Navigation Links
New Hepatitis C Drug Close to Gaining FDA Approval
Date:4/28/2011

THURSDAY, April 28 (HealthDay News) -- Boceprevir, a new medication from Merck & Co. that changes the way hepatitis C is treated, won unanimous support Wednesday from a panel of experts convened by the U.S. Food and Drug Administration.

The drug is one of two new medications against hepatitis C that are up for agency approval. Many experts believe that, if approved, boceprevir and the second medicine, telaprevir, could revolutionize treatment of hepatitis C-linked disease.

The U.S. Centers for Disease Control and Prevention estimated 17,000 new hepatitis C virus infections in the United States in 2007. Many people with the disease have no symptoms until it has caused liver damage, sometimes so severe that a liver transplant is needed.

Studies found that when used with two older drugs, boceprevir reduced levels of the virus more effectively than the existing treatments. Merck, headquartered in Whitehouse Station, N.J., hopes to sell the medication under the brand name Victrelis, according to Dow Jones.

Telaprevir, a similar drug made by Vertex Pharmaceuticals of Cambridge, Mass., is scheduled for review Thursday by the same panel of non-FDA experts.

Debra Birnkrant, director of FDA's antiviral-drugs division, said that both medications appear to increase the cure rate "to more than 30 percent above what we have today," Dow Jones reported.

The new drugs take treatment of hepatitis C in a new direction. Both boceprevir and telaprevir block protease, an enzyme that helps the virus reproduce. The earlier drugs, pegylated interferon and ribavirin, were meant to boost the immune system's defense against the virus. Together, the combined medications may offer new hope for the thousands of Americans with the contagious liver disease.

Asked if the available data supported use of boceprevir in combination with standard treatment of pegylated interferon and ribavirin, the panel of medical experts voted 18-0 in favor, Dow Jones reported. This is considered a recommendation to approve the drug.

Although FDA does not have to follow the panel's advice, it usually does.

One of the boceprevir studies found it effective for 66 percent of patients taking the three-drug regimen compared to 38 percent of those who received the standard two-drug treatment, Dow Jones said.

Some concerns still need to be addressed, including how to treat black patients, for whom the drugs seem to be less effective.

Studies submitted by the manufacturers showed the new drugs, when added to existing treatments, shortened the length of medication therapy, thereby reducing potential side effects. Patients currently require nearly 12 months of treatment.

Telaprevir's cure rates appear to be better than boceprevir's, the Associated Press reported.

Until the early 1990s, when testing of the nation's blood supply became routine, hepatitis C was often contracted from blood transfusions. Today it is most commonly associated with injection drug use. It is also transmitted through sexual contact with an infected person, the CDC said.

Earlier this year, a study from the Johns Hopkins School of Public Health called for greater efforts to reduce the population of hepatitis C-infected injection drug users. That study found that new cases of hepatitis C were decreasing only among younger injection drug users who had recently starting using the drugs.

More information

To learn more about hepatitis C, visit the U.S. National Library of Medicine.

-- HealthDay staff

SOURCES: U.S. Centers for Disease Control and Prevention; Associated Press


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. New screening system for hepatitis C
2. Groundbreaking research to find vaccine for hepatitis C
3. 1 in 5 At-Risk U.S. Babies Doesnt Get Hepatitis B Vaccine
4. Vaccination, Prevention Is Beating Back Hepatitis
5. Bipartisan Capitol Hill Media Event: Health Experts, Lawmakers to Urge Federal Government to Fix the Funding Failure for Chronic Viral Hepatitis
6. Hepatitis C treatment less effective in urban minority patients
7. Researchers identify potential new target for treating hepatitis C
8. Donor kidneys from Hepatitis C patients needlessly denied to patients with that infection
9. Henry Ford Hospital atudy: Hepatitis C infection doubles risk for kidney cancer
10. New Drug Shows Promise for Curing Hepatitis C
11. Hepatitis C Tied to Higher Kidney Cancer Risk
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... May 26, 2017 , ... Rob Lowe acts as ... production of the series is on hiking in American. Viewers can reconnect with America ... great benefits of hiking. , Many consumers have looked for an inventive new place ...
(Date:5/26/2017)... ... May 26, 2017 , ... “THE FLINTHILLS FAMILY-Our Journey to the Cross”: the personal journey of ... Cross” is the creation of published authors, Bob and Margaret Massey. Bob Massey is ... is "panther quick and leather tough." His love for others is apparent in all ...
(Date:5/26/2017)... ... ... Jack: Against All Odds”: the story of Coach Cactus Jack and the impact he ... creation of published author, Walter Hubbard, a retired wildlife and fisheries biologist and pharmacy ... Walter and Jane have three adult children and a granddaughter. Walter and ...
(Date:5/24/2017)... ... May 24, 2017 , ... In ... choosing the most appropriate instruments for research and understanding the basic principles that ... webinar will focus on innovations in stereo microscopy for brightfield and fluorescence typically ...
(Date:5/24/2017)... California (PRWEB) , ... May 24, 2017 , ... ... through innovative medical image management and interpretation, has received U.S. Food and Drug ... , Nucleus.io is a web-based, scalable and secure cloud platform for medical image ...
Breaking Medicine News(10 mins):
(Date:5/15/2017)... Inc., a privately-held CNS pharmaceutical company based in ... disease (PD), has enrolled the first patient in the RASMET ... study involving patients with PD and taking place at 12 ... period. The first stage is open label and involves single ... Denver , Boca Raton ...
(Date:5/10/2017)... Global Health Intelligence (GHI), the leading healthcare data analytics ... 2017 ranking of the Best-Equipped Hospitals in Latin America ... GHI,s hospitals database for Latin America , which is ... database covers 86% of the hospitals in Latin ... each institution in key areas such as beds, medical specialties, ...
(Date:5/9/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), ... has earned a spot on Forbes, "America,s ... ranked among 500 U.S. employers as well as in ... Services. The annual Forbes rankings ... of over 30,000 employees across 25 industries. The survey ...
Breaking Medicine Technology: