Drug effective for hepatitis C patients with low platelets Medical
Studies/Trials Published: Wednesday, 2-Jan-2008 Printer
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For patients with hepatitis C, having a low blood platelet
count is a frequent complication associated with advanced disease. This problem
is compounded by the fact that standard antiviral treatment for the disease can
further reduce platelet numbers to dangerously low levels, effectively denying
these patients the treatment they urgently need. Now, research published in the
New England Journal of Medicine finds that a new drug, eltrombopag, appears to
significantly boost platelet counts, opening the door to effective treatment.
"In this study, eltrombopag increased platelet counts in a dose-dependent
manner, allowing more patients to complete the first 12 weeks of antiviral
therapy -- an important treatment goal," says Dr. Samuel Sigal, who led the
study at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York
City -- one of 22 study sites.
Dr. Sigal is assistant professor of medicine in the Division of
Gastroenterology and Hepatology at Weill Cornell Medical College and assistant
attending hepatologist in the Center for Liver Diseases and Transplantation at
NewYork-Presbyterian/Weill Cornell.
The Phase 2 placebo-controlled study followed 74 patients with low platelet
counts and cirrhosis of the liver due to hepatitis C virus (HCV) infection.
Seventy-four percent of those randomized to take the lowest dose (30 milligrams
daily) saw their platelet counts go up significantly, while 79 percent and 95
percent of the participants saw increases with the higher doses (50 or 75
milligrams daily, respectively). And, 12 weeks of antiviral therapy were
completed by 36, 53 and 65 percent of patients at the three dose levels -- with
increased numbers matched to the size of the dose. Underlining the trend, less
than a quarter of patients receiving placebo completed their therapy.
The study identified side effects -- including headaches, dry mouth, abdominal
pain and nausea. None were serious enough to discontinue the therapy.
It's estimated that 4 million people in the U.S. and 170 million worldwide
carry the hepatitis C virus. HCV is transmitted primarily by blood and blood
products. The majority of infected individuals have either received blood
transfusions prior to 1990 (when screening of the blood supply for HCV was
implemented) or have used intravenous drugs. More rarely, it can also be
transmitted through sexual intercourse and perinatally (mother to baby).
The virus causes inflammation and scarring in the liver, and while it is
curable in about half of those who have it, it can lead to significant liver
damage, liver cancer and death in others. HCV infection is a common cause of
cirrhosis and the most common reason for a liver transplant.
With other eltrombopag findings, NewYork-Presbyterian/Weill Cornell's Dr.
James Bussel led research, also reported in the New England Journal of Medicine
, finding the platelet growth factor successfully increased platelet counts and
decreased bleeding in patients with Immune Thrombocytopenic Purpura (ITP), an
autoimmune disease that dramatically reduces the number of platelets in their
blood. (Dr. Bussel is an Advisory Board Member for GlaxoSmithKline; has received
research grant support, lecture fees, and consulting fees from GlaxoSmithKline;
and reports equity ownership in the company.)
The current study was sponsored by GlaxoSmithKline, which is developing
eltrombopag. Eltrombopag (marketed as Promacta in the U.S. and Revolade in
Europe) is an investigational oral, non-peptide platelet growth factor that
induces the proliferation and differentiation of cells to produce platelets.
While other drugs that restore normal platelet functions are infusions or
injections, eltrombopag is a once-a-day pill.
The study's principal investigator was Dr. John McHutchison, of the Duke
Clinical Research Institute, Durham, N.C. Additional participating institutions
included Royal Free Hospital, London; Virginia Commonwealth University Medical
Center, Richmond; Fundaci?e Investigaci?e Diego, San Juan; Hopital St. Joseph,
Marseille; Henry Ford Hospital and Health System, Detroit; GlaxoSmithKline; and
Beth Israel Deaconess Medical Center, Boston.
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