Virological, biochemical and serological responses at weeks 48 and 96
| At week 48 | At week 96 | |||||||
|---|---|---|---|---|---|---|---|---|
| Endpoint | Total (N=102) | TDF-TDF (n=50) | TDF/ETV-TDF (n=52) | p Value | Total (N=102) | TDF-TDF (n=50) | TDF/ETV-TDF (n=52) | p Value |
| N | 102 | 50 | 52 | – | 102 | 50 | 52 | – |
| HBV DNA <15 IU/mL, n (%) | 64 (62.7%) | 31 (62%) | 33 (63.5%) | 0.88 | 65 (63.7%) | 32 (64%) | 33 (63.5%) | 0.96 |
| HBV DNA <60 IU/mL, n (%) | 78 (76.5%) | 37 (74%) | 41 (78.8%) | 0.56 | 78 (76.5%) | 38 (76%) | 40 (76.9%) | 0.91 |
| HBV DNA change from baseline*, log10 IU/mL | −3.17±1.58 | −3.03±1.77 | −3.31±1.37 | 0.38 | −3.22±1.55 | −3.17±1.71 | −3.27±1.37 | 0.74 |
| Residual HBV DNA level†, log10 IU/mL | 2.02 (1.20–4.26) | 2.06 (1.30–4.26) | 1.79 (1.20–2.77) | 0.19 | 1.90 (1.32–3.57) | 1.94 (1.32–3.57) | 1.83 (1.41–2.59) | 0.55 |
| Virological breakthrough‡ | 2 (2%) | 1 (2%) | 1 (1.9%) | >0.99 | 3 (2.9%) | 1 (2%) | 2 (3.8%) | >0.99 |
| ALT normal, n (%) | 75 (73.5%) | 40 (80%) | 35 (67.3%) | 0.15 | 80 (78.4%) | 39 (78%) | 41 (78.8%) | 0.92 |
| ALT normalisation§, n/N (%) | 17/29 (58.6%) | 8/11 (72.7%) | 9/18 (50%) | 0.27 | 18/29 (62.1%) | 7/11 (63.6%) | 11/18 (61.1%) | >0.99 |
| HBeAg seroclearance¶, n/N (%) | 7/90 (7.8%) | 6/44 (13.6%) | 1/46 (2.2%) | 0.06 | 12/90 (13.3%) | 9/44 (20.5%) | 3/46 (6.5%) | 0.06 |
| HBeAg seroconversion¶, n/N (%) | 1/90 (1.1%) | 1/44 (2.3%) | 0/46 (0%) | 0.49 | 5/90 (5.6%) | 4/44 (9.1%) | 1/46 (2.2%) | 0.20 |
| HBsAg level decrease from baseline ≥ 0.5 log10 IU/mL, n (%) | 14 (13.7%) | 9 (18%) | 5 (9.6%) | 0.22 | 28 (27.5%) | 14 (28%) | 14 (26.9%) | 0.90 |
| HBsAg seroclearance, n | 0 | 0 | 0 | – | 0 | 0 | 0 | – |
Intention-to-treat population, missing equals failure.
*Mean±SD.
†Median (range) in patients who had HBV DNA detectable at weeks 48 and 96, respectively.
‡Cumulative number of patients with virological breakthrough. Virological breakthrough was defined as increases in HBV DNA levels ≥1 log10 IU/mL from nadir on two consecutive tests.
§Among those with abnormal ALT at baseline.
¶Among those HBeAg-positive at baseline.
ALT, alanine aminotransferase; ETV, entecavir; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; TDF, tenofovir disoproxil fumarate.