NDLI: Real-world application of the roadmap model in chronic hepatitis B patients with telbivudine therapy.

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Real-world application of the roadmap model in chronic hepatitis B patients with telbivudine therapy.

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Real-world application of the roadmap model in chronic hepatitis B patients with telbivudine therapy.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Yu, Hsien-Chung Lin, Kung-Hung Hsu, Ping-I Tsay, Feng-Woei Wang, Huay-Min Tsai, Tzung-Jiun Lai, Kwok-Hung
Description	Country affiliation: China Author Affiliation: Yu HC ( Division of Gastroenterology, Department of Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, Republic of China)
Abstract	BACKGROUND: The roadmap concept provides a strategy to maximize hepatitis B virus suppression and minimize drug resistance by add-on or switching therapy in patients with a suboptimal response at Week 24. The efficacy of this strategy in routine clinical practice remains to be validated. OBJECTIVE: The aim of our study was to validate the roadmap concept in the treatment of chronic hepatitis B, and to investigate the virologic efficacy and kinetics of quantitative hepatitis B surface antigen (qHBsAg) during telbivudine therapy in a real-world setting. METHODS: A prospective, cohort study enrolled 96 consecutive, treatment-naïve patients with chronic hepatitis B receiving telbivudine therapy. At Week 24, only 17 of 42 (40%) partial or inadequate responders (hepatitis B virus DNA 60-2000 and >2000 IU/mL, respectively) followed the roadmap model and consented to adefovir add-on therapy. The remaining patients continued to receive telbivudine monotherapy. RESULTS: At Week 96, none of the patients receiving adefovir add-on therapy, and 28% of patients receiving telbivudine monotherapy, either partial or inadequate responders, developed genotypic resistance (P = 0.03). Poor early qHBsAg kinetics (an increase in qHBsAg >0.4 log IU/mL at Week 12) was the only significant predictor of genotypic resistance (adjusted hazard ratio = 13.83; 95% CI, 1.79-106.76; P = 0.01). Telbivudine monotherapy was efficacious in 94% of partial responders who did not have poor early qHBsAg kinetics, remaining free of drug resistance after 2 years. CONCLUSIONS: The application of the roadmap model with add-on adefovir therapy prevented genotypic resistance. However, telbivudine monotherapy achieved a good response in the majority of partial responders who did not have poor early qHBsAg kinetics. Poor early qHBsAg kinetics was an early predictor of genotypic resistance at Week 96. Modification of the roadmap model to incorporate early qHBsAg kinetics may further optimize the efficacy of the treatment strategy of hepatitis B virus.
File Format	HTM / HTML
ISSN	01492918
Issue Number	9
Volume Number	35
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2013-09-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Adenine Analogs & Derivatives Antiviral Agents Therapeutic Use Hepatitis B Virus Drug Effects Hepatitis B, Chronic Drug Therapy Organophosphonates Thymidine Adult Dna, Viral Blood Drug Administration Schedule Drug Resistance, Viral Drug Therapy, Combination Female Hepatitis B Surface Antigens Immunology Hepatitis B e Antigens Virology Humans Male Middle Aged Prospective Studies Treatment Outcome Journal Article Research Support, U.s. Gov't, Non-p.h.s. Validation Studies
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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