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Previous Volume 357:2227-2236 November 29, 2007 Number 22 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set CME Exam Editorial by Schwartz, R. S. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

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 [ClinicalTrials.gov] .)

Source Information

From Duke University and Duke Clinical Research Institute, Durham, NC (J.G.M.); Royal Free Hospital, London (G.D.); Virginia Commonwealth University Medical Center, Richmond (M.L.S.); Fundación de Investigación de Diego, San Juan, Puerto Rico (M.R.-T.); Weill Medical College of Cornell University, New York (S.S.); Hôpital Saint Joseph, Marseille, France (M.B.); Charité, Berlin (T.B.); Henry Ford Hospital and Health System, Detroit (S.C.G.); GlaxoSmithKline, Greenford, United Kingdom (F.M.C.); GlaxoSmithKline, Research Triangle Park, NC (D.T.); GlaxoSmithKline, Philadelphia (N.B., J.J.); and Beth Israel Deaconess Medical Center, Boston (N.H.A.).

Address reprint requests to Dr. McHutchison at Duke University and Duke Clinical Research Institute, P.O. Box 17969, Durham, NC 27705, or at mchut001{at}mc.duke.edu.

Full Text of this Article

Related Letters:

Eltrombopag in Thrombocytopenia
Lawson A., Zimmer J., Hentges F., Andrès E., McHutchison J. G., Bussel J. B., Stone N. L., Arning M.
Extract | Full Text | PDF  
N Engl J Med 2008; 358:1072-1073, Mar 6, 2008. Correspondence

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