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

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

doi:10.1016/S1413-8670(12)70316-1

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Abstract

Background

Pegylated interferon (Peg-IFN) and standard interferon (IFN) play a significant role in the treatment of hepatitis C virus (HCV) infection. Biosimilar standard IFN is widely available in Brazil for the treatment of HCV infection genotypes 2 or 3, but its efficacy compared to Peg-IFN is unknown.

Objective

To compare the sustained virological response (SVR) rates following treatment with biosimilar standard IFN plus ribavirin (RBV) versus Peg-IFN plus RBV in patients with HCV genotypes 2 or 3 infection.

Methods

A retrospective cohort study was conducted in patients with HCV genotypes 2 or 3 infection treated with biosimilar standard IFN plus RBV or with Peg-IFN plus RBV. SVR rates of the two treatments were compared.

Results

From January 2005 to December 2010, 172 patients with a mean age of 44 +/− 9.3 years were included. There were eight (4.7%) patients with HCV genotype 2 infections. One hundred fourteen (66.3%) were treated with biosimilar standard IFN plus RBV, whist 58 (33.7%) patients were treated with Peg-IFN plus RBV. Between the two groups, there were no significant differences regarding age, gender, glucose level, platelet count, hepatic necroinflammatory grade, and hepatic fibrosis stage. Overall, 59.3% (102/172) patients had SVR. In patients treated with Peg-IFN plus RBV, 79.3% (46/58) had SVR compared to 49.1% (56/114) among those treated with biosimilar standard IFN plus RBV (p=0.0001).

Conclusion

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.

Keywords:

Interferons

Hepatitis C

Treatment outcome

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References

[1.]

W.R. Kim, R.S. Brown Jr., N.A. Terrault, H. El-Serag.

Burden of liver disease in the United States: summary of a workshop.

Hepatology, 36 (2002), pp. 227-242

http://dx.doi.org/10.1053/jhep.2002.34734 | Medline

[2.]

W.C. Grant, R.R. Jhaveri, J.G. McHutchison, K.A. Schulman, T.L. Kauf.

Trends in health care resource use for hepatitis C virus infection in the United States.

Hepatology, 42 (2005), pp. 1406-1413

http://dx.doi.org/10.1002/hep.20941 | Medline

[3.]

E.J. Bini, S. Mehandru.

Sustained virological response rates and health-related quality of life after interferon and ribavirin therapy in patients with chronic hepatitis C virus infection and persistently normal alanine aminotransferase levels.

Aliment Pharmacol Ther, 23 (2006), pp. 777-785

http://dx.doi.org/10.1111/j.1365-2036.2006.02819.x | Medline

[4.]

T. Poynard, J. McHutchison, M. Manns, et al.

Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C.

Gastroenterology, 122 (2002), pp. 1303-1313

Medline

[5.]

M.P. Manns, J.G. McHutchison, S.C. Gordon, et al.

Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial.

Lancet, 358 (2001), pp. 958-965

Medline

[6.]

M.W. Fried, M.L. Shiffman, K.R. Reddy, et al.

Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection.

N Engl J Med, 347 (2002), pp. 975-982

http://dx.doi.org/10.1056/NEJMoa020047 | Medline

[7.]

Ministério da Saúde (Brasil).

Portaria 639. Anexo I: Protocolo clínico e diretrizes terapêuticas da hepatite viral crônica tipo C.

Diário Oficial da União, DF, (2000), pp. 34

[8.]

Clinical guidelines for hepatitis C 2007, Dispõe sobre o Protocolo Clínico e Diretrizes Terapêuticas para Hepatite Viral C. 2007. Report N°: Portaria N° 34, de 28 de setembro de 2007; ID6065503-0. Brasil: Ministério da Saúde. Secretaria de Vigilância em Saúde. Departamento de DST AeHVPN.

[9.]

P. Bedossa, T. Poynard, The METAVIR cooperative study group.

An algorithm for the grading of activity in chronic hepatitis C.

Hepatology, 24 (1996), pp. 289-293

http://dx.doi.org/10.1002/hep.510240201 | Medline

[10.]

D. Ge, J. Fellay, A.J. Thompson, et al.

Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance.

Nature, 461 (2009), pp. 399-401

http://dx.doi.org/10.1038/nature08309 | Medline

[11.]

G.L. Davis, J.B. Wong, J.G. McHutchison, M.P. Manns, J. Harvey, J. Albrecht.

Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C.

Hepatology, 38 (2003), pp. 645-652

http://dx.doi.org/10.1053/jhep.2003.50364 | Medline

[12.]

I.M. Jacobson, R.S. Brown Jr., B. Freilich, et al.

Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial.

Hepatology, 46 (2007), pp. 971-981

http://dx.doi.org/10.1002/hep.21932 | Medline

[13.]

N. Khokhar.

Effectiveness of 48 weeks interferon alfa-2b in combination with ribavirin as initial treatment of chronic hepatitis.

J Ayub Med Coll Abbottabad, 14 (2002), pp. 5-8

Medline

[14.]

M.G. Rumi, A. Aghemo, R. D’Ambrosio, et al.

Lack of rapid virological response predicts interferon-alpha2b/ribavirin therapy failure in HCV genotype 2 patients: a single-centre study.

Antivir Ther, 12 (2007), pp. 1033-1040

Medline

[15.]

R.N. Acras, M.L. Pedroso, L.C. Caum, J.C. Pisani, H.M. Amarante, E.R. Carmes.

The sustained response rates for chronic hepatitis C patients undergoing therapy with the several interferons and ribavarins supplied by Brazilians Health Ministry is comparable to those reported in the literature.

Arq Gastroenterol, 41 (2004), pp. 3-9

http://dx.doi.org//S0004-28032004000100002 | Medline

[16.]

A.V. Alves, A.P. de Azevedo, C. Perin, et al.

Interferon-alpha and ribavirin therapy on chronic hepatitis C virus infection: the experience of Rio Grande do Sul State Health Department, Brazil.

Arq Gastroenterol, 40 (2003), pp. 227-232

http://dx.doi.org//S0004-28032003000400006 | Medline

[17.]

E.R. Parise, A.C. de Oliveira, R.D. Conceição, A.C. Amaral, K. Leite.

Response to treatment with interferon-alpha and ribavirin in patients with chronic hepatitis C virus genotypes 2 and 3 depends on the degree of hepatic fibrosis.

Braz J Infect Dis, 10 (2006), pp. 78-81

Medline

[18.]

F.L. Gonçales Jr., A. Vigani, N. Gonçales, et al.

Weight-based combination therapy with peginterferon alpha-2b and ribavirin for naïve, relapser and non-responder patients with chronic hepatitis C.

Braz J Infect Dis, 10 (2006), pp. 311-316

Medline

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