Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
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Post-Marketing Surveillance for the Safety and Effectiveness of Adefovir in Patients with Chronic Hepatitis B

아데포비어의 안전성 및 유효성 평가를 위한 시판 후 조사

  • 신근영 (경북대학교 의과전문대학원 내과학교실) ;
  • 최홍미 (글락소스미스클라인) ;
  • 오신영 (글락소스미스클라인) ;
  • 김준형 (글락소스미스클라인) ;
  • 이일섭 (글락소스미스클라인) ;
  • 권영오 (경북대학교 의과전문대학원 내과학교실)
  • Received : 2011.10.31
  • Accepted : 2011.12.26
  • Published : 2011.12.30
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Abstract

Background: To investigate the safety and effectiveness of adefovir in Korean patients with chronic hepatitis B, an observational study was carried out. Methods: A total of 4,393 patients with chronic hepatitis B were enrolled from February 2004 to February 2010. For the safety assessment, investigators recorded the occurrence of observed and patient-reported adverse events (AEs) throughout the course of treatment. Antiviral effectiveness was assessed by measuring the degree of symptom improvement and the reduction of HBV DNA after 12 weeks of treatment. Results: Of the 4,393 patients, 4,158 patients were evaluated for safety and 3,867 patients for effectiveness assessment. A total of 118 AEs were reported in 4,158 patients (1.8 %). The most frequent AE was hepatic failure (0.2 %) followed by coughing (0.2 %), hepatic neoplasm (0.2 %), abdominal pain (0.1 %), dyspepsia (0.1 %), nausea (0.1 %), flatulence (0.1 %), hepatic cirrhosis (0.1 %), asthenia (0.1 %), increase in sputum production (0.1 %), and varicose vein (0.1 %). The incidence of unexpected AEs was 0.9 %. Forty-nine cases of serious AE were reported in 32 patients but all of those were thought to be unrelated to adefovir according to physician's evaluations. The rate of subjects with well effectiveness was 96.2 %. Conclusion: Adefovir was clinically well tolerated and effective in treatment of chronic hepatitis B patients.

Keywords

Acknowledgement

Supported by : GSK

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