Table 1.
Observed changes in HBV DNA and pgRNA during the on-treatment phase in study 211 (FAS).
| Patients originating from study 201 (on-treatment phase) | ||||||
|---|---|---|---|---|---|---|
| VS HBeAg (-) |
VS HBeAg (+) |
|||||
| PBO + NrtI n = 10 |
VBR + NrtI n = 16 |
Total n = 26 |
PBO + NrtI n = 16 |
VBR + NrtI n = 27 |
Total n = 43 |
|
| HBV DNA TND | ||||||
| Baseline∗ | 6/10 (60) | 13/16 (81) | 19/26 (73) | 8/15 (53) | 16/27 (59) | 24/43 (57) |
| HBV DNA TND | ||||||
| EOT∗ | 8/10 (80) | 13/16 (81) | 21/26 (81) | 8/16 (50) | 8/27 (30) | 16/43 (37) |
| HBV DNA TND | ||||||
| Baseline† | 9/10 (90) | 12/16 (75) | 21/26 (81) | 5/16 (31) | 18/27 (67) | 23/43 (53) |
| HBV DNA TND | ||||||
| EOT† | 10/10 (100) | 14/14 (100) | 24/24 (100) | 13/15 (87) | 23/27 (85) | 36/42 (86) |
| HBV DNA change from baseline, log10 IU/ml, mean (SD) | ||||||
| EOT | -0.1 (0.14) | 0.2 (0.81) | 0.1 (0.64) | 0.0 (0.23) | 0.2 (0.61) | 0.1 (0.51) |
| HBV pgRNA change from baseline, log10 U/ml, mean (SD) | ||||||
| EOT | 0 (0.00) | 0.1 (0.38) | 0.1 (0.29) | -1.4 (1.02) | 0 (0.47) | -0.5 (0.98) |
| HBV TNA change from baseline, log10 U/ml, mean (SD)‡ | ||||||
| EOT | 0 (0.00) | 0 (0.00) | 0 (0.00) | -1.2 (1.10) | 0.0 (0.14) | -0.5 (0.91) |
| Patients originating from study 202 (TN HBeAg +; on-treatment phase) | |||
|---|---|---|---|
| PBO + ETV n = 11 |
VBR + ETV n = 12 |
Total N = 23 |
|
| HBV DNA TND | |||
| Baseline∗ | 0 | 0 | 0 |
| Week 2∗ | 0 | 0 | 0 |
| HBV DNA TND | |||
| EOT∗ | 3/11 (27) | 3/12 (25) | 6/23 (26) |
| HBV DNA TND | |||
| Baseline† | ND§ | ND§ | ND§ |
| Week 2† | 0¶ | 1/8 (13) | 1/13 (8) |
| HBV DNA TND | |||
| EOT† | 5/5 (100) | 3/8 (38) | 8/13 (62) |
| HBV DNA change from baseline, log10 IU/ml, mean (SD) | |||
| EOT | -2.1 (1.08) | -0.8 (0.70) | -1.4 (1.09) |
| HBV pgRNA change from baseline, log10 U/ml, mean (SD) | |||
| EOT | -3.0 (1.38) | -0.6 (0.75) | -1.7 (1.60) |
Data shown are n/N (%) unless otherwise stated.
EOT, end of treatment; ETV, entecavir; FAS, full analysis set; LOD, limit of detection; ND, not determined; NrtI, nucleos(t)ide reverse transcriptase inhibitor; PBO, placebo; pgRNA, pregenomic RNA; TN, treatment-naive; TNA, total nucleic acids; TND, target not detected; VBR, vebicorvir; VS, virologically-suppressed.
Assessed by COBAS TaqMan; LOD = 10 IU/ml.
Assessed by Assembly Biosciences, Inc. HBV DNA assay; LOD = 5 IU/ml.
TNA = HBV DNA + HBV pgRNA.
Patient HBV DNA TND levels were ND given that values were well above the LOD for the less sensitive COBAS assay.
The denominator for patients originating from study 202 is 5 for PBO + ETV.