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

BMC Gastroenterology

Table 3 Safety profiles of the study patients

Adverse event category	Telbivudine (n = 47)	Entecavir (n = 50)	P-value
Any adverse event	29 (61.7%)	29 (58.0%)	0.71
Serious adverse events^a	2 (4.3%)	1 (2.0%)	0.52
Discontinuation due to adverse event^b	3 (6.4%)	0	0.11
Dose reduction due to adverse event	0	0	-
Deaths	0	0	-
Serum CK >3 x ULN	3 (6.4%)	0	0.11
Myopathy	1 (2.1%)	0	0.30
HCC^c, n (%)	1 (2.1%)	0	0.30
Serum creatinine ≥0.5 mg/dL above baseline	0	0	-
eGFR <50 mL · min⁻¹ · 1.73 m^(2)-1	0	0	-

^aTelbivudine group: cholangitis with intra-hepatic duct stone, hepatocellular carcinoma; Entecavir group: scrub typhus. None was determined to be related to study drug administration
^bBy headache, gastrointestinal issues, and myopathy (n = 1 each). The symptoms improved after discontinuation of the treatment
^cHCC was diagnosed at week 36
CK creatine kinase, ULN upper limit of normal, HCC hepatocellular carcinoma, eGFR estimated glomerular filtration rate

ISSN: 1471-230X