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A randomized, placebo‐controlled study of the NS 5B inhibitor beclabuvir with peginterferon/ribavirin for HCV genotype 1
Beclabuvir is a potent, non‐nucleoside inhibitor of the HCV NS 5B RNA polymerase, with nanomolar activity against HCV genotypes 1, 3, 4, 5 and 6 in vitro . This study evaluated the efficacy and safety of beclabuvir, in combination with peginterferon alfa‐2a (peg IFN ) and ribavirin ( RBV ), in HCV g...
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| Published in: | Journal of viral hepatitis 2015-08, Vol.22 (8), p.658-664 |
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| Main Authors: | , , , , , , , , , , , , , , |
| Format: | Article |
| Language: | English |
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| cited_by | cdi_FETCH-LOGICAL-c742-85ea3e60045ef514bea206614f65951e900b3268f0269eebd470c083d063a45e3 |
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| cites | cdi_FETCH-LOGICAL-c742-85ea3e60045ef514bea206614f65951e900b3268f0269eebd470c083d063a45e3 |
| container_end_page | 664 |
| container_issue | 8 |
| container_start_page | 658 |
| container_title | Journal of viral hepatitis |
| container_volume | 22 |
| creator | Tatum, H. Thuluvath, P. J. Lawitz, E. Martorell, C. DeMicco, M. Cohen, S. Rustgi, V. Ravendhran, N. Ghalib, R. Hanson, J. Zamparo, J. Zhao, J. Cooney, E. Treitel, M. Hughes, E. |
| description | Beclabuvir is a potent, non‐nucleoside inhibitor of the
HCV NS
5B
RNA
polymerase, with nanomolar activity against
HCV
genotypes 1, 3, 4, 5 and 6
in vitro
. This study evaluated the efficacy and safety of beclabuvir, in combination with peginterferon alfa‐2a (peg
IFN
) and ribavirin (
RBV
), in
HCV
genotype 1. In this randomized (1:1:1), double‐blinded, placebo‐controlled, dose‐ranging phase 2a study, 39 treatment‐naive patients chronically infected with
HCV
genotype 1 were treated for 48 weeks with beclabuvir (75 mg or 150 mg) plus peg
IFN
(180 μg) and
RBV
(1000 mg/day [ |
| doi_str_mv | 10.1111/jvh.12372 |
| format | article |
| fullrecord | <record><control><sourceid>crossref</sourceid><recordid>TN_cdi_crossref_primary_10_1111_jvh_12372</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>10_1111_jvh_12372</sourcerecordid><originalsourceid>FETCH-LOGICAL-c742-85ea3e60045ef514bea206614f65951e900b3268f0269eebd470c083d063a45e3</originalsourceid><addsrcrecordid>eNotkMFOwzAQRC0EEqVw4A98RSLt2o7d5FgqSpEqOFBxjexk3bhK48hJi9oTn8A38iWkwFxmpJndwyPklsGI9Rpv9uWIcTHhZ2TAhJIRT1JxfsqSRyAhviRXbbsBYIJLNiDHKQ26LvzWHbG4p02lczT--_Mr93UXfFVhQdtuVxyot7Qrkb68UflAXV064zofqMG80ma3d4F-uK6kDa5d3WGwGHw9Ds7ovnI1tf12MXuna6x9d2iQsmtyYXXV4s2_D8lq_riaLaLl69PzbLqM8knMo0SiFqgAYolWstig5qAUi62SqWSYAhjBVWKBqxTRFPEEckhEAUro_kYMyd3f2zz4tg1osya4rQ6HjEF2Ypb1zLJfZuIHO-RgyA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>A randomized, placebo‐controlled study of the NS 5B inhibitor beclabuvir with peginterferon/ribavirin for HCV genotype 1</title><source>Wiley-Blackwell Read & Publish Collection</source><creator>Tatum, H. ; Thuluvath, P. J. ; Lawitz, E. ; Martorell, C. ; DeMicco, M. ; Cohen, S. ; Rustgi, V. ; Ravendhran, N. ; Ghalib, R. ; Hanson, J. ; Zamparo, J. ; Zhao, J. ; Cooney, E. ; Treitel, M. ; Hughes, E.</creator><creatorcontrib>Tatum, H. ; Thuluvath, P. J. ; Lawitz, E. ; Martorell, C. ; DeMicco, M. ; Cohen, S. ; Rustgi, V. ; Ravendhran, N. ; Ghalib, R. ; Hanson, J. ; Zamparo, J. ; Zhao, J. ; Cooney, E. ; Treitel, M. ; Hughes, E.</creatorcontrib><description>Beclabuvir is a potent, non‐nucleoside inhibitor of the
HCV NS
5B
RNA
polymerase, with nanomolar activity against
HCV
genotypes 1, 3, 4, 5 and 6
in vitro
. This study evaluated the efficacy and safety of beclabuvir, in combination with peginterferon alfa‐2a (peg
IFN
) and ribavirin (
RBV
), in
HCV
genotype 1. In this randomized (1:1:1), double‐blinded, placebo‐controlled, dose‐ranging phase 2a study, 39 treatment‐naive patients chronically infected with
HCV
genotype 1 were treated for 48 weeks with beclabuvir (75 mg or 150 mg) plus peg
IFN
(180 μg) and
RBV
(1000 mg/day [<75 kg] or 1200 mg/day [≥75 kg])
vs
peg
IFN
/
RBV
alone. The primary efficacy endpoint of extended rapid virologic response (undetectable
HCV RNA
at treatment weeks 4 and 12) was achieved by 76.9% (10/13) of patients receiving beclabuvir 75 mg and 38.5% (5/13) receiving beclabuvir 150 mg
vs
0% receiving peg
IFN
/
RBV
alone. Higher response rates were observed among patients receiving beclabuvir 75 mg for all secondary efficacy endpoints, including sustained virologic response at follow‐up weeks 12 or 24. Three patients experienced virologic breakthrough on treatment, all in the beclabuvir 150‐mg treatment group. Beclabuvir was well tolerated at both doses, with the most commonly observed adverse events (headache, fatigue, nausea, decreased appetite, irritability, depression and insomnia) consistent with those observed with peg
IFN
/
RBV
. In conclusion, beclabuvir was both effective and well tolerated when administered in combination with peg
IFN
/
RBV
for the treatment of chronic
HCV GT
1, supporting the study of beclabuvir as part of an all‐oral regimen for
HCV GT
1.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/jvh.12372</identifier><language>eng</language><ispartof>Journal of viral hepatitis, 2015-08, Vol.22 (8), p.658-664</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c742-85ea3e60045ef514bea206614f65951e900b3268f0269eebd470c083d063a45e3</citedby><cites>FETCH-LOGICAL-c742-85ea3e60045ef514bea206614f65951e900b3268f0269eebd470c083d063a45e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27898,27899</link.rule.ids></links><search><creatorcontrib>Tatum, H.</creatorcontrib><creatorcontrib>Thuluvath, P. J.</creatorcontrib><creatorcontrib>Lawitz, E.</creatorcontrib><creatorcontrib>Martorell, C.</creatorcontrib><creatorcontrib>DeMicco, M.</creatorcontrib><creatorcontrib>Cohen, S.</creatorcontrib><creatorcontrib>Rustgi, V.</creatorcontrib><creatorcontrib>Ravendhran, N.</creatorcontrib><creatorcontrib>Ghalib, R.</creatorcontrib><creatorcontrib>Hanson, J.</creatorcontrib><creatorcontrib>Zamparo, J.</creatorcontrib><creatorcontrib>Zhao, J.</creatorcontrib><creatorcontrib>Cooney, E.</creatorcontrib><creatorcontrib>Treitel, M.</creatorcontrib><creatorcontrib>Hughes, E.</creatorcontrib><title>A randomized, placebo‐controlled study of the NS 5B inhibitor beclabuvir with peginterferon/ribavirin for HCV genotype 1</title><title>Journal of viral hepatitis</title><description>Beclabuvir is a potent, non‐nucleoside inhibitor of the
HCV NS
5B
RNA
polymerase, with nanomolar activity against
HCV
genotypes 1, 3, 4, 5 and 6
in vitro
. This study evaluated the efficacy and safety of beclabuvir, in combination with peginterferon alfa‐2a (peg
IFN
) and ribavirin (
RBV
), in
HCV
genotype 1. In this randomized (1:1:1), double‐blinded, placebo‐controlled, dose‐ranging phase 2a study, 39 treatment‐naive patients chronically infected with
HCV
genotype 1 were treated for 48 weeks with beclabuvir (75 mg or 150 mg) plus peg
IFN
(180 μg) and
RBV
(1000 mg/day [<75 kg] or 1200 mg/day [≥75 kg])
vs
peg
IFN
/
RBV
alone. The primary efficacy endpoint of extended rapid virologic response (undetectable
HCV RNA
at treatment weeks 4 and 12) was achieved by 76.9% (10/13) of patients receiving beclabuvir 75 mg and 38.5% (5/13) receiving beclabuvir 150 mg
vs
0% receiving peg
IFN
/
RBV
alone. Higher response rates were observed among patients receiving beclabuvir 75 mg for all secondary efficacy endpoints, including sustained virologic response at follow‐up weeks 12 or 24. Three patients experienced virologic breakthrough on treatment, all in the beclabuvir 150‐mg treatment group. Beclabuvir was well tolerated at both doses, with the most commonly observed adverse events (headache, fatigue, nausea, decreased appetite, irritability, depression and insomnia) consistent with those observed with peg
IFN
/
RBV
. In conclusion, beclabuvir was both effective and well tolerated when administered in combination with peg
IFN
/
RBV
for the treatment of chronic
HCV GT
1, supporting the study of beclabuvir as part of an all‐oral regimen for
HCV GT
1.</description><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><recordid>eNotkMFOwzAQRC0EEqVw4A98RSLt2o7d5FgqSpEqOFBxjexk3bhK48hJi9oTn8A38iWkwFxmpJndwyPklsGI9Rpv9uWIcTHhZ2TAhJIRT1JxfsqSRyAhviRXbbsBYIJLNiDHKQ26LvzWHbG4p02lczT--_Mr93UXfFVhQdtuVxyot7Qrkb68UflAXV064zofqMG80ma3d4F-uK6kDa5d3WGwGHw9Ds7ovnI1tf12MXuna6x9d2iQsmtyYXXV4s2_D8lq_riaLaLl69PzbLqM8knMo0SiFqgAYolWstig5qAUi62SqWSYAhjBVWKBqxTRFPEEckhEAUro_kYMyd3f2zz4tg1osya4rQ6HjEF2Ypb1zLJfZuIHO-RgyA</recordid><startdate>201508</startdate><enddate>201508</enddate><creator>Tatum, H.</creator><creator>Thuluvath, P. J.</creator><creator>Lawitz, E.</creator><creator>Martorell, C.</creator><creator>DeMicco, M.</creator><creator>Cohen, S.</creator><creator>Rustgi, V.</creator><creator>Ravendhran, N.</creator><creator>Ghalib, R.</creator><creator>Hanson, J.</creator><creator>Zamparo, J.</creator><creator>Zhao, J.</creator><creator>Cooney, E.</creator><creator>Treitel, M.</creator><creator>Hughes, E.</creator><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>201508</creationdate><title>A randomized, placebo‐controlled study of the NS 5B inhibitor beclabuvir with peginterferon/ribavirin for HCV genotype 1</title><author>Tatum, H. ; Thuluvath, P. J. ; Lawitz, E. ; Martorell, C. ; DeMicco, M. ; Cohen, S. ; Rustgi, V. ; Ravendhran, N. ; Ghalib, R. ; Hanson, J. ; Zamparo, J. ; Zhao, J. ; Cooney, E. ; Treitel, M. ; Hughes, E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c742-85ea3e60045ef514bea206614f65951e900b3268f0269eebd470c083d063a45e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tatum, H.</creatorcontrib><creatorcontrib>Thuluvath, P. J.</creatorcontrib><creatorcontrib>Lawitz, E.</creatorcontrib><creatorcontrib>Martorell, C.</creatorcontrib><creatorcontrib>DeMicco, M.</creatorcontrib><creatorcontrib>Cohen, S.</creatorcontrib><creatorcontrib>Rustgi, V.</creatorcontrib><creatorcontrib>Ravendhran, N.</creatorcontrib><creatorcontrib>Ghalib, R.</creatorcontrib><creatorcontrib>Hanson, J.</creatorcontrib><creatorcontrib>Zamparo, J.</creatorcontrib><creatorcontrib>Zhao, J.</creatorcontrib><creatorcontrib>Cooney, E.</creatorcontrib><creatorcontrib>Treitel, M.</creatorcontrib><creatorcontrib>Hughes, E.</creatorcontrib><collection>CrossRef</collection><jtitle>Journal of viral hepatitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tatum, H.</au><au>Thuluvath, P. J.</au><au>Lawitz, E.</au><au>Martorell, C.</au><au>DeMicco, M.</au><au>Cohen, S.</au><au>Rustgi, V.</au><au>Ravendhran, N.</au><au>Ghalib, R.</au><au>Hanson, J.</au><au>Zamparo, J.</au><au>Zhao, J.</au><au>Cooney, E.</au><au>Treitel, M.</au><au>Hughes, E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized, placebo‐controlled study of the NS 5B inhibitor beclabuvir with peginterferon/ribavirin for HCV genotype 1</atitle><jtitle>Journal of viral hepatitis</jtitle><date>2015-08</date><risdate>2015</risdate><volume>22</volume><issue>8</issue><spage>658</spage><epage>664</epage><pages>658-664</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>Beclabuvir is a potent, non‐nucleoside inhibitor of the
HCV NS
5B
RNA
polymerase, with nanomolar activity against
HCV
genotypes 1, 3, 4, 5 and 6
in vitro
. This study evaluated the efficacy and safety of beclabuvir, in combination with peginterferon alfa‐2a (peg
IFN
) and ribavirin (
RBV
), in
HCV
genotype 1. In this randomized (1:1:1), double‐blinded, placebo‐controlled, dose‐ranging phase 2a study, 39 treatment‐naive patients chronically infected with
HCV
genotype 1 were treated for 48 weeks with beclabuvir (75 mg or 150 mg) plus peg
IFN
(180 μg) and
RBV
(1000 mg/day [<75 kg] or 1200 mg/day [≥75 kg])
vs
peg
IFN
/
RBV
alone. The primary efficacy endpoint of extended rapid virologic response (undetectable
HCV RNA
at treatment weeks 4 and 12) was achieved by 76.9% (10/13) of patients receiving beclabuvir 75 mg and 38.5% (5/13) receiving beclabuvir 150 mg
vs
0% receiving peg
IFN
/
RBV
alone. Higher response rates were observed among patients receiving beclabuvir 75 mg for all secondary efficacy endpoints, including sustained virologic response at follow‐up weeks 12 or 24. Three patients experienced virologic breakthrough on treatment, all in the beclabuvir 150‐mg treatment group. Beclabuvir was well tolerated at both doses, with the most commonly observed adverse events (headache, fatigue, nausea, decreased appetite, irritability, depression and insomnia) consistent with those observed with peg
IFN
/
RBV
. In conclusion, beclabuvir was both effective and well tolerated when administered in combination with peg
IFN
/
RBV
for the treatment of chronic
HCV GT
1, supporting the study of beclabuvir as part of an all‐oral regimen for
HCV GT
1.</abstract><doi>10.1111/jvh.12372</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1352-0504 |
| ispartof | Journal of viral hepatitis, 2015-08, Vol.22 (8), p.658-664 |
| issn | 1352-0504 1365-2893 |
| language | eng |
| recordid | cdi_crossref_primary_10_1111_jvh_12372 |
| source | Wiley-Blackwell Read & Publish Collection |
| title | A randomized, placebo‐controlled study of the NS 5B inhibitor beclabuvir with peginterferon/ribavirin for HCV genotype 1 |
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