Sof+Dac combined tablet RVR

This topic has 24 replies, 13 voices, and was last updated 8 years, 11 months ago by Sirchinenge.

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5 December 2015 at 7:39 am #5270
Dr James
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@fixhepc
As a sanity check prior to the REDEMPTION trials kicking off we’ve been doing some one week RVR testing, getting patients to take the trial meds for a week before continuing one with routine treatment.

Here are the first results for the previously non existent one size fits all combined Sof/Dac tablet formulation….

GT 1a 59 years male F1
Tested on 20/11 and 28/11
HCV RNA 1,462,806 => 77
ALT 47 => 19

GT 2b 66 years male F4
Tested on 18/11 and 25/11
HCV RNA 4,763,201 => 3698
ALT 435 => 132
Retest 27/11 (Day 9 – Specialist, also Cobas) HCV RNA 939

GT 3a 46 years male F4
Tested on 20/11 and 27/11
HCV RNA 7369 => Undetected
ALT 51 => 17

GT 3a 55 years male F3/F4
21/11 (started 23/11) and 30/11
ALT 148 -> 87
HCV RNA 239,000 => <15

So it definitely looks like you can successfully mix Sof and Dac in the same tablet.

YMMV
5 December 2015 at 8:15 am #5274
Gaj
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@gaj
Hi Dr James,

Results of RVR look good (the gt2 really speaks to me).

Are you saying that you were trialling a potential pressed/moulded style of combined sof/dac tablet as opposed to sof/dac in capsule(s)?

G

G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
5 December 2015 at 10:24 am #5279
Jimmy6429
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@jimmy6429
I noticed very little difference from the Corevegin from Incepta to the Mesochem Sof/Dac API as far as sides are concerned. These are pretty amazing results in seven days. Will make the drugs easier to distribute especially in 3rd world situations and places like jails.

3 years cured, Sof/Dac, thanks Doc Freeman, hepc only a distant memory, go for it ppl
5 December 2015 at 5:43 pm #5293
Jolie
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@jolie
Wov!, those are fab results,
I wish now I waited for this combo pill to be available, but impatience got the better of me….
Best of luck with the rest of the Trials Doc, although you probably don’t need it looking at the results so far.

Thanks for your passion & courage in helping to get rid of HCV everywhere, you’re truly amazing human being

Geno 3, Fibro 8.7 pKA, tx experinced in 2005 – Peg/Riba, relapsed.
Started tx 1/12/2015 with Indian Sofo & Chinese Dac.
5 weeks result all normal, ALT 18 – down from ALT 73 at the start of tx.
5 weeks HCV PCR RNA – UND. – down from 2 ML
9 weeks HCV PCR RNA – UND.
6 December 2015 at 10:41 pm #5339
zhuk
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@zhuk
Some really impressive results there Dr James, good to know that this dosage method is just as efficacious. Roll on the Redemption trials!

GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 – 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 – 6 weeks UNDETECTED
AST 26
ALT 26
7 December 2015 at 1:05 am #5342
Paul-Jarman-facebook
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@paul-jarman-facebook
How do we get 10 million doses of this into the country ?

Two time relapser.

SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated

GT 3 – about 28 yrs with HCV
10 December 2015 at 1:19 am #5725
emilio
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@emilio
Awesome results and I’m wondering if these types of reductions happen mostly. And that the mopping up happens from this point to week 4. So all but destroys and then the body takes a little time to eliminate the gabbage? Em
10 December 2015 at 1:25 am #5727
Alsdad
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@alsdad
Does the DAA kill log relate to the viral load log? As in: If you have a viral load of log 6.1, will the DAAs reduce that viral load by their equivalent kill log cycle?
10 December 2015 at 1:28 am #5729
Paul-Jarman-facebook
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@paul-jarman-facebook
I think it takes time to knock off the stragglers if we have scar tissue on our livers. If it wasn’t for that you could have slightly higher doses and maybe add another drug for only a few weeks and we would all be cured.

Two time relapser.

SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated

GT 3 – about 28 yrs with HCV
10 December 2015 at 6:10 am #5765
Dr James
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@fixhepc
Yes, the big kill is in the first week which is why people tend to get the worst sides at the start.

Then it’s just mopping up the stragglers which takes longer with cirrhosis.

The last few weeks of treatment a being delivered to a Hep C negative person, but the problem is we can’t measure to see if we can stop yet, so we over treat by quite a few weeks just to be sure. For example low fibrosis GT1 patients really only need 8 weeks Sof/Led

YMMV
10 December 2015 at 2:57 pm #5809
LondonGirl
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@londongirl
Yes, Worth an extra 4 weeks, apparently I am ‘low’ fibrosis, but as NHS England aren’t offering any diagnostics & Prev fibro questionable, how can one tell? Better to do the full 12?

GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC
10 December 2015 at 3:20 pm #5812
zhuk
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@zhuk
I reckon yes, LG. 12 wks might be a bit overkill for those of us less affected, but I’d rather give it the greater chance to knock off all the bastards. Plus, considering we are both lightweights, we are going to get a greater dose per/kg bodyweight than those of average build, which pharma sets standard dosages for.

I would rather be sure…I’ve only got one shot at this

GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 – 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 – 6 weeks UNDETECTED
AST 26
ALT 26
13 December 2015 at 9:38 pm #6177
Enkel
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@enkel
Hi Doc,

If someone relapses after the treatment of 3 month sof/led for geno 1, can he use then sof/dac?

Male, Fibro F1. Geno 1b. ALT 67 before treatment Viral load 5 million. My huge viral load replicates in my nervous system as I suffer anxiety.
Started Twinvir 12/12/15.
Two weeks
ALT 17 at 2 weeks
Viral Load UND at 2 weeks
ALT 13.5 at 7 weeks EOT
ALT 10.5 at 15 weeks EOT
ALT 13 at 27 weeks EOT, VL UND, Cured
14 December 2015 at 9:06 am #6214
Armen-Beglaryan-facebook
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- Novice
@armen-beglaryan-facebook
Darvoni: 6 tablets in a box
darvoni price offer:
– USD60 per box + currier charge
https://www.facebook.com/darvoni.beacon/?fref=ts
14 December 2015 at 10:12 am #6217
Paul-Jarman-facebook
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@paul-jarman-facebook
Enkel wrote:

Hi Doc,

If someone relapses after the treatment of 3 month sof/led for geno 1, can he use then sof/dac?

I think it depends on lots of factors Enkel, hopefully one of the experts will chime in on this one.

cheers

Two time relapser.

SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated

GT 3 – about 28 yrs with HCV
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