Navigation Links
New anti-viral drug shows promise for dramatic improvement in hepatitis C treatment
Date:8/8/2010

INDIANAPOLIS Adding a direct acting anti-viral drug to the standard treatment regimen for hepatitis C significantly increases the cure rate in the most difficult to treat patients, according to a research report published Monday in the online edition of the journal The Lancet.

The research team, led by Paul Kwo, M.D., of Indiana University School of Medicine, reported that adding the drug nearly doubled the treatment's effectiveness when given for 48 weeks in one treatment arm of the study.

An estimated 3.2 million Americans and 170 million people worldwide are infected with the hepatitis C virus, but many do not know it. In the United States, 70 percent of affected individuals are infected with genotype 1 hepatitis C, the most difficult to treat. Although there may be no symptoms for years, long-term infection can cause cirrhosis and the disease is a leading cause of liver cancer and liver transplantation. Hepatitis C infections occur mainly through transmission of infected blood, such as via injection drug use, and there is no vaccine.

Currently fewer than half of patients with genotype 1 hepatitis C are treated effectively by the standard combination of two drugs, peginterferon alfa-2b plus ribavirin, which is typically given for 48 weeks. The treatment can be difficult for some patients due to anemia and other side effects.

Adding the drug boceprevir increased the cure rate to as high as 75 percent in those who received 48 weeks of the three-drug combination therapy, compared to 38 percent of those in the control group, who received the standard two-drug treatment for 48 weeks, said Dr. Kwo, associate professor of medicine at the IU School of Medicine. The two-year phase 2 trial was conducted at 67 sites with 520 patients in the U.S., Canada and Europe.

In the boceprevir study, known as the SPRINT-1 trial, researchers tested several different options to evaluate the effectiveness of the combination therapy:

  • To test whether the addition of boceprevir could make it possible to shorten treatment times, some patients were randomly selected to receive the three-drug combination for 28 weeks, some for 48 weeks.
  • Researchers also investigated whether a 4 week lead-in with the standard two-drug combination prior to the addition of boceprevir to the treatment regime could improve sustained virologic response rates. The goal was to see if allowing the interferon and ribavirin to reach steady state levels -- which would activate the immune system and reduce virus levels -- before adding boceprevir would improve the response rates as well as reduce the virus' ability to develop resistance to boceprevir, said Kwo.
  • In another arm of the trial, researchers tested whether a lower dose of ribavirin could reduce the anemia side effects while still treating the virus effectively.

"Both 28- and 48-week boceprevir regimens significantly increased sustained virologic response rates which is the best definition of a cure we have compared to the 48 week control," said Dr. Kwo. "The 48-week treatment arm with 4 weeks of peg interferon lead-in and 44 weeks of peg interferon, ribavirin, and boceprevir led to the largest improvement over the control group ever reported. That's very impressive."

Boceprevir, a product of Merck & Co., is an HCV protease inhibitor a compound designed to block a function key to viral reproduction in the cell. Boceprevir directly targets the hepatitis C virus, Kwo noted, while peginterferon and ribavirin are less specific, acting more generally to stimulate the body's virus-fighting immune system.

The best results were reported for the 103 patients who were treated for four weeks with the standard two drug regiment, followed by 44 weeks of the three-drug regimen including boceprevir: 75 percent of these patients tested negative for evidence of the virus six months after the end of treatment. Results for the other treatment arms were:

  • 67 percent of those who received the three drug regimen for 48 weeks with no lead-in treatment tested negative for the virus (103 patients).
  • 56 percent of those who received the two-drug lead-in for four weeks, followed by 24 weeks of the three drug treatment tested negative for the virus (103 patients).
  • 54 percent of those who received the three-drug treatment for 28 weeks with no lead-in tested negative for the virus (107 patients).
  • 38 percent of the control group, who received the standard two-drug treatment for 48 weeks tested negative for the virus (104 patients).

Patients receiving the low-dose of ribavirin did not fare as well just 36 percent were virus-free after 48 weeks of treatment.

"Based on this phase 2 study, it appears that if this drug receives final approval approximately two-thirds of patients will be able to be treated successfully with 28 weeks of treatment and one-third will need 48 weeks of treatment, though this will require confirmation from the phase 3 trials, from which preliminary results were recently released," said Dr. Kwo.


'/>"/>

Contact: Eric Schoch
eschoch@iupui.edu
317-274-7722
Indiana University School of Medicine
Source:Eurekalert  

Related medicine news :

1. Surgery better than radiation, hormone treatments for some prostate cancer, study shows
2. Women Can Safely Get Pregnant Right After Miscarriage, Study Shows
3. Study shows splitting bowel preparation dosage is most effective cleansing method before colonoscopy
4. Epilepsy Drugs Dont Raise Suicide Risk, Study Shows
5. Iron-regulating protein is strong predictor of breast cancer prognosis, study shows
6. Brain study shows that thinking about God reduces distress -- but only for believers
7. Survey of coastal residents shows Gulf oil spill has significant impact on families
8. Vaccine Shows Some Promise Against Advanced Cancers
9. Women attracted to men in red, research shows
10. Most youth hockey injuries caused by accidents, not checking, UB study shows
11. Most Men With Low-Risk Prostate Cancer Treated Aggressively, Study Shows
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
New anti-viral drug shows promise for dramatic improvement in hepatitis C treatment
(Date:2/5/2016)... ... February 05, 2016 , ... Stuart Bentkover, MD, FACS ... Designed to provide the most effective tattoo removal today, Dr. Bentkover is the only ... Developed by Cynosure, the PicoSure has been approved by the Food and Drug Administration ...
(Date:2/5/2016)... ... 05, 2016 , ... Colorize is a web theme package created ... next using Colorize's dynamic moving camera. Colorize is perfect for personal and web related ... environment with 1 to 5 focus points per scene, stage floor scene presets that ...
(Date:2/5/2016)... ... ... Health and wellness is a topic that should concern all Americans; however, ... an illness. Migraines are a severe form of a headache and often are accompanied ... the pain on their worst enemy, the feeling can last for many hours and ...
(Date:2/5/2016)... Ramsey, NJ (PRWEB) , ... February 05, 2016 ... ... Optimizing Primary Care for Patients with Rare Diseases, a continuing medical education (CME) ... conference is the first of its kind—and a first for ACCORD, whose mission ...
(Date:2/5/2016)... ... February 05, 2016 , ... KICVentures ( http://www.kicventures.com ) announced ... in New York City on Thursday, January 21, 2016. Kingsley R. Chin, ... alumnus of the varsity Columbia soccer program) spoke at the event, offering professional ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)...  The Senior Care Pharmacy Coalition (SCPC) today ... Jason Chaffetz (R-UT) and Ranking Member ... , "Developments in the Prescription Drug Market," to ... about abusive pharmacy benefit manager (PBM) pricing practices. ... Member Elijah Cummings (D-MD) are diligent, serious lawmakers ...
(Date:2/4/2016)... , Feb. 4, 2016  Montoya Love is ... in the field of Pharmaceuticals. Montoya is the Regulatory ... Manufacturing and ... Becton Dickinson provides healthcare institutions, clinical laboratories ... throughout fifty countries across the globe. ...
(Date:2/4/2016)... Mettler-Toledo International Inc. (NYSE: MTD ) today announced ... highlights: , Sales in local currency increased ... Reported sales decreased 3% as currency reduced sales growth ... per diluted share as reported (EPS) were $4.44, compared ... was $4.65, an increase of 10% over the prior-year ...
Breaking Medicine Technology: