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Farglitazar lacks antifibrotic activity in patients with chronic hepatitis C infection.

Publication ,  Journal Article
McHutchison, J; Goodman, Z; Patel, K; Makhlouf, H; Rodriguez-Torres, M; Shiffman, M; Rockey, D; Husa, P; Chuang, W-L; Levine, R; Jonas, M ...
Published in: Gastroenterology
April 2010

BACKGROUND & AIMS: Farglitazar (GI262570), an insulin-sensitizing agent, selectively binds and activates peroxisome proliferator-activated receptor gamma (PPARgamma) and inhibits stellate cell activation. We evaluated its antifibrotic effect in patients with chronic hepatitis C that did not respond to standard-of-care therapy. METHODS: Patients with fibrosis of Ishak stages 2-4 (n = 265), based on analysis of liver biopsy samples, were randomly assigned to groups given once-daily doses of 0.5 mg farglitazar, 1.0 mg farglitazar, or placebo for 52 weeks; repeat liver biopsy samples were then obtained. The primary end points were changes in levels of alpha-smooth muscle actin (SMA) expression and collagen, based on morphometry and ranked histologic assessments. RESULTS: Two hundred nine patients had paired biopsy specimens adequate for analysis (81.5% with pretreatment Ishak scores of stage 2 or 3). There was no overall difference in SMA (P = .58) or collagen (P = .99) levels at week 52. SMA levels increased by a median of 49% in samples from patients given placebo, 58% in patients given 0.5 mg farglitizar and 52% in patients given 1.0 mg farglitizar, respectively. Collagen increased by 27% in placebo samples and 31% in samples from patients given either dose of farglitizar. There were no significant differences between treatment groups in the ranked assessment of paired biopsy specimens or in the proportion of patients with a change in fibrosis score > or = Ishak stage. CONCLUSIONS: In patients with chronic hepatitis C and moderate fibrosis, 52 weeks of treatment with farglitazar does not affect stellate cell activation or fibrosis (measured by morphometry or comparison of paired biopsy specimens).

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Published In

Gastroenterology

DOI

EISSN

1528-0012

Publication Date

April 2010

Volume

138

Issue

4

Start / End Page

1365 / 1373.e2

Location

United States

Related Subject Headings

  • Tyrosine
  • PPAR gamma
  • Oxazoles
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Liver
  • Humans
  • Hepatitis C, Chronic
  • Gastroenterology & Hepatology
 

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McHutchison, J., Goodman, Z., Patel, K., Makhlouf, H., Rodriguez-Torres, M., Shiffman, M., … Farglitizar Study Investigators, . (2010). Farglitazar lacks antifibrotic activity in patients with chronic hepatitis C infection. Gastroenterology, 138(4), 1365-1373.e2. https://doi.org/10.1053/j.gastro.2009.12.003
McHutchison, John, Zachary Goodman, Keyur Patel, Hala Makhlouf, Maribel Rodriguez-Torres, Mitchell Shiffman, Don Rockey, et al. “Farglitazar lacks antifibrotic activity in patients with chronic hepatitis C infection.Gastroenterology 138, no. 4 (April 2010): 1365-1373.e2. https://doi.org/10.1053/j.gastro.2009.12.003.
McHutchison J, Goodman Z, Patel K, Makhlouf H, Rodriguez-Torres M, Shiffman M, et al. Farglitazar lacks antifibrotic activity in patients with chronic hepatitis C infection. Gastroenterology. 2010 Apr;138(4):1365-1373.e2.
McHutchison, John, et al. “Farglitazar lacks antifibrotic activity in patients with chronic hepatitis C infection.Gastroenterology, vol. 138, no. 4, Apr. 2010, pp. 1365-1373.e2. Pubmed, doi:10.1053/j.gastro.2009.12.003.
McHutchison J, Goodman Z, Patel K, Makhlouf H, Rodriguez-Torres M, Shiffman M, Rockey D, Husa P, Chuang W-L, Levine R, Jonas M, Theodore D, Brigandi R, Webster A, Schultz M, Watson H, Stancil B, Gardner S, Farglitizar Study Investigators. Farglitazar lacks antifibrotic activity in patients with chronic hepatitis C infection. Gastroenterology. 2010 Apr;138(4):1365-1373.e2.
Journal cover image

Published In

Gastroenterology

DOI

EISSN

1528-0012

Publication Date

April 2010

Volume

138

Issue

4

Start / End Page

1365 / 1373.e2

Location

United States

Related Subject Headings

  • Tyrosine
  • PPAR gamma
  • Oxazoles
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Liver
  • Humans
  • Hepatitis C, Chronic
  • Gastroenterology & Hepatology