenolate mofetil 1.5 g bid	Mycophenolate mofetil 540 mg bid	Mycophenolate mofetil 540 mg bid	Mycophenolate mofetil 750 mg bid	Mycophenolate mofetil 540 mg bid	Mycophenolate mofetil 720 mg bid
	Tacrolimus (FK506) 0.5 mg bid	Tacrolimus (FK506) 1.5 mg bid	Tacrolimus (FK506) 2 mg bid	Tacrolimus (FK506) 2 mg bid	Cyclosporine 75 mg bid	Tacrolimus (FK506) 0.5 mg bid
1st adjustment	FK506 0.5 mg qd + 1 mg qn (3 wk after the treatment for his blood drug concentration of FK506 was 3.7 ng/mL).	No	No	Mycophenolate mofetil 1000 mg bid	Cyclosporine 75 mg qd + 50 mg qn (5 d after the treatment for his blood drug concentration of cyclosporine rose to 277.9 ng/mL).	No
				FK506 3 mg bid (11 wk after the treatment for his blood drug concentration of FK506 was 5.4 ng/mL).
2nd adjustment	FK506 4 mg bid (8 wk after the treatment for his blood drug concentration of FK506 was 6.4 ng/mL).	No	No	No	Mycophenolate mofetil 720 mg bid (45 d after the treatment was begun).	No
3rd adjustment	Mycophenolate mofetil 1000 mg bid (one month after the treatment)	No	No	No	No	No