Author, Year [Ref] |
No of patients |
HCV genotypes, n [%] |
Cirrhosis, n [%] |
Treatment experienced, n [%] |
Treatment regimen with duration |
ETR, n [%] SVR 12, n [%] |
Side effects, n [%] |
Singh T, 20167 |
Total = 8, All on HD |
Total = 8 G1a = 3 G1b = 3 G3 = 1 G4 = 1 |
3 (37%), All compensated |
1 (12.5%) |
4 = SOF 400 mg/SMV 150 mg, 12 wk 4 = SOF 400 mg/LDV 90 mg, 12 wk |
ETR=8/8 (100%) SVR 12 = 7/7 (100%) |
Total=4 [50%] Dose reduction or discontinuation because of side effects=0 1 = nausea, vomiting 1 = headache 1 = insomnia 1 = Hb drop> 2 g/dL |
Saxena v, 20168 |
Total = 73 e-GFR≤45 ml/min = 73 e-GFR≤30 ml/min = 17 On HD = 5 HIV co-infection = 3 Prior LT = 36 Prior Kidney transplant = 6 |
Total = 73 G1a = 33 G1b = 15 G1-ns = 8 G2 = 11 G3 = 4 G4 = 1 Other = 1 |
47 (64%) History of decompensation = 34 HCC = 1 |
39 (53%) |
5 = SOF 400 mg/PEG-RBV, 12 wk 16 = SOF 400 mg/RBV, 12 wk 39 = SOF 400 mg/SMV, 12 wk 13 = SOF 400 mg/SMV/RBV, 12 wk |
SVR 12 = Overall 53/64 (83%) 2/4 (50%) 12/14 (86%) 28/35 (80%) 11/11 (100%) |
Early treatment discontinuation = 5 (7%) Discontinuation because of side effects = 3 (4%) Anaemia = 22 (30%) Required transfusion(s) = 10 (20%) Needed Erythropoietin stimulating drugs = 9 (12%) Reduction in RBV because of anaemia = 11/34 (32%) RBV discontinuation = 4/34 (12%) Worsening renal function = 11 (15%) Fatigue = 22 (30%) Headache = 10 (14%) Nausea = 11 (15% Any serious adverse events = 16 (22%) Cardiac serious adverse events = 3 (4%) Death = 1 (1%) [Post-LT patient with worsening renal function and liver decompensation] |
Dumortier J, 20169 |
Total = 50 e-GFR<35 ml/min = 35; On HD = 15 Prior LT = 11 Prior Kidney transplant = 17 |
Total = 50 G1a = 7 G1b = 21 G2 = 6 G3 = 5 G4 = 9 G5 = 2 |
27 [54%] |
36 [72%] |
A reduced dose of SOF (400 mg 3 times a week patients and 400 mg/d in non-HD patients was used 4 = SOF/RBV, 12 wk 3 = SOF/RBV, 24 wk 2 = SOF/RBV/PEG-IFN, 12 wk 19 = SOF/DCV, 12 wk 8 = SOF/DCV, 24 wk 1 = SOF/DCV/RBV, 12 wk 2 = SOF/DCV/RBV, 24 wk 1 = SOF/SMV/RBV, 12 wk 10 = SOF/SMV, 12 wk |
ETR=48/50 (96%, 1 patient died before week 12, 1 patient received liver/kidney transplantation before week 12). SVR 12 = 43/50 (86%). |
Discontinuation because of side effects = 0 Hb<8 g/dL = 3 (6%) Required transfusion(s) = 2 (4%) Reduction in RBV because of anaemia = 2 (16.7%) Headache = 16 (32%) Asthenia = 14 (28%) Digestive discomfort (ie, diarrhoea or nausea) = 10 (20%) Insomnia = 8 (16%) In non-HD patients, median e-GFR not significantly modified during treatment |
Nazario HE, 201610 |
Total = 17 e-GFR<30 mL/min = 2 On HD = 15 |
Total = 17 G1a = 13 G1b = 4 |
8 (47%); Decompensated = 2 |
3 (18%) |
SOF 400 mg/SMV 150 mg, 12 wks |
ETR=16/17 (94%); 1 pt did not get end of treatment testing SVR 12 wk = 17/17 (100%) |
Discontinuation because of side effects = 0 Insomnia = 2 (12%) Nausea = 1 (5%); Headache = 1 (5%) Anaemia = 1 (5%); received BT |
Desnoyer A. 20166 |
Total 12 on HD 2 = HIV co-infection 1 = prior renal transplant |
Total = 12 G1a = 3 G1b = 5 G1na = 3 G2 = 1 |
10/12 (83.3%) |
6/12 (50%) |
SOF 400 mg QD or TIW was used 1 = SOF QD/SMV QD, 12 wk 1 = SOF QD/SMVQD, 24 wk 1 = SOF QD/LDV QD, 12 wk 1 = SOF QD/DCV QD, 12 wk 2 = SOF QD/DCV QD, 24 wk 3 = SOF TIW/DCV QD, 12 wk 2 = SOF TIW/DCV QD, 24 wk 1 = SOF TIW/RBV BID, 12 wk |
SVR 12 wk = 10 Relapse = 2 |
Discontinuation because of side effects = 0 Anaemia = 3; headache = 2; Sepsis (unrelated to drug) = 1 |
Bhamidimarri KR. 201511 |
Total = 15 e-GFR≤30 mL/min = 15 On dialysis = 12 |
Total = 15 G1a = 10 G1b = 5 |
9/15 (60%) 1 = decompensated |
9/15 (60%) |
Half dose SOF was used 14 = SOF/SMV, 12 weeks 1 = SOF/SMV, 24 weeks |
ETR = 15/15 (100%) SVR 12 = 13/15 (87%) |
Discontinuation or dose adjustment because of side effects = 0 Anaemia = 13%; Fatigue = 20% Rash/itching = 13%; Loss of appetite = 7% |
Hundemer GL. 201512 |
Total = 6 e-GFR≤30 mL/min = 6 On HD = 2 Prior LT = 1 Prior Kidney transplant = 1 |
Total = 6 G1a = 3 G1b = 1 G1na = 2 |
3/6 (50%) |
3/6 (50%) |
SO F400 mg daily was used 3 = SOF/SMV 150 mg daily, 12 wk 2 = SOF/RBV 200 mg twice daily, 24 wk 1 = SOF/RBV 600 mg twice daily/PEG-IFN 180 μg weekly, 12 wk |
ETR=6/6 (100%) SVR12 = 4/6 (66.6%) |
Discontinuation because of side effects = 1 (IFN regimen) Anaemia = 3 Leucopenia = 1 AKI (Lupus like immune complex diseases) = 1 |
Vionnet J. 201613 |
Total = 2 e-GFR≤30 mL/min = 2 On HD = 1 Prior LT = 1 Prior Kidney transplant = 1t HBV co-infection = 1 |
Total = 2 G1a = 2 |
1/2 (50%) |
1/2 (50%) |
1 = SOF 400 mg every other day/DCV 60 mg daily, 24 wk 1 = SOF 200 mg daily/DCV 60 mg daily, 24 wk |
ETR = 2/2 (100%) SVR 12 = 2/2 (100%) |
Discontinuation because of side effects = 0 Atrial fibrillation at wk 14 = 1 Superior mesenteric vein thrombosis 4 wk after EOT = 1 |
Beinhardt S. 201614 |
Total = 25 On dialysis = 10 |
Total = 25 G1a = 4 G1b = 12 G3a = 4 G4 = 4 G1b/3a = 1 |
12/25 (48%) Decompensated = 6 |
10/25 (40%) |
SOF 400 mg daily was used 1 = SOF/PEG/RBV 1 = SOF/LDV 8 = SOF+SMV 13 = SOF+DCV 1 = SOF+RBV 1 = DCV/SMV |
SVR 12 = 24/25 (96%) |
Severe adverse reactions = 6 SOF dose reduction = 1 (sepsis induced pancytopenia) RBV dose reduction = 1 Anaemia = 1 Thrombocytopenia = 2 Hepatic encephalopathy = 1 Pneumonia = 1 Peritonitis (Patient on PD) = 1 Kidney function remained stable patients not on dialysis |
Agarwal SK, 201715 |
Total = 62 On HD = 62 |
Total = 62 G1 = 40 G2 = 1 G3 = 18 G4 = 2 G6 = 1 |
0 (0) |
0 (0) |
All patients treated for 12 wk 39 = SOF 400 mg A/D/RBV 200 mg/d 2 = SOF 400 mg/d/RBV 200 mg/d 6 = SOF 400 mg A/D/DCV 60 mg/d 15 = SOF 400 mg/d/DCV 60 mg/d |
SVR 12 = Overall = 59/62 (95.2%) 37/39 (94.8%) 2/2 (100%) 6/6 (100%) 14/15 (93.3%) |
Dyspepsia = 23 (37%) Increase in erythropoietin dose among ribavirin treated = 23/41 (56%) 4 = Tuberculosis 3 = Bacterial pneumonia |