Navigation Links
FDA Approves Victrelis for Hepatitis C
Date:5/13/2011

SILVER SPRING, Md., May 13, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.

When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.

Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.

"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."

According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.

Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.

Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.

People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.

Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.

The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).

Victrelis is marketed by Whitehouse Station, N.J.-based Merck.

For more information:

FDA: Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

FDA: What's New at FDA in Hepatitis
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htm

FDA: Hepatitis C Tests
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125785.htm

CDC: Hepatitis C Information for the Public

http://www.cdc.gov/hepatitis/C/index.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves New Treatment for Rare Type of Pancreatic Cancer
2. FDA Approves Novartis Drug Afinitor to Treat Pancreatic Neuroendocrine Tumors
3. FDA Approves Tradjenta™ (linagliptin) Tablets for the Treatment of Type 2 Diabetes
4. FDA Approves New Treatment for Type 2 Diabetes
5. FDA Approves Zytiga for Late-Stage Prostate Cancer
6. FDA Approves Updated, Clarified Indication for Use for iFuse Implant System®
7. FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
8. FDA Approves the First Vaccine to Prevent Meningococcal Disease in Infants and Toddlers
9. FDA Approves Actemra to Treat Rare Form of Juvenile Arthritis
10. FDA Approves New Medical Device for Form of Brain Cancer
11. FDA Approves the NovoTTF-100A System for the Treatment of Patients With Recurrent Glioblastoma Multiforme (GBM) Brain Tumors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/1/2017)... 1, 2017 Nutriceutical Holdings (NH), parent company ... (VRS), and KD Pharma Group have decided to join ... KD Pharma Group. KD Pharma Group will become the ... acquire the entire company. "We believe we ... committed to growing the NH companies by providing us ...
(Date:5/29/2017)... Israel, May 29, 2017  Cellect Biotechnology Ltd. (NASDAQ: ... technology which enables the functional selection of stem cells, ... for the first quarter ended March 31 st , ... our accomplishments in the first quarter of 2017," said ... quarter, we announced the treatment of the first blood ...
(Date:5/23/2017)...  Leaf Healthcare, recognized for developing one of ... ulcer prevention, will unveil its comprehensive mobility monitoring ... Nurses, National Teaching Institute and Critical Care Exposition ... Patient Monitoring System is the first mobility monitoring ... system seamlessly tracks patient movement throughout the mobility ...
Breaking Medicine Technology:
(Date:6/24/2017)... ... June 24, 2017 , ... Dr. ... 217 Portion Road in Lake Ronkonkoma, Dental365 offers patients high-quality and affordable routine ... visits to the dentist fit into their patients’ busy lifestyles. Dental365 also gladly ...
(Date:6/23/2017)... VA (PRWEB) , ... June 23, 2017 , ... ... of what is needed and will ultimately do significant harm to people with ... to everyone. , "While it leaves in place the Affordable Care Act ...
(Date:6/23/2017)... ... 23, 2017 , ... The Military Officers Association of America (MOAA) announced its ... Affairs, retired Marine Col. Thomas G. Bowman. , Bowman currently serves as the staff ... intimacy with the issues and challenges veterans face with the VA. Following a 30-year ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... Goodcents Deli ... , The restaurant is located at 4210 SW 21st St. Topeka, Kan. 66604 (near ... owner of Graham Restaurant Group who owns three other locations in the Topeka and ...
(Date:6/23/2017)... , ... June 23, 2017 , ... 21 Middle East ... (EF) has selected 21 leaders from government, business and civil society in 11 countries ... the U.S. this fall, engaging in a transformative exchange of knowledge and ideas with ...
Breaking Medicine News(10 mins):