Multicenter Study of Pegylated Interferon α-2a Monotherapy for Hepatitis C Virus-Infected Patients on Hemodialysis: REACH Study
Many studies have reported poor vital prognosis in hepatitis C virus (HCV)‐infected dialysis patients. The rate of HCV‐infected dialysis patients in Japan is as high as 9.8%, and antiviral therapy is believed to be important for improving vital prognosis. We conducted a multicenter study to examine...
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| creator | Kikuchi, Kan Akiba, Takashi Nitta, Kosaku Masakane, Ikuto Ando, Ryoichi Izumi, Namiki Atsukawa, Masanori Yamazaki, Chikao Kato, Fumi Hotta, Naoki Tominaga, Yoshihiro Orito, Etsuro Hora, Kazuhiko Nagasawa, Masaki Kasahara, Hiroshi Kawaguchi, Masanori Kimura, Hiroyuki Ikebe, Norisato Kawanishi, Hideki Moriishi, Misaki Shigemoto, Kenichiro Harada, Takashi Hirakata, Hideki Watanabe, Hiroshi Nosaki, Tsuyoshi Tsubouchi, Hirohito Imawari, Michio Akizawa, Tadao |
| description | Many studies have reported poor vital prognosis in hepatitis C virus (HCV)‐infected dialysis patients. The rate of HCV‐infected dialysis patients in Japan is as high as 9.8%, and antiviral therapy is believed to be important for improving vital prognosis. We conducted a multicenter study to examine the administration method for pegylated interferon α‐2a (PEG‐IFNα‐2a) monotherapy in HCV‐infected dialysis. We studied 56 patients: 14 with low viral loads (HCV RNA < 5.0 log IU/mL) were treated with 90 μg PEG‐IFNα‐2a weekly, 42 with high viral loads (HCV RNA ≥ 5.0 log IU/mL) were treated with 135 μg PEG‐IFNα‐2a weekly. We examined the sustained virological response (SVR), factors affecting the SVR, and treatment safety. The overall SVR rate was 39% (22/56); that for genotype 1, genotype 2, low viral loads, and high viral loads was 29%, 67%, 93%, and 21%, respectively. From receiver operating characteristic (ROC) analysis, the HCV RNA cutoff values likely to achieve SVR for genotypes 1 and 2 were |
| doi_str_mv | 10.1111/1744-9987.12189 |
| format | Article |
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The rate of HCV‐infected dialysis patients in Japan is as high as 9.8%, and antiviral therapy is believed to be important for improving vital prognosis. We conducted a multicenter study to examine the administration method for pegylated interferon α‐2a (PEG‐IFNα‐2a) monotherapy in HCV‐infected dialysis. We studied 56 patients: 14 with low viral loads (HCV RNA < 5.0 log IU/mL) were treated with 90 μg PEG‐IFNα‐2a weekly, 42 with high viral loads (HCV RNA ≥ 5.0 log IU/mL) were treated with 135 μg PEG‐IFNα‐2a weekly. We examined the sustained virological response (SVR), factors affecting the SVR, and treatment safety. The overall SVR rate was 39% (22/56); that for genotype 1, genotype 2, low viral loads, and high viral loads was 29%, 67%, 93%, and 21%, respectively. From receiver operating characteristic (ROC) analysis, the HCV RNA cutoff values likely to achieve SVR for genotypes 1 and 2 were <5.7 log IU/mL (SVR rate: 64% 9/14) and <6.5 log IU/mL (SVR rate: 88% 7/8), respectively. If there was HCV RNA negativation at 4 weeks (rapid virological response), the SVR rate was 94% (16/17), whereas it was 6% (1/16) if there was HCV RNA positivity at 24 weeks. The rate of treatment discontinuation from adverse events or aggravated complications was 25% (14/56). High SVR rates can potentially be achieved with PEG‐IFN monotherapy by identifying the target patients, based on virus type and viral load before initiating treatment and by modifying therapy during treatment according to responsiveness.</description><identifier>ISSN: 1744-9979</identifier><identifier>EISSN: 1744-9987</identifier><identifier>DOI: 10.1111/1744-9987.12189</identifier><identifier>PMID: 25196061</identifier><language>eng</language><publisher>Australia: Blackwell Publishing Ltd</publisher><subject>Aged ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Female ; Follow-Up Studies ; Genotype ; Hemodialysis ; Hepacivirus - genetics ; Hepatitis C - drug therapy ; Hepatitis C - virology ; Hepatitis C virus ; Humans ; Interferon-alpha - adverse effects ; Interferon-alpha - therapeutic use ; Japan ; Male ; Middle Aged ; Pegylated interferon α-2a ; Polyethylene Glycols - adverse effects ; Polyethylene Glycols - therapeutic use ; Prognosis ; Rapid virological response ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Renal Dialysis ; RNA, Viral - blood ; Sustained virological response ; Treatment Outcome ; Viral Load</subject><ispartof>Therapeutic apheresis and dialysis, 2014-12, Vol.18 (6), p.603-611</ispartof><rights>2014 The Authors. Therapeutic Apheresis and Dialysis © 2014 International Society for Apheresis</rights><rights>2014 The Authors. Therapeutic Apheresis and Dialysis © 2014 International Society for Apheresis.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3909-9a07f05418810877cbb413e883ad4a7b5dd8f7d36c9361712d88211b19324e313</citedby><cites>FETCH-LOGICAL-c3909-9a07f05418810877cbb413e883ad4a7b5dd8f7d36c9361712d88211b19324e313</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%2F1744-9987.12189$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2F1744-9987.12189$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25196061$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kikuchi, Kan</creatorcontrib><creatorcontrib>Akiba, Takashi</creatorcontrib><creatorcontrib>Nitta, Kosaku</creatorcontrib><creatorcontrib>Masakane, Ikuto</creatorcontrib><creatorcontrib>Ando, Ryoichi</creatorcontrib><creatorcontrib>Izumi, Namiki</creatorcontrib><creatorcontrib>Atsukawa, Masanori</creatorcontrib><creatorcontrib>Yamazaki, Chikao</creatorcontrib><creatorcontrib>Kato, Fumi</creatorcontrib><creatorcontrib>Hotta, Naoki</creatorcontrib><creatorcontrib>Tominaga, Yoshihiro</creatorcontrib><creatorcontrib>Orito, Etsuro</creatorcontrib><creatorcontrib>Hora, Kazuhiko</creatorcontrib><creatorcontrib>Nagasawa, Masaki</creatorcontrib><creatorcontrib>Kasahara, Hiroshi</creatorcontrib><creatorcontrib>Kawaguchi, Masanori</creatorcontrib><creatorcontrib>Kimura, Hiroyuki</creatorcontrib><creatorcontrib>Ikebe, Norisato</creatorcontrib><creatorcontrib>Kawanishi, Hideki</creatorcontrib><creatorcontrib>Moriishi, Misaki</creatorcontrib><creatorcontrib>Shigemoto, Kenichiro</creatorcontrib><creatorcontrib>Harada, Takashi</creatorcontrib><creatorcontrib>Hirakata, Hideki</creatorcontrib><creatorcontrib>Watanabe, Hiroshi</creatorcontrib><creatorcontrib>Nosaki, Tsuyoshi</creatorcontrib><creatorcontrib>Tsubouchi, Hirohito</creatorcontrib><creatorcontrib>Imawari, Michio</creatorcontrib><creatorcontrib>Akizawa, Tadao</creatorcontrib><title>Multicenter Study of Pegylated Interferon α-2a Monotherapy for Hepatitis C Virus-Infected Patients on Hemodialysis: REACH Study</title><title>Therapeutic apheresis and dialysis</title><addtitle>Ther Apher Dial</addtitle><description>Many studies have reported poor vital prognosis in hepatitis C virus (HCV)‐infected dialysis patients. The rate of HCV‐infected dialysis patients in Japan is as high as 9.8%, and antiviral therapy is believed to be important for improving vital prognosis. We conducted a multicenter study to examine the administration method for pegylated interferon α‐2a (PEG‐IFNα‐2a) monotherapy in HCV‐infected dialysis. We studied 56 patients: 14 with low viral loads (HCV RNA < 5.0 log IU/mL) were treated with 90 μg PEG‐IFNα‐2a weekly, 42 with high viral loads (HCV RNA ≥ 5.0 log IU/mL) were treated with 135 μg PEG‐IFNα‐2a weekly. We examined the sustained virological response (SVR), factors affecting the SVR, and treatment safety. The overall SVR rate was 39% (22/56); that for genotype 1, genotype 2, low viral loads, and high viral loads was 29%, 67%, 93%, and 21%, respectively. From receiver operating characteristic (ROC) analysis, the HCV RNA cutoff values likely to achieve SVR for genotypes 1 and 2 were <5.7 log IU/mL (SVR rate: 64% 9/14) and <6.5 log IU/mL (SVR rate: 88% 7/8), respectively. If there was HCV RNA negativation at 4 weeks (rapid virological response), the SVR rate was 94% (16/17), whereas it was 6% (1/16) if there was HCV RNA positivity at 24 weeks. The rate of treatment discontinuation from adverse events or aggravated complications was 25% (14/56). High SVR rates can potentially be achieved with PEG‐IFN monotherapy by identifying the target patients, based on virus type and viral load before initiating treatment and by modifying therapy during treatment according to responsiveness.</description><subject>Aged</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Genotype</subject><subject>Hemodialysis</subject><subject>Hepacivirus - genetics</subject><subject>Hepatitis C - drug therapy</subject><subject>Hepatitis C - virology</subject><subject>Hepatitis C virus</subject><subject>Humans</subject><subject>Interferon-alpha - adverse effects</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Japan</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pegylated interferon α-2a</subject><subject>Polyethylene Glycols - adverse effects</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Prognosis</subject><subject>Rapid virological response</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Renal Dialysis</subject><subject>RNA, Viral - blood</subject><subject>Sustained virological response</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><issn>1744-9979</issn><issn>1744-9987</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMFu1DAURS0EoqWwZoe8ZJPWL05im90oLc2IaRlBKUvLSV7AkEmmtiPIjl_iR_gmEtLOFm9s-Z17n3QIeQnsFKZzBiJJIqWkOIUYpHpEjg8_jw9voY7IM--_MRbHCedPyVGcgspYBsfk19XQBlthF9DRj2GoR9o3dItfxtYErOl6HjTo-o7--R3Fhl71XR--ojP7kTa9owXuTbDBeprTW-sGH627Bqs5u50GU7GnU7jAXV9b047e-jf0w8UqL5Z1z8mTxrQeX9zfJ-TT24ubvIg27y_X-WoTVVwxFSnDRMPSBKQEJoWoyjIBjlJyUydGlGldy0bUPKsUz0BAXEsZA5SgeJwgB35CXi-9e9ffDeiD3llfYduaDvvBa8i4SiYpkEzo2YJWrvfeYaP3zu6MGzUwPWvXs1g9S9b_tE-JV_flQ7nD-sA_eJ6AdAF-2BbH__Xpm9X2oThactYH_HnIGfddZ4KLVH--vtQyv71-d7451wX_C5Hhm-o</recordid><startdate>201412</startdate><enddate>201412</enddate><creator>Kikuchi, Kan</creator><creator>Akiba, Takashi</creator><creator>Nitta, Kosaku</creator><creator>Masakane, Ikuto</creator><creator>Ando, Ryoichi</creator><creator>Izumi, Namiki</creator><creator>Atsukawa, Masanori</creator><creator>Yamazaki, Chikao</creator><creator>Kato, Fumi</creator><creator>Hotta, Naoki</creator><creator>Tominaga, Yoshihiro</creator><creator>Orito, Etsuro</creator><creator>Hora, Kazuhiko</creator><creator>Nagasawa, Masaki</creator><creator>Kasahara, Hiroshi</creator><creator>Kawaguchi, Masanori</creator><creator>Kimura, Hiroyuki</creator><creator>Ikebe, Norisato</creator><creator>Kawanishi, Hideki</creator><creator>Moriishi, Misaki</creator><creator>Shigemoto, Kenichiro</creator><creator>Harada, Takashi</creator><creator>Hirakata, Hideki</creator><creator>Watanabe, Hiroshi</creator><creator>Nosaki, Tsuyoshi</creator><creator>Tsubouchi, Hirohito</creator><creator>Imawari, Michio</creator><creator>Akizawa, Tadao</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>7X8</scope></search><sort><creationdate>201412</creationdate><title>Multicenter Study of Pegylated Interferon α-2a Monotherapy for Hepatitis C Virus-Infected Patients on Hemodialysis: REACH Study</title><author>Kikuchi, Kan ; Akiba, Takashi ; Nitta, Kosaku ; Masakane, Ikuto ; Ando, Ryoichi ; Izumi, Namiki ; Atsukawa, Masanori ; Yamazaki, Chikao ; Kato, Fumi ; Hotta, Naoki ; Tominaga, Yoshihiro ; Orito, Etsuro ; Hora, Kazuhiko ; Nagasawa, Masaki ; Kasahara, Hiroshi ; Kawaguchi, Masanori ; Kimura, Hiroyuki ; Ikebe, Norisato ; Kawanishi, Hideki ; Moriishi, Misaki ; Shigemoto, Kenichiro ; Harada, Takashi ; Hirakata, Hideki ; Watanabe, Hiroshi ; Nosaki, Tsuyoshi ; Tsubouchi, Hirohito ; Imawari, Michio ; Akizawa, Tadao</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3909-9a07f05418810877cbb413e883ad4a7b5dd8f7d36c9361712d88211b19324e313</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Genotype</topic><topic>Hemodialysis</topic><topic>Hepacivirus - genetics</topic><topic>Hepatitis C - drug therapy</topic><topic>Hepatitis C - virology</topic><topic>Hepatitis C virus</topic><topic>Humans</topic><topic>Interferon-alpha - adverse effects</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Japan</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pegylated interferon α-2a</topic><topic>Polyethylene Glycols - adverse effects</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Prognosis</topic><topic>Rapid virological response</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Renal Dialysis</topic><topic>RNA, Viral - blood</topic><topic>Sustained virological response</topic><topic>Treatment Outcome</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kikuchi, Kan</creatorcontrib><creatorcontrib>Akiba, Takashi</creatorcontrib><creatorcontrib>Nitta, Kosaku</creatorcontrib><creatorcontrib>Masakane, Ikuto</creatorcontrib><creatorcontrib>Ando, Ryoichi</creatorcontrib><creatorcontrib>Izumi, Namiki</creatorcontrib><creatorcontrib>Atsukawa, Masanori</creatorcontrib><creatorcontrib>Yamazaki, Chikao</creatorcontrib><creatorcontrib>Kato, Fumi</creatorcontrib><creatorcontrib>Hotta, Naoki</creatorcontrib><creatorcontrib>Tominaga, Yoshihiro</creatorcontrib><creatorcontrib>Orito, Etsuro</creatorcontrib><creatorcontrib>Hora, Kazuhiko</creatorcontrib><creatorcontrib>Nagasawa, Masaki</creatorcontrib><creatorcontrib>Kasahara, Hiroshi</creatorcontrib><creatorcontrib>Kawaguchi, Masanori</creatorcontrib><creatorcontrib>Kimura, Hiroyuki</creatorcontrib><creatorcontrib>Ikebe, Norisato</creatorcontrib><creatorcontrib>Kawanishi, Hideki</creatorcontrib><creatorcontrib>Moriishi, Misaki</creatorcontrib><creatorcontrib>Shigemoto, Kenichiro</creatorcontrib><creatorcontrib>Harada, Takashi</creatorcontrib><creatorcontrib>Hirakata, Hideki</creatorcontrib><creatorcontrib>Watanabe, Hiroshi</creatorcontrib><creatorcontrib>Nosaki, Tsuyoshi</creatorcontrib><creatorcontrib>Tsubouchi, Hirohito</creatorcontrib><creatorcontrib>Imawari, Michio</creatorcontrib><creatorcontrib>Akizawa, Tadao</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>MEDLINE - Academic</collection><jtitle>Therapeutic apheresis and dialysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kikuchi, Kan</au><au>Akiba, Takashi</au><au>Nitta, Kosaku</au><au>Masakane, Ikuto</au><au>Ando, Ryoichi</au><au>Izumi, Namiki</au><au>Atsukawa, Masanori</au><au>Yamazaki, Chikao</au><au>Kato, Fumi</au><au>Hotta, Naoki</au><au>Tominaga, Yoshihiro</au><au>Orito, Etsuro</au><au>Hora, Kazuhiko</au><au>Nagasawa, Masaki</au><au>Kasahara, Hiroshi</au><au>Kawaguchi, Masanori</au><au>Kimura, Hiroyuki</au><au>Ikebe, Norisato</au><au>Kawanishi, Hideki</au><au>Moriishi, Misaki</au><au>Shigemoto, Kenichiro</au><au>Harada, Takashi</au><au>Hirakata, Hideki</au><au>Watanabe, Hiroshi</au><au>Nosaki, Tsuyoshi</au><au>Tsubouchi, Hirohito</au><au>Imawari, Michio</au><au>Akizawa, Tadao</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicenter Study of Pegylated Interferon α-2a Monotherapy for Hepatitis C Virus-Infected Patients on Hemodialysis: REACH Study</atitle><jtitle>Therapeutic apheresis and dialysis</jtitle><addtitle>Ther Apher Dial</addtitle><date>2014-12</date><risdate>2014</risdate><volume>18</volume><issue>6</issue><spage>603</spage><epage>611</epage><pages>603-611</pages><issn>1744-9979</issn><eissn>1744-9987</eissn><abstract>Many studies have reported poor vital prognosis in hepatitis C virus (HCV)‐infected dialysis patients. The rate of HCV‐infected dialysis patients in Japan is as high as 9.8%, and antiviral therapy is believed to be important for improving vital prognosis. We conducted a multicenter study to examine the administration method for pegylated interferon α‐2a (PEG‐IFNα‐2a) monotherapy in HCV‐infected dialysis. We studied 56 patients: 14 with low viral loads (HCV RNA < 5.0 log IU/mL) were treated with 90 μg PEG‐IFNα‐2a weekly, 42 with high viral loads (HCV RNA ≥ 5.0 log IU/mL) were treated with 135 μg PEG‐IFNα‐2a weekly. We examined the sustained virological response (SVR), factors affecting the SVR, and treatment safety. The overall SVR rate was 39% (22/56); that for genotype 1, genotype 2, low viral loads, and high viral loads was 29%, 67%, 93%, and 21%, respectively. From receiver operating characteristic (ROC) analysis, the HCV RNA cutoff values likely to achieve SVR for genotypes 1 and 2 were <5.7 log IU/mL (SVR rate: 64% 9/14) and <6.5 log IU/mL (SVR rate: 88% 7/8), respectively. If there was HCV RNA negativation at 4 weeks (rapid virological response), the SVR rate was 94% (16/17), whereas it was 6% (1/16) if there was HCV RNA positivity at 24 weeks. The rate of treatment discontinuation from adverse events or aggravated complications was 25% (14/56). High SVR rates can potentially be achieved with PEG‐IFN monotherapy by identifying the target patients, based on virus type and viral load before initiating treatment and by modifying therapy during treatment according to responsiveness.</abstract><cop>Australia</cop><pub>Blackwell Publishing Ltd</pub><pmid>25196061</pmid><doi>10.1111/1744-9987.12189</doi><tpages>9</tpages></addata></record> |
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| ispartof | Therapeutic apheresis and dialysis, 2014-12, Vol.18 (6), p.603-611 |
| issn | 1744-9979 1744-9987 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Aged Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Female Follow-Up Studies Genotype Hemodialysis Hepacivirus - genetics Hepatitis C - drug therapy Hepatitis C - virology Hepatitis C virus Humans Interferon-alpha - adverse effects Interferon-alpha - therapeutic use Japan Male Middle Aged Pegylated interferon α-2a Polyethylene Glycols - adverse effects Polyethylene Glycols - therapeutic use Prognosis Rapid virological response Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Renal Dialysis RNA, Viral - blood Sustained virological response Treatment Outcome Viral Load |
| title | Multicenter Study of Pegylated Interferon α-2a Monotherapy for Hepatitis C Virus-Infected Patients on Hemodialysis: REACH Study |
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