Comparison of the Efficacies and Safety of Combined Therapy between Telbivudine Plus Adefovir and Lamivudine Plus Adefovir in Patients with Hepatitis B Virus Infection in Real-World Practice.
OBJECTIVE
Chronic hepatitis B infection remains a significant health issue worldwide. This study evaluated the efficacy and safety of combined therapy using lamivudine plus adefovir (LAM+ADV) versus telbivudine plus adefovir (LdT+ADV) and the corresponding renal function change and safety.


METHODS
This study enrolled a total of 171 patients (110 patients received LAM+ADV and 60 patients received LdT+ADV). We analyzed the changes in renal function using the estimated glomerular filtration rate (eGFR). The DNA undetectable rate, hepatitis B e antigen (HBeAg) seroconversion rate, and alanine aminotransferase (ALT) normalization rate were analyzed. We checked the serum uric acid, phosphate and creatine kinase, and lactic acid levels to analyze safety. We observed these patients for 48 to 240 weeks and checked their serum profile every 6 months.


RESULTS
There was no statistically significant difference between the two groups in anti-hepatitis B virus (HBV) efficacy in terms of DNA undetectable rate, ALT normalization rate, and HBeAg seroconversion rate. Both the LAM+ADV and LdT+ADV groups had stable or improved renal function. However, a higher eGFR was found in the LdT+ADV group with continuous serum fluctuation during 3 years of combined therapy as well as a higher serum creatine kinase level.


CONCLUSIONS
Long-term LdT+ADV combined therapy and LAM+ADV combined therapy were both associated with stable or improved renal function. The clinical efficacy was similar between the two groups, but the LdT group had a higher serum creatine kinase level. We need to monitor the data regularly in clinical practice.
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan.
Ming-Tsung
http://orcid.org/0000-0003-0009-0707
MT
Lin
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan.
Yi-Hao
YH
Yen
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan.
Ming-Chao
MC
Tsai
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan.
Po-Lin
PL
Tseng
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan.
Kuo-Chin
KC
Chang
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan.
Cheng-Kun
CK
Wu
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan.
Tsung-Hui
TH
Hu
D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D000328:Adult; D015415:Biomarkers / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D012189:Retrospective Studies; D000077712:Telbivudine; D013936:Thymidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D016896:Treatment Outcome
D015415:Biomarkers; D063065:Organophosphonates; D000077712:Telbivudine; D019259:Lamivudine; C053001:adefovir; D000225:Adenine; D013936:Thymidine