Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2012 |
| Outros Autores: | , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/29359 http://dx.doi.org/10.1590/S0004-28032012000200010 |
Resumo: | O estudo foi apresentado em um dos seminários de Bio-Manguinhos. |
| id |
CRUZ_51c7d350bb77b7d873c6f7f5fb534614 |
|---|---|
| oai_identifier_str |
oai:www.arca.fiocruz.br:icict/29359 |
| network_acronym_str |
CRUZ |
| network_name_str |
Repositório Institucional da FIOCRUZ (ARCA) |
| repository_id_str |
2135 |
| spelling |
Gonçalves, Candice Beatriz TreterAmaral, Karine MedeirosSander, Guilherme BeckerMartins, Norberto Luis CamposPereira, LisandraPicon, Paulo Dornelles2018-10-04T18:02:12Z2018-10-04T18:02:12Z2012GONÇALVES, C. B. T. et al. Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample. Arquivos de Gastroenterologia, v. 49, n. 2, p. 150-156, abr. / jun. 2012.0004-2803https://www.arca.fiocruz.br/handle/icict/29359http://dx.doi.org/10.1590/S0004-28032012000200010O estudo foi apresentado em um dos seminários de Bio-Manguinhos.Estudos de farmacovigilância têm por objeto a detecção, avaliação, compreensão e prevenção dos riscos dos efeitos adversos dos medicamentos ou qualquer outro possível problema relacionado com medicamento. A alfainterferona (IFN) está sendo produzida por Bio-Manguinhos/Fiocruz e utilizada no tratamento da hepatite C crônica no âmbito do Sistema Único de Saúde (SUS). OBJETIVO: Conhecer o perfil de segurança e efetividade deste IFN em uma amostra de pacientes brasileiros com hepatite crônica pelo vírus C genótipos 2 e 3, em Porto Alegre, RS, Brasil. MÉTODO: Trata-se de uma coorte de pacientes com hepatite crônica pelo vírus C genótipos 2 e 3 tratados com IFN e ribavirina e acompanhados em um serviço ambulatorial especializado no sul do Brasil. Os eventos adversos foram coletados e classificados de acordo com a gravidade em entrevistas mensais estruturadas. Para medida de eficácia foi avaliada a carga viral do HCV antes, ao final e 24 semanas após o término do tratamento. RESULTADOS: Foram acompanhados 141 pacientes no período do estudo, sendo 52,5% do sexo feminino com média de idade de 52 anos. Os eventos adversos mais frequentes foram fadiga (84%), cefaleia (79%) e mialgia (75%). Ocorreram 13 interrupções de tratamento por eventos adversos, sendo nove destes considerados eventos adversos graves. A resposta virológica ao final do tratamento foi de 54,6% e 24 semanas após de 39,7%, considerando todos os pacientes que iniciaram o tratamento. CONCLUSÃO: O produto produzido por Bio-Manguinhos possui eficácia e um perfil de eventos adversos e de resposta virológica sustentada comparáveis aos encontrados na literatura. Este é o primeiro estudo de farmacovigilância realizado com o produto brasileiro. Estes dados serão úteis para planejamento e gestão do tratamento desta doença no Brasil.Context - Pharmacovigilance studies aim to detect, assess, understand and prevent risks of adverse effects of medications or any other possible drug related problem. Alpha interferon is being produced by Bio-Manguinhos/Fiocruz, Rio de Janeiro, RJ, Brazil and used in the treatment of chronic hepatitis C at Brazilian National Health System. Objective - To study the safety profile and effectiveness of alpha interferon in a sample of Brazilian patients with chronic hepatitis C genotypes 2 and 3, in Porto Alegre, RS, Brazil. Method - We followed a cohort of chronic hepatitis C genotypes 2 and 3 patients treated with alpha interferon plus ribavirin in a specialized outpatient clinic in southern Brazil. Adverse events were collected and classified according to severity in monthly structured interviews. To measure effectiveness, hepatitis C viral load was evaluated before, at the end and 24 weeks after the treatment. Results - We followed 141 patients during the study period, of which 52.5% were female with mean age of 52 years. The most frequent adverse events were fatigue (84%), headache (79%) and myalgia (75%). There were 13 treatment interruptions due to adverse events, 9 of those considered serious adverse events. Virological response at end of treatment was 54.6% and after 24 weeks 39.7%, considering all patients who started treatment. Conclusion - The product produced by Bio-Manguinhos has similar efficacy and adverse event and sustained virological response profiles comparable to those found in the literature. This is the first study of pharmacovigilance performed with the Brazilian product. These data will be useful for planning and management of this disease in Brazil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Secretaria da Saúde do Estado do Rio Grande do Sul. Porto Alegre, RS, Brasil.Universidade Federal do Rio Grande do Sul. Hospital de Clínicas de Porto Alegre. Porto Alegre, RS, Brasil.enghttps://www.arca.fiocruz.br/handle/icict/27435Hepatite C crônicaInterferon alfaRibavirinaSistemas de notificação de reações adversas a medicamentosHepatitis C, chronicInterferon alphaRibavirinAdverse drug reaction reporting systemsHepatite C crônicaInterferon-alfaRibavirinaSistemas de Notificação de Reações Adversas a MedicamentosEffectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sampleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txttext/plain1748https://www.arca.fiocruz.br/bitstream/icict/29359/1/license.txt8a4605be74aa9ea9d79846c1fba20a33MD51ORIGINALBio-0010.pdfBio-0010.pdfapplication/pdf346908https://www.arca.fiocruz.br/bitstream/icict/29359/2/Bio-0010.pdf3a64423258c8d5c94a127fa4fbd3b0e1MD52TEXTBio-0010.pdf.txtBio-0010.pdf.txtExtracted texttext/plain34399https://www.arca.fiocruz.br/bitstream/icict/29359/3/Bio-0010.pdf.txt6cf87de3ad0589eb0c4156c6f9573547MD53icict/293592018-10-05 02:01:23.579oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352018-10-05T05:01:23Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.pt_BR.fl_str_mv |
Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample |
| title |
Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample |
| spellingShingle |
Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample Gonçalves, Candice Beatriz Treter Hepatite C crônica Interferon alfa Ribavirina Sistemas de notificação de reações adversas a medicamentos Hepatitis C, chronic Interferon alpha Ribavirin Adverse drug reaction reporting systems Hepatite C crônica Interferon-alfa Ribavirina Sistemas de Notificação de Reações Adversas a Medicamentos |
| title_short |
Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample |
| title_full |
Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample |
| title_fullStr |
Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample |
| title_full_unstemmed |
Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample |
| title_sort |
Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample |
| author |
Gonçalves, Candice Beatriz Treter |
| author_facet |
Gonçalves, Candice Beatriz Treter Amaral, Karine Medeiros Sander, Guilherme Becker Martins, Norberto Luis Campos Pereira, Lisandra Picon, Paulo Dornelles |
| author_role |
author |
| author2 |
Amaral, Karine Medeiros Sander, Guilherme Becker Martins, Norberto Luis Campos Pereira, Lisandra Picon, Paulo Dornelles |
| author2_role |
author author author author author |
| dc.contributor.author.fl_str_mv |
Gonçalves, Candice Beatriz Treter Amaral, Karine Medeiros Sander, Guilherme Becker Martins, Norberto Luis Campos Pereira, Lisandra Picon, Paulo Dornelles |
| dc.subject.other.pt_BR.fl_str_mv |
Hepatite C crônica Interferon alfa Ribavirina Sistemas de notificação de reações adversas a medicamentos |
| topic |
Hepatite C crônica Interferon alfa Ribavirina Sistemas de notificação de reações adversas a medicamentos Hepatitis C, chronic Interferon alpha Ribavirin Adverse drug reaction reporting systems Hepatite C crônica Interferon-alfa Ribavirina Sistemas de Notificação de Reações Adversas a Medicamentos |
| dc.subject.en.pt_BR.fl_str_mv |
Hepatitis C, chronic Interferon alpha Ribavirin Adverse drug reaction reporting systems |
| dc.subject.decs.pt_BR.fl_str_mv |
Hepatite C crônica Interferon-alfa Ribavirina Sistemas de Notificação de Reações Adversas a Medicamentos |
| description |
O estudo foi apresentado em um dos seminários de Bio-Manguinhos. |
| publishDate |
2012 |
| dc.date.issued.fl_str_mv |
2012 |
| dc.date.accessioned.fl_str_mv |
2018-10-04T18:02:12Z |
| dc.date.available.fl_str_mv |
2018-10-04T18:02:12Z |
| dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
| dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.citation.fl_str_mv |
GONÇALVES, C. B. T. et al. Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample. Arquivos de Gastroenterologia, v. 49, n. 2, p. 150-156, abr. / jun. 2012. |
| dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/29359 |
| dc.identifier.issn.pt_BR.fl_str_mv |
0004-2803 |
| dc.identifier.doi.none.fl_str_mv |
http://dx.doi.org/10.1590/S0004-28032012000200010 |
| identifier_str_mv |
GONÇALVES, C. B. T. et al. Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample. Arquivos de Gastroenterologia, v. 49, n. 2, p. 150-156, abr. / jun. 2012. 0004-2803 |
| url |
https://www.arca.fiocruz.br/handle/icict/29359 http://dx.doi.org/10.1590/S0004-28032012000200010 |
| dc.language.iso.fl_str_mv |
eng |
| language |
eng |
| dc.relation.uri.pt_BR.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/27435 |
| dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.source.none.fl_str_mv |
reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
| instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
| instacron_str |
FIOCRUZ |
| institution |
FIOCRUZ |
| reponame_str |
Repositório Institucional da FIOCRUZ (ARCA) |
| collection |
Repositório Institucional da FIOCRUZ (ARCA) |
| bitstream.url.fl_str_mv |
https://www.arca.fiocruz.br/bitstream/icict/29359/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/29359/2/Bio-0010.pdf https://www.arca.fiocruz.br/bitstream/icict/29359/3/Bio-0010.pdf.txt |
| bitstream.checksum.fl_str_mv |
8a4605be74aa9ea9d79846c1fba20a33 3a64423258c8d5c94a127fa4fbd3b0e1 6cf87de3ad0589eb0c4156c6f9573547 |
| bitstream.checksumAlgorithm.fl_str_mv |
MD5 MD5 MD5 |
| repository.name.fl_str_mv |
Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ) |
| repository.mail.fl_str_mv |
repositorio.arca@fiocruz.br |
| _version_ |
1813009176296685568 |