Table 2.
Summary of Studies Evaluating the Safety and Efficacy of Sofosbuvir‐Based Regimens in Patients with Severe Renal Dysfunction
| Author | Number with CrCl < 30 mL/min | Number on Dialysis | Regimen (%) | Cohort (%) | Safety and Comments | SVR Rate |
|---|---|---|---|---|---|---|
| Saxena et al. 16 | 13 | 5 |
SOF/PEG/RBV (5) SOF/RBV (19) SOF/SMV (48) SOF/SMV/RBV (15) |
GT1a/b (77) Liver transplant (50) Kidney transplant (8) Cirrhosis (64) Decompensated cirrhosis (73) |
‐Increased anemia in those receiving RBV ‐Worsening of RF in those with CrCl <45 ‐GFR ≤ 30 and GFR 31‐45 had similar safety outcomes ‐Total of 72 patients enrolled in study, only 18 had eGFR < 30 mL/min. |
81% |
| Hundemer et al. 17 | 4 | 2 |
SOF/SMV (50) SOF/RBV (33) SOF/PEG/RBV (16) |
Liver transplant (17) Cirrhosis (50) |
‐Increased anemia in those receiving RBV (3) ‐Worsening renal function (1) |
67% |
| Bhamidimarri et al. 18 | 3 | 12 | Half dose SOF/SMV (100) |
GT1a/b (100) Cirrhosis (60) Decompensated cirrhosis (7) |
‐No serious adverse events | 87% |
| Perumpail et al. 19 | 1 | 1 | Half dose SOF/SMV (100) | Liver transplant (100) | ‐No serious adverse events | 100% |
| Desnoyer et al. 20 | 0 | 12 | SOF daily (58) vs. SOF TIW (41) + SMV, DCV, or LDV |
GT1a/b (92) Cirrhosis (83) |
‐No serious adverse events ‐SOF‐007 plasma not linked with adverse events |
82% |
| Nazaro et al. 21 | 2 | 15 | SOF/SMV (100) |
GT1a/b (100) Cirrhosis (47) |
‐Worsening anemia requiring blood transfusion (1) | 100% |
| Singh et al. 22 | 0 | 8 |
SOF/SMV (50) SOF/LDV (50) |
GT1a/1b (75) Cirrhosis (37) |
‐Uncontrolled nausea and vomiting requiring hospitalization | 100% |
| Dumortier et al.23 | 9 | 35 |
SOF/RBV (14) SOF/RBV/PEG (4) SOF/DCV ± RBV (60) SOF/SMV (22) |
GT1a/1b (56) Cirrhosis (54) Liver transplant (22) Kidney transplant (34) Decompensated cirrhosis (4) |
‐2 deaths; liver failure at 12 weeks of treatment, and unknown reasons 2 months after completing therapy ‐Anemia requiring blood transfusion (3) |
86% |
| Cox‐North et al. (this study) | 9 | 20 |
SOF/LDV (65) SOF/LDV/RBV (6) SOF/DCV (20) SOF/RBV (6) |
GT1a/b (69) Liver transplant (38) Kidney transplant (10) Cirrhosis (45) Decompensated cirrhosis (17) |
‐One death due to myocardial infarction | 97% |
Abbreviations: PEG, pegylated interferon; SMV, simeprevir; TIW, three times a week.