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Dig Dis Sci. 2017 Mar;62(3):784-793. doi: 10.1007/s10620-017-4448-7. Epub 2017 Jan 11.

Effectiveness and Safety of Entecavir or Tenofovir in a Spanish Cohort of Chronic Hepatitis B Patients: Validation of the Page-B Score to Predict Hepatocellular Carcinoma.

Author information

1
Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Passeig Vall Hebron, 119-129, 08035, Barcelona, Spain.
2
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
3
Liver Pathology Unit, Departments of Biochemistry and Microbiology (Virology Unit), Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Barcelona, Spain.
4
Liver Unit, Hospital U. Puerta de Hierro, Universidad Autonoma de Madrid, Majadahonda, Madrid, Spain.
5
Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, Barcelona, Spain.
6
Digestive Diseases Department, Hospital Universitario 12 de octubre, Madrid, Spain.
7
Digestive Diseases Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
8
Gastroenterology and Hepatology Unit, Hospital Universitario Valdecilla, IDIVAL, Facultad de Medicina, Santander, Spain.
9
Digestive Diseases Department, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.
10
Digestive Diseases Department, Hospital Universitario Virgen del Rocío, Seville, Spain.
11
Digestive Diseases Department, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain.
12
Digestive Diseases Department, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.
13
Digestive Diseases Department, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.
14
Digestive Diseases Department, Hospital Universitario Virgen de Valme, Seville, Spain.
15
Liver Unit, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
16
Digestive Diseases Department, Hospital Universitario del Sureste, Arganda del Rey, Madrid, Spain.
17
Digestive Diseases Department, Hospital Universitario de Girona Dr. Josep Trueta, Girona, Spain.
18
Digestive Diseases Department, Hospital San Pedro de Alcántara, Cáceres, Spain.
19
Digestive Diseases Department, Hospital Universitario de Móstoles, Móstoles, Madrid, Spain.
20
Digestive Diseases Department, Hospital Clínico San Carlos, Madrid, Spain.
21
Digestive Diseases Department, Hospital Infanta Cristina, Parla, Madrid, Spain.
22
Internal Medicine Department, Hospital General de Segovia, Segovia, Spain.
23
Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Passeig Vall Hebron, 119-129, 08035, Barcelona, Spain. mbuti@vhebron.net.
24
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. mbuti@vhebron.net.

Abstract

BACKGROUND:

Long-term antiviral therapy has resulted in viral suppression and biochemical response in chronic hepatitis B, although the risk of hepatocellular carcinoma has not been abolished. The Page-B score could be useful to estimate the probability of HCC.

AIMS:

To analyze the effectiveness and safety of entecavir or tenofovir for more than 4 years and the usefulness of Page-B score in the real-world setting.

METHODS:

Analysis of Caucasian chronic hepatitis B subjects treated with entecavir or tenofovir from the prospective, multicenter database CIBERHEP.

RESULTS:

A total of 611 patients were enrolled: 187 received entecavir and 424 tenofovir. Most were men, mean age 50 years, 32% cirrhotic and 16.5% HBeAg-positive. Mean follow-up was 55 (entecavir) and 49 (tenofovir) months. >90% achieved HBV DNA <69 IU/mL and biochemical normalization by months 12 and 36, respectively. Cumulative HBeAg loss and anti-HBe seroconversion were achieved by 33.7 and 23.8%. Four patients lost HBsAg; three HBeAg-positive. Renal function remained stable on long-term follow-up. Fourteen (2.29%) developed HCC during follow-up all of them with baseline Page-B ≥10. Nine were diagnosed within the first 5 years of therapy. This contrasts with the 27 estimated by Page-B, a difference that highlights the importance of regular HCC surveillance even in patients with virological suppression.

CONCLUSIONS:

Entecavir and tenofovir achieved high biochemical and virological response. Renal function remained stable with both drugs. A Page-B cut-off ≥10 selected all patients at risk of HCC development.

KEYWORDS:

Effectiveness; Entecavir; Hepatitis B; Hepatocellular carcinoma; Page-B; Safety; Tenofovir

PMID:
28078526
DOI:
10.1007/s10620-017-4448-7
[Indexed for MEDLINE]
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