Table 1. Patient characteristics in the pooled population of studies 110 (HBeAg-positive) and 108 (HBeAg-negative) in patients from China.
| TAF 25 mg (n = 227) | TDF 300 mg (n = 107) | Total ( n= 334) | |
|---|---|---|---|
| Mean age (years [range]) | 38 (18–69) | 40 (20–73) | 38 (18–73) |
| Age ≥ 50 years (n [%]) | 31 (14) | 24 (22)* | 55 (16) |
| Male (n [%]) | 162 (71) | 82 (77) | 244 (73) |
| Asian (n [%]) | 227 (100) | 107 (100) | 334 (100) |
| Mean BMI (kg/m2 [SD]) | 24 (3.4) | 24 (3.1) | 24 (3.3) |
| Mean HBV DNA (log10 IU/mL [SD]) | 6.4 (1.87) | 6.4 (1.81) | 6.4 (1.85) |
| HBV DNA ≥ 8 log10 IU/mL (n [%]) | 55 (24) | 22 (21) | 77 (23) |
| Median ALT (Q1, Q3) | 85 (53, 160) | 90 (60, 185) | 88 (56, 165) |
| HBeAg status | |||
| Positive | 121 (53)† | 59 (55)† | 180 (54) |
| Negative | 106 (47)† | 48 (45)† | 154 (46) |
| HBV genotype | |||
| B | 90 (40) | 33 (31) | 123 (37) |
| C | 131 (58) | 74 (69) | 205 (61) |
| B/C | 2 (1) | 0 | 2 (0.6) |
| D | 2 (1) | 0 | 2 (0.6) |
| Unknown | 2 (1) | 0 | 2 (0.6) |
| History of cirrhosis | |||
| Yes | 5/56 (9) | 7/25 (28)‡ | 12/81 (15) |
| No | 51/56 (91) | 18 (72) | 69 (85) |
| Indeterminate/unknown | 171 | 82 | 253 |
| Mean FibroTest score (range) | 0.41 (0.04–0.98) | 0.44 (0.06–0.96) | 0.42 (0.04–0.98) |
| FibroTest score ≥0.75 | 24/224 (11) | 13/103 (13) | 37/327 (11) |
| Previous nucleos(t)ide use (n [%]) | 86 (38) | 38 (36) | 124 (37) |
| Previous adefovir dipivoxil (n [%]) | 47 (21) | 23 (21) | 70 (21) |
| Previous lamivudine (n [%]) | 35 (15) | 18 (17) | 53 (16) |
| Prior entecavir, n (%) | 48 (21) | 18 (17) | 66 (20) |
| Median eGFR by Cockcroft-Gault (Q1, Q3) | 113 (98, 129) | 113 (97, 125) | 113 (97, 128) |
| Diabetes mellitus | 21 (9) | 5 (5) | 26 (8) |
| Cardiovascular disease | 9 (4) | 1 (1) | 10 (3) |
| Hypertension | 18 (8) | 13 (12) | 31 (9) |
| Hyperlipidemia | 4 (2) | 3 (3) | 7 (2) |
| Total hip BMD clinical status | |||
| Normal (T-score ≥ −1.0) | 59/93 (63) | 31/54 (57) | 90/147 (61) |
| Osteopenia (−2.5 ≤ T-score < −1.0) | 33/93 (35) | 22/54 (41) | 55/147 (37) |
| Osteoporosis (T-score < −2.5) | 0/93 | 1/54 (2) | 1/147 (0.7) |
| Status not determined | 1/93 (1) | 0/54 | 1/147 (0.7) |
| Lumbar spine BMD clinical status | |||
| Normal (T-score ≥ −1.0) | 38/94 (40) | 25/54 (46) | 63/148 (43) |
| Osteopenia (−2.5 ≤ T-score < −1.0) | 51/94 (54) | 25/54 (46) | 76/148 (51) |
| Osteoporosis (T-score < −2.5) | 4/94 (4) | 4/54 (7) | 8/148 (5) |
| Status not determined | 1/94 (1) | 0/54 | 1/148 (0.7) |
| Median 25-hydroxy vitamin D (ng/mL [Q1, Q3]) | 18.8 (13.2, 24.4) | 18.4 (14, 23.6) | 18.8 (13.6, 24.4) |
*p = 0.044; †HBeAg status for 5 patients (TAF n = 3, TDF n = 2) in Study 108 changed from negative to positive between the screening and baseline visits, and in Study 110, HBeAg status for 5 patients (TAF n = 5) changed from positive to negative between the screening and baseline visits; ‡p = 0.0265.