A pilot trial of recombinant interleukin-12 in patients with chronic hepatitis C who previously failed treatment with interferon-α
OBJECTIVE: Interleukin-12 is a cytokine with a multitude of immunomodulatory actions. Currently, interferon-α (IFN-α) monotherapy and combination treatment with IFN and ribavirin are the only therapies with proven efficacy against chronic hepatitis C infection. The purpose of this study was to asses...
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| Veröffentlicht in: | The American journal of gastroenterology 2001-08, Vol.96 (8), p.2473-2479 |
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| container_issue | 8 |
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| container_title | The American journal of gastroenterology |
| container_volume | 96 |
| creator | O’Brien, Christopher B Moonka, Dilip K Henzel, Barbara S Caufield, Maureen DeBruin, Michael F |
| description | OBJECTIVE:
Interleukin-12 is a cytokine with a multitude of immunomodulatory actions. Currently, interferon-α (IFN-α) monotherapy and combination treatment with IFN and ribavirin are the only therapies with proven efficacy against chronic hepatitis C infection. The purpose of this study was to assess the safety and antiviral activity of recombinant interleukin-12 (rhIL-12) in adults with chronic hepatitis C who did not achieve a sustained response to previous IFN-α therapy.
METHODS:
This was a randomized, placebo-controlled, double-blind trial. We randomized 24 patients to one of three dose groups: 30 ng/kg, 100 ng/kg, and 300 ng/kg. Within each group, six patients received rhIL-12, and two patients received placebo administered
s.c. twice a week for 12 wk.
RESULTS:
Three of six patients treated with rhIL-12 at a dose of 300 ng/kg had loss of detectable hepatitis C RNA by reverse transcription-polymerase chain reaction compared with the placebo group (
p = 0.05). All patients relapsed at the end of the 3-month treatment period. No other dose group demonstrated a loss of detectable hepatitis C RNA.
CONCLUSIONS:
RhIL-12 at 300 ng/kg can suppress hepatitis C RNA to undetectable levels by reverse transcription-polymerase chain reaction, although relapse occurred when treatment was stopped. RhIL-12 was well tolerated with the most common side effects being flu-like symptoms and headaches. |
| doi_str_mv | 10.1016/S0002-9270(01)02520-5 |
| format | Article |
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Interleukin-12 is a cytokine with a multitude of immunomodulatory actions. Currently, interferon-α (IFN-α) monotherapy and combination treatment with IFN and ribavirin are the only therapies with proven efficacy against chronic hepatitis C infection. The purpose of this study was to assess the safety and antiviral activity of recombinant interleukin-12 (rhIL-12) in adults with chronic hepatitis C who did not achieve a sustained response to previous IFN-α therapy.
METHODS:
This was a randomized, placebo-controlled, double-blind trial. We randomized 24 patients to one of three dose groups: 30 ng/kg, 100 ng/kg, and 300 ng/kg. Within each group, six patients received rhIL-12, and two patients received placebo administered
s.c. twice a week for 12 wk.
RESULTS:
Three of six patients treated with rhIL-12 at a dose of 300 ng/kg had loss of detectable hepatitis C RNA by reverse transcription-polymerase chain reaction compared with the placebo group (
p = 0.05). All patients relapsed at the end of the 3-month treatment period. No other dose group demonstrated a loss of detectable hepatitis C RNA.
CONCLUSIONS:
RhIL-12 at 300 ng/kg can suppress hepatitis C RNA to undetectable levels by reverse transcription-polymerase chain reaction, although relapse occurred when treatment was stopped. RhIL-12 was well tolerated with the most common side effects being flu-like symptoms and headaches.</description><identifier>ISSN: 0002-9270</identifier><identifier>EISSN: 1572-0241</identifier><identifier>DOI: 10.1016/S0002-9270(01)02520-5</identifier><identifier>PMID: 11513193</identifier><language>eng</language><publisher>Oxford: Elsevier Inc</publisher><subject>Adjuvants, Immunologic - therapeutic use ; Analysis of Variance ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Antiviral Agents - therapeutic use ; Biological and medical sciences ; Cytokines - blood ; Double-Blind Method ; Enzyme-Linked Immunosorbent Assay ; Female ; Hepatitis C, Chronic - drug therapy ; Humans ; Interferon-alpha - therapeutic use ; Interleukin-12 - therapeutic use ; Liver Function Tests ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Pilot Projects ; Reverse Transcriptase Polymerase Chain Reaction ; RNA, Viral - blood ; Treatment Failure ; Treatment Outcome</subject><ispartof>The American journal of gastroenterology, 2001-08, Vol.96 (8), p.2473-2479</ispartof><rights>2001 Am. Coll. of Gastroenterology</rights><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-536bf46d9544103c72fca461af5ffc52881a7341323876838792172946871d093</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1110063$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11513193$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>O’Brien, Christopher B</creatorcontrib><creatorcontrib>Moonka, Dilip K</creatorcontrib><creatorcontrib>Henzel, Barbara S</creatorcontrib><creatorcontrib>Caufield, Maureen</creatorcontrib><creatorcontrib>DeBruin, Michael F</creatorcontrib><title>A pilot trial of recombinant interleukin-12 in patients with chronic hepatitis C who previously failed treatment with interferon-α</title><title>The American journal of gastroenterology</title><addtitle>Am J Gastroenterol</addtitle><description>OBJECTIVE:
Interleukin-12 is a cytokine with a multitude of immunomodulatory actions. Currently, interferon-α (IFN-α) monotherapy and combination treatment with IFN and ribavirin are the only therapies with proven efficacy against chronic hepatitis C infection. The purpose of this study was to assess the safety and antiviral activity of recombinant interleukin-12 (rhIL-12) in adults with chronic hepatitis C who did not achieve a sustained response to previous IFN-α therapy.
METHODS:
This was a randomized, placebo-controlled, double-blind trial. We randomized 24 patients to one of three dose groups: 30 ng/kg, 100 ng/kg, and 300 ng/kg. Within each group, six patients received rhIL-12, and two patients received placebo administered
s.c. twice a week for 12 wk.
RESULTS:
Three of six patients treated with rhIL-12 at a dose of 300 ng/kg had loss of detectable hepatitis C RNA by reverse transcription-polymerase chain reaction compared with the placebo group (
p = 0.05). All patients relapsed at the end of the 3-month treatment period. No other dose group demonstrated a loss of detectable hepatitis C RNA.
CONCLUSIONS:
RhIL-12 at 300 ng/kg can suppress hepatitis C RNA to undetectable levels by reverse transcription-polymerase chain reaction, although relapse occurred when treatment was stopped. RhIL-12 was well tolerated with the most common side effects being flu-like symptoms and headaches.</description><subject>Adjuvants, Immunologic - therapeutic use</subject><subject>Analysis of Variance</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cytokines - blood</subject><subject>Double-Blind Method</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Female</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Humans</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Interleukin-12 - therapeutic use</subject><subject>Liver Function Tests</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Pilot Projects</subject><subject>Reverse Transcriptase Polymerase Chain Reaction</subject><subject>RNA, Viral - blood</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><issn>0002-9270</issn><issn>1572-0241</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcuOFCEUhonROD2jj6BhYcy4KD0HiqJqZSYdb8kkLtQ1oSlIo1RRAj2TWftEvojPJH2JunMDgXz_z8kHIU8QXiJg9-oTALBmYBIuAV8AEwwacY-sUEjWAGvxPln9Qc7Iec5fAVAwKR6SM0SBHAe-Ij-u6OJDLLQkrwONjiZr4rTxs54L9XOxKdjdNz83yOqRLrp4O5dMb33ZUrNNcfaGbu3-vvhM1_R2G-mS7I2PuxzuqNM-2LHWW12mmjwGD8XO1nTz6-cj8sDpkO3j035Bvrx983n9vrn--O7D-uq6MXyA0gjebVzbjYNoWwRuJHNGtx1qJ5wzgvU9aslb5Iz3suvrMjCUbGi7XuIIA78gz4-9S4rfdzYXNflsbAh6tnVYJRGRMS4rKI6gSTHnZJ1akp90ulMIam9fHeyrvVoFqA72lai5p6cHdpvJjn9TJ90VeHYCdDY6uKRn4_M_HAJ0e-z1EbPVxo23SWVTrRs7-vo7RY3R_2eS35REoY4</recordid><startdate>20010801</startdate><enddate>20010801</enddate><creator>O’Brien, Christopher B</creator><creator>Moonka, Dilip K</creator><creator>Henzel, Barbara S</creator><creator>Caufield, Maureen</creator><creator>DeBruin, Michael F</creator><general>Elsevier Inc</general><general>Blackwell Publishing</general><scope>IQODW</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><scope>8BM</scope></search><sort><creationdate>20010801</creationdate><title>A pilot trial of recombinant interleukin-12 in patients with chronic hepatitis C who previously failed treatment with interferon-α</title><author>O’Brien, Christopher B ; Moonka, Dilip K ; Henzel, Barbara S ; Caufield, Maureen ; DeBruin, Michael F</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c390t-536bf46d9544103c72fca461af5ffc52881a7341323876838792172946871d093</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Adjuvants, Immunologic - therapeutic use</topic><topic>Analysis of Variance</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Cytokines - blood</topic><topic>Double-Blind Method</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Female</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Humans</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Interleukin-12 - therapeutic use</topic><topic>Liver Function Tests</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Pilot Projects</topic><topic>Reverse Transcriptase Polymerase Chain Reaction</topic><topic>RNA, Viral - blood</topic><topic>Treatment Failure</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>O’Brien, Christopher B</creatorcontrib><creatorcontrib>Moonka, Dilip K</creatorcontrib><creatorcontrib>Henzel, Barbara S</creatorcontrib><creatorcontrib>Caufield, Maureen</creatorcontrib><creatorcontrib>DeBruin, Michael F</creatorcontrib><collection>Pascal-Francis</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><collection>ComDisDome</collection><jtitle>The American journal of gastroenterology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>O’Brien, Christopher B</au><au>Moonka, Dilip K</au><au>Henzel, Barbara S</au><au>Caufield, Maureen</au><au>DeBruin, Michael F</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A pilot trial of recombinant interleukin-12 in patients with chronic hepatitis C who previously failed treatment with interferon-α</atitle><jtitle>The American journal of gastroenterology</jtitle><addtitle>Am J Gastroenterol</addtitle><date>2001-08-01</date><risdate>2001</risdate><volume>96</volume><issue>8</issue><spage>2473</spage><epage>2479</epage><pages>2473-2479</pages><issn>0002-9270</issn><eissn>1572-0241</eissn><abstract>OBJECTIVE:
Interleukin-12 is a cytokine with a multitude of immunomodulatory actions. Currently, interferon-α (IFN-α) monotherapy and combination treatment with IFN and ribavirin are the only therapies with proven efficacy against chronic hepatitis C infection. The purpose of this study was to assess the safety and antiviral activity of recombinant interleukin-12 (rhIL-12) in adults with chronic hepatitis C who did not achieve a sustained response to previous IFN-α therapy.
METHODS:
This was a randomized, placebo-controlled, double-blind trial. We randomized 24 patients to one of three dose groups: 30 ng/kg, 100 ng/kg, and 300 ng/kg. Within each group, six patients received rhIL-12, and two patients received placebo administered
s.c. twice a week for 12 wk.
RESULTS:
Three of six patients treated with rhIL-12 at a dose of 300 ng/kg had loss of detectable hepatitis C RNA by reverse transcription-polymerase chain reaction compared with the placebo group (
p = 0.05). All patients relapsed at the end of the 3-month treatment period. No other dose group demonstrated a loss of detectable hepatitis C RNA.
CONCLUSIONS:
RhIL-12 at 300 ng/kg can suppress hepatitis C RNA to undetectable levels by reverse transcription-polymerase chain reaction, although relapse occurred when treatment was stopped. RhIL-12 was well tolerated with the most common side effects being flu-like symptoms and headaches.</abstract><cop>Oxford</cop><pub>Elsevier Inc</pub><pmid>11513193</pmid><doi>10.1016/S0002-9270(01)02520-5</doi><tpages>7</tpages></addata></record> |
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| ispartof | The American journal of gastroenterology, 2001-08, Vol.96 (8), p.2473-2479 |
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| subjects | Adjuvants, Immunologic - therapeutic use Analysis of Variance Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Antiviral Agents - therapeutic use Biological and medical sciences Cytokines - blood Double-Blind Method Enzyme-Linked Immunosorbent Assay Female Hepatitis C, Chronic - drug therapy Humans Interferon-alpha - therapeutic use Interleukin-12 - therapeutic use Liver Function Tests Male Medical sciences Middle Aged Pharmacology. Drug treatments Pilot Projects Reverse Transcriptase Polymerase Chain Reaction RNA, Viral - blood Treatment Failure Treatment Outcome |
| title | A pilot trial of recombinant interleukin-12 in patients with chronic hepatitis C who previously failed treatment with interferon-α |
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