Sofosburvir + Daclatasvir (Changed from led day4)

This topic has 27 replies, 9 voices, and was last updated 8 years, 7 months ago by Dr James.

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14 January 2016 at 11:17 am #9073
Stew-H
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- Treatment Warrior
@stew-h
If you’re Geno 1a Sof +Led has the best cure rate with Sof + Dac more of a generalised treatment irrespective of reflux problems
Its advised to take only 20mg of nexium on an empty stomach at the same time you take Ledipasvir if you have acid reflux.
I myself have stopped taking nexium as I have now been diagnosed with bile reflux mistaken as acid reflux and take Ursofalk
No more vomiting in pain for hours on end and 24 hr nausea
I still wake up after approx. 4hrs sleep evey night with fevers , pain and nausea, my mouth full of bile

Diagnosed Hep C 2013
Geno Type: 1a
Treatment: Na√Øve
Cirrhosis
F4
2015 GGT 227 AST 79 ALT 89 Platelets 88
2016 Treatment Generic Harvoni Finished 29 March 2016
GGT 30 AST 19 ALP 67 Platelets 91
Qualitative Test Results April 12
Hepatitis C NAT (NA): Not Detected
P.C.R Test for Hep C 4th July: Negative
Virus Free
stewart.henstock@hotmail.com
14 January 2016 at 3:40 pm #9110
Dr James
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- Guardian Angel
@fixhepc
If you’re Geno 1a Sof +Led has the best cure rate with Sof + Dac more of a generalised treatment irrespective of reflux problems

Sof+Dac

GT1 ALLY-2 naive (80/83) experienced (43/44) Aggregate 96.8% (123/127)
GT1a ALLY-2 naive 96% (68/71) experienced 97% (32/33) Aggregate 96.2% (100/104)
GT1b ALLY-2 ALLY-2 naive 100% (12/12) experienced 100% (11/11) Aggregate 100% (23/23)
Past Failure ALLY-2 98% (43/44)

Sof+Led

GT1 ION-1 98% (142/145) ION-3 96% 96% (165/172) Aggregate 96.8% (307/317)
GT1a ION-1 98% (142/145) ION-3 96% 96% (165/172) Aggregate 96.8% (307/317)
GT1b ION-1 100% (67/67) ION-3 98% (43/44) Aggregate 99.1% (110/111)
Past Failure ION-3 94% (102/109)

Not a lot between them, but the data for Sof+Led is more robust due to better n

With F4

Sof+Dac ALLY-2 naive 89% (8/9) experienced 92% (12/13) Aggregate 91% (20/22)
Sof+Led ION-1 97% (32/33)

So although Sof+Led looks better on % basis the entire stats for Sof+Dac and Sof+Led are based on 55 patients, of whom 3 failed.

PPIs prevent Ledipasvir absorption so I would recommend Sof+Dac

YMMV
14 January 2016 at 7:57 pm #9119
kenbasman
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- Guardian Angel
@kenbasman
Hi there,
I had bad reflux, gastritis and esophagitis b4 starting tx. After about 2 days of tx it got WAY better. Now, after a month of treatment I take 20 mg of omeprazole with the generic harvoni about once a week and occaisonally an alka-seltzer in the afternoon (once or twice a week).
That’s just me, but I would guess that after just a few days of tx you could very well have way less reflux problems.
I wish you luck!

HCV 35 yrs G1a F3 Tx naive
started Lesovir-C 15/12/2015
pre tx: VL 5,250,000 ALT 374 AST 208
FIBROSCORE 10.4

4 weeks tx ALT 29/ AST 33. VL < 12 UI/mL 8 weeks tx ALT 29/ AST 34. VL UND 4 weeks after tx UND. SVR4. ALT 24/AST 18
16 January 2016 at 8:30 am #9412
pkhow
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- Acolyte
@pkhow
I have just over 2 weeks to go now on my treatment Sofos+Dacl having changed from my origional intention of Sofos+Led due to my need to use PPIs.
I have Geno1b which i think has a slightly better chance of clearing the virus than1a when treating with Sofos+Dacl or least as good as using Ledipsavir.
Did i do the right thing in switching combo’s. ops: Am I correct in what i have concluded or is the data on Sofos+Dacl just not available in large enough numbers to be sure.?

Thanks / Good luck to everyone here on treatment and those who are going to undertake it.

Genotype1b probably since 1978.
On prior TX. Started TX 11nov15
Sofosburvir + Daclatasvir FixHepC
VL Undetected 4weeks thanks to
Dr Freeman and FixHepC
16 January 2016 at 9:20 am #9417
Gaj
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- Guardian Angel
@gaj
Hi pkhow,

Your last choice! The results are so close anyway that until millions are treated we won’t know with any certainty. And then it will only be statistics from previous history and not what will happen next time.

Anyway you were UND at 4 weeks so looks like you made the right choice, relax and enjoy. You are well on the way to SVR.

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
27 March 2016 at 8:46 am #14524
rightsaidfred
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- Guardian Angel
@rightsaidfred
Hello Guys,

With regard to taking PPI’s, what about using H2 antagonists instead? I have been doing this. I try to avoid taking any at all, and do not on good days. When I do I leave it for 4 hours after taking sof/dac and take a very small dose, usually 75mg. H2 ants. work less well but do take the edge off reflux, they also have a shorter half life than PPI’s. I would welcome any comment from Dr Freeman.

G3a. Probably infected 40 years ago.
Diagnosed July 2015
7/7/2015: ALP 69, ALT 209, WBC 5.8, VL 40,000. Fibroscan 9.5 Kpa.
Commenced treatment Sof/Dac (Natco Pharma) 24 wks in Feb 16
VL UND @ 4 wks, 12 wks

EOT 6/7/16
SVR 12
SVR 24

PHEW! Thank you so much Dr James, Monkmeds and all at Fixhepc
27 March 2016 at 8:54 am #14525
rightsaidfred
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- Guardian Angel
@rightsaidfred
Sorry, I forgot to say that the h2 antagonist I’ve been taking is ranitidine.

G3a. Probably infected 40 years ago.
Diagnosed July 2015
7/7/2015: ALP 69, ALT 209, WBC 5.8, VL 40,000. Fibroscan 9.5 Kpa.
Commenced treatment Sof/Dac (Natco Pharma) 24 wks in Feb 16
VL UND @ 4 wks, 12 wks

EOT 6/7/16
SVR 12
SVR 24

PHEW! Thank you so much Dr James, Monkmeds and all at Fixhepc
27 March 2016 at 10:11 am #14533
Dr James
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- Guardian Angel
@fixhepc
Ledipasvir absorbs better in acid conditions. PPIs and H2 antagonists have the same impact.

The original research data showing the absorption issue was in dogs primed with famotidine – another H2 antagonist.

It is best to use Sof+Dac if you need to use any antacid medications.

You are taking Sof+Dac so can take as much or as little Ranitidine as you require when you require it.

YMMV
27 March 2016 at 10:35 am #14534
beaches
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- Guardian Angel
@beaches
Hi Dr Freeman;

empty stomach or with or after food, does it matter? I’ve been taking mine shortly before bed, is that the best idea?
Thanks

Genotype 1a
Diagnosed in 2004, had HCV for all my adult life. Until 2016!!!!
Harvoni treatment, started 19 March 2016
4 week results Bilirubin 12 down from 14 pre treatment,
Gamma 25 down from 52, ALT 19 down from 63, AST 19 down from 47,
VL <15 down from a lazy 6 million or so

EOT Results
Bilirubin 10, GGT 18, ALT 19, AST 21, VL UND

12 Weeks post EOT
Bilirubin 11, GGT 16, ALT 22, AST 20, VL UND
Cured baby
27 March 2016 at 12:42 pm #14542
Dr James
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- Guardian Angel
@fixhepc
For Sof + Led late in the evening probably gives best absorption. For Sof + Dac it probably does not matter. It seems to work regardless.

YMMV
28 March 2016 at 9:56 pm #14581
kenbasman
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- Guardian Angel
@kenbasman
Jeez. I hope I didn’t screw things up. I followed the reccomendations on the harvoni pdf of taking 20 mg or less of omperazole at the same time as my sof/led in fasting conditions in the morning. I probably took it about 32 days total of the 12 week treatment. More towards the EOT. I guess I will see what happens when I go for my VL info next week…

HCV 35 yrs G1a F3 Tx naive
started Lesovir-C 15/12/2015
pre tx: VL 5,250,000 ALT 374 AST 208
FIBROSCORE 10.4

4 weeks tx ALT 29/ AST 33. VL < 12 UI/mL 8 weeks tx ALT 29/ AST 34. VL UND 4 weeks after tx UND. SVR4. ALT 24/AST 18
30 March 2016 at 5:43 pm #14644
pkhow
- Topics: 2
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- Total: 10
- Acolyte
@pkhow
I changed right at the start from SOF+LED to SOF+DAC as i had to take PPIs(Nexium). I did all the research i could found so little between them that I changed to Dac combo and was able to keep taking my Nexium.
I am now 2 months post treatment ( 90 days treatment) with No detectable Virus. Although the sample numbers are small for Sof+Dac i am sure as larger numbers come through that this combination is at least as good as Sof+Led. Its obvious given Gileads track record that the combination in Harvoni is only because Gilead purchased the rights to Led then instantly dropped support of trials with Sof+ Dac.

Genotype1b probably since 1978.
On prior TX. Started TX 11nov15
Sofosburvir + Daclatasvir FixHepC
VL Undetected 4weeks thanks to
Dr Freeman and FixHepC
31 March 2016 at 7:02 am #14677
Dr James
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- Guardian Angel
@fixhepc
Hi Ken,

With any luck it should not matter. With a single dose to famotidine (not a PPI but like a PPI in action) primed dogs the AUC (Area Under The Curve) was about 50% less than without the antacid. Lower AUC means less drug means lower blood levels, however……

The 1/2 life (time taken to get rid of 1/2 the dose) of Ledipasvir is ~ 48 hours so once it’s in it hangs around for quite a while. That means what happens on any given day has very little impact on the steady state blood levels, and these levels were calculated to have a safety margin over the minimum requirement.

Say you took a PPI for 1/3 of your treatment, and this reduced absorbtion by 50% on those days. Overall that is only a 1/6th ie 17% average reduction.

Somebody who is 17% heavier than you already suffers from a 17% reduction in mg/kg concentration.

We know we don’t need to adjust the dose in large people so we can intuit that the base dose is well and truly enough, so don’t panic!

YMMV
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