TABLE 1.
Virologic Status at End of Treatment and Follow‐up With Different Therapeutic Outcomes in the REP 401 Study
| Virologic Milestone | Rebound n = 11 (%) | Virologic Control n = 15* (%) | Functional Cure n = 14 (%) | P Value † | P Value † (Virologic Control vs. Functional Cure) | |
|---|---|---|---|---|---|---|
| Status at end of treatment | ||||||
| HBsAg | <10 IU/mL | 3 (27) | 11 (73) | 14 (100) | <0.001 | 0.099 |
| <1 IU/mL | 3 (27) | 11 (73) | 14 (100) | <0.001 | 0.099 | |
| <0.05 IU/mL | 1 ‡ (9) | 9 (60) | 14 (100) | <0.001 | 0.016 | |
| <0.005 IU/mL | 1 ‡ (9) | 8 (53) | 14 (100) | <0.001 | 0.006 | |
| Anti‐HBs | >10 IU/mL | 3 (27) | 8 (53) | 13 (93) | 0.002 | 0.035 |
| >100 IU/mL | 0 | 8 (53) | 10 (71) | <0.001 | 0.450 | |
| >1,000 IU/mL | 0 | 4 (27) | 8 (71) | 0.006 | 0.139 | |
| >10,000 IU/mL | 0 | 2 (13) | 8 (57) | 0.001 | 0.021 | |
| HBsAg IC < 3,000 RLU | 4 (36) | 6 (40) | 5 (29) | 1 | 1 | |
| HBV DNA | <LLOQ | 9 (82) | 11 (73) | 12 (86) | 0.792 | 0.651 |
| TND | 5 (45) | 8 (53) | 10 (71) | 0.155 | 0.217 | |
| HBV RNA | <LLOQ | 3 (27) | 12 (80) | 13 (93) | 0.001 | 0.597 |
| TND | 2 (18) | 3 (20) | 5 (36) | 0.591 | 0.427 | |
| HBcrAg < LLOQ | 6 (55) | 10 (66) | 13 (93) | 0.093 | 0.169 | |
| Status at end of follow‐up | ||||||
| HBsAg | <10 IU/mL | 0 | 8 (53) | 14 (100) | <0.001 | 0.006 |
| <1 IU/mL | 0 | 5 (33) | 14 (100) | <0.001 | 0.002 | |
| <0.05 IU/mL | 0 | 3 (20) | 14 (100) | <0.001 | <0.001 | |
| <0.005 IU/mL | 0 | 2 (13) | 14 (100) | <0.001 | <0.001 | |
| Anti‐HBs | >10 IU/mL | 1 (9) | 5 (33) | 14 (100) | <0.001 | <0.001 |
| >100 IU/mL | 0 | 2 (13) | 14 (100) | <0.001 | <0.001 | |
| >1,000 IU/mL | 0 | 0 | 14 (100) | <0.001 | <0.001 | |
| >10,000 IU/mL | 0 | 0 | 7 (50) | <0.001 | <0.001 | |
| HBsAg IC < 3,000 RLU | 3 (27) | 12 (80) | 11 § (79) | 0.014 | 1 | |
| HBV DNA | <LLOQ | 0 | 8 (53) | 14 (100) | <0.001 | <0.001 |
| TND | 0 | 4 (27) | 14 (100) | <0.001 | <0.001 | |
| HBV RNA | <LLOQ | 3 (27) | 13 (87) | 14 (100) | <0.001 | <0.001 |
| TND | 2 (18) | 5 (33) | 13 (93) | <0.001 | 0.002 | |
| HBcrAg < LLOQ | 6 (55) | 13 (87) | 14 (100) | 0.010 | 0.483 | |
*
Participant 02‐005 included HBsAg = 3.04 IU/mL, anti‐HBs = 8.41 mIU/mL, DNA < LLOQ, and ALT 60 U/L (ULN = 50 U/L).
†
Determined by Fisher’s exact test.
‡
Participant 03‐020 self‐withdrew from therapy early for personal reasons.( 19 )
§
For the 3 participants with functional cure with HBsAg IC > 3,000 RLU at end of follow‐up, 2 experienced no change from baseline and 1 experienced > 1 log10 decline in HBsAg IC during follow‐up.
Abbreviations: FC, functional control; VC, virologic control.