Navigation Links
New antiviral drug shows promise for dramatic improvement in hepatitis C treatment
Date:8/9/2010

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. Longer Antiviral Therapy Reduces Lung Transplant Complications
2. Antiviral therapy during compensated cirrhosis most cost-effective approach
3. New Study: Improved Immune System with Gene-Eden, a Natural Antiviral Supplement that Targets Chronic Viruses
4. New anti-viral drug shows promise for dramatic improvement in hepatitis C treatment
5. Surgery better than radiation, hormone treatments for some prostate cancer, study shows
6. Women Can Safely Get Pregnant Right After Miscarriage, Study Shows
7. Study shows splitting bowel preparation dosage is most effective cleansing method before colonoscopy
8. Epilepsy Drugs Dont Raise Suicide Risk, Study Shows
9. Iron-regulating protein is strong predictor of breast cancer prognosis, study shows
10. Brain study shows that thinking about God reduces distress -- but only for believers
11. Survey of coastal residents shows Gulf oil spill has significant impact on families
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
New antiviral drug shows promise for dramatic improvement in hepatitis C treatment
(Date:5/26/2016)... ... May 26, 2016 , ... ... the Foundation Fighting Blindness, Long Island Chapter on June 4, 2016, 1:30-3:30 pm ... Dr. Maisel, founder of Retina Group of New York , is a ...
(Date:5/26/2016)... Los Angeles, CA (PRWEB) , ... May 26, 2016 , ... In an effort to ... Snapchat videos available to both Snapchat users and those who do not use the app. ... available on his new page, Dr. Mohebi Live . , Dr. Mohebi says, ...
(Date:5/26/2016)... ... May 26, 2016 , ... Leadership of Life Science Logistics ... organization has earned its ISO 13485 certification, indicating the company’s quality control system ... and policies associated with ISO quality standard 13485. , BSI Group America, ...
(Date:5/26/2016)... ... May 26, 2016 , ... The Lung Institute ... a six-week smoking cessation class starting June 6 at their clinic in downtown Tampa. ... . , Additionally, the Lung Institute has created a free downloadable 4 Week ...
(Date:5/26/2016)... ... May 26, 2016 , ... Nike Yoga Camps at East ... practices, arts & crafts, discussions, and games all geared towards enhancing your child’s ... combined backgrounds in kids’ yoga, collegiate sport yoga instruction, and global yoga training. ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... 27, 2016 According to the ... is driving ambulatory blood pressure monitoring system market growth. ... their ability to respond to different pressure rates, leading ... lead to various cardiovascular disorders such as heart failure, ... diseases are growing in prevalence each year. WHO estimates ...
(Date:5/26/2016)... , May 26, 2016 According ... "Medical Waste Management Market - U.S. Industry Analysis, Size, Share, ... management market in the U.S. was valued at US$ 5.89 ... CAGR of 3.4% from 2015 to 2023 to reach US$ ... analysis of current and emerging needle free drug delivery devices ...
(Date:5/25/2016)... May 25,2016 FDA 510(k) ... Cellvizio platform for urological and surgical applications ... inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy ... in the US with the 12 th ... Administration (FDA). This new FDA clearance covers Confocal ...
Breaking Medicine Technology: