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Mongolian Medical Sciences ; : 17-23, 2019.
Article in English | WPRIM | ID: wpr-975054

ABSTRACT

Introduction@#Worldwide, an estimated two billion people have evidence of HBV infection, and approximately 240 million have CHB. In this study, a representative group of Mongolian adults was tested for hepatitis B virus (HBV) in 2017. The prevalence estimates of HBV the general Mongolian adult population were found to be 11.1%, respectively.</br> In April 2017, EASL added a drug newly approved for treatment of CHB, tenofovir alafenamide (TAF) to their list of recommended first-line therapies. The requirement for long-term therapy in chronic HBV highlights the importance of these efficacy and safety trends, however their true clinical relevance is yet to be established and further studies with long-term follow up and real-world clinical data are needed.@*Goal@#Evaluate for result of tenofovir alafenamide in the treatment of chronic hepatitis B infection.@*Materials and Methods@#The clinical trials have evaluated TAF in HBeAg-positive and HBeAg-negative chronic HBV patients. The trials have similar designs and are randomized, double blind, non-inferiority studies. The primary efficacy endpoint was the proportion of patients with HBV DNA<29 IU/ml at week 24 and 48. Other prespecified efficacy endpoints were the proportion of patients with HBsAg seroncoversion to anti-HBs at week 24 and 48. Key secondary safety end- points at week 24 and 48 included the percentage change in T-score, and Z-score bone mineral density (BMD), percentage change in BMD and change from baseline serum creatinine.@*Results@#The primary efficacy endpoint, an HBV DNA level <29 IU/ml at week 24, was achieved by 120 (59.1%) of 203 patients receiving TAF, which was non-inferior to the 63 (55.2%) of 114 patients receiving TDF who had an HBV DNA<29 IU/ml. After 24 weeks of treatment, patients receiving TAF had significantly smaller reductions in bone mineral density (BMD) compared with patients receiving TDF.@*Conclusion@#The development of TAF, specifically designed to deliver potent antiviral activity but with an improved safety profile compared with TDF, is therefore timely.

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