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KMID : 1011320190110020102
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Journal of Pharmacoepidemiology and Risk Management
2019 Volume.11 No. 2 p.102 ~ p.112
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A Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Telbivudine (Sebivoⓡ)
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Choi Jung-Nam
Kwon Hye-Jin
Lee Keun-Sung
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Abstract
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Objective: To investigate the safety and effectiveness of telbivudine in Korean patients with chronic hepatitis B, a post-marketing surveillance (PMS) was conducted to meet the local Health Authority regulatory requirements.
Methods: A total of 3,955 patients with chronic hepatitis B were enrolled from October 2008 to September 2012. Safety evaluation was based on the incidence of adverse events (AEs) and serious adverse events (SAEs) during routine drug use. Effectiveness was assessed by measuring the reduction of hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) level and loss of HBeAg/HBeAg seroconversion rate after 6 months of treatment.
Results: Of the 3,955 patients, 3,895 patients were evaluated for safety and 2,821 patients for effectiveness assessment. A total of 356 AEs was reported in 263 patients (6.75%). The most frequent AEs were elevated creatine phosphokinase (CPK) (1.16%) followed by malignant hepatic neoplasm (0.67%), HBV DNA increased (0.28%), and abdominal pain (0.28%). One hundred and sixty-one cases of SAEs were reported from 120 (3.08%) patients, but most of those cases were thought to be not related to telbivudine according to physician’s evaluations. The incidence of serious adverse drug reactions (SADRs) were 0.23%. The rate of subjects with good effectiveness in terms of HBV DNA reduction was 86.88%.
Conclusion: Telbivudine was clinically well tolerated and effective in the treatment of chronic hepatitis B patient in the routine clinical environment.
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KEYWORD
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Telbivudine, Hepatitis B, Safety, Effectiveness, Alanine aminotransferase, Post marketing surveillance
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