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Hep C Discussion Forum -> Post Treatment -> Waiting for Newer meds.
Post Info TOPIC: Waiting for Newer meds.
Matt Chris


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RE: Waiting for Newer meds.
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Hey Gracie

Your Question -Sofosbvir/Ledipasvir or daclatasvir/sofosbuvir and do you know if they will be out in the next year or so?

Gilead's Combo Sofosbuvir & ledipasvir would be available in Sept. or Oct. depending if the FDA grants Gilead's request for priority review which speeds up the NDA from 10 months to 6 months, hopefully that is what will happen because a lot of us relapsed patients are waiting for that combo because it has so far has the highest SVR percentages for a phase III study.

We all will keep a keen interest in the EASL convention on April 9-13 from London for the abstracts and trials info/data on many of the soon to be approved treatment regiments. This will tell us a lot about the success of the leaders in development, Abbvie, BMS, Gilead, J&J and Merck.

Daclatasvir and Sofosbuvir will be out likely sometime in the following year 2015 or 2016. BMS which developed Daclatasvir has its own all oral triple regiment so the combo Daclatasvir and Sofosbuvir may only be prescribed as a off label or later as a approved FDA treatment.

The first available and IMHO the best available will be Gileads combo in the fall of 2014, that is what I hope I can hold out for.

matt

 

   



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
Tig


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Hi Gracie,

Here's a little info from BMS and news on the release. Note the two studies currently mentioned, the phase 3 UNITY and ALLY studies. The Unity trials appear to deal with HIV, HBV and HCV studies. Information below.

"In 2013, Bristol-Myers Squibbs investigational all-oral 3DAA Regimen (daclatasvir/ asunaprevir/BMS-791325) received FDA Breakthrough Therapy Designation, which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic treatment naïve and experienced patients, as well as cirrhotic treatment naïve and experienced patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing. - See more at: http://news.bms.com/press-release/bristol-myers-squibb-receives-us-fda-breakthrough-therapy-designation-all-oral-daclata#sthash.zGjJFoXK.dpuf

In addition, enrollment has begun for the Phase III ALLY Program, in which daclatasvir in combination with sofosbuvir, is being studied in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients and patients infected with HCV genotype 3. - See more at: http://news.bms.com/press-release/bristol-myers-squibb-receives-us-fda-breakthrough-therapy-designation-all-oral-daclata#sthash.zGjJFoXK.dpuf"

 

DACLATASVIR

Clinical Trials: ALLY Phase III

Clinical Trials: UNITY Phase Info 

 

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Gracie


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I'm waiting now too gatekeep. Which one is better for triple treatment failures, Sofosbvir/Ledipasvir or daclatasvir/sofosbuvir and do you know if they will be out in the next year or so?

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  1. Gracie

1A. Previously treated non responder Rebetron in 2000 And Incevik in 2014 with a breakthrough at week 12. Fibroscan 15.5. VL 6,000,000. Finished 24 weeks harvoni on Dec. 19, 2015. SVR. Latest Fibroscan 8.8.
gatekeep


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Yeah I'm waiting to see witch way Rx goes. I bought myself some time.

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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
Zlikster


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Hey Brian, that should be THE ONE :) hope u can nail that combo!



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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!
robertsamx


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gatekeeper, daclatasvir/sofosbuvir is coming to a phase 3 soon, keep your eyes open looking for this trial, should be soon. RC

i will look into the details  and post today RC      NCT02032875   



-- Edited by robertsamx on Tuesday 25th of February 2014 12:51:02 PM



-- Edited by robertsamx on Tuesday 25th of February 2014 12:52:56 PM

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 M-68, 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   
Matt Chris


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Hey Brian

Yes, if you can wait this should be a powerhouse combo of DAA's that you have not been exposed to. Should be available in late 2014

matt 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
mallani


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Hi Brian,

If I were you, I'd wait for this one too. Good luck.



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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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I sure hope something better comes out for treatment. It would be wonderful if the virus became something that was easily treatment with little impact on people's lives during treatment.

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Genotype 3.  Treatment started on 1/11/2013 with Ribavirin and Pegatron.  Week 4 UND.  Week 12 UND.  Ended treatment on 6/28/2013.  Six months post treatment 12/04/2013 SVR.
gatekeep


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After relapsing after 48 weeks of hellish trip Rx. I went to Tufts Boston for the latest on new treatment. I was told to hold out a few months for the all oral Rx Sofosbvir/Ledipasvir fixed dose combination. Fingers crossed

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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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