Table 2.
SVR12 rates in advanced liver disease and postliver transplant treated with LDV/SOF + RBV
| Trial | Treatment duration, number | SVR12 rate | 95% CI | BKT/REL |
|---|---|---|---|---|
| SOLAR-134 | ||||
| Pretransplant Cohort A | ||||
| CTP.B | 12 weeks (n=30) | 26/30 (87) | 72–95 | 0/3 |
| 24 weeks (n=29) | 24/27 (89) | 74–97 | 0/1 | |
| CTP.C | 12 weeks (n=23) | 19/22 (86) | 68–96 | 0/1 |
| 24 weeks (n=26) | 20/23 (87) | 70–96 | 0/2 | |
| Posttransplant Cohort B | ||||
| No cirrhosis | 12 weeks (n=55) | 53/55 (96) | 89–99 | 0/2 |
| Group III | 24 weeks (n=56) | 56/56 (98) | 92–100 | 0/0 |
| CTP.A | 12 weeks (n=26) | 25/26 (96) | 83–100 | 0/0 |
| Group IV | 24 weeks (n=25) | 24/25 (96) | 82–100 | 0/0 |
| CTP.B | 12 weeks (n=26) | 22/26 (85) | 68–95 | 0/1 |
| Group V | 24 weeks (n=26) | 23/26 (88) | 73–97 | 0/0 |
| CTP.C | 12 weeks (n=5) | 3/5 (60) | 19–92 | 0/2 |
| Group VI | 24 weeks (n=4) | 3/4 (75) | 25–99 | 0/1 |
| Fib. chol. | 12 weeks (n=4) | 4/4 (100) | 47–100 | 0/0 |
| Group VII | 24 weeks (n=2) | 2/2 (100) | 22–100 | 0/0 |
| SOLAR-236 | ||||
| Posttransplant (F0–F3 + CTP.A) | 12 weeks (n=86) | 82/86 (95) | NA | NA/1 |
| 24 weeks (n=82)* | 64/65 (98) | NA | NA/0 | |
| Pre-/posttransplant (CTP.B/C) | 12 weeks (n=78) | 61/72 (85) | NA | NA/7 |
| 24 weeks (n=82)* | 60/68 (88) | NA | A/2 |
Notes:
*
27 patients in the 24 week arm did not reach SVR12; ten patients did not meet inclusion criteria (seven patients who were transplanted + three patients without inclusion criteria) and were excluded.
Abbreviations: BKT/REL, breakthrough/relapse; 95% CI, 95% confidence interval; CTP A, B, C, Child–Trucotte–Pugh of class A, B and C; F, fibrosis score according to the METAVIR classification; Fib. chol., fibrosing cholangitis; LDV/SOF, ledipasvir and sofosbuvir; NA, not applicable; RBV, ribavirin; SVR12, sustained virologic response 12 weeks off therapy.