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61th Annual Meeting of the American Association for the Study of Liver Diseases
Boston, MA, Hynes Convention Center
October 30-November 3, 2010
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Maintained long-term suppression of HBV replication in NUC-na´ve patients with chronic hepatitis B treated with ETV monotherapy in field practice: the Italian multicenter experience
  Reported by Jules Levin
61st Annual AASLD Nov 2 Boston 2010
P. Lampertico1; M. Vigano1; R. Soffredini1; F. Facchetti1; E. Minola2; F. Suter2; S. Zaltron3; A. Vavassori3; G. A. Gubertini4; C. Magni4; A. Testa5; G. Antonucci5; G. Pinzello6; M. Vinci6; E. Fatta7; S. Fargion7; P. Del Poggio8; B. Coco9; M. R. Brunetto9; M. Andreoletti10; T. Santantonio11; G. Colloredo12; S. Fagiuoli13; A. Colombo14; F. Fumagalli Maldini15; M. Pozzi16; N. M. Terreni17; M. Quagliuolo18; G. Lunghi19; M. Colombo1
1. 1st Division of Gastroenterology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Universita degli Studi di Milano, Milan, Italy.
2. Infectious Diseases, Ospedali Riuniti di Bergamo, Bergamo, Italy.
3. Department of Infectious Diseases, AO Spedali Civili, Universita di Brescia, Brescia, Italy.
4. I and II Div. Infectious Diseases, Ospedale Luigi Sacco , Milano, Italy.
5. INMI, L. Spallanzani IRCCS, Roma, Italy.
6. SC Epatologia e Gastroenterologia, Ospedale Niguarda Ca' Granda, Milano, Italy.
7. Internal Medicine 1b, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Universita degli Studi di Milano, Milano, Italy.
8. UO Epatologia, Ospedale di Treviglio, Treviglio, Italy.
9. UO Epatologia, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
10. S.C. Medicina Generale, Ospedale "A.Manzoni", Lecco, Italy.
11. Clinic of Infectious Diseases, Universita di Foggia, Foggia, Italy.
12. Div. of Medicine, Policlinico San Pietro, Bergamo, Italy.
13. Gastroenterology Unit, Liver and Lung Transplantation Centre, Ospedali Riuniti di Bergamo, Bergamo, Italy.
14. UO Medicina, servizio di Epatologia, Ospedale Sant'Anna, Como, Italy.
15. Liver Center, Clinica Medica, Azienda Ospedaliera S. Gerardo, Universita Milano Bicocca, Monza, Italy.
16. UO Medicina, Ospedale Fatebenefratelli, Erba, Italy.
17. UO Gastroenterologia, Ospedale Valduce, Como, Italy.
18. UO Gastroenterologia, Azienda Ospedaliera di Melegnano, Melegnano, Italy. 19. Istituto di Medicina Preventiva, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Universita degli Studi di Milano, Milano, Italy.
Aim of the study was to assess the long-term effectiveness and safety of Entecavir (ETV) in NUC-na´ve patients treated in field practice.
Methods: 418 consecutive NUC-na´ve patients with chronic hepatitis B were recruited in 18 Liver Units in Italy and treated with ETV 0.5 mg for 30 months (2-38). Liver function tests and HBV DNA, assessed by a sensitive assays, were performed every 3 months. Virological breakthrough was defined as > 1 log U increase of viremia, a "blip" was the reoccurrence of detectable viremia (< 1 log IU/ml) in a virological responder.
Results: At baseline, median age was 58 years, 76% males, 83% HBeAg negatives, 49% cirrhotics, 56% with concomitant diseases/medications. Median HBV DNA was 6.0 log IU/ml (range 1.5->9.0) and ALT were elevated in 85% of the patients. During ETV treatment, 90% of the patients achieved undetectable HBV DNA: virological response rates were 67%, 86%, 92%, 95% and 96% at month 6, 12, 18, 24, and 30. The corresponding features for ALT normalization were 69%, 81%, 85%, 87% and 93%. After achieving undetectable HBV DNA, few patients had blips of viremia which were not confirmed in the following visits in the vast majority of cases. Primary non response at week 12, partial virological response at week 48 and virological breakthroughs occurred in < 1%, 14% and < 1% of the patients. TDF was added to ETV in 17 patients with partial virological response. Of the 39 partial virologial responders at week 48 not rescued with TDF and followed for additional 6-9 months, only 20 (50%) cleared viremia spontaneously. No major safety issues were reported. Median serum creatinine remained unchanged during treatment: from 0.90 (0.50-9.0) at baseline to 0.90 (0.91 (0.50-8.0) mg/dl at the last visit. A greater than 0.3 or 0.5 mg/dl increase of serum creatinine in the last visit versus baseline occurred in 3% and 0.6% of the patients, respectively. Blood phosphorus levels dropped below 2.3 mg/dl in 1% of the patients.
In conclusion, the vast majority of NUC-na´ve patients treated with ETV monotherapy in field practice achieved and maintained a virological response through 30 months.

M. Colombo: Research grant from Roche, Gilead; Advisory Board/Speaker Bureau for Roche, Gilead, BMS, Novartis
P. Lampertico: Advisory Board/Speaker Bureau for Gilead, Roche, BMS, GSK, Novartis
M. Brunetto: Advisory Board/Speaker Bureau for Roche, Schering-Plough, Gilead, BMS, Abbott