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本帖最后由 StephenW 于 2012-12-8 10:07 编辑
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| PRESENTATION TYPE: Oral or Poster | CURRENT CATEGORY: Hepatitis B | CURRENT DESCRIPTORS: I02. Treatment and Clinical Trials | TITLE: Adding peginterferon alfa-2a to entecavir increases HBsAg decline and HBeAg clearance - first results from a global randomized trial (ARES study) | AUTHORS (FIRST NAME, LAST NAME): Milan J. Sonneveld1, Qing Xie2, Ning-Ping Zhang3, Qin Zhang4, Fehmi Tabak5, Adrian Streinu-cercel6, Jiyao Wang3, Ramazan Idilman7, Annikki de Niet8, Mircea. Diculescu9, Anneke J. van Vuuren1, Elke Verhey1, Bettina E. Hansen1, 10, Harry L. Janssen1 | Institutional Author(s): | INSTITUTIONS (ALL): 1. Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.
2. Infectious Diseases, Ruijin Hospital, Jiaotong University, Shanghai, China.
3. Gastroenterology and Hepatology, Zhong Shan Hospital, Fu Dan University, Shanghai, China.
4. Gastroenterology and Hepatology, Shanghai Public Health Center, Fu Dan University, Shanghai, China.
5. Infectious Diseases, Cerrahpasa Medical School, Istanbul, Turkey.
6. National Institute of Infectious Disease, Bucharest, Romania.
7. Gastroenterology and Hepatology, University of Ankara, Ankara, Turkey.
8. Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, Netherlands.
9. Gastroenterology, Fundeni Cinical Institute, Bucharest, Romania.
10. Public Health, Erasmus MC University Medical Center Rotterdam, Rotterdam, Netherlands.
| ABSTRACT BODY: Background. Entecavir (ETV) is a potent inhibitor of viral replication in HBeAg-positive chronic hepatitis B (CHB) patients, but serological response is infrequently achieved and indefinite therapy should therefore be anticipated in the majority of patients. Addition of peginterferon (PEG-IFN) to ETV may increase serological response rates.
Methods. In this investigator-initiated randomized controlled trial 184 HBeAg-positive patients with compensated liver disease were enrolled at 15 sites in Europe and China and allocated to either ETV 0.5mg daily alone for 48 weeks or a 24 week addition of PEG-IFN alfa-2a 180 ug weekly after 24 weeks of ETV monotherapy. Response (HBeAg loss with HBV DNA <200 IU/mL) was assessed at week 48, and responders were allowed to discontinue treatment after 24 weeks consolidation treatment (week 72), with subsequent off-treatment follow-up until week 96. Results at week 48 are presented here.
Results. 177 patients received at least one dose of allocated treatment, 93 ETV alone and 84 ETV with PEG-IFN add-on. Sixty-one percent of patients were of Asian ethnicity and all major HBV genotypes were present (A/B/C/D in 7/19/42/32%). A total of 160 patients had reached week 48 by June 2012, and the remaining patients will do so within 2 months. Patients were comparable with regard to important baseline characteristics, except for HBsAg which was higher in patients receiving combination therapy (4.28 versus 4.03 log IU/mL, p=0.05). Response, as well as HBeAg loss alone, was achieved in 18% of patients who received PEG-IFN add-on, compared to 8% of patients treated with ETV alone (p=0.07). PEG-IFN add-on resulted in more decline of HBV DNA (6.33 versus 5.91 log IU/mL, p=0.05), HBeAg (1.99 versus 1.56 log IU/mL, p=0.01) and HBsAg (0.84 versus 0.32 log IU/mL, p<0.001) at week 48. Only one patient (who received PEG-IFN add-on) had clearance of HBsAg at week 48. After adjustment for the differences in baseline HBsAg levels, addition of PEG-IFN was independently associated with response at week 48 (adjusted odds ratio: 3.63, 95% CI: 1.24 – 10.7, p=0.01). Add-on PEG-IFN was well-tolerated and no relevant safety concerns were raised.
Conclusion. A 24 week add-on of PEG-IFN treatment increases HBsAg decline and clearance of HBeAg and may therefore improve the chances of finite treatment in HBeAg-positive CHB patients treated with ETV.
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Co-Author Disclosure Status | The following authors have completed their AASLD 2012 disclosure: | Milan Sonneveld: Disclosure completed | Qing Xie: Disclosure completed | Ning-Ping Zhang: Disclosure completed | Qin Zhang: Disclosure completed | Fehmi Tabak: Disclosure completed | Adrian Streinu-cercel: Disclosure completed | Jiyao Wang: Disclosure completed | Ramazan Idilman: Disclosure completed | Annikki de Niet: Disclosure completed | Mircea. Diculescu: Disclosure completed | Anneke van Vuuren: Disclosure completed | Elke Verhey: Disclosure completed | Bettina Hansen: Disclosure completed | Harry Janssen: Disclosure completed |
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