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Article: A dose-finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infection

TitleA dose-finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infection
Authors
Issue Date2004
PublisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/
Citation
Hepatology, 2004, v. 40 n. 3, p. 719-726 How to Cite?
AbstractCurrent therapy for chronic hepatitis B is suboptimal as a result of limited durable response rates, cumulative viral resistance, and/or poor tolerability. Telbivudine has potent antiviral activity against hepatitis B virus (HBV) in vitro and in the woodchuck model and has a promising preclinical safety profile. In this first clinical study of telbivudine, safety, antiviral activity, and pharmacokinetics were assessed in 43 adults with hepatitis B e antigen-positive chronic hepatitis B. This placebo-controlled dose-escalation trial investigated 6 telbivudine daily dosing levels (25, 50, 100, 200, 400, and 800 mg/d); treatment was given for 4 weeks, with 12 weeks' follow-up. Serum HBV DNA levels were monitored via quantitative polymerase chain reaction. The results indicate that telbivudine was well tolerated at all dosing levels, with no dose-related or treatment-related clinical or laboratory adverse events. telbivudine plasma pharmacokinetics were dose-proportional within the studied dose range. Marked dose-related antiviral activity was evident, with a maximum at telbivudine doses of 400 mg/d or more. In the 800mg/d cohort, the mean HBV DNA reduction was 3.75 log 10 copies/mL at week 4, comprising a 99.98% reduction in serum viral load. Correspondingly, posttreatment return of viral load was slowest in the high-dose groups. Viral dynamic analyses suggested a high degree of efficiency of inhibition of HBV replication by telbivudine and helped refine selection of the optimal dose. In conclusion, these results support expanded clinical studies of this new agent for the treatment of hepatitis B.
Persistent Identifierhttp://hdl.handle.net/10722/77810
ISSN
2015 Impact Factor: 11.711
2015 SCImago Journal Rankings: 4.752
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLai, CLen_HK
dc.contributor.authorLim, SGen_HK
dc.contributor.authorBrown, NAen_HK
dc.contributor.authorZhou, XJen_HK
dc.contributor.authorLloyd, DMen_HK
dc.contributor.authorLee, YMen_HK
dc.contributor.authorYuen, MFen_HK
dc.contributor.authorChao, GCen_HK
dc.contributor.authorMyers, MWen_HK
dc.date.accessioned2010-09-06T07:35:59Z-
dc.date.available2010-09-06T07:35:59Z-
dc.date.issued2004en_HK
dc.identifier.citationHepatology, 2004, v. 40 n. 3, p. 719-726en_HK
dc.identifier.issn0270-9139en_HK
dc.identifier.urihttp://hdl.handle.net/10722/77810-
dc.description.abstractCurrent therapy for chronic hepatitis B is suboptimal as a result of limited durable response rates, cumulative viral resistance, and/or poor tolerability. Telbivudine has potent antiviral activity against hepatitis B virus (HBV) in vitro and in the woodchuck model and has a promising preclinical safety profile. In this first clinical study of telbivudine, safety, antiviral activity, and pharmacokinetics were assessed in 43 adults with hepatitis B e antigen-positive chronic hepatitis B. This placebo-controlled dose-escalation trial investigated 6 telbivudine daily dosing levels (25, 50, 100, 200, 400, and 800 mg/d); treatment was given for 4 weeks, with 12 weeks' follow-up. Serum HBV DNA levels were monitored via quantitative polymerase chain reaction. The results indicate that telbivudine was well tolerated at all dosing levels, with no dose-related or treatment-related clinical or laboratory adverse events. telbivudine plasma pharmacokinetics were dose-proportional within the studied dose range. Marked dose-related antiviral activity was evident, with a maximum at telbivudine doses of 400 mg/d or more. In the 800mg/d cohort, the mean HBV DNA reduction was 3.75 log 10 copies/mL at week 4, comprising a 99.98% reduction in serum viral load. Correspondingly, posttreatment return of viral load was slowest in the high-dose groups. Viral dynamic analyses suggested a high degree of efficiency of inhibition of HBV replication by telbivudine and helped refine selection of the optimal dose. In conclusion, these results support expanded clinical studies of this new agent for the treatment of hepatitis B.en_HK
dc.languageengen_HK
dc.publisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/en_HK
dc.relation.ispartofHepatologyen_HK
dc.rightsHepatology. Copyright © John Wiley & Sons, Inc.en_HK
dc.titleA dose-finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infectionen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0270-9139&volume=40&spage=719&epage=726&date=2004&atitle=A+Dose-finding+Study+of+Once-daily+Oral+Telbivudine+in+HBeAg-positive+Patients+with+Chronic+Hepatitis+B+Virus+Infectionen_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.emailYuen, MF:mfyuen@hkucc.hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.identifier.authorityYuen, MF=rp00479en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1002/hep.20374en_HK
dc.identifier.pmid15349912-
dc.identifier.scopuseid_2-s2.0-4544271613en_HK
dc.identifier.hkuros97686en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-4544271613&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume40en_HK
dc.identifier.issue3en_HK
dc.identifier.spage719en_HK
dc.identifier.epage726en_HK
dc.identifier.isiWOS:000223684500029-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridLim, SG=7404081127en_HK
dc.identifier.scopusauthoridBrown, NA=7403548663en_HK
dc.identifier.scopusauthoridZhou, XJ=35291162500en_HK
dc.identifier.scopusauthoridLloyd, DM=7402321593en_HK
dc.identifier.scopusauthoridLee, YM=8525696700en_HK
dc.identifier.scopusauthoridYuen, MF=7102031955en_HK
dc.identifier.scopusauthoridChao, GC=36643443300en_HK
dc.identifier.scopusauthoridMyers, MW=7402143002en_HK

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