Therapeutic effectiveness of biosimilar standard interferon versus pegylated interferon for chronic hepatitis C genotypes 2 or 3

Vigani, Aline Gonzalez; Gonçales, Eduardo S L; Pavan, Maria Helena Postal; Genari, Flavia; Tozzo, Raquel; Lazarini, Mariana; Fais, Viviane Cristina; Feltrin, Adriana; Gonçales, Neiva Sellan Lopes; Gonçales, Fernando Lopes

doi:10.1590/s1413-86702012000300003

Cited by 4 publications

(4 citation statements)

References 11 publications

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“…Another intriguing finding from the current study was that 100% (4/4) of HCV genotype 2-infected patients achieved SVR while less than 50% (4/9) of HCV genotype 1-infected patients achieved SVR. Although the number of eligible cases examined was exceedingly small, the antiviral treatment results are similar to those previously reported for larger cohorts of patients without thrombocytopenia, 13 , 14 suggesting that splenectomy does not reduce the antiviral efficacy of IFN-based treatment.…”

supporting

confidence: 78%

Splenectomy prior to antiviral therapy in patients with hepatitis C virus related decompensated cirrhosis

Ji¹,

Zhang²,

Huang³

et al. 2013

The Brazilian Journal of Infectious Diseases

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Patients with hepatitis C virus-related decompensated cirrhosis can benefit from interferon-based antiviral therapy, but the common complication of cytopenia is a contraindication for this treatment. Splenectomy prior to interferon therapy may alleviate this problem. To investigate whether splenectomy improves the efficacy of antiviral therapy, 13 interferon-naïve hepatitis C virus decompensated cirrhotic patients underwent splenectomy between January 2008 and January 2011, followed 1-3 months later by an interferon-based therapeutic regimen (pegylated/standard interferon-α combined with ribavirin for 48 weeks). Ten (76.9%) of the patients developed postoperative complications, which included minor portal vein thrombosis (2/13, 15.4%) and transient ascites (8/13, 61.5%). At one-month post-splenectomy, the patients showed significantly increased platelet (pre-surgery: 48.2±15.9 vs. 186.0±70.6×10(3)μL(-1), p<0.001) and leukocyte (2.1±0.5 vs. 5.7±1.4×10(3)μL(-1), p<0.001) counts. Eight (61.5%) of the patients achieved sustained virological response, including all HCV genotype 2a-infected patients (4/4, 100%) and some of the genotype 1b-infected patients (4/9, 44.4%). Temporary interferon-α suspension was required for one patient to address severe intestinal infection. These results indicate that splenectomy prior to interferon-based therapy was safe and may facilitate adherence to subsequent antiviral therapy in selected HCV cirrhotic patients with portal hypertension and hypersplenism.

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supporting

confidence: 78%

Splenectomy prior to antiviral therapy in patients with hepatitis C virus related decompensated cirrhosis

Ji¹,

Zhang²,

Huang³

et al. 2013

The Brazilian Journal of Infectious Diseases

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“…Recently, a study evaluating the comparison of two treatments for patients with Hepatitis C Virus (HCV) genotypes 2 and 3 of infection, using a biosimilar standard alpha-interferon (IFN) plus ribavirin (RBV) and the second one using pegylated interferon (Peg-INF) plus RBV, was performed by researchers from the State University of Campinas (Unicamp). In this study, it was observed that the treatment with Peg-INF was more efficient on causing sustained virological response (SVR) in the patients analyzed than when the biosimilar INF was applied, concluding that, in this case, the biosimilar molecules was not the best option for the treatment of patients with HCV genotypes 2 and 3 [62].…”

Section: Biopharmaceuticals and Biosimilars In Brazilmentioning

confidence: 86%

Biopharmaceutical and Biosimilar Products in Brazil: From Political To Biotechnological Overview

Basso¹

2013

J Bioequiv Availab

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According to the World Health Organization (WHO), one third of the world's population don't have the necessary access to pharmaceutical products, including essential drugs. In Brazil, the Governmental Health System (SUS) distributes some medicaments for free to the population. They were, then, classified into three categories in the country: basic, strategic and specialized components. Among these categories, the last one is highlighted due to the expensive costs of its products, which are essential for the treatment of rare and specific diseases. For this reason, the Ministry of Health created, in 1993, the Program for Specialized Medicaments, where all the drugs included in this category were distributed for free through Clinics and Hospitals. During the first year of this Program's implementation, there were 15 different items distributed into 31 distinct presentations. Nowadays, the list expanded to 150 different items dispensed into 310 presentations. Hence, the availability of imported pharmaceutical products in Brazil overloaded the expenses by the Brazilian Ministry of Health. Only during 2011, US$ 1.5 billion were spent on these products, where 30% of this amount was related to specialized ones. In order to reduce costs, the Brazilian Federal Government developed, in 2004, the Technological Innovation Law. According to the Decree number 6.041, the National Politics for Biotechnology and the National Committee of Biotechnology were created in order to stimulate the development of Biotechnology for human health, targeting mainly the national production of biopharmaceuticals. Furthermore, the end of patents for several medicaments during the last 5 years enhanced the motivation for national production of new drugs. In this way, some Governmental Institutions, in partnership with International Pharmaceutical Industries, started developing the first biosimilar molecules. Therefore, this report describes the evolution of Biotechnology in Brazil, relating the laws, regulations and Programs created along the last 20 years for Human Health application.

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“…Sobre lo antes mencionado, hay que señalar el hecho de que en Brasil los pacientes de genotipo no 1 solo pueden recibir Peg-IFN si presentan fibrosis avanzada, los otros solo pueden ser tratados con IFN biosimilar estándar, el cual es más barato en términos de salud pública pero ha demostrado ser peor que el Peg-IFN en eficacia. Vigani y colaboradores han demostrado que el Peg-IFN + RBV está asociado con mayores tasas de RVS cuando se compara con el IFN biosimilar estándar independientemente de la etapa de la fibrosis (79,3% versus 49,1%, p = 0,0001) (9).…”

Section: Discussionunclassified

¿Cuál es el perfil de los pacientes en espera de nuevos tratamientos para la hepatitis C?

Peruchi

Bansho

Tonon

et al. 2016

Rev. Colomb. Gastroenterol.

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Introducción: hasta hace poco, el tratamiento estándar de oro para la hepatitis C eran los interferones pegilados (Peg-IFN) en combinación con la ribavirina (RBV). Con la llegada de nuevos fármacos, se propuso evaluar los resultados del tratamiento y a los pacientes en espera de la nueva terapia. Materiales y métodos: este estudio analítico transversal evaluó el resultado del tratamiento en individuos con hepatitis C crónica, y luego comparó a individuos que tienen experiencia en no responder al tratamiento basado en interferón (IFN) con individuos sin experiencia de tratamiento previo. Resultados: el estudio incluyó 192 individuos. Entre 87 pacientes sometidos a tratamiento, se observaron bajas tasas de respuesta viral sostenida (RVS). La comparación de los 105 pacientes no tratados previamen- te y los 87 que habían recibido tratamiento con IFN previamente evidenció que entre los pacientes en espera de nuevas terapias, los individuos sin tratamiento previo presentaron mayor proporción de genotipo 1 (68% frente a 49%; p = 0,028), menores niveles de ALT (91,1 ± 73,0 frente a 126,0 ± 73,40 U/L; p = 017), de AST (70,1 ± 51,3 frente a 89,7 ± 47,40 U/L; p = 050), de GGT (85,3 ± 85,1 frente a 148,4 ± 123,9 U/L; p = 0,007) y menor proporción de fibrosis significativa (24,3 frente a 83,3; p <0,001). Conclusiones: las tasas de RVS fueron bajas. La mayoría de posibles candidatos para el tratamiento por VHC no lo han tenido y son de genótipo-1 con histología leve.

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Therapeutic effectiveness of biosimilar standard interferon versus pegylated interferon for chronic hepatitis C genotypes 2 or 3

Abstract: In patients with HCV genotypes 2 or 3 infection, a higher SVR was observed in patients receiving Peg-IFN plus RBV related to patients treated with biosimilar standard IFN plus RBV.

Cited by 4 publications

References 11 publications

Splenectomy prior to antiviral therapy in patients with hepatitis C virus related decompensated cirrhosis

Splenectomy prior to antiviral therapy in patients with hepatitis C virus related decompensated cirrhosis

Biopharmaceutical and Biosimilar Products in Brazil: From Political To Biotechnological Overview

¿Cuál es el perfil de los pacientes en espera de nuevos tratamientos para la hepatitis C?

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