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Post Info TOPIC: Telaprevir twice-daily works as well as every eight hours, safe for hep C patients with cirrhosis (news from ASSLD)
LC


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RE: Telaprevir twice-daily works as well as every eight hours, safe for hep C patients with cirrhosis (news from ASSLD)
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mallani wrote:

Rather annoying they should publish this now. I suspect if they used Victrelis, the results would be similar. The FDA should have insisted on this trial before Incivek was approved. The high pill burden at disruptive intervals (7-9 hrs), with the need for 20gms fat,  is one of the reasons for poor patient acceptance and compliance. This is particularly so in Victrelis with the much longer PI course.

Note that the SVR figures are low- only treatment naive patients were trialled, so there would be a % of Interferon Insensitive patients.


From what I am reading, boceprevir (Victrelis) sounds like it doesn't have as bad of side effects than telaprevir (Incivek) does, but isn't as potent.  Just so it does the job though. - http://www.fiercebiotech.com/press-releases/first-interferon-free-regimens-treatment-hepatitis-c-virus-are-expected-lau



__________________

Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 



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Hi Dillo,

My pessimism isn't based on ingratitude, you've got that right.

Yes I am so blessed to have the insurance and be able to take some time off of work to do this. I have a wonderful husband who is willing to carry much of the load we carried together, and my medical team is caring and compassionate.

I am blessed because my body is responding. I'm blessed because my heart is full of light, and not so much of the darkness that filled my spirit in the past.

I hope that I can be useful, in the future, to others who are walking in the shoes I wear today.

50 is going to be a good year.

Thanks Dillo for helping me find clarity today.



__________________

HCV 1A 1980. Dual tx 2003 -UND at wk 11-discontinued due to severe depression

Started Triple 4/16/13 for 24 weeks

UND wk 4,6,8,12,17 & 24

E.O.T. 9/29/13

EOT + 12 weeks=SVR, and EOT +26 weeks=Cured!



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Kellie wrote:

Hi Dillo, I agree, these triple treatments will be replaced in the future with superior ones with less sx and less treatment time. OR the triple treatment with all the knarly side effects (in the US) will be reserved for those that don't have good insurance. Given to the folks that are on state funded medical programs.  I do believe the pharmaceutical companies will not want to give these triple tx so easily up with so much $ to be made. The better treatments will be givin to those with the better insurance or those that will be able to finance it themselves.. I'm a bit pessimistic today. Maybe I'll feel differently after tx is over.... doubt it.



-- Edited by Kellie on Monday 3rd of June 2013 02:32:51 AM


 There are also other PTI's that are in the works that won't require the Interferon. That seems to be the big sticking point with new treatments. I don't know that they or that Gilead's approach guarantees no sx or that they will be as effective on different geos. Different strokes for different folks and the long term relapse rates are unknown.

I do think some more than others are going to be high. Insurance company are probably going to be even more discriminate.

I was just referring to some reading I saw...

Vertex: The Sun Sets On Incivek

Don't get me wrong....right now I think we (as in you, I and anyone else having a UD on it) are lucky to have it.



-- Edited by Dillo on Tuesday 4th of June 2013 05:51:43 PM

__________________

GT 1a Started triple tx with Incivek, Pegasys, and Riba 2-6-2013. UND at 4,6,12,23,& 24 wks EOT 7-26-2013. Probably had Hep C for 20-30 years. Don't really know when I got it.



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They also said 70% had non-favorable IL28B gene variants so that's not too bad. The non favorable didn't look that high in these trials.

Prove 2 Trial.

 

I believe and I have seen reports that the first two DAA's will eventually be phased out as better treatments come along. Lots of stuff in the works now that they understand what a profitable venture this can be.



__________________

GT 1a Started triple tx with Incivek, Pegasys, and Riba 2-6-2013. UND at 4,6,12,23,& 24 wks EOT 7-26-2013. Probably had Hep C for 20-30 years. Don't really know when I got it.



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Hi Dillo, I agree, these triple treatments will be replaced in the future with superior ones with less sx and less treatment time. OR the triple treatment with all the knarly side effects (in the US) will be reserved for those that don't have good insurance. Given to the folks that are on state funded medical programs.  I do believe the pharmaceutical companies will not want to give these triple tx so easily up with so much $ to be made. The better treatments will be givin to those with the better insurance or those that will be able to finance it themselves.. I'm a bit pessimistic today. Maybe I'll feel differently after tx is over.... doubt it.



-- Edited by Kellie on Monday 3rd of June 2013 02:32:51 AM

__________________

HCV 1A 1980. Dual tx 2003 -UND at wk 11-discontinued due to severe depression

Started Triple 4/16/13 for 24 weeks

UND wk 4,6,8,12,17 & 24

E.O.T. 9/29/13

EOT + 12 weeks=SVR, and EOT +26 weeks=Cured!



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Not sure what to make of this. If it adds to how future patients will be treated; then its Good News. But I've heard of about a zillion breakthroughs in the last 15 years. Whether its two or three times a day, it still only works for a percent of us. The reason drug companies might be in such a hurry to park brand new ambulances at the base of the cliff, just might have something to do with profit. Hopefully we can get to the point that fewer folks are infected and those that are, can be treated efficiently. Then Ill light the candles on the cake.  



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Genotype 1a, IL 28 = CT  Interferon and riba 48 wks in 99, Daily Peg and Riba 18 months in 2007, Started Incivek, Peg, Riba 6/21/12. 4th stage cirrhosis. Last Dart will be May 23 2013.



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Totally Remarkable! Incivek has done a number on me. I wish they would have proved this earlier.

__________________

25 yrs HepC. type 1a geno. 6mill viral load,3.5 out of a 4 liver biop.started Sept.19, 2012,Tx.Rib.,Incivek, Peg,4wk. Vl 61,undetected @12 wks,undetec.Wk 24



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Rather annoying they should publish this now. I suspect if they used Victrelis, the results would be similar. The FDA should have insisted on this trial before Incivek was approved. The high pill burden at disruptive intervals (7-9 hrs), with the need for 20gms fat,  is one of the reasons for poor patient acceptance and compliance. This is particularly so in Victrelis with the much longer PI course.

Note that the SVR figures are low- only treatment naive patients were trialled, so there would be a % of Interferon Insensitive patients.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Telaprevir twice-daily works as well as every eight hours, safe for hepatitis C patients with cirrhosis

News from ASSLD 2012, provided by NAM

The HCV protease inhibitor telaprevir (Incivo or Incivek) taken twice daily with pegylated interferon plus ribavirin is as likely to produce sustained virological suppression as the approved three-times-daily schedule, with similar safety and tolerability even for people with advanced liver fibrosis, according to study findings presented last week at the 63rd AnnualMeeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.

The pivotal trials that supported approval of telaprevir - one of the first direct-acting antiviral agents for hepatitis C treatment - administered the drug every eight hours. But this dosing regimen is inconvenient for patients, which may result in missed doses and reduced effectiveness.

Maria Buti from Hospital Vall d'Hebron in Barcelona and colleagues conducted the phase 3 open-label OPTIMIZE trial comparing telaprevir twice-daily versus every eight hours, to see if less frequent dosing is non-inferior to the approved regimen.

OPTIMIZE enrolled 740 previously untreated patients with genotype1 chronic hepatitis C, mostly in Europe and North America. About 60% were men, more than 90% were white and the mean age was 48 years. Nearly 60% had harder-to-treat HCV subtype 1a and about 70% had non-favourable IL28B gene variants. About 30% had advanced liver disease (stage F3-F4),including 14% with cirrhosis.

Read full article...

http://www.hepctrust.org.uk/News_Resources/news/2012/November/Telaprevir+twice-daily+works+as+well+as+every+eight+hours+safe+for+hepatitis+C+patients+with+cirrhos

 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 

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