Large-scale surveillance study of the safety and effectiveness of entecavir in Korean patients with chronic hepatitis B
نویسندگان
چکیده
BACKGROUND/AIMS Entecavir (ETV) is effective and safe antiviral agent against hepatitis B virus (HBV) in clinical and real-world setting but, most studies were performed in single institute or have limitation in patient's number. A large-scale nation-wide real-world surveillance study was carried out to investigate safety, efficacy and clinical effectiveness of ETV in Korean patients with chronic hepatitis B (CHB). METHODS Between 2006 and 2012, 3,444 patients were enrolled from 132 Korean institutions. For the safety assessment, investigators recorded the occurrence of observed and patient-reported adverse events (AEs), as well as laboratory abnormalities. Efficacy, which consisted of change in HBV DNA and alanine aminotransferase (ALT), was evaluated in patients who had received at least 16 weeks of ETV treatment. Overall clinical effectiveness, based on improvement of ALT, HBV DNA and patient's symptoms, was evaluated by physicians. RESULTS Of the patients, 3,367 were evaluated for safety and 3,115 for efficacy and clinical effectiveness. Three hundred and eighty AEs were reported in 255 cases (7.57%), and 67 adverse drug reactions in 54 cases (1.6%). Serious AEs (SAE) were 19 events in nine cases (0.27%). Serious adverse drug reactions (SADR) were three events in two cases (0.06%), and unexpected SAE/SADR were three events in two cases (0.06%). Medical history and concomitant medications were factors inf luencing incidence rates of AEs. Overall clinical effectiveness rate was 96.53%, which was clinically assessed as marked improved or improved state. CONCLUSIONS This study showed that ETV was well tolerated and clinically effective in Korean patients with CHB in a real-world nation-wide setting.
منابع مشابه
Association between KIR Genes and Efficacy of Treatment of HBeAg-Positive Chronic Hepatitis B Patients with Entecavir
Background: Entecavir (ETV) is commonly used to treat chronic hepatitis B (CHB) in China. However, certain percentages of e-Antigen (HBeAg) positive CHB patients do not respond to ETV therapy. Objective: To investigate whether the killer immunoglobulin-like receptor (KIR) genes were associated with seroconversion in HBeAg positive CHB responder patients treated with ETV. Methods: Polymerase cha...
متن کاملThe Effectiveness of Group Cognitive-Behavioral Therapy on the Lifestyle of Patients with Hepatitis B
Background: To promote general health in patients with hepatitis, it is vital to develop effective interventions to improve the lifestyle of these patients. The present study aimed to investigate the effectiveness of group cognitive-behavioral therapy (CBT) on the lifestyle of patients with hepatitis B. Methods: This was a quasi-experimental study with pretest-posttest control group design. A ...
متن کاملCost-effectiveness of entecavir versus adefovir for the treatment of chronic hepatitis B in patients with decompensated cirrhosis from a third-party US payer perspective
BACKGROUND Decompensated cirrhosis is a serious clinical complication of chronic hepatitis B (CHB) that places a large economic burden on the US health care system. Although entecavir has been shown to improve health outcomes in a cost-effective manner in mixed populations of CHB patients, the cost-effectiveness of entecavir has not been evaluated in CHB patients with decompensated cirrhosis. ...
متن کاملEntecavir is a potent anti-HBV drug superior to lamivudine: experience from clinical trials in China.
Infection with the hepatitis B virus (HBV) can result in chronic hepatitis B (CHB) in many patients. Patients with CHB require regular screening and monitoring to facilitate disease surveillance and to determine if/when treatment is indicated. The current goal of CHB treatment is sustained viral suppression with the aim of reducing or preventing hepatic injury and disease progression. Effective...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
دوره 33 شماره
صفحات -
تاریخ انتشار 2018