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Conference Paper: Prolonged efficacy and safety of 3 years of continuous telbivudine treatment in pooled data from globe and 015 studies in chronic hepatitis B patients

TitleProlonged efficacy and safety of 3 years of continuous telbivudine treatment in pooled data from globe and 015 studies in chronic hepatitis B patients
Authors
Issue Date2009
PublisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jhep
Citation
The International Liver Congress TM 2009. 44 Annual Meeting of the European Association for the Study of the Liver, Copenhagen, Denmark, 22–26 April 2009. In Journal of Hepatology, 2009, v. 50 n. Suppl 1, p. S331 How to Cite?
AbstractBackground and Aims: Telbivudine demonstrated superior efficacy vs lamivudine in adults with HBeAg-positive and HBeAg-negative CHB in the GLOBE and 015 studies. Most of the patients from these studies continued on telbivudine treatment in a 2-year extension trial (2303). The pooled (GLOBE and 015) efficacy and safety results for 3 years of telbivudine treatment are presented. Methods: 530 telbivudine-treated patients without genotypic resistance at the end of the core studies were enrolled into 2303 without study drug discontinuation. Of these patients, 496 (94%) completed 3 years of therapy, 7 (1%) of patients discontinued treatment due to efficacy and 27 (5%) discontinued therapy due to other reasons. The per protocol population of 503 patients was considered for this analysis. Results: At 3 years, among 293 HBeAg-positive patients, 75% had undetectable HBV DNA (<300 copies/mL) and 83% had ALT normalization. 55% of patients obtained HBeAg loss and 39% achieved HBeAg seroconversion, while 4 (2%) patients lost HBsAg and 1 patient had HBsAg seroconversion. Higher rates of PCR negativity (87%) and seroconversion (47%) were achieved at 3 years in patients who had undetectable HBV DNA at week 24 of the core studies. The cumulative seroconversion rate for 3 years was 54% and even higher − 70% − for patients with ALT levels 2 x ULN and HBV DNA levels <9 log10 copies/mL at GLOBE study baseline. Of the 210 HBeAg-negative patients, 85% had undetectable HBV DNA and 84% had ALT normalization at 3 years. The telbivudine safety profile was similar to the 2-year results. CK elevation was reported in 10%, myalgia in 4%, muscular weakness in 0.6%, and myositis in 0.4%. Rate of peripheral neuropathy (including paresthesia, neuralgia, polyneuropathy and sensory loss) was low (1.2%). No cases of rhabdomyolysis, lactic acidosis or other new safety signals were observed with continued telbivudine treatment to 3 years. Conclusions: Over 3 years, telbivudine treatment provides effective viral suppression and ALT normalization in HBeAg-positive and HBeAgnegative CHB patients with a favorable safety profile. In HBeAg-positive patients, telbivudine treatment achieves a high cumulative seroconversion rate, especially in patients with baseline characteristics predictive of good outcome.
Persistent Identifierhttp://hdl.handle.net/10722/62412
ISSN
2014 Impact Factor: 11.336
2014 SCImago Journal Rankings: 3.477

 

DC FieldValueLanguage
dc.contributor.authorHsu, CW-
dc.contributor.authorChen, YC-
dc.contributor.authorLiaw, YF-
dc.contributor.authorGane, E-
dc.contributor.authorManns, M-
dc.contributor.authorZeuzem, S-
dc.contributor.authorWang, Y-
dc.contributor.authorLai, CL-
dc.contributor.authorHou, J-
dc.contributor.authorLeung, N-
dc.contributor.authorBzowej, N-
dc.contributor.authorNiu, J-
dc.contributor.authorJia, J-
dc.contributor.authorHwang, SG-
dc.contributor.authorCakaloglu, Y-
dc.contributor.authorRen, H-
dc.contributor.authorPapatheodoridis, G-
dc.contributor.authorChen, Y-
dc.contributor.authorBao, W-
dc.contributor.authorLopez, P-
dc.date.accessioned2010-07-13T04:00:41Z-
dc.date.available2010-07-13T04:00:41Z-
dc.date.issued2009-
dc.identifier.citationThe International Liver Congress TM 2009. 44 Annual Meeting of the European Association for the Study of the Liver, Copenhagen, Denmark, 22–26 April 2009. In Journal of Hepatology, 2009, v. 50 n. Suppl 1, p. S331-
dc.identifier.issn0168-8278-
dc.identifier.urihttp://hdl.handle.net/10722/62412-
dc.description.abstractBackground and Aims: Telbivudine demonstrated superior efficacy vs lamivudine in adults with HBeAg-positive and HBeAg-negative CHB in the GLOBE and 015 studies. Most of the patients from these studies continued on telbivudine treatment in a 2-year extension trial (2303). The pooled (GLOBE and 015) efficacy and safety results for 3 years of telbivudine treatment are presented. Methods: 530 telbivudine-treated patients without genotypic resistance at the end of the core studies were enrolled into 2303 without study drug discontinuation. Of these patients, 496 (94%) completed 3 years of therapy, 7 (1%) of patients discontinued treatment due to efficacy and 27 (5%) discontinued therapy due to other reasons. The per protocol population of 503 patients was considered for this analysis. Results: At 3 years, among 293 HBeAg-positive patients, 75% had undetectable HBV DNA (<300 copies/mL) and 83% had ALT normalization. 55% of patients obtained HBeAg loss and 39% achieved HBeAg seroconversion, while 4 (2%) patients lost HBsAg and 1 patient had HBsAg seroconversion. Higher rates of PCR negativity (87%) and seroconversion (47%) were achieved at 3 years in patients who had undetectable HBV DNA at week 24 of the core studies. The cumulative seroconversion rate for 3 years was 54% and even higher − 70% − for patients with ALT levels 2 x ULN and HBV DNA levels <9 log10 copies/mL at GLOBE study baseline. Of the 210 HBeAg-negative patients, 85% had undetectable HBV DNA and 84% had ALT normalization at 3 years. The telbivudine safety profile was similar to the 2-year results. CK elevation was reported in 10%, myalgia in 4%, muscular weakness in 0.6%, and myositis in 0.4%. Rate of peripheral neuropathy (including paresthesia, neuralgia, polyneuropathy and sensory loss) was low (1.2%). No cases of rhabdomyolysis, lactic acidosis or other new safety signals were observed with continued telbivudine treatment to 3 years. Conclusions: Over 3 years, telbivudine treatment provides effective viral suppression and ALT normalization in HBeAg-positive and HBeAgnegative CHB patients with a favorable safety profile. In HBeAg-positive patients, telbivudine treatment achieves a high cumulative seroconversion rate, especially in patients with baseline characteristics predictive of good outcome.-
dc.languageeng-
dc.publisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jhep-
dc.relation.ispartofJournal of Hepatology-
dc.rights© <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.titleProlonged efficacy and safety of 3 years of continuous telbivudine treatment in pooled data from globe and 015 studies in chronic hepatitis B patients-
dc.typeConference_Paper-
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0168-8278&volume=50&issue=Suppl 1&spage=S331&epage=&date=2009&atitle=Prolonged+efficacy+and+safety+of+3+years+of+continuous+telbivudine+treatment+in+pooled+data+from+globe+and+015+studies+in+chronic+hepatitis+B+patientsen_HK
dc.identifier.emailLai, CL: hrmelcl@hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/S0168-8278(09)60913-2-
dc.identifier.hkuros161377-
dc.identifier.volume50-
dc.identifier.issueSuppl 1-
dc.identifier.spageS331-
dc.identifier.epageS331-
dc.publisher.placeNetherlands-

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