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Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C.

Publication ,  Journal Article
McHutchison, JG; Dusheiko, G; Shiffman, ML; Rodriguez-Torres, M; Sigal, S; Bourliere, M; Berg, T; Gordon, SC; Campbell, FM; Theodore, D ...
Published in: N Engl J Med
November 29, 2007

BACKGROUND: Eltrombopag is a new, orally active thrombopoietin-receptor agonist that stimulates thrombopoiesis. We evaluated its ability to increase platelet counts and facilitate treatment for hepatitis C virus (HCV) infection in patients with thrombocytopenia associated with HCV-related cirrhosis. METHODS: Seventy-four patients with HCV-related cirrhosis and platelet counts of 20,000 to less than 70,000 per cubic millimeter were randomly assigned to receive eltrombopag (30, 50, or 75 mg daily) or placebo daily for 4 weeks. The primary end point was a platelet count of 100,000 per cubic millimeter or more at week 4. Peginterferon and ribavirin could then be initiated, with continuation of eltrombopag or placebo for 12 additional weeks. RESULTS: At week 4, platelet counts were increased to 100,000 per cubic millimeter or more in a dose-dependent manner among patients for whom these data were available: in 0 of the 17 patients receiving placebo, in 9 of 12 (75%) receiving 30 mg of eltrombopag, in 15 of 19 (79%) receiving 50 mg of eltrombopag, and in 20 of 21 (95%) receiving 75 mg of eltrombopag (P<0.001). Antiviral therapy was initiated in 49 patients (in 4 of 18 patients receiving placebo, 10 of 14 receiving 30 mg of eltrombopag, 14 of 19 receiving 50 mg of eltrombopag, and 21 of 23 receiving 75 mg of eltrombopag) while the administration of eltrombopag or placebo was continued. Twelve weeks of antiviral therapy, with concurrent receipt of eltrombopag or placebo, were completed by 36%, 53%, and 65% of patients receiving 30 mg, 50 mg, and 75 mg of eltrombopag, respectively, and by 6% of patients in the placebo group. The most common adverse event during the initial 4 weeks was headache; thereafter, the adverse events were those expected with interferon-based therapy. CONCLUSIONS: Eltrombopag therapy increases platelet counts in patients with thrombocytopenia due to HCV-related cirrhosis, thereby permitting the initiation of antiviral therapy. (ClinicalTrials.gov number, NCT00110799.)

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 29, 2007

Volume

357

Issue

22

Start / End Page

2227 / 2236

Location

United States

Related Subject Headings

  • Thrombocytopenia
  • Recombinant Proteins
  • Receptors, Thrombopoietin
  • Pyrazoles
  • Polyethylene Glycols
  • Platelet Count
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Interferon-alpha
 

Citation

APA
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ICMJE
MLA
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McHutchison, J. G., Dusheiko, G., Shiffman, M. L., Rodriguez-Torres, M., Sigal, S., Bourliere, M., … TPL102357 Study Group, . (2007). Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med, 357(22), 2227–2236. https://doi.org/10.1056/NEJMoa073255
McHutchison, John G., Geoffrey Dusheiko, Mitchell L. Shiffman, Maribel Rodriguez-Torres, Samuel Sigal, Marc Bourliere, Thomas Berg, et al. “Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C.N Engl J Med 357, no. 22 (November 29, 2007): 2227–36. https://doi.org/10.1056/NEJMoa073255.
McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal S, Bourliere M, et al. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med. 2007 Nov 29;357(22):2227–36.
McHutchison, John G., et al. “Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C.N Engl J Med, vol. 357, no. 22, Nov. 2007, pp. 2227–36. Pubmed, doi:10.1056/NEJMoa073255.
McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal S, Bourliere M, Berg T, Gordon SC, Campbell FM, Theodore D, Blackman N, Jenkins J, Afdhal NH, TPL102357 Study Group. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med. 2007 Nov 29;357(22):2227–2236.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 29, 2007

Volume

357

Issue

22

Start / End Page

2227 / 2236

Location

United States

Related Subject Headings

  • Thrombocytopenia
  • Recombinant Proteins
  • Receptors, Thrombopoietin
  • Pyrazoles
  • Polyethylene Glycols
  • Platelet Count
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Interferon-alpha