Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France
P. Marcellin
(1)
,
F. Zoulim
(2)
,
C. Hezode
(3)
,
X. Causse
,
B. Roche
,
R. Truchi
,
A. Pauwels
,
D. Ouzan
(4)
,
J. Dumortier
(5, 2)
,
G.P. Pageaux
,
M. Bourliere
(6)
,
G. Riachi
(7)
,
J.P. Zarski
,
J.F. Cadranel
,
V. Tilliet
,
C. Stern
(8)
,
P. Petour
,
O. Libert
,
S.M. Consoli
(9, 10)
,
D. Larrey
1
Service d'hépatologie
2 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
3 Service d'hépato-gastro-entérologie [APHP Henri Mondor]
4 Institut Arnault Tzanck
5 Département d'hépatologie
6 Service d'Hépato-gastroentérologie
7 Hôpital Charles Nicolle [Rouen]
8 ICMUB - Institut de Chimie Moléculaire de l'Université de Bourgogne [Dijon]
9 UPD5 - Université Paris Descartes - Paris 5
10 Hôpital Européen Georges Pompidou
2 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
3 Service d'hépato-gastro-entérologie [APHP Henri Mondor]
4 Institut Arnault Tzanck
5 Département d'hépatologie
6 Service d'Hépato-gastroentérologie
7 Hôpital Charles Nicolle [Rouen]
8 ICMUB - Institut de Chimie Moléculaire de l'Université de Bourgogne [Dijon]
9 UPD5 - Université Paris Descartes - Paris 5
10 Hôpital Européen Georges Pompidou
F. Zoulim
- Fonction : Auteur
- PersonId : 890662
- IdHAL : fabien-zoulim
- ORCID : 0000-0002-2245-0083
X. Causse
- Fonction : Auteur
B. Roche
- Fonction : Auteur
R. Truchi
- Fonction : Auteur
A. Pauwels
- Fonction : Auteur
J. Dumortier
- Fonction : Auteur
- PersonId : 762386
- ORCID : 0000-0002-7824-5396
- IdRef : 07665933X
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
Domaines
CancerFormat du dépôt | Notice |
---|---|
Type de dépôt | Article dans une revue |
Titre |
en
Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France
|
Résumé |
en
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
|
Auteur(s) |
P. Marcellin
1
, F. Zoulim
2
, C. Hezode
3
, X. Causse
, B. Roche
, R. Truchi
, A. Pauwels
, D. Ouzan
4
, J. Dumortier
5, 2
, G.P. Pageaux
, M. Bourliere
6
, G. Riachi
7
, J.P. Zarski
, J.F. Cadranel
, V. Tilliet
, C. Stern
8
, P. Petour
, O. Libert
, S.M. Consoli
9, 10
, D. Larrey
1
Service d'hépatologie
( 74513 )
- Clichy
- France
2
UNICANCER/CRCL -
Centre de Recherche en Cancérologie de Lyon
( 139829 )
- 28, rue Laennec - 69373 Lyon
- France
3
Service d'hépato-gastro-entérologie [APHP Henri Mondor]
( 32907 )
- 94000 Créteil
- France
4
Institut Arnault Tzanck
( 469997 )
- Institut Arnaud Tzanck, Liver Unit, St. Laurent du Var, France
- France
5
Département d'hépatologie
( 223421 )
- France
6
Service d'Hépato-gastroentérologie
( 74482 )
- Marseille
- France
7
Hôpital Charles Nicolle [Rouen]
( 300106 )
- CHU de Rouen
1 rue de Germont, 76031 Rouen cedex
- France
8
ICMUB -
Institut de Chimie Moléculaire de l'Université de Bourgogne [Dijon]
( 24496 )
- Université de Bourgogne - 9 Avenue Alain Savary - BP 47870 - 21078 Dijon Cedex
- France
9
UPD5 -
Université Paris Descartes - Paris 5
( 301664 )
- 12, rue de l'École de Médecine - 75270 Paris cedex 06
- France
10
Hôpital Européen Georges Pompidou
( 188076 )
- France
|
Langue du document |
Anglais
|
Nom de la revue |
|
Vulgarisation |
Non
|
Comité de lecture |
Oui
|
Audience |
Internationale
|
Date de publication |
2016-01
|
Domaine(s) |
|
Mots-clés |
en
Aged, Comorbidity, Dna, France, Glomerular Filtration Rate, Hepatitis, Hepatitis B, history, Male, methods, Patients, Population, Tenofovir, therapy
|
DOI | 10.1007/s10620-015-4027-8 |
Pubmed Id | 26821154 |
PubMed Central | PMC5020114 |
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