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Conference Paper: Long-Term Histologic Improvement with Entecavir (ETV) Therapy in Patients with Chronic Hepatitis B (CHB) from Japanese and Worldwide Development Programs

TitleLong-Term Histologic Improvement with Entecavir (ETV) Therapy in Patients with Chronic Hepatitis B (CHB) from Japanese and Worldwide Development Programs
Authors
Issue Date2009
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
Citation
Gastroenterology, 2009, v. 136 n. 5 Suppl 1, p. A798-A799 Abstract no.320 How to Cite?
AbstractBackground: ETV 0.5mg improved liver histology in global and Japanese studies in nucleoside-naïve patients with CHB. We present long-term histological results from 2 cohorts of patients who participated in Japanese and global clinical trials. Methods: In Phase II Japanese studies, the long-term histology cohort consisted of nucleoside-naïve patients from study ETV-053 and LVD-refractory patients from study ETV-052, who subsequently entered rollover study ETV-060 and received ETV 0.5mg (nucleoside-naïve) or 1mg (LVD-refractory), had ≧3 years of ETV therapy, and evaluable biopsies at baseline, Weeks 48 and 148. In the global studies, the long-term histology cohort consisted of nucleoside-naïve patients treated with ETV 0.5mg (studies -022, -027), subsequently received ETV 1mg in rollover study ETV-901, had a median of 6 years of therapy (phase III baseline to -901 biopsy), and evaluable baseline and long-term liver biopsies. We evaluated histological improvement [≧2-point decrease in Knodell necroinflammatory (KNI) score, with no worsening of fibrosis and improvement in fibrosis (≥1-point decrease). Results: In the Japanese studies, 37 naïve and 27 LVD-refractory patients had biopsies from three time points. At Week 148: 100% of naïve and 89% of LVD-refractory patients had histological improvement; 47% of naïve and 32% of LVD-refractory patients had improvement in Knodell fibrosis score. Ninety-five percent of naïve and 56% of LVD-refractory patients had HBV DNA <400 copies/mL; 95% of naïve and 93% of LVD-refractory patients normalized ALT. In the global studies, 57 patients had evaluable long term biopsies (median: 6 years; range: 3−7 years). Results for these patients are shown in the table below. Conclusions: Japanese study results demonstrated significant virological suppression and histological improvement in both naïve and LVDrefractory CHB patients treated with ETV for 3 years. A median of 6 years of ETV therapy in the global studies resulted in potent and durable virological suppression and regression of fibrosis/cirrhosis in naïve patients.
Persistent Identifierhttp://hdl.handle.net/10722/224428
ISSN
2015 Impact Factor: 18.187
2015 SCImago Journal Rankings: 7.170

 

DC FieldValueLanguage
dc.contributor.authorLiaw, YF-
dc.contributor.authorChang, TT-
dc.contributor.authorWu, SS-
dc.contributor.authorSchiff, ER-
dc.contributor.authorKan, KH-
dc.contributor.authorLai, CL-
dc.contributor.authorSafadi, R-
dc.contributor.authorLee, SS-
dc.contributor.authorHalota, W-
dc.contributor.authorGoodman, ZD-
dc.contributor.authorZhang, H-
dc.contributor.authorIloeje, UH-
dc.contributor.authorBeebe, S-
dc.contributor.authorKreter, B-
dc.contributor.authorIshikawa, H-
dc.contributor.authorKatano, Y-
dc.contributor.authorTakaguchi, K-
dc.contributor.authorOmata, M-
dc.date.accessioned2016-04-05T03:55:18Z-
dc.date.available2016-04-05T03:55:18Z-
dc.date.issued2009-
dc.identifier.citationGastroenterology, 2009, v. 136 n. 5 Suppl 1, p. A798-A799 Abstract no.320-
dc.identifier.issn0016-5085-
dc.identifier.urihttp://hdl.handle.net/10722/224428-
dc.description.abstractBackground: ETV 0.5mg improved liver histology in global and Japanese studies in nucleoside-naïve patients with CHB. We present long-term histological results from 2 cohorts of patients who participated in Japanese and global clinical trials. Methods: In Phase II Japanese studies, the long-term histology cohort consisted of nucleoside-naïve patients from study ETV-053 and LVD-refractory patients from study ETV-052, who subsequently entered rollover study ETV-060 and received ETV 0.5mg (nucleoside-naïve) or 1mg (LVD-refractory), had ≧3 years of ETV therapy, and evaluable biopsies at baseline, Weeks 48 and 148. In the global studies, the long-term histology cohort consisted of nucleoside-naïve patients treated with ETV 0.5mg (studies -022, -027), subsequently received ETV 1mg in rollover study ETV-901, had a median of 6 years of therapy (phase III baseline to -901 biopsy), and evaluable baseline and long-term liver biopsies. We evaluated histological improvement [≧2-point decrease in Knodell necroinflammatory (KNI) score, with no worsening of fibrosis and improvement in fibrosis (≥1-point decrease). Results: In the Japanese studies, 37 naïve and 27 LVD-refractory patients had biopsies from three time points. At Week 148: 100% of naïve and 89% of LVD-refractory patients had histological improvement; 47% of naïve and 32% of LVD-refractory patients had improvement in Knodell fibrosis score. Ninety-five percent of naïve and 56% of LVD-refractory patients had HBV DNA <400 copies/mL; 95% of naïve and 93% of LVD-refractory patients normalized ALT. In the global studies, 57 patients had evaluable long term biopsies (median: 6 years; range: 3−7 years). Results for these patients are shown in the table below. Conclusions: Japanese study results demonstrated significant virological suppression and histological improvement in both naïve and LVDrefractory CHB patients treated with ETV for 3 years. A median of 6 years of ETV therapy in the global studies resulted in potent and durable virological suppression and regression of fibrosis/cirrhosis in naïve patients.-
dc.languageeng-
dc.publisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro-
dc.relation.ispartofGastroenterology-
dc.rightsPosting accepted manuscript (postprint): © <year>. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/-
dc.titleLong-Term Histologic Improvement with Entecavir (ETV) Therapy in Patients with Chronic Hepatitis B (CHB) from Japanese and Worldwide Development Programs-
dc.typeConference_Paper-
dc.identifier.emailLai, CL: hrmelcl@hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.identifier.hkuros181162-
dc.identifier.volume136-
dc.identifier.issue5 Suppl 1-
dc.identifier.spageA798-
dc.identifier.epageA799 Abstract no.320-
dc.publisher.placeUnited States-

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