Switching from entecavir to tenofovir disoproxil fumarate for HBeAg-positive chronic hepatitis B patients: a phase 4, prospective study

Table 1 Participant demographics and baseline characteristics (SP)

Baseline characteristic	TDF (N = 75)
Age (years), mean (± SD)	48.4 (± 9.35)
Sex, n (%)
Male	55 (73)
Female	20 (27)
Race, n (%)
Japanese	71 (95)
East Asian	4 (5)
HBV genotype, n (%)
A	1 (1)
B	2 (3)
C	72 (96)
HBV-DNA (log₁₀ IU/mL), mean (± SD)	0.92 (± 0.12)
ALT (IU/L), mean (± SD)	23.5 (± 18.13)
HBeAg, n (%)
Positive	70 (93)
Negative^a	5 (7)
HBsAg (IU/mL), mean (± SD)	5311.3 (± 5619.84)
HBcrAg (log₁₀ U/mL), mean (± SD)	5.5 (± 0.55)
eGFR by JSN-CKDI (mL/min/1.73m²), n (%)
< 60	0 (0)
60 to < 90	42 (56)
≥ 90	33 (44)
Urine beta-2-microglobulin (µg/g Cr), mean (± SD)	241.9 (305.58)
Protocol defined liver cirrhosis, n (%)
Yes	0 (0)
No	75 (100)

ALT alanine aminotransferase, Cr creatinine, eGFR by JSN-CKDI estimated glomerular filtration rate calculated by the Japanese Society of Nephrology-Chronic Kidney Disease Initiatives equation, HBV hepatitis B virus, HBeAg hepatitis B e-antigen, HBsAg hepatitis B surface antigen, HBcrAg hepatitis B core-related antigen, SD standard deviation, SP safety population, TDF tenofovir disoproxil fumarate
^aHBeAg-positive according to local in-hospital laboratory results, but HBeAg-negative according to central laboratory results at screening

ISSN: 1471-230X