Table 2.
Baseline characteristics by prior treatment history
| Characteristic | Treatment-naïve patients | Treatment-experienced patients | All patients |
|---|---|---|---|
| n/N (%) | 182/440 (41.4) | 258/440 (58.6) | 440/440 (100) |
| HBeAg-negative, n/n (%) | 121/419 (28.9) | 183/419 (43.7) | 304/419 (74.1)) |
| HBV DNA, IU/mL, mean (SD) | 3.41 × 107 (1.15 × 108) | 3.76 × 106 (2.05 × 107) | 1.63 × 107 (7.70 × 107) |
| HBV DNA, IU/mL, median (Q1–Q3)a | 4.1 × 104 (2270–6.8 × 106) | 20 (12–735) | 3.6 × 103 (40.0–3.95 × 105) |
| HBV DNA ≥2000 IU/mL, n/n (%) | 36/181 (19.9) | 16/257 (6.2) | 52/438 (11.9) |
| Normal ALT (≤ULNb), n/n (%) | 61/171 (35.3) | 179/251 (71.3) | 240/422 (56.9) |
| HBV DNA <69 IU/mL, n/n (%) | 10/182 (5.5) | 157/258 (60.9) | 167/440 (38.0) |
| Prior treatment regimen, n (%)c | |||
| IFN or PEG-IFN ± other | – | 68/258 (28.3) | – |
| LAM monotherapy | – | 28/258 (9.7) | – |
| ADV monotherapy | – | 21/258 (6.6) | – |
| ETV monotherapy | – | 13/258 (4.7) | – |
| LAM + ADV | – | 109/258 (32.2) | – |
| LAM + ADV + other | – | 38/258 (23.6) | – |
| Otherd | – | 7/258 (7.4) | – |
| Reason for initiating TDF, n (%) | |||
| Persistent viremia/suboptimal response | – | 64/258 (24.8) | – |
| Relapse | – | 38/258 (14.7) | – |
| Resistance development | – | 9/258 (3.5) | – |
| Adverse reaction | – | 10/258 (3.9) | – |
| Non-adherence | – | 5/258 (1.9) | – |
| Other (not specified) | – | 141/258 (54.7) | – |
| Laboratory and biochemical parameters | |||
| Serum creatinine, median (range), µmol/L | 77.0 (37.0, 1034.0) | 83.0 (29.0, 416.0) | 79.70 (29.0, 197.4) |
| CrCl, median (range), mL/min | 112.9 (52.4, 226.0) | 90.5 (29.3, 200.9) | 98.8 (29.3, 226.0) |
| eGFR, median (range), mL/min/1.73 m2 | 107.7 (56.5, 148.2) | 91.7 (33.3, 149.7) | 99.1 (33.3, 149.7) |
| ALT, median (range), U/L | 59.0 (7.0, 2174.0) | 29.0 (8.0, 521.0) | 35.0 (7.0, 828.0) |
ADV adefovir, ALT alanine aminotransferase, CrCl creatinine clearance, eGFR estimated glomerular filtration rate, HBeAg hepatitis B “e” antigen, ETV entecavir, IFN interferon, LAM lamivudine, PEG-IFN pegylated interferon, SD standard deviation, TDF tenofovir disoproxil fumarate, ULN upper limit of normal
aData were missing for one patient in the treatment-naïve group and one patient in the treatment-experienced group
bALT upper limit of normal was ≤43 U/L for males and ≤34 for females
cMultiple responses possible; 26 patients are included in both the interferon-containing regimen and LAM + ADV + other group
dIncludes unspecified treatment and treatment with telbivudine + ADV, ETV + ADV, and ETV + LAM