Patients in the eltrombopag group had a higher rate of events suggestive of progressive liver disease, 13% vs. 8%. However, "the majority of these events are those that are typical of patients with chronic liver disease," he noted. "In addition, what we did see is that there was no change throughout the study in either arm in MELD [Model for End-stage Liver Disease] score, Child-Pugh score, albumin, bilirubin, INR [international normalized ratio], or any of the standard parameters."
Patients in the trial were rigorously monitored for portal vein thrombosis with serial ultrasound and Doppler imaging, according to Dr. Afdhal. The rare thromboses detected were evident only on ultrasound, except for a single clinical thrombosis in a patient in the placebo group who had a tumor invading the portal vein.
"Unlike what we have previously presented, where there was a significant correlation between the elevation of thrombocytes and portal vein thrombosis, there is no easily apparent association here," he noted. "Many of these events took place in patients with platelet counts of less than 50,000, and many of these took place after the study was over."
Dr. Afdhal reported that he receives research support from Merck, Novartis, GlaxoSmithKline, Echosens, Vertex, Gilead, Quest, Pharmasset, and Abbott, and is an adviser to Gilead, Echosens, Biogen, Vertex, Novartis, Idera Pharmaceuticals, Boehringer Ingelheim, Human Genome Sciences, Biolex, FibroGen, Ligand, Spring Bank, Synexis, and GlaxoSmithKline, which manufactures Promacta.