scholarly journals Poly-ε-caprolactone microspheres containing interferon alpha as alternative formulations for the treatment of chronic hepatitis C

2012 ◽  
Vol 48 (1) ◽  
pp. 51-59 ◽  
Author(s):  
Cristiane da Silva Melo ◽  
Bruno Gonçalves Pereira ◽  
Armando Silva-Cunha ◽  
Sílvia Ligório Fialho
Keyword(s):  
Particle Size ◽  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Cell Line ◽  
Chronic Hepatitis C ◽  
Interferon Alpha ◽  
Encapsulation Efficiency ◽  
Hepatic Cell ◽  
Ifn Alpha

Interferon-alpha (IFN-alpha) is one of the main drugs used in the treatment of hepatitis C. Use of IFN-alpha has some limitations that result in poor treatment efficacy and low patient compliance. Therefore, the aim of this study was to develop poly-ε-caprolactone (PCL) microspheres containing IFN-alpha as an alternative for the treatment of chronic hepatitis C. Microspheres were prepared using the multiple emulsion followed by solvent evaporation technique. Particle size, surface morphology, drug content and encapsulation efficiency of the microspheres produced were evaluated. The stability of the formulation was assessed after 90 days at -20ºC. An in vitro release study was performed in PBS. In vitro cytotoxicity of the formulation was studied using hepatic cell line. The freeze-dried microspheres had mean particle size, IFN-alpha content, and encapsulation efficiency of 38.52 ± 4.64 µm, 15.52 ± 3.28% and 83.93 ± 5.76%, respectively. There were no significant changes during storage and the structural integrity of the protein was not compromised by the preparation technique. A total of 82% of the IFN-alpha was released after 28 days and the developed microspheres did not present cytotoxicity to the hepatic cell line. In vivo studies are currently underway to evaluate the biological activity of IFN-alpha encapsulated into microspheres.

scholarly journals A randomized controlled trial of recombinant interferon-alpha in chronic hepatitis C in hemophiliacs

Blood ◽  
1991 ◽  
Vol 78 (7) ◽  
pp. 1672-1677 ◽  
Author(s):  
M Makris ◽  
FE Preston ◽  
DR Triger ◽  
JC Underwood ◽  
L Westlake ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Liver Disease ◽  
Hepatitis C ◽  
Liver Biopsy ◽  
Chronic Hepatitis C ◽  
Interferon Alpha ◽  
Recombinant Interferon ◽  
Randomized Controlled ◽  
Ifn Alpha ◽  
Recombinant Interferon Alpha

Chronic liver disease associated with hepatitis C virus (HCV) is an important cause of morbidity and mortality in hemophilia. We have used recombinant interferon alpha-2b (IFN alpha-2b) in a randomized controlled liver biopsy trial to treat hemophiliacs with chronic hepatitis. Eighteen patients entered the study, 16 of whom were subsequently shown to have antibodies to the HCV. All underwent liver biopsy at entry and were randomized to either treatment with self- administered IFN alpha-2b, 3 million units subcutaneously thrice weekly (n = 10) or no treatment (control group) (n = 8). Nine subjects had chronic active hepatitis, seven had chronic persistent hepatitis, and two had cirrhosis. Twelve months after entry into the study 17 patients underwent a second liver biopsy. All biopsies were coded, assessed, and scored according to the histologic severity of the liver disease. Ten patients were administered IFN for 1 year, and in four patients normalization of alanine aminotransferase (ALT) occurred compared with none in the untreated group. After the second liver biopsy, six of the eight initial no-treatment patients were treated with interferon 3 million units thrice weekly for 6 months, and normalization of ALT was seen in five patients. Biochemical relapse within 4 months of stopping IFN occurred in one of four patients treated for 1 year and in four of five patients treated for 6 months. IFN treatment was well tolerated. Although the histologic scores of the two groups were similar at entry into the study, after 12 months the biopsy appearances in the treated group were significantly improved compared with the controls (P less than .01). Histologic improvement was noted in the three interferon- treated human immunodeficiency virus antibody-positive patients and also in other patients who had no biochemical response. We conclude that low-dose recombinant IFN alpha is effective in normalizing transaminases and improving the histologic appearances in at least 50% of hemophiliacs with chronic hepatitis C.

scholarly journals A randomized controlled trial of recombinant interferon-alpha in chronic hepatitis C in hemophiliacs

Blood ◽  
1991 ◽  
Vol 78 (7) ◽  
pp. 1672-1677 ◽  
Author(s):  
M Makris ◽  
FE Preston ◽  
DR Triger ◽  
JC Underwood ◽  
L Westlake ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Liver Disease ◽  
Hepatitis C ◽  
Liver Biopsy ◽  
Chronic Hepatitis C ◽  
Interferon Alpha ◽  
Recombinant Interferon ◽  
Randomized Controlled ◽  
Ifn Alpha ◽  
Recombinant Interferon Alpha

Abstract Chronic liver disease associated with hepatitis C virus (HCV) is an important cause of morbidity and mortality in hemophilia. We have used recombinant interferon alpha-2b (IFN alpha-2b) in a randomized controlled liver biopsy trial to treat hemophiliacs with chronic hepatitis. Eighteen patients entered the study, 16 of whom were subsequently shown to have antibodies to the HCV. All underwent liver biopsy at entry and were randomized to either treatment with self- administered IFN alpha-2b, 3 million units subcutaneously thrice weekly (n = 10) or no treatment (control group) (n = 8). Nine subjects had chronic active hepatitis, seven had chronic persistent hepatitis, and two had cirrhosis. Twelve months after entry into the study 17 patients underwent a second liver biopsy. All biopsies were coded, assessed, and scored according to the histologic severity of the liver disease. Ten patients were administered IFN for 1 year, and in four patients normalization of alanine aminotransferase (ALT) occurred compared with none in the untreated group. After the second liver biopsy, six of the eight initial no-treatment patients were treated with interferon 3 million units thrice weekly for 6 months, and normalization of ALT was seen in five patients. Biochemical relapse within 4 months of stopping IFN occurred in one of four patients treated for 1 year and in four of five patients treated for 6 months. IFN treatment was well tolerated. Although the histologic scores of the two groups were similar at entry into the study, after 12 months the biopsy appearances in the treated group were significantly improved compared with the controls (P less than .01). Histologic improvement was noted in the three interferon- treated human immunodeficiency virus antibody-positive patients and also in other patients who had no biochemical response. We conclude that low-dose recombinant IFN alpha is effective in normalizing transaminases and improving the histologic appearances in at least 50% of hemophiliacs with chronic hepatitis C.

Interferon-alpha and Ribavirin in Treating Children and Young Adults With Chronic Hepatitis C After Malignancy

PEDIATRICS ◽  
2000 ◽  
Vol 106 (4) ◽  
pp. e53-e53 ◽  
Author(s):  
H. Lackner ◽  
A. Moser ◽  
J. Deutsch ◽  
H. H. Kessler ◽  
M. Benesch ◽  
...  
Keyword(s):  
Young Adults ◽  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Interferon Alpha ◽  
Children And Young Adults
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