Table 3.
NUC Therapy, HBsAg and HBeAg Levels at Baseline, and HBV DNA Levels Pretherapy and Posttherapy
| Category | Heparc‐2002 | Heparc‐2003 | ||||
|---|---|---|---|---|---|---|
| Placebo | ARC‐520 Injection | Placebo | ARC‐520 Injection | |||
| 1 mg/kg | 2 mg/kg | 1 mg/kg | 2 mg/kg | |||
| NUC‐experienced patients | 19 of 20 | 17 of 17 | 21 of 21 | 11 of 11 | 10 of 10 | 11 of 11 |
| Mean (min, max) years of prior NUC therapy | 5.4 (1.5, 8.5) | 5.4 (2.5, 7.4) | 5.2 (1.4, 8.8) | 3.7 (1.4, 7.3) | 3.5 (1.2, 5.8) | 2.8 (1.0, 6.7) |
| Baseline log HBsAg | ||||||
| Mean (min, max) Log HBsAg (log IU/mL) | 3.3 (2.0, 4.5) | 3.2 (0.4, 4.2) | 2.6 (0.5, 3.8) | 3.7 (2.8, 4.4) | 3.3 (2.4, 4.1) | 3.3 (2.7, 4.1) |
| Baseline HBeAg | ||||||
| Mean (min, max) Log HBeAg (log PEIU/mL) | N/A | N/A | N/A | 0.7 (–1.1, 1.6) | –0.1 (–0.8, 1.0) | –0.2 (–1.7, 1.1) |
| HBV DNA day 1 | ||||||
| >20 IU/mL | 1 | 1 | 0 | 0 | 1 | 1 |
| <20 IU/mL | 9 | 5 | 4 | 7 | 2 | 5 |
| Not detected | 10 | 10 | 17 | 4 | 7 | 5 |
| Missing | 0 | 1 | 0 | 0 | 0 | 0 |
| HBV DNA day 113 EOS | ||||||
| >20 IU/mL | 0 | 0 | 0 | 1 | 0 | 0 |
| <20 IU/mL | 5 | 6 | 5 | 4 | 2 | 6 |
| Not detected | 12 | 11 | 13 | 4 | 4 | 2 |
| Missing/early term | 3 | 0 | 3 | 2 | 4 | 3 |