Telbivudine versus entecavir in patients with undetectable hepatitis B virus DNA: a randomized trial

BMC Gastroenterology

Table 2 Serological, virological, and biochemical responses at week 48

Variables	Telbivudine (n = 47)	Entecavir (n = 50)	P-value
Serologic Responses
Change in HBsAg level from baseline^a,b, log₁₀ IU/mL	−0.03 ± 0.14	−0.05 ± 0.11	0.57
HBsAg level^{a, c}, log₁₀ IU/mL	3.37 (3.22 - 3.63)	3.39 (3.10 - 3.67)	0.65
HBsAg seroclearance, n (%)	0 (0%)	0 (0%)	NA
HBsAg level decline from baseline >0.5 log₁₀ IU/mL, n (%)	0 (0%)	0 (0%)	NA
HBsAg level decline from baseline >0.1 log₁₀ IU/mL, n (%)	11 (23.4%)	15 (30.0%)	0.46
HBeAg seroclearance^d, n (%)	2/40 (5.0%)	5/33 (15.2%)	0.14
HBeAg seroconversion^d, n (%)	0/40 (0%)	2/33 (6.1%)	0.11
Virologic Responses
Virologic breakthrough, n (%)	11 (23.4%)	0 (0%)	<0.001
Genotypic resistance, n (%)	7 (14.9%)	0 (0%)	0.005
Virologic response at week 48, n (%)	30 (63.8%)	49 (98.0%)	<0.001

Missing values were considered as failure for categorical endpoints
^aAmong participants whose serum HBsAg and HBV DNA level at week 48 was available (n = 37 in the Telbivudine group, n = 49 in the Entecavir group)
^bMean ± standard deviation (SD)
^cMedian (interquartile range)
^dAmong HBeAg-positive patients at randomization (n = 73)
HBsAg hepatitis B surface antigen, HBeAg hepatitis B envelope antigen, NA not applicable

ISSN: 1471-230X