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Efficacy of switching to telbivudine plus adefovir in suboptimal responders to lamivudine plus adefovir

 Hana Park  ;  Jun Yong Park  ;  Seung Up Kim  ;  Do Young Kim  ;  Kwang-Hyub Han  ;  Chae Yoon Chon  ;  Sang Hoon Ahn 
 WORLD JOURNAL OF GASTROENTEROLOGY, Vol.19(43) : 7671-7679, 2013 
Journal Title
Issue Date
Adenine/administration & dosage ; Adenine/adverse effects ; Adenine/analogs & derivatives* ; Adenine/therapeutic use ; Administration, Oral ; Adult ; Aged ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use* ; Biomarkers/blood ; DNA, Viral/blood ; Drug Administration Schedule ; Drug Resistance, Viral* ; Drug Substitution* ; Drug Therapy, Combination ; Female ; Hepatitis B e Antigens/blood ; Hepatitis B virus/drug effects* ; Hepatitis B virus/genetics ; Hepatitis B virus/immunology ; Hepatitis B, Chronic/diagnosis ; Hepatitis B, Chronic/drug therapy* ; Humans ; Lamivudine/administration & dosage ; Lamivudine/adverse effects ; Lamivudine/therapeutic use* ; Male ; Middle Aged ; Organophosphonates/administration & dosage ; Organophosphonates/adverse effects ; Organophosphonates/therapeutic use* ; Patient Selection ; Prospective Studies ; Republic of Korea ; Thymidine/administration & dosage ; Thymidine/adverse effects ; Thymidine/analogs & derivatives* ; Thymidine/therapeutic use ; Time Factors ; Treatment Failure ; Viral Load ; Young Adult
Antiviral resistance ; Chronic hepatitis B ; Lamivudine ; Suboptimal response ; Telbivudine
To examine the efficacy of telbivudine (LdT) + adefovir (ADV) vs continuation of lamivudine (LAM) + ADV in patients with LAM-resistant chronic hepatitis B (CHB) who show a suboptimal response to LAM + ADV.
This was a randomized, active-control, open-label, single-center, parallel trial. All eligible patients were enrolled in this study in Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea, between March 2010 and March 2011. Hepatitis Be antigen (HBeAg)-positive CHB patients whose serum hepatitis B virus (HBV) DNA remained detectable despite at least 6 mo of LAM + ADV therapy were included. Enrolled patients were randomized to either switching to LdT (600 mg/d orally) plus ADV (10 mg/d orally) (LdT + ADV group) or to continuation with LAM (100 mg/d orally) plus ADV (10 mg/d orally) (LAM + ADV group), and were followed for 48 wk. One hundred and six patients completed the 48-wk treatment period. Serum HBV DNA, HBeAg status, liver biochemistry and safety were monitored at baseline and week 12, 24, 36 and 48.
The duration of prior LAM + ADV treatment was 18.3 (LdT + ADV) and 14.9 mo (LAM + ADV), respectively (P = 0.131). No difference was seen in baseline serum HBV DNA between the two groups [3.66 (LdT + ADV) vs 3.76 (LAM + ADV) log10 IU/mL, P = 0.729]. At week 48, although there was no significant difference in the mean reduction of serum HBV DNA from baseline between LdT + ADV group and LAM + ADV group (-0.81 vs -0.47 log10 IU/mL, P = 0.167), more patients in the LdT + ADV group had undetectable HBV DNA levels compared to those in the LAM + ADV group (30.2% vs 11.5%, P = 0.019). Three patients with LdT + ADV treatment and 2 patients with LAM + ADV treatment achieved HBeAg loss. The patients in both groups tolerated the treatment well without serious adverse events. The proportion of patients with estimated glomerular filtration rate ≥ 90 mL/min per 1.73 m(2) in the LdT + ADV group increased from 49.1% (26/53) at baseline to 58.5% (31/53) at week 48, while that in the LAM + ADV group decreased from 37.7% (20/53) at baseline to 30.2% (16/53) at week 48.
The switch to LdT + ADV in suboptimal responders to LAM + ADV showed a significantly higher rate of virologic response at week 48. These results suggest that LdT + ADV could be a therapeutic option for patients who are unable to use enofovir disoproxil fumarate for any reason.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Do Young(김도영)
Kim, Seung Up(김승업) ORCID logo https://orcid.org/0000-0002-9658-8050
Park, Jun Yong(박준용) ORCID logo https://orcid.org/0000-0001-6324-2224
Park, Ha Na(박하나)
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Chon, Chae Yoon(전재윤)
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
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