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Research Article
The long-term benefits of nucleos(t)ide analogs in compensated HBV cirrhotic patients with no or small esophageal varices: A 12-year prospective cohort study
Pietro Lampertico1, Federica Invernizzi1, Mauro Viganò2, Alessandro Loglio1, Giampaolo Mangia1, Floriana Facchetti1, Massimo Primignani1, Manol Jovani1, Massimo Iavarone1, Mirella Fraquelli3, Giovanni Casazza4, Roberto de Franchis5, Massimo Colombo1, ,
1 “A.M. and A. Migliavacca” Center for Liver Disease, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy
2 Division of Hepatology, Ospedale San Giuseppe, Università degli Studi di Milano, Italy
3 Division of Gastroenterology and Endoscopy, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy
4 Department of Biomedical and Clinical Sciences, Ospedale Luigi Sacco, Università degli Studi di Milano, Milan, Italy
5 Division of Gastroenterology, Ospedale Luigi Sacco, Università degli Studi di Milano, Milan, Italy
Received 22 October 2014, Revised 14 May 2015, Accepted 8 June 2015, Available online 19 June 2015
Background & Aims
Esophageal varices (EV) are a marker of disease severity in compensated cirrhosis due to hepatitis B virus (HBV) which predicts also the risk of hepatocellular carcinoma (HCC), clinical decompensation and anticipated liver related death. The dynamics and prognostic significance of EV in patients under long-term HBV suppression by nucleos(t)ide analogs (NUC), are poorly known.
Methods
A standardized protocol (Baveno) including 414 upper gastrointestinal (GI) endoscopies was applied to 107 HBeAg-negative compensated cirrhotic patients (93% Child-Pugh A) during a median of 12 (range 2 to 17) years of NUC therapy. Patients who initially started on lamivudine (LMV) and then developed resistance (LMV-R), were rescued by early administration of adefovir, or were switched to tenofovir. Surveillance included serum HBV DNA every three months and abdominal ultrasound every six months.
Results
Twenty-seven patients had baseline F1 EV which regressed in 18, remained unchanged in eight and progressed in one patient; the 12-year cumulative incidence of EV regression was 83% (95% CI: 52–92%). De novo F1/F2 EV developed in 6/80 patients with a 12-year cumulative incidence of 10% (95% CI: 5–20%). Six of seven patients with de novo varices or progression of pre-existing varices had either a clinical breakthrough due to LMV-R and/or developed a HCC. No bleedings from ruptured EV occurred, 12 patients died (9 HCC) and 15 were transplanted (13 HCC): the 12-year cumulative incidence of HCC and overall survival was 33% (95% CI: 24–42%) and 76% (95% CI: 67–83%), respectively.
Conclusions
Long-term pharmacological suppression of HBV in HBeAg-seronegative patients with compensated cirrhosis leads to a significant regression of pre-existing EV accompanied by a negligible risk of developing de novo EV.
Abbreviations
EV, esophageal varices; NUC, nucleos(t)ide analogs; GI, gastrointestinal; LMV, lamivudine; LMV-R, lamivudine resistance; HCC, hepatocellular carcinoma; HBV, hepatitis B virus; HVPG, hepatic venous pressure gradient; EGDS, esophago-gastroduodenoscopy; PHG, portal hypertensive gastropathy; GOV, gastro-esophageal varices; IGV, isolated gastric varices; LT, liver transplantation; RWM, red wale marks; HIV, human immunodeficiency virus; US, abdominal ultrasound
Keywords
Hepatitis B virus; Cirrhosis; Esophageal varices; Nucleos(t)ide analogs; Gastrointestinal bleeding; Hepatocellular carcinoma; HBsAg clearance; Transient elastography
Corresponding author. Address: Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università di Milano, Via F. Sforza 35, 20122 Milan, Italy. Tel.: +39 0255035432; fax: +39 0250320700.
Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier Ireland Ltd. All rights reserved.
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