Cytopenias during treatment of HIV-HCV-coinfection with pegylated interferon and ribavirin: safety analysis of the OPERA study.
Identifieur interne : 000162 ( PubMed/Curation ); précédent : 000161; suivant : 000163Cytopenias during treatment of HIV-HCV-coinfection with pegylated interferon and ribavirin: safety analysis of the OPERA study.
Auteurs : Emanuele Pontali [Italie] ; Elena Angeli ; Anna M. Cattelan ; Ivana Maida ; Paola Nasta ; Gabriella Verucchi ; Antonietta Caputo ; Claudio Iannacone ; Massimo PuotiSource :
- Antiviral therapy ; 2015.
English descriptors
- KwdEn :
- Adult, Anemia (chemically induced), Anemia (pathology), Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Cell Count, Coinfection, Female, HIV Infections (drug therapy), HIV Infections (pathology), HIV Infections (virology), HIV-1 (drug effects), HIV-1 (physiology), Hepacivirus (drug effects), Hepacivirus (physiology), Hepatitis C, Chronic (drug therapy), Hepatitis C, Chronic (pathology), Hepatitis C, Chronic (virology), Humans, Interferon-alpha (administration & dosage), Interferon-alpha (adverse effects), Male, Middle Aged, Neutropenia (chemically induced), Neutropenia (pathology), Polyethylene Glycols (administration & dosage), Polyethylene Glycols (adverse effects), Recombinant Proteins (administration & dosage), Recombinant Proteins (adverse effects), Ribavirin (administration & dosage), Ribavirin (adverse effects), Thrombocytopenia (chemically induced), Thrombocytopenia (pathology), Viral Load (drug effects).
- MESH :
- chemical , administration & dosage : Antiviral Agents, Interferon-alpha, Polyethylene Glycols, Recombinant Proteins, Ribavirin.
- chemical , adverse effects : Antiviral Agents, Interferon-alpha, Polyethylene Glycols, Recombinant Proteins, Ribavirin.
- chemically induced : Anemia, Neutropenia, Thrombocytopenia.
- drug effects : HIV-1, Hepacivirus, Viral Load.
- drug therapy : HIV Infections, Hepatitis C, Chronic.
- pathology : Anemia, HIV Infections, Hepatitis C, Chronic, Neutropenia, Thrombocytopenia.
- physiology : HIV-1, Hepacivirus.
- virology : HIV Infections, Hepatitis C, Chronic.
- Adult, Cell Count, Coinfection, Female, Humans, Male, Middle Aged.
Abstract
Until recently, recommendations for HCV treatment in HIV-coinfected patients have been combination therapy with pegylated interferon (PEG-IFN) and ribavirin (RBV). However, this treatment is often accompanied with cytopenias which lead to drug-dose reduction/discontinuation, therefore influencing sustained virological response (SVR). This study aimed at evaluating incidence and predictors of cytopenias and to define their impact on SVR in Italian HIV-HCV-coinfected patients undergoing PEG-IFN/RBV treatment.
DOI: 10.3851/IMP2781
PubMed: 24831457
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Cattelan</name></author><author><name sortKey="Maida, Ivana" sort="Maida, Ivana" uniqKey="Maida I" first="Ivana" last="Maida">Ivana Maida</name></author><author><name sortKey="Nasta, Paola" sort="Nasta, Paola" uniqKey="Nasta P" first="Paola" last="Nasta">Paola Nasta</name></author><author><name sortKey="Verucchi, Gabriella" sort="Verucchi, Gabriella" uniqKey="Verucchi G" first="Gabriella" last="Verucchi">Gabriella Verucchi</name></author><author><name sortKey="Caputo, Antonietta" sort="Caputo, Antonietta" uniqKey="Caputo A" first="Antonietta" last="Caputo">Antonietta Caputo</name></author><author><name sortKey="Iannacone, Claudio" sort="Iannacone, Claudio" uniqKey="Iannacone C" first="Claudio" last="Iannacone">Claudio Iannacone</name></author><author><name sortKey="Puoti, Massimo" sort="Puoti, Massimo" uniqKey="Puoti M" first="Massimo" last="Puoti">Massimo Puoti</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="doi">10.3851/IMP2781</idno><idno type="RBID">pubmed:24831457</idno><idno type="pmid">24831457</idno><idno type="wicri:Area/PubMed/Corpus">000162</idno><idno type="wicri:Area/PubMed/Curation">000162</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Cytopenias during treatment of HIV-HCV-coinfection with pegylated interferon and ribavirin: safety analysis of the OPERA study.</title><author><name sortKey="Pontali, Emanuele" sort="Pontali, Emanuele" uniqKey="Pontali E" first="Emanuele" last="Pontali">Emanuele Pontali</name><affiliation wicri:level="1"><nlm:affiliation>Department of Infectious Diseases, Galliera Hospital, Genoa, Italy. pontals@yahoo.com.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Infectious Diseases, Galliera Hospital, Genoa</wicri:regionArea></affiliation></author><author><name sortKey="Angeli, Elena" sort="Angeli, Elena" uniqKey="Angeli E" first="Elena" last="Angeli">Elena Angeli</name></author><author><name sortKey="Cattelan, Anna M" sort="Cattelan, Anna M" uniqKey="Cattelan A" first="Anna M" last="Cattelan">Anna M. Cattelan</name></author><author><name sortKey="Maida, Ivana" sort="Maida, Ivana" uniqKey="Maida I" first="Ivana" last="Maida">Ivana Maida</name></author><author><name sortKey="Nasta, Paola" sort="Nasta, Paola" uniqKey="Nasta P" first="Paola" last="Nasta">Paola Nasta</name></author><author><name sortKey="Verucchi, Gabriella" sort="Verucchi, Gabriella" uniqKey="Verucchi G" first="Gabriella" last="Verucchi">Gabriella Verucchi</name></author><author><name sortKey="Caputo, Antonietta" sort="Caputo, Antonietta" uniqKey="Caputo A" first="Antonietta" last="Caputo">Antonietta Caputo</name></author><author><name sortKey="Iannacone, Claudio" sort="Iannacone, Claudio" uniqKey="Iannacone C" first="Claudio" last="Iannacone">Claudio Iannacone</name></author><author><name sortKey="Puoti, Massimo" sort="Puoti, Massimo" uniqKey="Puoti M" first="Massimo" last="Puoti">Massimo Puoti</name></author></analytic><series><title level="j">Antiviral therapy</title><idno type="e-ISSN">2040-2058</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Anemia (chemically induced)</term><term>Anemia (pathology)</term><term>Antiviral Agents (administration & dosage)</term><term>Antiviral Agents (adverse effects)</term><term>Cell Count</term><term>Coinfection</term><term>Female</term><term>HIV Infections (drug therapy)</term><term>HIV Infections (pathology)</term><term>HIV Infections (virology)</term><term>HIV-1 (drug effects)</term><term>HIV-1 (physiology)</term><term>Hepacivirus (drug effects)</term><term>Hepacivirus (physiology)</term><term>Hepatitis C, Chronic (drug therapy)</term><term>Hepatitis C, Chronic (pathology)</term><term>Hepatitis C, Chronic (virology)</term><term>Humans</term><term>Interferon-alpha (administration & dosage)</term><term>Interferon-alpha (adverse effects)</term><term>Male</term><term>Middle Aged</term><term>Neutropenia (chemically induced)</term><term>Neutropenia (pathology)</term><term>Polyethylene Glycols (administration & dosage)</term><term>Polyethylene Glycols (adverse effects)</term><term>Recombinant Proteins (administration & dosage)</term><term>Recombinant Proteins (adverse effects)</term><term>Ribavirin (administration & dosage)</term><term>Ribavirin (adverse effects)</term><term>Thrombocytopenia (chemically induced)</term><term>Thrombocytopenia (pathology)</term><term>Viral Load (drug effects)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiviral Agents</term><term>Interferon-alpha</term><term>Polyethylene Glycols</term><term>Recombinant Proteins</term><term>Ribavirin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Interferon-alpha</term><term>Polyethylene Glycols</term><term>Recombinant Proteins</term><term>Ribavirin</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Anemia</term><term>Neutropenia</term><term>Thrombocytopenia</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>HIV-1</term><term>Hepacivirus</term><term>Viral Load</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>HIV Infections</term><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Anemia</term><term>HIV Infections</term><term>Hepatitis C, Chronic</term><term>Neutropenia</term><term>Thrombocytopenia</term></keywords><keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>HIV-1</term><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>HIV Infections</term><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Cell Count</term><term>Coinfection</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Until recently, recommendations for HCV treatment in HIV-coinfected patients have been combination therapy with pegylated interferon (PEG-IFN) and ribavirin (RBV). However, this treatment is often accompanied with cytopenias which lead to drug-dose reduction/discontinuation, therefore influencing sustained virological response (SVR). This study aimed at evaluating incidence and predictors of cytopenias and to define their impact on SVR in Italian HIV-HCV-coinfected patients undergoing PEG-IFN/RBV treatment.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">24831457</PMID><DateCreated><Year>2015</Year><Month>03</Month><Day>06</Day></DateCreated><DateCompleted><Year>2015</Year><Month>11</Month><Day>23</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2040-2058</ISSN><JournalIssue CitedMedium="Internet"><Volume>20</Volume><Issue>1</Issue><PubDate><Year>2015</Year></PubDate></JournalIssue><Title>Antiviral therapy</Title><ISOAbbreviation>Antivir. Ther. (Lond.)</ISOAbbreviation></Journal><ArticleTitle>Cytopenias during treatment of HIV-HCV-coinfection with pegylated interferon and ribavirin: safety analysis of the OPERA study.</ArticleTitle><Pagination><MedlinePgn>39-48</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3851/IMP2781</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Until recently, recommendations for HCV treatment in HIV-coinfected patients have been combination therapy with pegylated interferon (PEG-IFN) and ribavirin (RBV). However, this treatment is often accompanied with cytopenias which lead to drug-dose reduction/discontinuation, therefore influencing sustained virological response (SVR). This study aimed at evaluating incidence and predictors of cytopenias and to define their impact on SVR in Italian HIV-HCV-coinfected patients undergoing PEG-IFN/RBV treatment.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">OPERA was a multicentric, observational study conducted in 98 Italian centres. Patients with HIV-HCV coinfection were administered with PEG-IFN/RBV combination treatment for 48 weeks. Incidence and time of onset of cytopenias and multiple bone marrow toxicity (mBMT) was monitored. Logistic regression analysis assessed factors associated with SVR, anaemia, neutropenia, thrombocytopenia and mBMT.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Between 2005 and 2011, 1,523 patients were enrolled. Anaemia (haemoglobin <10 g/dl) occurred in 197 (12.9%) patients and a haemoglobin drop ≥3 g/dl was recorded in 796 (52.3%). Anaemia did not impact on SVR, its rate being 42.1% and 38.1%, respectively, in patients with and without anaemia (P=0.31). Therapy discontinuation due to anaemia occurred in 47 patients (3.1%). Neutropenia (<1,000 neutrophils/mm(3)) occurred in 652 (42.8%) patients, and SVR was higher (P<0.001) for patients with neutropenia (44.8%) compared to without neutropenia (34%). Patients developing neutropenia did not have an increased risk of developing infections. Thrombocytopenia (<100,000 platelets/mm(3)) occurred in 595 (39.1%) patients, SVR was not influenced by it (38.2% versus 38.9% in patients with and without thrombocytopenia, respectively; P=0.79), and 16 patients (1.1%) discontinued therapy due to it. Cirrhosis was found in 148/734 evaluated patients (20.2%) and was significantly associated with thrombocytopenia (P<0.0001). mBMT was found in 417 patients (27.4%).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Cytopenias are frequent side effects of PEG-IFN/RBV combination therapy in HIV-HCV-coinfected patients. However, SVR is not negatively affected by their presence, nor is there an increased risk of infections in patients developing neutropenia. Several predicting factors for the onset of cytopenias have been unravelled, which will help to identify early those patients at high risk of developing cytopenia.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pontali</LastName><ForeName>Emanuele</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Galliera Hospital, Genoa, Italy. pontals@yahoo.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Angeli</LastName><ForeName>Elena</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Cattelan</LastName><ForeName>Anna M</ForeName><Initials>AM</Initials></Author><Author ValidYN="Y"><LastName>Maida</LastName><ForeName>Ivana</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Nasta</LastName><ForeName>Paola</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Verucchi</LastName><ForeName>Gabriella</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Caputo</LastName><ForeName>Antonietta</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Iannacone</LastName><ForeName>Claudio</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Puoti</LastName><ForeName>Massimo</ForeName><Initials>M</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017429">Clinical Trial, Phase IV</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D064888">Observational Study</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>05</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Antivir Ther</MedlineTA><NlmUniqueID>9815705</NlmUniqueID><ISSNLinking>1359-6535</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D016898">Interferon-alpha</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011994">Recombinant Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C100416">peginterferon alfa-2a</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C417083">peginterferon alfa-2b</NameOfSubstance></Chemical><Chemical><RegistryNumber>30IQX730WE</RegistryNumber><NameOfSubstance UI="D011092">Polyethylene Glycols</NameOfSubstance></Chemical><Chemical><RegistryNumber>49717AWG6K</RegistryNumber><NameOfSubstance UI="D012254">Ribavirin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000740">Anemia</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000139">chemically induced</QualifierName><QualifierName MajorTopicYN="N" UI="Q000473">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000998">Antiviral Agents</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D002452">Cell Count</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D060085">Coinfection</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015658">HIV Infections</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="N" UI="Q000473">pathology</QualifierName><QualifierName MajorTopicYN="N" UI="Q000821">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015497">HIV-1</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000187">drug effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000502">physiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016174">Hepacivirus</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000187">drug effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000502">physiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019698">Hepatitis C, Chronic</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="N" UI="Q000473">pathology</QualifierName><QualifierName MajorTopicYN="N" UI="Q000821">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016898">Interferon-alpha</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009503">Neutropenia</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000139">chemically induced</QualifierName><QualifierName MajorTopicYN="N" UI="Q000473">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011092">Polyethylene Glycols</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011994">Recombinant Proteins</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012254">Ribavirin</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013921">Thrombocytopenia</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000139">chemically induced</QualifierName><QualifierName MajorTopicYN="N" UI="Q000473">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019562">Viral Load</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000187">drug effects</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>4</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2014</Year><Month>5</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>5</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>5</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.3851/IMP2781</ArticleId><ArticleId IdType="pubmed">24831457</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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