Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years

Hepatology International - Tập 9 - Trang 243-250 - 2015
Maria Buti1, Scott Fung2, Edward Gane3, Nezam H. Afdhal4, Robert Flisiak5, Selim Gurel6, John F. Flaherty7, Eduardo B. Martins8, Leland J. Yee8, Phillip Dinh9, Jeffrey D. Bornstein9, G. Mani Subramanian9, Harry L. A. Janssen10, Jacob George11, Patrick Marcellin12
1Servei de Medicina Interna-Hepatologia, Hospital General Universitari Vall d’Hebron, Barcelona, Spain
2Department of Medicine, Toronto General Hospital, University of Toronto, Toronto, Canada
3Department of Gastroenterology and Hepatology, Auckland City Hospital, Auckland, New Zealand
4Department of Hepatology, Beth Israel Deaconess Medical Center, Boston, USA
5Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland
6Department of Gastroenterology, University of Uludag, Bursa, Turkey
7Gilead Sciences Inc., Foster City, USA
8Gilead Sciences, Inc, Foster City, USA
9Gilead Sciences, Inc., Foster City, USA
10Division of Gastroenterology, Erasmus MC University Hospital, Rotterdam, The Netherlands
11Storr Liver Unit, Westmead Millennium Institute, Westmead Hospital, University of Sydney, Westmead, Australia
12Service d’Hépatologie, Viral Hepatitis Research Centre, Hôpital Beaujon, Clichy, France

Tóm tắt

Phase 3 clinical studies have shown that long-term treatment with tenofovir disoproxil fumarate (TDF) can suppress hepatitis B viral load and promote significant fibrosis regression and cirrhosis reversal in a majority of treated chronic hepatitis B (CHB) patients. This retrospective analysis investigated the impact of baseline cirrhosis status on virologic, serologic, and histologic outcomes in patients treated with TDF. Patients enrolled in studies GS-US-174-0102 and GS-US-174-0103 who had baseline liver biopsy–diagnosed cirrhosis and entered the open-label phase of the studies were included in the virologic and serologic analyses. Patients (both HBeAg positive and negative) with paired liver biopsies at baseline and 5 years (N = 348) were included in a histologic analysis. After 5 years on study, comparing patients with and without baseline cirrhosis, respectively: 99.2 and 98.0 % achieved virologic response (hepatitis B viral load < 69 IU/ml) (p = 0.686); 79.7 and 81.9 % had normal serum levels of alanine aminotransferase (p = 0.586); 4.0 and 1.2 % developed hepatocellular carcinoma (p = 0.044). In HBeAg-positive patients with and without baseline cirrhosis, HBsAg loss occurred in 14.4 and 8.3 % of patients, respectively (p = 0.188). One HBeAg-negative patient had HBsAg loss. This represents the largest analyses to date of CHB patients with sequential liver biopsies demonstrating that treatment with TDF for up to 5 years is associated with favorable virologic, serologic, and histologic outcomes, regardless of baseline cirrhosis status. Notably, histologic improvement was observed in the majority of cirrhotic and noncirrhotic patients.

Tài liệu tham khảo

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