TABLE 1.
Baseline characteristics before monotherapy in the REP 401 study25
| Parameters | Delayed triple group | Early triple group |
|---|---|---|
| Participants | 20 | 20 |
| Documented history of infection before therapy [median (range)] (y) | 9 (0.1–19) | 7 (0.25–26) |
| Previous therapy | ||
| NUCs | 0 | 1 |
| pegIFN | 0 | 0 |
| Age [median (range)] | 40.5 (22–53) | 40.5 (23–52) |
| Males [n (%)] | 17 (85) | 16 (80) |
| HBV genotype [n (%)] | ||
| A | 1 (5) | 2 (10) |
| D | 19 (95) | 18 (90) |
| Fibroscan [n (%)] | ||
| ≤7 kPa | 12 (60) | 10 (50) |
| >7–9 kPa | 4 (20) | 7 (35) |
| >9–11 kPa | 0 (0) | 2 (10) |
| >11 kPa | 4 (20) | 1 (5) |
| Virologic baseline [median (IQR)] | ||
| HBV DNA (log10 IU/mL) | 4.62 (2.07) | 5.00 (1.19) |
| HBsAg (log10 IU/mL) | 3.97 (0.67) | 3.94 (0.36) |
| Anti-HBs (mIU/mL) | 0 (0.42) | 0 (0.13) |
| ALT [median (range)] (U/L) | 49 (21–302) | 56.5 (2–276) |
| Normal ALT ( <50 U/L) [n (%)] | 11 (55) | 8 (40) |
| Platelets [median (range)] (×106/mL) | 175 (148–260) | 168.5 (124–331) |
| Liver median stiffness [median (range)] (kPa) | 6.65 (4.3–14.1) | 7.3 (4.4–19.6) |
Note: The delayed triple therapy group (called the control group in the REP 401 study) consists of participants treated with TDF alone and then dual therapy with TDF+pegIFN followed by triple therapy with TDF+pegIFN+NAPs (termed delayed triple). The early triple therapy (called the experimental group in the REP 401 study) group consists of participants treated with TDF alone, followed by triple therapy with TDF+pegIFN+NAPs (termed early triple).
Abbreviations: ALT, alanine aminotransferase; IQR, interquartile range; NAP, nucleic-acid polymer; NUC, nucleos(t)ide analog; pegIFN, pegylated interferon-α2a; TDF, tenofovir-disoproxil-fumarate.