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Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B
Summary This single‐arm, open‐label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide‐naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(−)...
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| Published in: | Journal of viral hepatitis 2014-01, Vol.21 (1), p.74-76 |
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| Main Authors: | , , , , , , , |
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| Language: | English |
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| container_end_page | 76 |
| container_issue | 1 |
| container_start_page | 74 |
| container_title | Journal of viral hepatitis |
| container_volume | 21 |
| creator | Jeffers, L. Van Rensburg, C. J. Banks, A. Schechter, M. Schmidt, S. J. Hu, W. Llamoso, C. Parana, R. |
| description | Summary
This single‐arm, open‐label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide‐naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(−) compensated CHB of self‐described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA 50 IU/mL at Week 48 or last on‐treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies. |
| doi_str_mv | 10.1111/jvh.12144 |
| format | article |
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This single‐arm, open‐label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide‐naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(−) compensated CHB of self‐described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA <50 IU/mL. Rates for HBeAg loss (11/22; 50%) and HBeAg seroconversion (9/22; 41%) were high, possibly due to the high HBV genotype A prevalence (70%). No patient experienced virological breakthrough. Samples for resistance testing were available in 6/8 patients with HBV DNA >50 IU/mL at Week 48 or last on‐treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/jvh.12144</identifier><identifier>PMID: 24112755</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adult ; African Americans ; Antiviral Agents - administration & dosage ; Antiviral Agents - adverse effects ; Antiviral Agents - pharmacology ; antiviral therapy ; DNA, Viral - blood ; Female ; Guanine - administration & dosage ; Guanine - adverse effects ; Guanine - analogs & derivatives ; Guanine - pharmacology ; hepatitis B e antigen ; Hepatitis B e Antigens - blood ; Hepatitis B virus ; Hepatitis B virus - drug effects ; Hepatitis B virus - isolation & purification ; hepatitis B virus DNA ; Hepatitis B, Chronic - drug therapy ; Humans ; Male ; Microbial Sensitivity Tests ; nucleos(t)ide analogue ; Treatment Outcome ; Viral Load</subject><ispartof>Journal of viral hepatitis, 2014-01, Vol.21 (1), p.74-76</ispartof><rights>2013 John Wiley & Sons Ltd</rights><rights>2013 John Wiley & Sons Ltd.</rights><rights>Copyright © 2014 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24112755$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jeffers, L.</creatorcontrib><creatorcontrib>Van Rensburg, C. J.</creatorcontrib><creatorcontrib>Banks, A.</creatorcontrib><creatorcontrib>Schechter, M.</creatorcontrib><creatorcontrib>Schmidt, S. J.</creatorcontrib><creatorcontrib>Hu, W.</creatorcontrib><creatorcontrib>Llamoso, C.</creatorcontrib><creatorcontrib>Parana, R.</creatorcontrib><title>Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B</title><title>Journal of viral hepatitis</title><addtitle>J Viral Hepat</addtitle><description>Summary
This single‐arm, open‐label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide‐naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(−) compensated CHB of self‐described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA <50 IU/mL. Rates for HBeAg loss (11/22; 50%) and HBeAg seroconversion (9/22; 41%) were high, possibly due to the high HBV genotype A prevalence (70%). No patient experienced virological breakthrough. Samples for resistance testing were available in 6/8 patients with HBV DNA >50 IU/mL at Week 48 or last on‐treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies.</description><subject>Adult</subject><subject>African Americans</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - pharmacology</subject><subject>antiviral therapy</subject><subject>DNA, Viral - blood</subject><subject>Female</subject><subject>Guanine - administration & dosage</subject><subject>Guanine - adverse effects</subject><subject>Guanine - analogs & derivatives</subject><subject>Guanine - pharmacology</subject><subject>hepatitis B e antigen</subject><subject>Hepatitis B e Antigens - blood</subject><subject>Hepatitis B virus</subject><subject>Hepatitis B virus - drug effects</subject><subject>Hepatitis B virus - isolation & purification</subject><subject>hepatitis B virus DNA</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Microbial Sensitivity Tests</subject><subject>nucleos(t)ide analogue</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNqNkc1uEzEQxy0Eoh9w4AWQJS7lsI0_17vHpNAWWoEKERwtrzNWnG68wd5NyVPxELwY3qb0wAlfPPL8_jPj-SP0ipJTms9ktV2eUkaFeIIOKS9lwaqaPx1jyQoiiThARymtCKGcSfocHTBBKVNSHqI4Db3f-mhaDM55a-wOdw5D6MGa_I59wGGwLXTppH_rF1AE8_vXFvDG9D5TaaRnrbG3k6mLWR_wApLNGXzn-yW2y9gFb_ESRkHvE569QM-caRO8fLiP0fz8_fzssrj-fPHhbHpdeJ5HLpQBJo0gpK4USEkbx0TDoLJOVlY1jCwIlK6xtWVcMCco41Bl0NVgFCh-jE72ZTex-zFA6vXa58Ha1gTohqSpqFlJBKflf6AqL6vmSmb0zT_oqhtiyP_IVFlWlSDl2Pv1AzU0a1joTfRrE3f6794zMNkDd76F3WOeEj0aqrOh-t5Q_fHb5X2QFcVe4VMPPx8VJt7q3FBJ_f3Thb66mn1992V-o2_4HwU8ods</recordid><startdate>201401</startdate><enddate>201401</enddate><creator>Jeffers, L.</creator><creator>Van Rensburg, C. J.</creator><creator>Banks, A.</creator><creator>Schechter, M.</creator><creator>Schmidt, S. J.</creator><creator>Hu, W.</creator><creator>Llamoso, C.</creator><creator>Parana, R.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>7T7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope></search><sort><creationdate>201401</creationdate><title>Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B</title><author>Jeffers, L. ; Van Rensburg, C. J. ; Banks, A. ; Schechter, M. ; Schmidt, S. J. ; Hu, W. ; Llamoso, C. ; Parana, R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-i3504-7ae25a400987e551bf24b2e8cf58c7b20d0e6fbc9c2342f4123e8e55f9ea7e73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>African Americans</topic><topic>Antiviral Agents - administration & dosage</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - pharmacology</topic><topic>antiviral therapy</topic><topic>DNA, Viral - blood</topic><topic>Female</topic><topic>Guanine - administration & dosage</topic><topic>Guanine - adverse effects</topic><topic>Guanine - analogs & derivatives</topic><topic>Guanine - pharmacology</topic><topic>hepatitis B e antigen</topic><topic>Hepatitis B e Antigens - blood</topic><topic>Hepatitis B virus</topic><topic>Hepatitis B virus - drug effects</topic><topic>Hepatitis B virus - isolation & purification</topic><topic>hepatitis B virus DNA</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>Humans</topic><topic>Male</topic><topic>Microbial Sensitivity Tests</topic><topic>nucleos(t)ide analogue</topic><topic>Treatment Outcome</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jeffers, L.</creatorcontrib><creatorcontrib>Van Rensburg, C. J.</creatorcontrib><creatorcontrib>Banks, A.</creatorcontrib><creatorcontrib>Schechter, M.</creatorcontrib><creatorcontrib>Schmidt, S. J.</creatorcontrib><creatorcontrib>Hu, W.</creatorcontrib><creatorcontrib>Llamoso, C.</creatorcontrib><creatorcontrib>Parana, R.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Journal of viral hepatitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jeffers, L.</au><au>Van Rensburg, C. J.</au><au>Banks, A.</au><au>Schechter, M.</au><au>Schmidt, S. J.</au><au>Hu, W.</au><au>Llamoso, C.</au><au>Parana, R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B</atitle><jtitle>Journal of viral hepatitis</jtitle><addtitle>J Viral Hepat</addtitle><date>2014-01</date><risdate>2014</risdate><volume>21</volume><issue>1</issue><spage>74</spage><epage>76</epage><pages>74-76</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>Summary
This single‐arm, open‐label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide‐naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(−) compensated CHB of self‐described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA <50 IU/mL. Rates for HBeAg loss (11/22; 50%) and HBeAg seroconversion (9/22; 41%) were high, possibly due to the high HBV genotype A prevalence (70%). No patient experienced virological breakthrough. Samples for resistance testing were available in 6/8 patients with HBV DNA >50 IU/mL at Week 48 or last on‐treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>24112755</pmid><doi>10.1111/jvh.12144</doi><tpages>3</tpages></addata></record> |
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| subjects | Adult African Americans Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Antiviral Agents - pharmacology antiviral therapy DNA, Viral - blood Female Guanine - administration & dosage Guanine - adverse effects Guanine - analogs & derivatives Guanine - pharmacology hepatitis B e antigen Hepatitis B e Antigens - blood Hepatitis B virus Hepatitis B virus - drug effects Hepatitis B virus - isolation & purification hepatitis B virus DNA Hepatitis B, Chronic - drug therapy Humans Male Microbial Sensitivity Tests nucleos(t)ide analogue Treatment Outcome Viral Load |
| title | Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B |
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