Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus

Table 1 Details of 13 cases with hepatic decompensation/serious adverse events

Case	Rx	Genotype	Age	Sex	Years since transplant	Baseline1					1st event wk	First episode	Later episodes	Overall outcome	SVR 12(Y/N)
						Hemoglobin(g/dL)	Platelets(× 103/μL)	Albumin(g/dL)	Total bilirubin(mg/dL)	ALT(U/L)
1	SOF/RBV	13	77	F	5.0	9.3	78	2.9	0.6	33	15.4	Hospitalized for SBP	Hospitalized for SBP, ascites, anemia; jaundice, hyperkalemia	Hospitalized for fall soon after EOT, developed ICH, eventually died in hospital	Died
	24 wk2
2	SOF/RBV	2	70	M	17.0	7.9	13	3.9	4.7	15	4.3	Hospitalized for PSE	None	Transferred to Hospice, died	Died
	24 wk
3	SOF/RBV	13	37	F	1.2	8.9	143	2.9	16.9	39	2.9	Hospitalized for failure to thrive, jaundice, anemia requiring transfusion	Hospitalized for jaundice, anemia requiring transfusion, blurred vision	Completed 48 wk of treatment, never undetectable	N
	48 wk
4	SOF/RBV	3	49	M	1.9	12.4	138	4.4	0.7	43	2.0	Anemia requiring transfusion	Anemia requiring transfusion	Completed treatment	Y
	24 wk
5	SOF/RBV	13	67	M	13.2	11.8	118	3.1	2.1	72	2.9	Anemia requiring transfusion	Worsening ascites requiring increased dose of diuretics	Hemoglobin level and ascites improved after intervention; completed treatment but relapsed	N
	24 wk
6	SOF/RBV	12	56	F	1.5	13.0	152	5.0	0.7	44	2.9	Anemia requiring transfusion	None	Hemoglobin improved after transfusion; completed treatment	Y
	24 wk
7	SOF/RBV	12	70	F	7.3	12.0	127	3.6	0.4	60	4.4	Symptomatic anemia, no transfusion, treatment discontinued	None	Viral load detectable 4 mo after treatment discontinuation	N
	24 wk
8	SOF/PEG/RBV	2	65	F	6.0	12.7	85	3.6	0.3	38	6.6	Anemia requiring transfusion	Anemia requiring multiple transfusions	Completed treatment	Y
	24 wk3
9	SOF/RBV	12	60	M	9.1	11.3	94	3.6	0.8	199	5.0	Anemia requiring transfusion	Hospitalized for hyperglycemia, anemia requiring transfusion; treatment discontinued	Detectable viral load 7 wk after treatment discontinued	N
	24 wk
10	SOF/RBV	4	64	F	7.5	9.6	98	2.7	5.5	24	2.4	Anemia requiring transfusion	Hospitalized for SBP, anemia requiring transfusion, treatment discontinued	Hemoglobin improved after transfusions; viral load undetectable at treatment discontinuation; became detectable 1 mo later	N
	24 wk
11	SOF/RBV	12	49	M	2.2	15.2	113	3.9	0.6	74	5.9	Admitted for acute cholangitis after presenting with fever, jaundice, diarrhea	None	Resolution of presenting symptoms with antibiotics, biliary stent placement; completed treatment, relapsed	N
	24 wk
12	SOF/RBV	3	56	M	1.1	10.7	65	3.6	1.1	94	9.0	Hospitalized for partial SBO	Hospitalized for hyperkalemia	SBO resolved with conservative medical management	Y
	24 wk
13	SOF/RBV	13	68	M	1.7	10.7	196	1.9	2.2	24	5.0	Hospitalized, PSE, UTI	Hospitalized for recurrent PSE due to UTI	Completed treatment, +EOT response, relapsed 4 wk post-EOT	N
	24 wk

¹Baseline: indicates the most recent laboratory values prior to treatment initiation;

²SOF/RBV: Sofosbuvir/Ribavirin;

³SOF/PEG/RBV: Sofosbuvir/PEG-interferon/Ribavirin. Laboratory Reference Range: Hemoglobin (g/dL), Ref: 13.9-16.3; Platelets (× 10³/μL), Ref: 150-450; Albumin (g/dL), Ref: 3.5-4.9; Total Bilirubin (mg/dL), Ref: 0.1-1.2; ALT (U/L), Ref: 1-53. ALT: Alanine aminotransferase; SVR: Sustained virological response; SBP: Spontaneous bacterial peritonitis; EOT: End of treatment; ICH: Intracranial hemorrhage; PSE: Portosystemic encephalopathy; SBO: Small bowel obstruction; UTI: Urinary tract infection.