Eltrombopag for Thrombocytopenia in Patients with Cirrhosis Associated with Hepatitis C－快樂小藥師 Im pharmacist nichts glücklich

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.)