Characteristics per treatment arm of 67 HBeAg-negative patients with chronic hepatitis B
| Stop (n=45) | Continue (n=22) | |
| Randomisation | ||
| Age (years) | 49 (10) | 50 (9) |
| Male sex, n (%) | 26 (58) | 14 (64) |
| Asian/Caucasian race, % | 98/2 | 95/5 |
| Body mass index (kg/m2) | 25 (5) | 25 (5) |
| HBV genotype: A/B/C/D, %* | 0/18/27/2 | 0/14/32/0 |
| TDF/ETV monotherapy, n | 41/4 | 21/1 |
| Duration of NA therapy (years) | 7.6 (3.1) | 6.8 (2.4) |
| Prior use of other NA agents, n (%)† | 15 (33) | 9 (41) |
| Prior (PEG-) interferon therapy, n (%) | 4 (8.9) | 3 (14) |
| Duration of HBeAg seroconversion (years) | 3.8 (2.3) | 4.1 (2.2) |
| Duration of undetectable HBV DNA (years)‡ | 6.0 (2.3) | 5.1 (2.4) |
| ALT (× ULN) | 0.6 (0.2) | 0.7 (0.2) |
| Anti-HBe positive, n (%) | 41 (91) | 21 (95) |
| HBsAg (log IU/mL) | 3.1 (0.6) | 3.0 (1.0) |
| METAVIR fibrosis score 0/1/2/3/4, % | 30/34/30/7/0 | 32/27/18/14/9 |
| Liver stiffness (kPa) | 4.9 (1.0) | 5.2 (1.6) |
| Start of therapy | ||
| ALT (× ULN) | 2.5 (2.8) | 2.3 (1.8) |
| HBV DNA (log IU/mL) | 6.1 (1.8) | 6.0 (1.3) |
| HBeAg negative, n (%) | 27 (60) | 13 (59) |
Continuous data presented as mean (SD).
*HBV genotype was known for 31 (46%) patients.
†Other NA agents comprised adefovir dipivoxil, emcitrabine, lamivudine or telbivudine.
‡Undetectable HBV DNA was defined as <20 IU/mL.
ALT, alanine aminotransferase; AST, aspartate transaminase; ETV, entecavir; NA, nucleos(t)ide analogue; PEG, pegylated; TDF, tenofovir disoproxil fumarate;ULN, upper limit of normal.