EASL- Eltrombopag Increases Platelet Counts During HCV Treatment in Patients With Thrombocytopenia

By Chris Berrie

BARCELONA, Spain -- April 25, 2012 -- Eltrombopag increases and maintains platelet counts throughout treatment with pegylated interferon (PEG IFN) alfa-2b and ribavirin (RBV) among patients with thrombocytopenia and chronic hepatitis C virus (HCV) who would otherwise be ineligible for antiviral therapy.

In addition, eltrombopag was associated with clinically meaningful improvement in sustained virological response (SVR), researchers said here April 20 at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL).

However, there was an increased incidence of thromboembolic complications with eltrombopag treatment, which requires further analysis, according to Geoffrey Dusheiko, MD, Royal Free Hospital, London, United Kingdom, and colleagues.

Thrombocytopenia limits the ability of many patients with cirrhosis and HCV to initiate and maintain PEG-IFN alfa-2b/RBV therapy. PEG IFN alfa-2b is not recommended for patients with platelets <100 Gi/L.

In the first part of the study, patients with HCV and platelets <75 Gi/Lreceived eltrombopag 25 mg (increased to 50, 75, or 100 mg daily until platelets reached ≥100 Gi/L). For the second part of the study, patients eligible for PEG-IFN alfa-2b/RBV were randomised to receive eltrombopag (n =506) or placebo (n = 253).

Treatment was administered for 24 weeks or 48 weeks according to genotype. The primary endpoint was SVR.

Compared with placebo, eltrombopag was associated with improved SVR (19% vs13%; P =.0202), fewer antiviral dose reductions (P=.0001), improved early virological response (62% vs 41%; P <.0001),and end-of-treatment response (38% vs 23%; P <.0001).

Patients with the lowest platelet counts at baseline and the highest viral load at screening showed the greatest benefits of eltrombopag treatment.

Serious adverse events occurred more often in the eltrombopag group than in the placebo group (20% vs 15%). More deaths occurred in the eltrombopag group (4% vs 2%).

Treatment with eltrombopag appeared to be associated with increased thromboembolic events (4% vs <1%), including portal vein thrombosis (2% vs 0%),and events suggestive of progressive liver disease (13% vs 6%).

We had higher rates of thromboembolic events and transient hepatobiliary events in the eltrombopag arm, and this would require evaluation in this group of patients in need of treatment,ö concluded Dr. Dusheiko.

Funding for this study was provided by GlaxoSmithKline.
[Presentation title: Results of ENABLE 2, a Phase 3, Placebo-Controlled, Multicenter Study of Eltrombopag, Peginterferon Alfa-2b, and Ribavirin Treatment in Patients With Hepatitis C and Thrombocytopenia. Abstract 060]

Source: DGNews