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EASL early data

This one is the abbott trial;

http://www.bloomberg.com/news/2012-04-04/abbott-hepatitis-c-therapy-cures-patients-failed-by-other-drugs.html?cmpid=yhoo

"Abbott Hepatitis C Therapy Works After Other Drugs Fail
By Drew Armstrong - Apr 4, 2012 9:56 AM CT

Abbott Laboratories (ABT)’ experimental hepatitis C treatment cured almost half of patients who weren’t able to eliminate the virus with therapies now on the market, according to a study that boosted the company’s shares.

The Abbott-funded research found that eight of 17 patients who didn’t improve on standard-of-care treatments had no detectible virus levels after three months on the therapy, which combines two products, the Abbott Park, Illinois-based company said in a statement. Abbott rose less than 1 percent to $61.69 at 10:49 a.m., after jumping 2.3 percent to $62.57, the highest price since at least 1980, according data compiled by Bloomberg.

Abbott, Bristol-Myers Squibb Co. (BMY), Gilead Sciences Inc. (GILD), Vertex Pharmaceuticals Inc. and Merck & Co. are seeking a cure that doesn’t need interferon, an injection tied to flu-like side effects. The Abbott data is good enough to get U.S. approval if supported in larger trials, said Scott Brun, vice president of infectious disease development.

“We’re comfortable that these are the types of results that when confirmed in a larger phase II program that would allow us to move forward,” Brun said by telephone.

Among Abbott’s competitors in the hepatitis C market, Gilead fell 1.7 percent to $47.30 and Bristol dropped less than a percent to $33.76.
50 Patients

Abbott’s study examined 50 hepatitis C patients, who were given a combination of the antiviral drugs ABT-450, ABT-072, ritonavir and ribavirin. The 17 who were treated before showed a 47 percent cure rate, while those who had never been treated had a rate of between 93 and 95 percent, Abbott said.

Abbott is in the process of splitting into a diversified products company led by its medical device division, and a drug company, to be called AbbVie. The drugmaker is seeking products to replace its top-seller Humira, a $7.9 billion-a-year injection used to treat arthritis.

The study is part of a research program in the second of three phases of clinical trials before U.S. regulators at the Food and Drug Administration rule on the drug.

Abbott previewed results from one of the studies for investors in October, showing that it could cure around 90 percent of patients who had never been treated. The release of the data caused Pharmasset, now owned by Gilead, to fall 8.6 percent in a day. Abbott has said it hopes to have a treatment on the market by 2015. "
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Please note the last sentence.  That makes THREE that I am aware of the may offer an interferon free treatment w/FDA on or by 2015.  I am expecting  we may hear about the Bristol Myers Squibb compounds and protocols soon as well.

best,
Willy
18 Responses
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Avatar universal
Thanks NYGirl
I just may wait a little longer for all orals cause of the TT still only being 63% clear with inc or Vic
Helpful - 0
179856 tn?1333547362
I have both G1A and G1B and both are gone.  Really dont stress too much over being a 1B...it can be taken care of just like 1A.

I have a friend who was 1A and 1B also and she only beat 1B and still has 1A I believe.  It's all G1 after all.

Most likely (we didn't have the test way back when) I was a TT as well because I double dosed my riba pretty much and doubled the IFN a few times and still did not clear until almost week 24 so I had to treat for 72.  But it worked I have been SVR for five or six years now.

You can do it too.  Plus with the PIs the IL test is not relevent any longer the PIs will wipe it out regardless really.  They just like to use CCs in trials cause the interferon riba chance alone is better it seems to me.
Helpful - 0
Avatar universal
2015 sounds great.  Progress is moving quickly, which gives us so much more hope!
Helpful - 0
Avatar universal
Thank you Willy 50
I think the 1B is ok

It is the TT I am worried about since they selected CC for the study  I thought I read somewhere
Helpful - 0
Avatar universal
http://www.natap.org/2012/HCV/040412_04.htm

"The second, smaller study--called "Pilot"--combined ABT-450 boosted by Norvir, ribavirin, and ABT-072. All 11 patients had received no prior therapy. This group of patients had a subtype of the virus that generally responds well to an interferon-based regimen and thus considered among the easier forms to treat."
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I'd like to have this better/more clearly explained.  I can't tell if they are talking about genotype or subtype such as G-1b as contrasted to 1-a.
Generally, the 1b's are responding better to these treatments than 1-a's.


http://www.thestreet.com/story/11484416/1/winners-losers-from-easl-hep-c-data-dump.html?puc=yahoo&cm_ven=YAHOO
Helpful - 0
Avatar universal
Well from a non clinical perspective it seems that RIBA is the glue in all these study's that hold the cake together not the interfereon

Given I am TT and not CC
I hope that I amas a responsive, as I have decided to try to get into a study on the next phase as opposed to 3x with Vic

I thought TT was interfereon resistant

Not RIBA resistant

Makes me wonder why did they only select CC patients for a non interfereon trial?
Helpful - 0
Avatar universal
Currently in week 8 of the arm that has Abt333. Abt267, Abt450,Riba, & Ritonavir
wk1 208
wk2 <25
wk3 <25
wk4 Und
Wk6 <25/ alt 8, ast 10
wk waiting for results 50-50 chance and nervous
Co-worker and me did this together, she went Und second week, and relapsed week 3, big and didn't have the Abt 333. Males seem to be doing better than females, just my observation. Having HCV IL28B-CC is giving better odds, only what I have heard, study nurse is friend. I wish I could have waited, trials like these are usually closer to research hospitals, not in the rural area where I live, I realize these are the risks of trials and dosage adjustments, and med combos are key.
Helpful - 0
Avatar universal
It is amazing how quickly new treatments are coming now, when for years we had only the standard SOC. It would be great if we could completely wipe out the Hep C virus, within the next 20 years, and there is now alot more hope for that goal~
Helpful - 0
179856 tn?1333547362
"A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subjects"

Wow. Just wow.

You so smart Will, like Michael that's why I always defer to your intelligence... ;)
Helpful - 0
Avatar universal
Thx. Willy .. I have been followuing this also...

cando ..looks like those 8 are done and SVR'd



12-Week Interferon-Free Regimen of ABT-450/r+ABT-333+Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naïve HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders"

•The objectives of this Phase 2 study were to assess safety and tolerability of 12-week, interferon-free regimens in HCV GT1 patients who were either treatment-naïve or previous non-responders. The trial had three arms with three primary endpoints – rapid virological response (RVR) at week 4 and SVR at weeks 4 and 12.
•Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based.
•95 percent (18 of 19) of treatment-naïve patients infected with HCV GT1
(17 GT 1a, 2 GT 1b) achieved SVR12 with ABT-450/r 250/100 mg dosed once daily (QD) + ABT-333 400 mg dosed twice daily (BID) + ribavirin (Arm 1).
•93 percent (13 of 14) of treatment-naïve patients infected with HCV GT1
(11 GT 1a, 3 GT 1b) achieved SVR12 with ABT-450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 2).
•One patient in Arm 1 discontinued due to asymptomatic isolated ALT/AST elevations at week 2. One patient in Arm 2 discontinued due to noncompliance in week 1. All remaining patients in Arms 1 and 2 completed treatment and achieved SVR12. In Arm 3, six patients experienced viral breakthrough while on treatment and three patients relapsed after treatment stopped.
•In the trial the most common adverse events were fatigue (42 percent), nausea (22 percent) and headache (20 percent).

•47 percent (8 of 17) of patients with HCV GT1 (16 GT 1a, 1 GT 1b) who had previously not responded to other HCV treatments achieved SVR12 with
ABT-450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 3).


Study M12-267 (Pilot)


"A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subjects"

•The objectives of the 12-week, Phase 2 study were to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-450/r 150/100 mg QD and ABT-072 400 mg QD + ribavirin administered for 12 weeks.
•The study was conducted in 11 treatment-naïve adults with host IL28B "CC" genotype from multiple ethnic backgrounds with non-cirrhotic HCV GT1
(8 GT 1a, 3 GT 1b). Ribavirin 1,000-1,200 mg/day was weight-based and dosed twice daily.
•The primary endpoint was percentage of patients with HCV RNA <25 IU/mL from week 4 through 12. Other trial endpoints include early virologic response, RVR and SVR through 24 weeks.
•100 percent of patients maintained HCV RNA levels <25 IU/mL from weeks
4 through 12 of treatment, and all had undetectable HCV RNA from week 5 to the end of treatment.
•91 percent of patients (10 of 11) achieved SVR24.
•In the trial, the most common adverse events reported were headache, fatigue, nausea and dry skin. There were no premature discontinuations.
Helpful - 0
Avatar universal
I'm ready; stick a fork in me.  : )  12 weeks; 90%
That's what I'm talking about.  : )
Helpful - 0
179856 tn?1333547362
Might finally be something there for you Willy! Phase 3 wouldn't' be too shabby!
Helpful - 0
Avatar universal
This is a preliminary report.  There will be more made available, but I don't have a sense of timetable.

when I first heard about the triallast summer, and the results were preliminary, and there were fewer people; 12 I think, and maybe incomplete SVR4's.  So I think there was a second wave of treatment; I'd have to check but it could be both naives and TX experienced.

If there was incomplete response, slow response, no-viral reponse some of these could have either ended treatment or segued into SOC for longer treatment periods, and which means some could still be treating or awaiting EOT PCR's.  I haven't looked.  No doubt there will be more on this, especially after EASL.  Sometimes even additional arms may be in operation, such as a control arm and they won't reveal until the whole thing is done; I've no idea.

http://clinicaltrials.gov/ct2/show/NCT01221298?term=ABT-450%2C+ABT-072%2C+ritonavir+and+ribavirin&rank=2

Looks like this is one....

willy -back to work

One of my interests is that if this is to approved by 2015, that means phase 3 trials are upcoming.

willy
Helpful - 0
179856 tn?1333547362
I took it to mean they were still on treatment, I can't imagine 12 week all orals that sounds too good to be true and certainly there would be no SVR data.......right?


Still it's less than 50% while PIs certainly for non-responders offer better odds right? I mean all oral is great but being cured it greatER.  ;)
Helpful - 0
Avatar universal
"The Abbott-funded research found that eight of 17 patients who didn’t improve on standard-of-care treatments had no detectible virus levels after three months on the therapy"

So are these people cured or still on therapy?
Helpful - 0
179856 tn?1333547362
Wow, just wow. Wish I could have waited for that!!!!!!!!!!!
Helpful - 0
163305 tn?1333668571
Great news. Thanks for keeping us updated.
Helpful - 0
Avatar universal
Wow thank you!
Helpful - 0
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