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 eventsa | 2 (4.3%) | 1 (2.0%) | 0.52 |
| Discontinuation due to adverse eventb | 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 |
| HCCc, 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