TABLE 2.
Efficacy of Bulevirtide therapy
| Weeks BLV therapy | Dose (mg/day) | Week 24 | Week 36 | Week 48 | Week 60 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change HDV‐RNA (log) vs. baseline | ALT normal (Y/N) | CR (Y/N) | Change HDV‐RNA (log) vs. baseline | ALT normal (Y/N) | CR (Y/N) | Change HDV‐RNA (log) vs. baseline | ALT normal (Y/N) | CR (Y/N) | Change HDV‐RNA (log) vs. baseline | ALT normal (Y/N) | CR (Y/N) | |||
| P1 | 137 | 10 | −2.80 | N | N | −3.68 | Y | Y | −4.65 | Y | Y | TND | Y | Y |
| P2 a | 130 | 2‐10 | −0.68 | N | N | −0.72 | N | N | −1.16 | N | N | −1.20 | Y | N |
| P3 | 77 | 2 | −2.70 | N | N | −3.49 | Y | Y | −2.80 | Y | Y | −2.94 | Y | Y |
| P4 a | 64 | 2 | −2.60 | Y | Y | −2.59 | Y | Y | −3.00 | Y | Y | −2.90 | Y | Y |
| P5 | 8 | 2 | DO | — | — | |||||||||
| P6 a | 74 | 2 | −0.50 | Y | N | −0.46 | Y | N | −0.47 | Y | N | −2.31 | Y | Y |
| P7 a | 65 | 2 | −0.63 | Y | N | −0.85 | Y | N | −0.52 | Y | N | −0.82 | Y | N |
| P8 | 116 | 2 | −3.30 | Y | Y | TND | Y | N | TND | Y | Y | TND | Y | Y |
| P9 a | 63 + 52 | 2 | −1.14 | N | N | −1.56 | Y | N | TND | Y | Y | TND | Y | Y |
| P10 a | 83 | 2 | −2.15 | Y | Y | −2.39 | Y | Y | −3.00 | Y | Y | −3.00 | Y | Y |
| P11 a | 24 + 37 | 2 | −1.32 | N | N | DO, restartc | — | — | ||||||
| P12 a | 62 | 2 | −0.86 | Y | N | −0.86 | Y | N | TND | Y | Y | TND | Y | Y |
| P13 a | 62 | 2 | −1.33 | Y | N | Missing | Y | N | −1.37 | Y | N | −1.25 | Y | N |
| P14 a | 24 | 2 | −2.10 | Y | Y | LTX | — | — | ||||||
| P15 | 60 | 2 | −0.74 | Y | N | Missing | Y | N | −1.67 | Y | N | −2.30 | N | N |
| P16 | 48 | 2 | −1.36 | Y | N | TND | Y | Y | TND | Y | Y | |||
| P17 a | 48 | 2 | TND | Y | Y | TND | Y | Y | TND | Y | Y | |||
| P18 a | 51 | 2 | −0.86 | Y | N | −1.75 | Y | N | −2.71 | Y | Y | |||
| P19 a | 65 | 2 | −1.29 | N | N | −1.69 | N | N | −1.32 | Y | N | −1.90 | Y | N |
| P20 a | 49 | 2 | −2.09 | Y | Y | −2.59 | Y | Y | −1.75 | Y | N | |||
| P21 a | 48 | 2 | −2.50 | Y | Y | −2.50 | Y | Y | −4.15 | Y | Y | |||
| P22 | 48 | 2 | −2.13 | N | N | −2.56 | N | N | −2.40 | N | N | |||
| P23 a | 52 | 2 | −1.76 | N | N | −2.00 | Y | Y | −2.46 | Y | Y | |||
| Total | VR b :10/22 (45%) | 14/22 (64%) | 7/22 (32%) | VR b :11/20 (55%) | 17/20 (85%) | 10/20 (50%) | VR b :13/20 (65%) | 18/20 (90%) | 12/20 (60%) | VR b :9/13 (69%) | 12/13 (92%) | 8/13 (62%) | ||
Note: Highlighted in yellow background: PEGIFN added prior to this date.
Abbreviations: CR, combined response; DO, drop out; TND, target not detected; LTX, liver transplantation.
a
Patient with cirrhosis.
b
VR, virological response: >2log decline or TND.
c
PEGIFN was added at week 20 of retherapy.