1Service d'Hépatologie, Hôpital Beaujon, 100 Bv du Gal Leclerc, Pavillion Abrami, 92110, Clichy, France. firstname.lastname@example.org.
2Hôpital de la Croix Rousse, Lyon, France. email@example.com.
3Hôpital Henri Mondor, AP-HP, INSERM U955, Universite Paris-Est, Créteil, France. firstname.lastname@example.org.
4Centre Hospitalier Régional, Orléans, France. email@example.com.
5Hôpital Paul Brousse, Villejuif, France. firstname.lastname@example.org.
6Hôpital de l'Archet, Nice, France. email@example.com.
7Centre Hospitalier, Gonesse, France. firstname.lastname@example.org.
8Institut Arnault Tzanck, Saint Laurent Du Var, France. Denis.email@example.com.
9Hôpital Edouard Hériot, Lyon, France. firstname.lastname@example.org.
10Hôpital Saint Eloi, Montpellier, France. email@example.com.
11Hôpital Saint Joseph, Marseille, France. firstname.lastname@example.org.
12Hôpital Charles Nicolle, Rouen, France. Ghassan.Riachi@chu-rouen.fr.
13Hôpital de la Tronche, Grenoble, France. JPZarski@chu-grenoble.fr.
14Centre Hospitalier Laennec, Creil, France. Jeanfrancois.CADRANEL@ghpso.fr.
15Gilead Sciences, Boulogne-Billancourt, France.
16Gilead Sciences, Boulogne-Billancourt, France. Pascal.Petour@gilead.com.
17Hôpital Européen Georges Pompidou, Paris, France. email@example.com.
18Hôpital Saint Eloi, Montpellier, France. firstname.lastname@example.org.
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.
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.
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.
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.