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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.

Abstract

BACKGROUND AND AIM

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.

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  • Authors+Show Affiliations

    ,

    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.

    ,

    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.

    ,

    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.

    ,

    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.

    ,

    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.

    ,

    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.

    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.

    Source

    PloS one 11:11 2016 pg e0165416

    MeSH

    Adenine
    Adult
    Biomarkers
    Drug Therapy, Combination
    Female
    Glomerular Filtration Rate
    Hepatitis B, Chronic
    Humans
    Lamivudine
    Male
    Middle Aged
    Organophosphonates
    Retrospective Studies
    Thymidine
    Treatment Outcome

    Pub Type(s)

    Comparative Study
    Journal Article

    Language

    eng

    PubMed ID

    27806120

    Citation

    TY - JOUR T1 - 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. AU - Lin,Ming-Tsung, AU - Yen,Yi-Hao, AU - Tsai,Ming-Chao, AU - Tseng,Po-Lin, AU - Chang,Kuo-Chin, AU - Wu,Cheng-Kun, AU - Hu,Tsung-Hui, Y1 - 2016/11/02/ PY - 2016/05/04/received PY - 2016/10/11/accepted PY - 2016/11/3/pubmed PY - 2017/6/27/medline PY - 2016/11/3/entrez SP - e0165416 EP - e0165416 JF - PloS one JO - PLoS ONE VL - 11 IS - 11 N2 - BACKGROUND AND AIM: 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. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/27806120/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_ L2 - http://dx.plos.org/10.1371/journal.pone.0165416 ER -