Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C

John G. McHutchison, Geoffrey Dusheiko, Mitchell L. Shiffman, Maribel Rodriguez-Torres, Samuel H. Sigal, Marc Bourliere, Thomas Berg, Stuart C. Gordon, Fiona M. Campbell, Dickens Theodore, Nicole Blackman, Julian Jenkins, Nezam H. Afdhal

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Abstract

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.)

Original languageEnglish (US)
Pages (from-to)2227-2236
Number of pages10
JournalNew England Journal of Medicine
Volume357
Issue number22
DOIs
StatePublished - Nov 29 2007
Externally publishedYes

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Hepatitis C
Thrombocytopenia
Fibrosis
Placebos
Platelet Count
Hepacivirus
Antiviral Agents
eltrombopag
Therapeutics
Thrombopoietin Receptors
Thrombopoiesis
Ribavirin
Virus Diseases
Interferons
Headache

ASJC Scopus subject areas

  • Medicine(all)

Cite this

McHutchison, J. G., Dusheiko, G., Shiffman, M. L., Rodriguez-Torres, M., Sigal, S. H., Bourliere, M., ... Afdhal, N. H. (2007). Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. New England Journal of Medicine, 357(22), 2227-2236. https://doi.org/10.1056/NEJMoa073255

Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. / McHutchison, John G.; Dusheiko, Geoffrey; Shiffman, Mitchell L.; Rodriguez-Torres, Maribel; Sigal, Samuel H.; Bourliere, Marc; Berg, Thomas; Gordon, Stuart C.; Campbell, Fiona M.; Theodore, Dickens; Blackman, Nicole; Jenkins, Julian; Afdhal, Nezam H.

In: New England Journal of Medicine, Vol. 357, No. 22, 29.11.2007, p. 2227-2236.

Research output: Contribution to journalArticle

McHutchison, JG, Dusheiko, G, Shiffman, ML, Rodriguez-Torres, M, Sigal, SH, Bourliere, M, Berg, T, Gordon, SC, Campbell, FM, Theodore, D, Blackman, N, Jenkins, J & Afdhal, NH 2007, 'Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C', New England Journal of Medicine, vol. 357, no. 22, pp. 2227-2236. https://doi.org/10.1056/NEJMoa073255
McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal SH, Bourliere M et al. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. New England Journal of Medicine. 2007 Nov 29;357(22):2227-2236. https://doi.org/10.1056/NEJMoa073255
McHutchison, John G. ; Dusheiko, Geoffrey ; Shiffman, Mitchell L. ; Rodriguez-Torres, Maribel ; Sigal, Samuel H. ; Bourliere, Marc ; Berg, Thomas ; Gordon, Stuart C. ; Campbell, Fiona M. ; Theodore, Dickens ; Blackman, Nicole ; Jenkins, Julian ; Afdhal, Nezam H. / Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. In: New England Journal of Medicine. 2007 ; Vol. 357, No. 22. pp. 2227-2236.
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AU - Sigal, Samuel H.

AU - Bourliere, Marc

AU - Berg, Thomas

AU - Gordon, Stuart C.

AU - Campbell, Fiona M.

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AU - Jenkins, Julian

AU - Afdhal, Nezam H.

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N2 - 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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