Bristol-Myers Squibb New Drug Combo for Hepatitis C Shows Promise

Has anyone Heard about this new drugs and trials?

[Bernyh]

Heres  the article  
WEDNESDAY, Jan. 18 (HealthDay News) -- A new cocktail of two investigational drugs appears to have successfully cleared the hepatitis C virus in people who don't respond to standard treatment.

What's more, the approach seems to work without the need for injections with interferon alpha, an onerous medication that causes serious side effects in many patients.

Scientists from seven U.S. medical centers and drug maker Bristol-Myers Squibb published the small study in the Jan. 19 issue of the New England Journal of Medicine that is being heralded as "landmark" research.

"We saw a sustained virologic response -- the virus was undetectable in the patients -- during treatment and remained undetectable after the drugs were stopped," said study author Dr. Anna Lok, director of clinical hepatology at the University of Michigan Medical School in Ann Arbor.

Hepatitis C virus, spread through contact with contaminated blood, is the most common form of the virus and affects 180 million people globally, including 4.1 million Americans. It's the leading cause of chronic liver disease, and can lead to liver cancer. The standard treatment includes injections of the antiviral drug interferon alpha, which isn't tolerated well by everyone, said Dr. Andrew Muir, director of gastroenterology and hepatology research at the Duke Clinical Research Institute. Its many side effects include flu-like symptoms, fatigue, fever and depression.

"Many patients cannot complete treatment or decide not to take treatment because of interferon alpha," Muir said.

The study had two arms, said Lok. A group of 10 patients received four medications, including the two investigational drugs, the antivirals daclatasvir and asunaprevir, along with the standard treatment combination of interferon and ribavirin. The other arm of the study included 11 patients who received only the two investigational drugs. Both groups underwent treatment for 24 weeks.

The 10 patients on the four-drug regimen experienced a sustained virologic response with undetectable virus at the end of treatment and again at 12 weeks beyond their treatment, the researchers reported. In the two-drug group, four of the 11 patients also had undetectable levels of the hepatitis C virus in their blood 12 weeks after treatment ended.

All of the patients were infected with genotype 1, the most common type of hepatitis C virus in the United States, and had not responded to previous treatment with interferon and ribavirin, said Lok.

"The four-drug arm was very impressive. These patients had not shown a response before and now we get a 90 to 100 percent rate of sustained response," said Lok.

She said even though only four patients in the two-drug group reached a sustained response, this is the first study to show it can be achieved without interferon or ribavirin.

"Clearly, this is the biggest development in hepatitis C research in a very long time," said Dr. Raymond Chung, director of hepatology at Massachusetts General Hospital in Boston, who wrote an accompanying editorial in the same issue of the journal. "It has enormous implications for our ability to treat many more patients with regimens that are significantly more tolerable."

The most common side effects reported were headache, diarrhea, nausea and fatigue, the study authors said.

Chung called the study "a watershed moment" because it suggests that an interferon-free treatment is possible. "The conventional wisdom for quite some time has been that hepatitis C would likely not be curable without an interferon backbone."

Duke's Dr. Muir added, "The study is also exceptional because it included patients we would describe as the most difficult to treat." Their viral load did not go down very much when they underwent interferon and ribavirin treatment in the past.

The new drugs are not FDA-approved yet, but a number of trials are under way, said Chung, who believes an interferon-sparing regimen is only a few years away. "It is not beyond belief that we'll have an all-oral therapy available as early as 2015. That's the pace it's going right now," he said.

[Aaron57]

Glad to see advancements being made .. science is moving fast these days ...

However I for one find this article using the term "SVR" at EOT and again 12 weeks post Tx disturbing and misleading ...

We know EOT 12 Wk. PCR being Und is a very good indication of 24 week EOT - SVR ... but not 100% conclusive ..

"We saw a sustained virologic response -- the virus was undetectable in the patients -- during treatment and remained undetectable after the drugs were stopped"

"The 10 patients on the four-drug regimen experienced a sustained virologic response with undetectable virus at the end of treatment and again at 12 weeks beyond their treatment, the researchers reported. In the two-drug group, four of the 11 patients also had undetectable levels of the hepatitis C virus in their blood 12 weeks after treatment ended."

[leebambee]

I can't imagine those poor people in the 4 drug study group and ask their sx...although the success rate is impressive.
Btw, my good friend is engaged to a pharm chemist who worked directly with the tx I'm on. It's great to shake his hand.

[curiouslady1]

I am quite confused by this study since there are other drugs being investigated that give SVR without ifn.  This seems like old news.  Can you provide the link?  UM is my study site and I would like to ask Dr. Lok about it.   It may be from an earlier study that just got published.  

[nowhine]

Might it be this study......
http://www.natap.org/2011/EASL/EASL_28.htm

[nygirl7]

Very promising and yes nowhine I think you are right that looks like the trial to me! Thanks.

[curiouslady1]

I cannot get this web page.  Is there some sort of restriction on viewing it?

[nygirl7]

Popped right up for me and I am at work behind a serious firewall that usually blocks just about everything for me :(

[nowhine]

Below is the first section of the page. Maybe you can do a search. The page comes up for me. Here it is again just in case.

http://www.natap.org/2011/EASL/EASL_28.htm


HCV Cured With out Peginterferon/ribavirin with 2 oral HCV drugs BMS790052+BMS650032: Quadruple Therapy With BMS-790052, BMS-650032 and Peg-IFN/RBV for 24 Weeks Results in 100% SVR12 in HCV Genotype 1 Null Responders: "HCV infection can be cured without interferon & ribavirin: 2 orals BMS790052+BMS650032"  


  
  Reported by Jules Levin
EASL 2011 April 2 Berlin Germany

Presented by Anna Lok

from Jules: this is the biggest story & news to come out of this meeting, needless to say, and the biggest advancement in medicine in 50 years. In this study 4/11 null-responders receiving BMS-790052 (NS5A inhibitor) + BMS-650032 (protease inhibitor) alone for 24 weeks achieved SVR12 & SVR24. The presentation says "HCV infection can be cured without interferon & ribavirin". BMS-790052 & BMS-650032 with peg/RBV for 24 weeks: 10/10 patients achieved SVR12 & 9/10 achieved SVR24: "QUAD therapy can result in a high rate of cure in this difficult to treat population" (1 patient < LLOQ at week 24 post treatment undetectable on retesting 35 days later). This is the proof of concept we have been waiting for that at least some patients can be cured without peg/rbv, now these are the hardest to treat patients null-responders.  

[curiouslady1]

Awesome!  Thank you!  Now I understand why Dr. Lok was so excited when I was first recruited back in August and why there was so much chatter about EASL there.  I will go to the library and look it up in the New England Journal of Medicine if I can't access it here.  

[mike716]

Hiya, nygirl. Greetings from your ole buddy Mike, the nyguy. Glad to see you're still around here.

Hugs and xxxx.

Mike

[curiouslady1]

This thread has basically the same information as this thread.
http://www.medhelp.org/posts/Hepatitis-C/DID-YOU-HEAR-THE-GOOOOD-NEWS/show/1668577