Baseline characteristics of study patients
| Characteristics | Total | TDF-TDF | TDF/ETV-TDF |
|---|---|---|---|
| N | 102 | 50 | 52 |
| Age*, years | 50 (26–70) | 49 (28–68) | 50 (26–70) |
| Male, n (%) | 88 (86.3%) | 42 (84%) | 46 (88.5%) |
| ALT*, IU/L | 32 (12–275) | 31 (12–275) | 33 (13–183) |
| Normal ALT, n (%) | 73 (71.6%) | 39 (78%) | 34 (65.4%) |
| Bilirubin*, mg/dL | 0.9 (0.3–2.5) | 0.9 (0.3–2.0) | 0.9 (0.3–2.5) |
| Albumin*, g/dL | 4.4 (3.4–5.2) | 4.4 (3.4–5.2) | 4.4 (3.5–5.0) |
| INR* | 0.99 (0.85–1.40) | 0.98 (0.86–1.20) | 0.99 (0.85–1.40) |
| Creatinine*, mg/dL | 0.9 (0.5–1.4) | 0.9 (0.5–1.3) | 0.9 (0.6–1.4) |
| eGFR*, mL/min/1.73 m2 | 94 (54–142) | 94 (63–142) | 94 (54–123) |
| Phosphate*, mg/dL | 3.2 (1.7–4.5) | 3.2 (1.7–4.5) | 3.3 (2.0–4.3) |
| Cirrhosis†, n (%) | 19 (18.6%) | 6 (12%) | 13 (25%) |
| HBeAg-positivity, n (%) | 90 (88.2%) | 44 (88%) | 46 (88.5%) |
| HBV DNA*, log10 IU/mL | 3.38 (1.78–9.00) | 3.27 (1.78–9.00) | 3.50 (2.04–8.79) |
| HBV genotype C, n (%) | 102 (100%) | 50 (100%) | 52 (100%) |
| ADV-resistance mutations‡, n (%) | 102 (100%) | 50 (100%) | 52 (100%) |
| Single (rtA181T/V or rtN236T) | 68 (66.7%) | 35 (70%) | 33 (63.5%) |
| Double (rtA181T/V and rtN236T) | 34 (33.3%) | 15 (30%) | 19 (36.5%) |
| LAM-resistance mutations‡, n (%) | 85 (83.3%) | 39 (78%) | 46 (88.5%) |
| ETV-resistance mutations‡, n (%) | 40 (39.2%) | 16 (32%) | 24 (46.2%) |
| Ongoing treatment at baseline, n (%) | |||
| ADV | 10 (9.8%) | 3 (6%) | 7 (13.5%) |
| ETV | 5 (4.9%) | 3 (6%) | 2 (3.8%) |
| ADV+LAM | 20 (19.6%) | 12 (24%) | 8 (15.4%) |
| ADV+LdT | 7 (6.9%) | 4 (8%) | 3 (5.8%) |
| ADV+ETV | 60 (58.8%) | 28 (56%) | 32 (61.5%) |
| Response to ongoing treatments at baseline, n (%) | |||
| Partial virological response | 90 (88.2%) | 43 (86%) | 47 (90.4%) |
| Virological breakthrough | 12 (11.8%) | 7 (14%) | 5 (9.6%) |
| Previously exposed NUC§, n (%) | |||
| ADV only | 2 (2%) | 0 | 2 (3.8%) |
| ADV and LAM | 14 (13.7%) | 7 (14%) | 7 (13.5%) |
| ADV and ETV | 4 (3.9%) | 1 (2%) | 3 (5.8%) |
| ADV, LAM and LdT | 6 (5.9%) | 2 (4%) | 4 (7.7%) |
| ADV, LAM and ETV | 61 (59.8%) | 30 (60%) | 31 (59.6%) |
| ADV, LAM, LdT and ETV | 15 (14.7%) | 10 (20%) | 5 (9.6%) |
| Prior treatment with interferon, n (%) | 7 (6.9%) | 5 (10%) | 2 (3.8%) |
| Overall duration of prior NUC treatment*, months | 109 (11–194) | 129 (29–181) | 96 (11–194) |
*Median (range).
†Cirrhosis was diagnosed by ultrasonography with identification of liver surface nodularity and splenomegaly.
‡Genotypic resistance test was performed by both direct sequencing and RFMP analysis. HBV resistance mutation to LAM was defined as rtM204V/I±rtL180M. HBV resistance mutation to ETV was defined as rtT184A/C/F/G/I/L/S, rtS202G, or rtM250 L/V, in addition to rtM204V/I.
§NUCs that were used >6 months.
ADV, adefovir dipivoxil (10 mg/day); ALT, alanine aminotransferase; eGFR, glomerular filtration rate estimated by the Modification of Diet in Renal Disease equation; ETV, entecavir (1 mg/day); HBeAg, hepatitis B e antigen; INR, international normalised ratio; LAM, lamivudine (100 mg/day); LdT, telbivudine; NUC, nucleos(t)ide analogue; RFMP, restriction fragment mass polymorphism; TDF, tenofovir disoproxil fumarate (300 mg/day).