Viral suppression and cirrhosis regression with tenofovir disoproxil fumarate in Asians with chronic hepatitis B.
Dig Dis Sci
; 60(1): 260-8, 2015 Jan.
Article
en En
| MEDLINE
| ID: mdl-25179493
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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Adenina
/
Inhibidores de la Transcriptasa Inversa
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Hepatitis B Crónica
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Organofosfonatos
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Cirrosis Hepática
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Límite:
Female
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Humans
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Male
Idioma:
En
Revista:
Dig Dis Sci
Año:
2015
Tipo del documento:
Article