Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Digestive Diseases and Sciences Année : 2016

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

F. Zoulim
X. Causse
  • Fonction : Auteur
B. Roche
  • Fonction : Auteur
R. Truchi
  • Fonction : Auteur
A. Pauwels
  • Fonction : Auteur
D. Ouzan
  • Fonction : Auteur
G.P. Pageaux
  • Fonction : Auteur
J.P. Zarski
  • Fonction : Auteur
J.F. Cadranel
  • Fonction : Auteur
V. Tilliet
  • Fonction : Auteur
P. Petour
  • Fonction : Auteur
O. Libert
  • Fonction : Auteur
D. Larrey
  • Fonction : Auteur

Résumé

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-naive 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 \textgreater/=65 years; and comorbidities were reported in 39 %. After 12 months, 92 % of the overall cohort achieved virologic response (HBV DNA \textless69 IU/mL) which was maintained to 36 months (96 %); virologic response was achieved by \textgreater90 % 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

Dates et versions

hal-01812701 , version 1 (11-06-2018)

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Citer

P. Marcellin, F. Zoulim, C. Hezode, X. Causse, B. Roche, et al.. Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France. Digestive Diseases and Sciences, 2016, ⟨10.1007/s10620-015-4027-8⟩. ⟨hal-01812701⟩
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