Author information
1Service d'Hépatologie, Hôpital Beaujon, 100 Bv du Gal Leclerc, Pavillion Abrami, 92110, Clichy, France. patrick.marcellin@bjn.aphp.fr.
2Hôpital de la Croix Rousse, Lyon, France. fabien.zoulim@inserm.fr.
3Hôpital Henri Mondor, AP-HP, INSERM U955, Universite Paris-Est, Créteil, France. christophe.hezode@hmn.aphp.fr.
4Centre Hospitalier Régional, Orléans, France. xavier.causse@chr-orleans.fr.
5Hôpital Paul Brousse, Villejuif, France. bruno.roche@pbr.aphp.fr.
6Hôpital de l'Archet, Nice, France. truchi.r@chu-nice.fr.
7Centre Hospitalier, Gonesse, France. arnaud.pauwels@ch-gonesse.fr.
8Institut Arnault Tzanck, Saint Laurent Du Var, France. Denis.ouzan@wanadoo.fr.
9Hôpital Edouard Hériot, Lyon, France. jerome.dumortier@chu-lyon.fr.
10Hôpital Saint Eloi, Montpellier, France. gp-pageaux@chu-montpellier.fr.
11Hôpital Saint Joseph, Marseille, France. mbourliere@hopital-saint-joseph.fr.
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. silla.consoli@egp.aphp.fr.
18Hôpital Saint Eloi, Montpellier, France. dom-larrey@chu-montpellier.fr.
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.