Virologic and biochemical responses to clevudine in patients with chronic HBV infection- associated cirrhosis: data at week 48
Clevudine shows high rates of virologic and biochemical responses in patients with chronic hepatitis B. However, the efficacy and safety of clevudine in patients with cirrhosis are unknown. The aims of this study were to evaluate the safety and to assess the virologic and the biochemical responses t...
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| Veröffentlicht in: | Journal of viral hepatitis 2011-04, Vol.18 (4), p.287-293 |
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| container_title | Journal of viral hepatitis |
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| creator | Kim, J. H. Yim, H. J. Jung, E. S. Jung, Y. K. Seo, Y. S. Yeon, J. E. Lee, H. S. Um, S. H. Byun, K. S. |
| description | Clevudine shows high rates of virologic and biochemical responses in patients with chronic hepatitis B. However, the efficacy and safety of clevudine in patients with cirrhosis are unknown. The aims of this study were to evaluate the safety and to assess the virologic and the biochemical responses to clevudine in patients with cirrhosis with chronic hepatitis B virus (HBV) infection. We reviewed data from treatment‐naïve patients with chronic hepatitis B with and without cirrhosis who started clevudine between April 2007 and March 2008 (n = 52, hepatitis B without cirrhosis n = 21 and chronic hepatitis B with cirrhosis n = 31) at Korea University Ansan/Guro Hospital. All of the patients were treated for more than 48 weeks. The mean age was older in the patients with cirrhosis. Baseline HBV DNA levels were 6.9 and 7.78 log copies/mL (P = 0.042), and alanine aminotransferase (ALT) levels were 104.9 and 147.4 IU/L (P = 0.204), for those with and without cirrhosis, respectively. Virologic response (HBV DNA |
| doi_str_mv | 10.1111/j.1365-2893.2010.01304.x |
| format | Article |
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H. ; Yim, H. J. ; Jung, E. S. ; Jung, Y. K. ; Seo, Y. S. ; Yeon, J. E. ; Lee, H. S. ; Um, S. H. ; Byun, K. S.</creator><creatorcontrib>Kim, J. H. ; Yim, H. J. ; Jung, E. S. ; Jung, Y. K. ; Seo, Y. S. ; Yeon, J. E. ; Lee, H. S. ; Um, S. H. ; Byun, K. S.</creatorcontrib><description>Clevudine shows high rates of virologic and biochemical responses in patients with chronic hepatitis B. However, the efficacy and safety of clevudine in patients with cirrhosis are unknown. The aims of this study were to evaluate the safety and to assess the virologic and the biochemical responses to clevudine in patients with cirrhosis with chronic hepatitis B virus (HBV) infection. We reviewed data from treatment‐naïve patients with chronic hepatitis B with and without cirrhosis who started clevudine between April 2007 and March 2008 (n = 52, hepatitis B without cirrhosis n = 21 and chronic hepatitis B with cirrhosis n = 31) at Korea University Ansan/Guro Hospital. All of the patients were treated for more than 48 weeks. The mean age was older in the patients with cirrhosis. Baseline HBV DNA levels were 6.9 and 7.78 log copies/mL (P = 0.042), and alanine aminotransferase (ALT) levels were 104.9 and 147.4 IU/L (P = 0.204), for those with and without cirrhosis, respectively. Virologic response (HBV DNA <1000 copies/mL) (87.1%vs 71.4%, P = 0.24) and biochemical response (83.9%vs 80.9%, P = 0.99) at week 48 were not significantly different between the two groups. Early virologic response at week 12 was even higher in the patients with cirrhosis (61.3%vs 28.6%, P = 0.026). Neither ALT flare nor newly onset hepatic decompensation was found in the patients with cirrhosis, whereas ALT flare was transiently observed in 14.3% of the chronic hepatitis group. In conclusion, although clevudine may produce a transient elevation of ALT during the early treatment period, such findings were not observed in patients with cirrhosis and the virologic and biochemical responses of the groups were comparable.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/j.1365-2893.2010.01304.x</identifier><identifier>PMID: 20367793</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Alanine Transaminase - blood ; Antiviral Agents - administration & dosage ; Antiviral Agents - adverse effects ; Arabinofuranosyluracil - administration & dosage ; Arabinofuranosyluracil - adverse effects ; Arabinofuranosyluracil - analogs & derivatives ; biochemical response ; Cirrhosis ; clevudine ; Data processing ; DNA, Viral - blood ; Female ; Hepatitis ; Hepatitis B virus ; Hepatitis B, Chronic - complications ; Hepatitis B, Chronic - drug therapy ; Humans ; Korea ; liver cirrhosis ; Liver Cirrhosis - drug therapy ; Liver Function Tests ; Male ; Middle Aged ; Treatment Outcome ; Viral Load ; virologic response</subject><ispartof>Journal of viral hepatitis, 2011-04, Vol.18 (4), p.287-293</ispartof><rights>2010 Blackwell Publishing Ltd</rights><rights>2010 Blackwell Publishing Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4384-b04a44f90a7633e2f323b918e5fb8f15684d44a7e2d32895e4722820d1668ff53</citedby><cites>FETCH-LOGICAL-c4384-b04a44f90a7633e2f323b918e5fb8f15684d44a7e2d32895e4722820d1668ff53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2893.2010.01304.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2893.2010.01304.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20367793$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, J. H.</creatorcontrib><creatorcontrib>Yim, H. J.</creatorcontrib><creatorcontrib>Jung, E. S.</creatorcontrib><creatorcontrib>Jung, Y. K.</creatorcontrib><creatorcontrib>Seo, Y. S.</creatorcontrib><creatorcontrib>Yeon, J. E.</creatorcontrib><creatorcontrib>Lee, H. S.</creatorcontrib><creatorcontrib>Um, S. H.</creatorcontrib><creatorcontrib>Byun, K. S.</creatorcontrib><title>Virologic and biochemical responses to clevudine in patients with chronic HBV infection- associated cirrhosis: data at week 48</title><title>Journal of viral hepatitis</title><addtitle>J Viral Hepat</addtitle><description>Clevudine shows high rates of virologic and biochemical responses in patients with chronic hepatitis B. However, the efficacy and safety of clevudine in patients with cirrhosis are unknown. The aims of this study were to evaluate the safety and to assess the virologic and the biochemical responses to clevudine in patients with cirrhosis with chronic hepatitis B virus (HBV) infection. We reviewed data from treatment‐naïve patients with chronic hepatitis B with and without cirrhosis who started clevudine between April 2007 and March 2008 (n = 52, hepatitis B without cirrhosis n = 21 and chronic hepatitis B with cirrhosis n = 31) at Korea University Ansan/Guro Hospital. All of the patients were treated for more than 48 weeks. The mean age was older in the patients with cirrhosis. Baseline HBV DNA levels were 6.9 and 7.78 log copies/mL (P = 0.042), and alanine aminotransferase (ALT) levels were 104.9 and 147.4 IU/L (P = 0.204), for those with and without cirrhosis, respectively. Virologic response (HBV DNA <1000 copies/mL) (87.1%vs 71.4%, P = 0.24) and biochemical response (83.9%vs 80.9%, P = 0.99) at week 48 were not significantly different between the two groups. Early virologic response at week 12 was even higher in the patients with cirrhosis (61.3%vs 28.6%, P = 0.026). Neither ALT flare nor newly onset hepatic decompensation was found in the patients with cirrhosis, whereas ALT flare was transiently observed in 14.3% of the chronic hepatitis group. In conclusion, although clevudine may produce a transient elevation of ALT during the early treatment period, such findings were not observed in patients with cirrhosis and the virologic and biochemical responses of the groups were comparable.</description><subject>Adult</subject><subject>Alanine Transaminase - blood</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Antiviral Agents - adverse effects</subject><subject>Arabinofuranosyluracil - administration & dosage</subject><subject>Arabinofuranosyluracil - adverse effects</subject><subject>Arabinofuranosyluracil - analogs & derivatives</subject><subject>biochemical response</subject><subject>Cirrhosis</subject><subject>clevudine</subject><subject>Data processing</subject><subject>DNA, Viral - blood</subject><subject>Female</subject><subject>Hepatitis</subject><subject>Hepatitis B virus</subject><subject>Hepatitis B, Chronic - complications</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>Humans</subject><subject>Korea</subject><subject>liver cirrhosis</subject><subject>Liver Cirrhosis - drug therapy</subject><subject>Liver Function Tests</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><subject>virologic response</subject><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkE1vEzEQhi0EoqXwF5BvnDb4c9eLxIFW0IAqQAJSxMXyesfE6Wad2g5JL_x2vKTkjC8eed5nRn4QwpTMaDkvVzPKa1kx1fIZI-WVUE7EbP8AnR4bD6dasopIIk7Qk5RWpKSYpI_RCSO8bpqWn6LfCx_DEH56i83Y484Hu4S1t2bAEdImjAkSzgHbAX5tez8C9iPemOxhzAnvfF5iu4xhLPz8fFGaDmz2YaywSSlYbzL02PoYlyH59Ar3JhtsMt4B3GChnqJHzgwJnt3fZ-jbu7dfL-bV1afL9xdvrioruBJVR4QRwrXENDXnwBxnvGupAuk65aisleiFMA2wnpe_SxANY4qRnta1ck7yM_TiMHcTw-0WUtZrnywMgxkhbJNWDaOsrdWUVIekjSGlCE5vol-beKcp0ZN8vdKTYz051pN8_Ve-3hf0-f2SbbeG_gj-s10Crw-BnR_g7r8H6w-L-VQVvjrwPmXYH3kTb3Td8Ebq64-X-rv4fC6uf8z1F_4HY1-iRg</recordid><startdate>201104</startdate><enddate>201104</enddate><creator>Kim, J. H.</creator><creator>Yim, H. J.</creator><creator>Jung, E. S.</creator><creator>Jung, Y. K.</creator><creator>Seo, Y. S.</creator><creator>Yeon, J. E.</creator><creator>Lee, H. S.</creator><creator>Um, S. H.</creator><creator>Byun, K. S.</creator><general>Blackwell Publishing Ltd</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>201104</creationdate><title>Virologic and biochemical responses to clevudine in patients with chronic HBV infection- associated cirrhosis: data at week 48</title><author>Kim, J. H. ; Yim, H. J. ; Jung, E. S. ; Jung, Y. K. ; Seo, Y. S. ; Yeon, J. E. ; Lee, H. S. ; Um, S. H. ; Byun, K. S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4384-b04a44f90a7633e2f323b918e5fb8f15684d44a7e2d32895e4722820d1668ff53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Alanine Transaminase - blood</topic><topic>Antiviral Agents - administration & dosage</topic><topic>Antiviral Agents - adverse effects</topic><topic>Arabinofuranosyluracil - administration & dosage</topic><topic>Arabinofuranosyluracil - adverse effects</topic><topic>Arabinofuranosyluracil - analogs & derivatives</topic><topic>biochemical response</topic><topic>Cirrhosis</topic><topic>clevudine</topic><topic>Data processing</topic><topic>DNA, Viral - blood</topic><topic>Female</topic><topic>Hepatitis</topic><topic>Hepatitis B virus</topic><topic>Hepatitis B, Chronic - complications</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>Humans</topic><topic>Korea</topic><topic>liver cirrhosis</topic><topic>Liver Cirrhosis - drug therapy</topic><topic>Liver Function Tests</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Treatment Outcome</topic><topic>Viral Load</topic><topic>virologic response</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, J. H.</creatorcontrib><creatorcontrib>Yim, H. J.</creatorcontrib><creatorcontrib>Jung, E. S.</creatorcontrib><creatorcontrib>Jung, Y. K.</creatorcontrib><creatorcontrib>Seo, Y. S.</creatorcontrib><creatorcontrib>Yeon, J. E.</creatorcontrib><creatorcontrib>Lee, H. S.</creatorcontrib><creatorcontrib>Um, S. H.</creatorcontrib><creatorcontrib>Byun, K. S.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Journal of viral hepatitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, J. H.</au><au>Yim, H. J.</au><au>Jung, E. S.</au><au>Jung, Y. K.</au><au>Seo, Y. S.</au><au>Yeon, J. E.</au><au>Lee, H. S.</au><au>Um, S. H.</au><au>Byun, K. S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Virologic and biochemical responses to clevudine in patients with chronic HBV infection- associated cirrhosis: data at week 48</atitle><jtitle>Journal of viral hepatitis</jtitle><addtitle>J Viral Hepat</addtitle><date>2011-04</date><risdate>2011</risdate><volume>18</volume><issue>4</issue><spage>287</spage><epage>293</epage><pages>287-293</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>Clevudine shows high rates of virologic and biochemical responses in patients with chronic hepatitis B. However, the efficacy and safety of clevudine in patients with cirrhosis are unknown. The aims of this study were to evaluate the safety and to assess the virologic and the biochemical responses to clevudine in patients with cirrhosis with chronic hepatitis B virus (HBV) infection. We reviewed data from treatment‐naïve patients with chronic hepatitis B with and without cirrhosis who started clevudine between April 2007 and March 2008 (n = 52, hepatitis B without cirrhosis n = 21 and chronic hepatitis B with cirrhosis n = 31) at Korea University Ansan/Guro Hospital. All of the patients were treated for more than 48 weeks. The mean age was older in the patients with cirrhosis. Baseline HBV DNA levels were 6.9 and 7.78 log copies/mL (P = 0.042), and alanine aminotransferase (ALT) levels were 104.9 and 147.4 IU/L (P = 0.204), for those with and without cirrhosis, respectively. Virologic response (HBV DNA <1000 copies/mL) (87.1%vs 71.4%, P = 0.24) and biochemical response (83.9%vs 80.9%, P = 0.99) at week 48 were not significantly different between the two groups. Early virologic response at week 12 was even higher in the patients with cirrhosis (61.3%vs 28.6%, P = 0.026). Neither ALT flare nor newly onset hepatic decompensation was found in the patients with cirrhosis, whereas ALT flare was transiently observed in 14.3% of the chronic hepatitis group. In conclusion, although clevudine may produce a transient elevation of ALT during the early treatment period, such findings were not observed in patients with cirrhosis and the virologic and biochemical responses of the groups were comparable.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>20367793</pmid><doi>10.1111/j.1365-2893.2010.01304.x</doi><tpages>7</tpages></addata></record> |
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| subjects | Adult Alanine Transaminase - blood Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Arabinofuranosyluracil - administration & dosage Arabinofuranosyluracil - adverse effects Arabinofuranosyluracil - analogs & derivatives biochemical response Cirrhosis clevudine Data processing DNA, Viral - blood Female Hepatitis Hepatitis B virus Hepatitis B, Chronic - complications Hepatitis B, Chronic - drug therapy Humans Korea liver cirrhosis Liver Cirrhosis - drug therapy Liver Function Tests Male Middle Aged Treatment Outcome Viral Load virologic response |
| title | Virologic and biochemical responses to clevudine in patients with chronic HBV infection- associated cirrhosis: data at week 48 |
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