Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-10

AUTHORS

Patrick Marcellin, Fabien Zoulim, Christophe Hézode, Xavier Causse, Bruno Roche, Régine Truchi, Arnaud Pauwels, Denis Ouzan, Jérôme Dumortier, Georges-Philippe Pageaux, Marc Bourlière, Ghassan Riachi, Jean-Pierre Zarski, Jean-François Cadranel, Valérie Tilliet, Christiane Stern, Pascal Pétour, Olivier Libert, Silla M. Consoli, Dominique Larrey

ABSTRACT

BACKGROUND AND AIMS: Tenofovir disoproxil fumarate (TDF) demonstrated potent and sustainable antiviral efficacy and a good safety profile in patients with chronic hepatitis B (CHB) in controlled clinical trials. Real-world data are important to confirm effectiveness and safety data in patient populations encountered in routine clinical practice. METHODS: This non-interventional, prospective, 36-month study included treatment-naïve and treatment-experienced patients with CHB initiating their first TDF regimen (monotherapy or combination therapy) in routine clinical practice in France. Clinical, virologic, biochemical, compliance, and safety data were collected. RESULTS: Data from 440 consecutive patients from 58 centers were analyzed. The majority of the cohort was male (71 %), hepatitis B "e" antigen-negative (HBeAg-) (74 %), and treatment-experienced (56 %); 11 % were aged ≥65 years; and comorbidities were reported in 39 %. After 12 months, 92 % of the overall cohort achieved virologic response (HBV DNA <69 IU/mL) which was maintained to 36 months (96 %); virologic response was achieved by >90 % of patients irrespective of HBeAg status, age, or prior treatment history. At 36 months, 77 % of patients had normal alanine aminotransferase levels. Fourteen patients lost hepatis B surface (HBs) antigen, and seven seroconverted to anti-HBs. TDF was well tolerated over the 36-month study, including in 14 women who became pregnant during the study. Median estimated glomerular filtration rate did not change markedly from baseline irrespective of prior treatment history. CONCLUSIONS: TDF demonstrated potent virologic and biochemical responses across a broad range of patients reflective of routine clinical practice. The safety profile was consistent with results from pivotal trials. More... »

PAGES

3072-3083

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10620-015-4027-8

DOI

http://dx.doi.org/10.1007/s10620-015-4027-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1052012037

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26821154


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