Cargando…

A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients

PURPOSE: Clevudine 30 mg showed potent antiviral activity with a marked post-treatment antiviral effect. However, long-term treatment with clevudine monotherapy induced resistance and myopathy in some cases. The objective of this study is to evaluate the preliminary efficacy and safety of the combin...

Descripción completa

Detalles Bibliográficos
Autores principales: Tak, Won Young, Yang, Jin Mo, Kim, Byung Ik, Baik, Soon Koo, Cheon, Gab Jin, Byun, Kwan Soo, Kim, Do Young, Yoo, Byung Chul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer India 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4116600/
https://www.ncbi.nlm.nih.gov/pubmed/25101150
http://dx.doi.org/10.1007/s12072-014-9537-5
_version_ 1782328617500409856
author Tak, Won Young
Yang, Jin Mo
Kim, Byung Ik
Baik, Soon Koo
Cheon, Gab Jin
Byun, Kwan Soo
Kim, Do Young
Yoo, Byung Chul
author_facet Tak, Won Young
Yang, Jin Mo
Kim, Byung Ik
Baik, Soon Koo
Cheon, Gab Jin
Byun, Kwan Soo
Kim, Do Young
Yoo, Byung Chul
author_sort Tak, Won Young
collection PubMed
description PURPOSE: Clevudine 30 mg showed potent antiviral activity with a marked post-treatment antiviral effect. However, long-term treatment with clevudine monotherapy induced resistance and myopathy in some cases. The objective of this study is to evaluate the preliminary efficacy and safety of the combination of clevudine 20 mg and adefovir compared to clevudine monotherapy. METHODS: Seventy-four patients were randomized to either a combination of clevudine 20 mg and adefovir or clevudine 20 or 30 mg and were treated for 2 years. The viral kinetics for 24 weeks, virological response [VR; hepatitis B virus (HBV) DNA less than 300 copies/ml], and the biochemical response [BR; normal alanine aminotransferase (ALT)] were assessed. RESULTS: There was no difference in baseline characteristics among the three groups. Viral kinetics study showed no statistically significant difference among them during 24 weeks. The combination group showed 95 % virological response with a statistically significant difference compared to the clevudine 30 mg (67 %) and 20 mg (71 %) groups (p = 0.0376). Biochemical response rates were similar in all groups (78–94 %). No resistance was reported in the combination group, while 20 % of patients treated with clevudine 30 mg or 20 mg reported resistance during 2 years. Muscle-related symptoms such as myalgia (1 in clevudine 30 mg, 1 in the combination group) and muscle weakness (1 in clevudine 30 mg, 2 in clevudine 20 mg) were reported in five patients (7 %); of these, three patients discontinued the study. CONCLUSION: We concluded that the combination of clevudine 20 mg and adefovir produced a potent antiviral response together with a good resistance profile compared to clevudine monotherapy at 96 weeks in this pilot study.
format Online
Article
Text
id pubmed-4116600
institution National Center for Biotechnology Information
language English
publishDate 2014
publisher Springer India
record_format MEDLINE/PubMed
spelling pubmed-41166002014-08-04 A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients Tak, Won Young Yang, Jin Mo Kim, Byung Ik Baik, Soon Koo Cheon, Gab Jin Byun, Kwan Soo Kim, Do Young Yoo, Byung Chul Hepatol Int Original Article PURPOSE: Clevudine 30 mg showed potent antiviral activity with a marked post-treatment antiviral effect. However, long-term treatment with clevudine monotherapy induced resistance and myopathy in some cases. The objective of this study is to evaluate the preliminary efficacy and safety of the combination of clevudine 20 mg and adefovir compared to clevudine monotherapy. METHODS: Seventy-four patients were randomized to either a combination of clevudine 20 mg and adefovir or clevudine 20 or 30 mg and were treated for 2 years. The viral kinetics for 24 weeks, virological response [VR; hepatitis B virus (HBV) DNA less than 300 copies/ml], and the biochemical response [BR; normal alanine aminotransferase (ALT)] were assessed. RESULTS: There was no difference in baseline characteristics among the three groups. Viral kinetics study showed no statistically significant difference among them during 24 weeks. The combination group showed 95 % virological response with a statistically significant difference compared to the clevudine 30 mg (67 %) and 20 mg (71 %) groups (p = 0.0376). Biochemical response rates were similar in all groups (78–94 %). No resistance was reported in the combination group, while 20 % of patients treated with clevudine 30 mg or 20 mg reported resistance during 2 years. Muscle-related symptoms such as myalgia (1 in clevudine 30 mg, 1 in the combination group) and muscle weakness (1 in clevudine 30 mg, 2 in clevudine 20 mg) were reported in five patients (7 %); of these, three patients discontinued the study. CONCLUSION: We concluded that the combination of clevudine 20 mg and adefovir produced a potent antiviral response together with a good resistance profile compared to clevudine monotherapy at 96 weeks in this pilot study. Springer India 2014-05-25 /pmc/articles/PMC4116600/ /pubmed/25101150 http://dx.doi.org/10.1007/s12072-014-9537-5 Text en © The Author(s) 2014 https://creativecommons.org/licenses/by/4.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Article
Tak, Won Young
Yang, Jin Mo
Kim, Byung Ik
Baik, Soon Koo
Cheon, Gab Jin
Byun, Kwan Soo
Kim, Do Young
Yoo, Byung Chul
A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients
title A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients
title_full A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients
title_fullStr A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients
title_full_unstemmed A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients
title_short A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients
title_sort randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis b patients
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4116600/
https://www.ncbi.nlm.nih.gov/pubmed/25101150
http://dx.doi.org/10.1007/s12072-014-9537-5
work_keys_str_mv AT takwonyoung arandomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT yangjinmo arandomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT kimbyungik arandomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT baiksoonkoo arandomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT cheongabjin arandomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT byunkwansoo arandomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT kimdoyoung arandomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT yoobyungchul arandomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT takwonyoung randomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT yangjinmo randomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT kimbyungik randomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT baiksoonkoo randomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT cheongabjin randomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT byunkwansoo randomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT kimdoyoung randomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients
AT yoobyungchul randomizedopenlabelstudycomparinglowdoseclevudineplusadefovircombinationtherapywithclevudinemonotherapyinnaivechronichepatitisbpatients