Interferon-free regimens in patients with hepatitis C infection and renal dysfunction or kidney transplantation

Table 2 Studies of interferon free regimens for treatment of hepatitis C virus patients with severe renal disease or under hemodialysis

Ref.	Patients, n	Patient characteristics	Regimen: Patients number (dose of sofosbuvir)	Sustained virological response at 12 wk, n/N	Adverse events, n
Pockros et al[25]	20	GT1: 20 patients (1a: 13)	3D ± RBV: 20	18/20 (EOT-VR: 20/20)	Death from drug unrelated cause (cardiac arrest at 14 d after the end of therapy): 1
Gomez et al[26]	33	GT1: 29 (1a: 6)	3D ± RBV: 33	31/31	Serious adverse events: 5 (all unrelated to study drugs)
		Age: 57 yr
Basu et al[27]	36	GT1: 36 (1a: 23)	3D ± RBV: 36	34/36	No serious adverse event
Roth et al[28]	122	GT1: 122 patients	Elbasvir/grazoprevir: 122	115/122	Serious adverse events: 16
Czul et al[29]	28	GT1: 26 (1a: 16)	SOF + SMV: 26	21/25	Encephalopathy: 1
		Age: 58 yr	SOF + RBV: 2 (200 mg/eod-400 mg/d)		Uncontrolled diarrhea: 1
Beinhardt et al[30]	15	GT1: 11 patients	SOF + DCV: 9	1/1 (EOT-VR: 5/5)	Pancytopenia at week 7: 1 (change SOF from every 24 h to every 48 h)
		Age: 52 yr	SOF + SMV: 5
			SMV + DCV: 1 (400 mg/d)
Dumortier et al[31]	50	GT1: 28 patients	SOF + RBV: 7	24/26 (EOT-VR: 50/50)	No serious adverse event
		Age: 60 yr	SOF + RBV + PEG-IFN: 2
			SOF + DCV ± RBV: 30
			SOF + SMV ± RBV: 11
Gane et al[32]	10	GT1: 9 (1a: 7)	SOF + RBV: 10 (200 mg/d)	4/10	Serious adverse events: 2 (diabetic acidosis, angina)
		Age: 62 yr
Nazario et al[33]	40	GT1: 26 (1a: 26)	SOF + LDV: 9	29/29	Drug discontinuation: 1 (unknown reason)
		Age: 57 yr	SOF + DCV: 2
			SOF + SMV: 29 (400 mg/d)
Baliellas et al[34]	21 (10 on hemodialysis)	GT1: 20 patients (1a: 2)	SMV + DCV: 12	17/19	No serious adverse event
		Age: 57 yr	SMV + DCV + RBV: 9
Moreno et al[35]	42	GT1: 25 (1a: 8)	SOF + RBV: 5	32/42	Drug discontinuation: 11
		Age: 54 yr	LDV/SOF: 8
			SOF + DCV: 14
			SOF + SMV: 3
			SMV + DCV: 12
Saxena et al[36]	19	GT1: 16 (1a: 8)	SOF + SMV + RBV: 2	SOF + SMV + RBV: 2/2	Therapy discontinuation: 1
			SOF + SMV: 11	SOF + SMV: 8/10	Serious adverse events: 3
			SOF + RBV: 5	SOF + RBV: 4/4
			SOF + RBV + PEG-IFN: 1 (400 mg/d)	SOF + RBV + PEG: 1/1
Martin et al[37]	10	GT1: 8 patients	SOF + RBV: 10 (400 mg/d)	6/10	Acute respiratory failure - drug discontinuation: 1, hematemesis: 1
		Age: 58 yr

DCV: Daclatasvir; EOT-VR: End of treatment virological response; GT: Genotype; RBV: Ribavirin; LDV: Ledipasvir; PEG-IFN: Pegylated interferon-alfa; SMV: Simeprevir; SOF: Sofosbuvir; 3D: Ombitasvir/paritaprevir/ritonavir plus dasabuvir; eod: Every other day; HCV: Hepatitis C virus.