Eltrombopag Effective for Hepatitis C Patients With Low Blood-Platelet Counts

[Guest guest]

Eltrombopag Effective for Hepatitis C Patients With Low Blood-Platelet Counts

12/31/2007

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. Sigal, who led the

study at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York

City -- one of 22 study sites.

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.

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.

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 GlaxoKline; has received

research grant support, lecture fees, and consulting fees from GlaxoKline;

and reports equity ownership in the company.)

The current study was sponsored by GlaxoKline, 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. McHutchison, of the Duke

Clinical Research Institute, Durham, N.C. Additional participating institutions

included Royal Free Hospital, London; Virginia Commonwealth University Medical

Center, Richmond; Fundación de Investigación de Diego, San ; Hopital St.

ph, Marseille; Henry Ford Hospital and Health System, Detroit;

GlaxoKline; and Beth Israel Deaconess Medical Center, Boston.

Source: NewYork-Presbyterian Hospital/Weill Cornell Medical Center

http://www.infectioncontroltoday.com/hotnews/eltrombopag-effectiveness.html

_________________________________________________________________

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[Guest guest]

Eltrombopag Effective for Hepatitis C Patients With Low Blood-Platelet Counts

12/31/2007

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. Sigal, who led the

study at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York

City -- one of 22 study sites.

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.

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.

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 GlaxoKline; has received

research grant support, lecture fees, and consulting fees from GlaxoKline;

and reports equity ownership in the company.)

The current study was sponsored by GlaxoKline, 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. McHutchison, of the Duke

Clinical Research Institute, Durham, N.C. Additional participating institutions

included Royal Free Hospital, London; Virginia Commonwealth University Medical

Center, Richmond; Fundación de Investigación de Diego, San ; Hopital St.

ph, Marseille; Henry Ford Hospital and Health System, Detroit;

GlaxoKline; and Beth Israel Deaconess Medical Center, Boston.

Source: NewYork-Presbyterian Hospital/Weill Cornell Medical Center

http://www.infectioncontroltoday.com/hotnews/eltrombopag-effectiveness.html

_________________________________________________________________

Share life as it happens with the new Windows Live.

http://www.windowslive.com/share.html?ocid=TXT_TAGHM_Wave2_sharelife_122007