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Viral Suppression and Cirrhosis Regression with Tenofovir Disoproxil Fumarate in Asians with Chronic Hepatitis B.
- Source :
- Digestive Diseases & Sciences; Jan2015, Vol. 60 Issue 1, p260-268, 9p
- Publication Year :
- 2015
-
Abstract
- Background: Chronic hepatitis B (CHB) is a major public health concern, particularly in endemic areas like Asia-Pacific. Sustained virologic suppression correlates with regression of histologic fibrosis and cirrhosis. Aim: This study evaluated efficacy and safety of tenofovir disoproxil fumarate (TDF) in Asian patients through 240 weeks of treatment. Methods: Post hoc analysis of the Asian subpopulation from two phase 3 clinical studies was performed. Following a 48-week randomized, double-blind evaluation of once-daily TDF versus once-daily adefovir dipivoxil, open-label TDF for up to 240 weeks was evaluated. Patients with both baseline and week 240 liver biopsies were evaluated for histologic changes. Results: At baseline, 189/641 (29 %) patients randomized were Asian. Sixty-eight percent of Asian patients were male; 50 % were hepatitis B e antigen (HBeAg)-positive. At week 240, similar proportions of Asian (88 %) and non-Asian (87 %) patients demonstrated improvement in liver histology, and 19/22 (86 %) Asian patients with baseline cirrhosis were no longer cirrhotic. By modified intent-to-treat analysis, 74 % of Asian patients and 76 % of non-Asian patients had HBV DNA <400 copies/mL at the end of week 240 ( P = 0.602). No differences were seen in HBeAg loss or seroconversion in Asian versus non-Asian patients. No Asian patient experienced hepatitis B surface antigen loss. Safety and tolerability of TDF through week 240, including changes in renal function and in hip/spine bone mineral density (from weeks 192 to 240), were comparable between Asian and non-Asian patients. Conclusions: Long-term virologic and histologic efficacy and safety of TDF are comparable in Asian and non-Asian CHB patients. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 01632116
- Volume :
- 60
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- Digestive Diseases & Sciences
- Publication Type :
- Academic Journal
- Accession number :
- 100254991
- Full Text :
- https://doi.org/10.1007/s10620-014-3336-7