Pre-op avatrombopag curbs platelet need in patients with liver disease

Last Updated: 2018-06-04

By Reuters Staff

NEW YORK (Reuters Health) - Pre-procedural avatrombopag (Doptelet, Dova) may reduce the need for platelet transfusions or rescue procedures for bleeding in patients with chronic liver disease (CLD) and thrombocytopenia, according to findings from two phase 3 trials.

In a paper online May 17 in Gastroenterology, Dr. Norah Terrault of the University of California, San Francisco, and colleagues note that such patients may require platelet transfusions before scheduled procedures to decrease the risk of bleeding.

Avatrombopag is a thrombopoietin-receptor agonist developed to boost platelet counts without transfusions. The U.S. Food and Drug Administration approved the drug for treating thrombocytopenia in patients with CLD on May 21.

The researchers conducted two studies in which a total of 435 patients were randomized in a 2:1 fashion to five daily doses of 40 mg or 60 mg of avatrombopag (depending on baseline platelet count) or to placebo. The primary endpoint was the proportion of patients not requiring platelet transfusion or rescue procedures for bleeding up to seven days after the scheduled procedure.

In the first study, ADAPT-1, 65.6% of patients who received avatrombopag 60 mg reached this endpoint compared to 22.9% of placebo patients. Corresponding proportions with 40 mg of the active agent were 88.1% and 38.2% (P<0.001 for both).

In the second study, ADAPT-2, 68.6% of the 60 mg group met the primary endpoint compared with 34.9% of placebo patients. This was true of 87.9% of the 40 mg group compare to 33.3% of those who received placebo (P<0.001 for both).

The findings "strongly support a positive benefit-risk profile of avatrombopag, and offers the opportunity to change the standard of care for the treatment of thrombocytopenia in patients with CLD who are scheduled to undergo a procedure and for whom the clinician has decided an increased platelet count is required," the researchers write.

"Avatrombopag," they conclude, "may provide physicians with a safe and effective alternative to platelet transfusions, simplifying the clinical management of these patients."

One of the authors of the study is an employee of Dova Pharmaceuticals, which also funded manuscript preparation.

Dr. Terrault did not respond to requests for comments.

SOURCE: https://bit.ly/2Hihgub

Gastroenterology 2018.