10 Updates

New Drug Combination Highly Effective For Hepatitis C

May 8 2014, 5:22am CDT | by

Hepatitis C, a bloodborne liver disease, primarily acquired via unscreened blood products or blood transfusions, IV drug use, or inadequate sterilization of medical equipment in the healthcare...

Filed under: news

 
 
 

11 weeks ago

New Drug Combination Highly Effective For Hepatitis C

May 8 2014, 5:22am CDT | by

Hepatitis C, a bloodborne liver disease, primarily acquired via unscreened blood products or blood transfusions, IV drug use, or inadequate sterilization of medical equipment in the healthcare setting, can potentially result in a condition known as cirrhosis or scarring of the liver and lead to liver cancer.

Hepatitis C represents the most common chronic viral infection in the US, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong ailment. It is estimated that 130–150 million people globally have chronic hepatitis C infection, with about 3.5-4 million in the US alone, and nearly 350,000 to 500,000 people globally die each year from hepatitis C-related liver diseases.

With an estimated 4 million people in the US with chronic hepatitis C,  the disease is now the nation’s leading cause of liver cancer and liver transplantation, and is more common than HIV/AIDS as a cause of death. While research is progressing, there is currently no available vaccine for hepatitis C.

On May 4, at the 45th annual Digestive Disease Week (DDW) meeting in Chicago, Dr. David Bernstein, chief of the division of hepatology at North Shore University Hospital, presented research involving a novel drug regimen for chronic hepatitis C.  The study involved more than 400 subjects with a subgroup of the disease, known as genotype 1A, who did not have cirrhosis.

The study was published May 4 in the online edition of the New England Journal of Medicine (NEJM).

In the study, subjects were given the experimental medications ABT-450/Ombitasvir and Dasabuvir with and without the antiviral drug ribavirin for 12 weeks. At the conclusion of the study period,  investigators reported that the experimental drugs cured 97 percent of the subjects.

“The majority of patients with hepatitis C in the United States are genotype 1A,” said Dr. Bernstein. “Historically, this has been one of the most difficult patient population’s to treat and cure.”

“This is an exciting advance in the treatment of chronic hepatitis C,” added Bernstein.

With the advent of a new and powerful group of oral drugs called directly acting antiviral agents (DAAs) evaluated in this study, patients now have the opportunity for a high cure rate for a disease that used to involve lengthy treatments with injectable drugs with potentially serious side effects.

Pegylated interferon (peg-IFN) and ribavirin (RBV), combination antiviral therapy, had been the standard treatment for hepatitis C  prior to arrival of DAAs with FDA approval in December, 2013.  This combination, involving up to 48 weeks of therapy, is effective against all the genotypes of hepatitis viruses (pan-genotypic). Unfortunately, interferon is poorly tolerated in some patients and not widely available globally to help all patients.  As a result, the majority of patients will not complete their treatment.

As a class, the DAAs are much safer, more effective and better tolerated than currently available options. Oral directly acting antiviral agents (DAAs) have significantly changed hepatitis C management by greatly decreasing requirements for monitoring and evaluation, while drastically improving cure rates.

“You have to take a step back and look at all of these steps as positive,” explained Bernstein, describing the multiple new drug regimens (DAAs) being evaluated for hepatitis C.  “There are going to be multiple types of regimens with various combinations for hepatitis C treatment,” according to Bernstein.

“This trial examined the efficacy of these new drugs on their own merit–not comparing these drugs to sofosbuvir (Sovaldi ),” explained Bernstein. “These are three new DAAs with or without ribavirin for the treatment of patients who are non-cirrhotic genotype 1A.”

“What you are getting is a 12-week response rate in the ribavirin group of 97% and in the non-ribavirin group, 90 %.  “It a high number and it’s very impressive”.

The current standard of care is interferon, ribavirin and now sofosbuvir which leads to about a 90% cure rate, explained Bernstein.

“What is unique about this study is that genotype 1A non-cirrhotics are the most common group seen in the US–and this is a large study that looked specifically at this population.” emphasized Bernstein.  “This is an exciting time– and this is a very important regimen, I believe.”

The key is that while the response rate to the medication regimen in this study is phenomenal, less  than 1 percent of patients treated experienced an adverse event. “Thats quite important”, Bernstein emphasized.

As the new regimen in this study has not yet been approved, the cost of this regimen is an unknown, according to Bernstein. But he ultimately believes that the high cost of the DAA class is ultimately related to the great amount of research and development involved in producing the drug.

In relation to the hefty price tag of this drug, Bernstein believes that as a society we have to look at cost vs value. In the US, he believes that we are more focused on cost. That said, he firmly believes that this drug represents more of a value proposition because it leads to a cure in such a high percentage of patients.

“We in this country look at cost, because it costs a lot,” explained Bernstein.  “But you are curing 97% percent of patients in 12 weeks–so, what is the value of that?”

The tremendous cost ($84,000 per course) of sofosbuvir (Sovaldi), while being equally efficacious to the response rates observed in the current study, has rattled many insurers, patient advocacy groups, as well as medicaid programs who believe that the cost of the drug could bankrupt the system. With the potential to significantly inflate the cost of treating hepatitis C, some believe that this may ultimately leave patients with a greater share of the cost of the expensive treatment. Some advocates believe that Gilead has taken corporate greed to a new level when they announced the price for the 12 week regimen.

Bernstein commented that the tremendous cost is obviously a concern because “it is all up-front” over a 12 week period, as opposed to an alternative scenario where such therapy might be spread out over a longer period (3 years) with a similar cost. In other words, if such a regimen required a longer time period for treatment, the outcry, Bernstein believes, might not be as forceful.

Bernstein does not in any way defend the cost of these drugs. He does, however, attempt to emphasize the intrinsic value of the 3 month therapy regimen.

“You will prevent the development of cirrhosis, you will prevent the need for liver transplantation, you will prevent the development of liver cancer– and there is a value to that long term. We have never been in this situation before–to cure hepatitis C–we are so successful that we are now concerned about it,”

According to Bernstein,we are now in a position to actually reduce the need for liver transplantation, as well as improve all-cause mortality since we can rid the patient of a virus which will slow disease progression as well as progression to liver cancer.

“The medical side has really progressed, but we have to figure out a way to pay for it,” said Bernstein. “Competition will likely bring prices down, but by what degree it’s not clear.”

Based on studies thus far, Bernstein said that 12 weeks of therapy produced the highest cure rates. Whether reducing the duration of therapy to 8 or 10 weeks would be as efficacious is unclear. However, it may effect a cost savings, Bernstein commented, if cure rates could approach results achieved at 12 weeks.

 
Update
10

7 weeks ago

RM47mil KWSG contributions still unclaimed

Jun 9 2014 7:54am CDT | Source: Business Times Malaysia

KUALA LUMPUR: About RM47 million of contributions in the Teachers Provident Fund (KWSG) still remain unclaimed, the Dewan Rakya ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
9

7 weeks ago

Gold shop lost almost RM1mil

Jun 9 2014 3:50am CDT | Source: Business Times Malaysia

KANGAR: A gold shop owner lost almost RM1 million after after the safe on in his shop was broken into by rob ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
8

7 weeks ago

Motion to debate MAS losses in Dewan Rakyat rejected

Jun 9 2014 3:39am CDT | Source: Business Times Malaysia

KUALA LUMPUR: AN emergency motion to debate the losses incurred by Malaysia Airlines last year, amounting to RM1.2 billion was rejected by the Dewan Ra ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
7

7 weeks ago

MH370 Tragedy: Hisham: RM27.6 mil spent on 1st phase of SAR

Jun 9 2014 2:11am CDT | Source: Business Times Malaysia

KUALA LUMPUR: Malaysia spent some RM27.6 million in its first phase of the search operations for missing Malaysia Airline flight MH370, said Acting Transport Minister, Datuk Seri Hishamm ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
6

7 weeks ago

9.1m litres of diesel seized in a month

Jun 8 2014 1:11am CDT | Source: Business Times Malaysia

PUTRAJAYA: The Domestic Trade, Cooperatives, and Consumerism ministry has seized some 9.1 million litres of diesel and property worth RM58 million since mounting ‘Operasi Diesel Selatan’ in the sou ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
5

7 weeks ago

Girl, 9, awarded RM2.78m compensation for medical negligence

Jun 6 2014 4:56am CDT | Source: Business Times Malaysia

KUALA LUMPUR: A nine-year-old girl who suffered brain damage during her birth at a government hospital was awarded over RM2.78 million ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
4

7 weeks ago

Malaysia's total trade in April up 12pc

Jun 5 2014 11:52pm CDT | Source: Business Times Malaysia

KUALA LUMPUR: Malaysia's total trade in April 2014 rose by 12 per cent from a year ago to RM123.86 billion due to growing trading activities, International Trade and Industry Minist ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
3

7 weeks ago

Works Ministry to spend RM20m for upgrading works at 50 accident black spots

Jun 4 2014 11:35pm CDT | Source: Business Times Malaysia

JOHOR BARU: The Works Ministry will implement upgrading works at 50 accident prone locations in the country that have been identified this year involving an allocation of RM20 mi ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
2

7 weeks ago

Najib launches loan scheme for Ramadan traders

Jun 4 2014 10:24pm CDT | Source: Business Times Malaysia

PUTRAJAYA: Prime Minister Datuk Seri Najib Razak today launches RM45 million Ramadan Bazaa ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
1

7 weeks ago

Residents bring up objection against Kidex to Suhakam

Jun 4 2014 4:49am CDT | Source: Business Times Malaysia

PETALING JAYA: A group of 20 Petaling Jaya residents held a meeting with the Human Rights Commission of Malaysia (Suhakam) over their objection against the proposed RM2.2 billion Kinrara Damansara Skyw ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 

Don't miss ...

 

<a href="/latest_stories/all/all/30" rel="author">Forbes</a>
Forbes is among the most trusted resources for the world's business and investment leaders, providing them the uncompromising commentary, concise analysis, relevant tools and real-time reporting they need to succeed at work, profit from investing and have fun with the rewards of winning.

 

blog comments powered by Disqus

Latest stories

Green spaces impact birth weight positively
London, July 29 (IANS) Where expecting mothers live can also have a bearing on the birth weight of their babies as researchers have found that mothers who live near green spaces deliver babies with significantly higher birth weights.
 
 
What makes you a pessimist?
London, July 29 (IANS) Cannot see thing turning out to be all right? A hyperactive habenula, half the size of a pea in the brain that tracks predictions about negative events, could be the key, a study suggests.
 
 
Russian space 'sex geckos' are safe for now
Moscow, July 29 (IANS) There is good news for the geckos aboard the Russian Foton-M4 space satellite meant to study the effects of microgravity on sex and reproduction.
 
 
This is why dogs sniff each other's butts
New York, July 29 (IANS) You may have witnessed this scene on the road quite often but the answer to why dogs sniff each other's butts is hidden in the chemical communication at the rear end.
 
 
 

Latest from the Network

More EU humanitarian assistance for Syria
Brussels, July 29 (IANS) The European Union (EU) Tuesday approved an increase in humanitarian and development assistance to Syria by 50 million euros ($67 million), an official statement said. In reaction to the...
Read more on Politics Balla
 
India's woman wrestler Vinesh bags gold
Glasgow, July 29 (IANS) Indian teenager Vinesh Phogat clinched the 2014 Commonwealth Games gold medal in the women's freestyle 48kg wrestling competition with a thrilling win over England's Yana Rattigan here Tuesday...
Read more on Sport Balla
 
Indian wrestler Amit Kumar wins gold
Glasgow, July 29 (IANS) Indian wrestler Amit Kumar won the gold medal in the men's freestyle 57kg category beating Nigerian Ebikweminomo Welson in the final of the 2014 Commonwealth Games here Tuesday. Amit won the...
Read more on Sport Balla
 
Nicole Richie and Joel Madden are parenting 'team'
Nicole Richie and Joel Madden don't want to follow the example of their own parents. The couple - who have children Harlow, six, and Sparrow, four - both saw their parents divorce when they were younger so vowed as soon...
Read more on Celebrity Balla
 
Justin Theroux's eggy gifts
Justin Theroux gives eggs as gifts. The 'Leftovers' actor and fiancee Jennifer Aniston keep chickens at their Los Angeles home but he admits his kind gesture actually does him a favor as the birds lay more eggs than...
Read more on Celebrity Balla
 
Ariana Grande reveals rift with father
Ariana Grande no longer talks to her father. The 'Problem' hitmaker - who recently had to cope with the death of her grandfather - has revealed that she fell out of touch with her dad last year but has come to terms...
Read more on Celebrity Balla
 
Ricki Hall feared meeting Sharon and Ozzy Osbourne
Kelly Osbourne's new boyfriend dreaded meeting her parents. Ricki Hall, 27, was thrilled to find rocker Ozzy Osbourne and his wife Sharon to be ''really welcoming'' as he was feeling intimidated ahead of their first...
Read more on Celebrity Balla
 
Rajput clinches men's 50m rifle 3 positions silver, Narang bronze
Glasgow, July 29 (IANS) Indian shooters Sanjeev Rajput and Gagan Narang claimed the silver and bronze, respectively, in the men's 50-metre rifle 3 positions at the Commonwealth Games here Tuesday. With 452.9 points,...
Read more on Sport Balla
 
China's former minister investigated for corruption
Beijing, July 29 (IANS/EFE) The Communist Party of China (CPC) Tuesday announced a probe into allegations of "grave violations of discipline" against former public security minister Zhou Yongkang, the highest-ranking...
Read more on Politics Balla
 
Apple Releases Updated Versions of 13-Inch and 15-Inch Retina MacBook Pros
The previously reported rumor has become true, as it refreshes the 13-Inch and 15-Inch MacBook Pros with Retina display on Tuesday.According to Apple Insider, the Retina MacBook Pros have been equipped with faster Intel...
Read more on Apple Balla