Efficacy of tenofovir alafenamide in the treatment of chronic hepatitis B infection
- VernacularTitle:Гепатитийн В вирусийн халдварыг тенофовир алафенамид эмээр эмчилсэн үр дүн
- Author:
Tuvshinbayar N
1
;
Amaraa R
1
;
Burmaajav B
2
;
Gegeebadrakh B
1
;
Dulguun B
1
;
Enkhtuvshin D
3
Author Information
1. Second General Hospital
2. Ach Medical University
3. Mongolian National University of Medical Sciences
- Publication Type:Journal Article
- Keywords:
Chronic hepatitis B infection;
HBV-DNA;
HBsAg;
HBeAg;
tenofoviralafenamidfumarate (TAF);
tenofovirdisoproxil fumarate (TDF)
- From:Mongolian Medical Sciences
2019;188(2):17-23
- CountryMongolia
- Language:Mongolian
-
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.
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.
- Full text:2019-188(2);17-23.pdf
