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Post Info TOPIC: About Accommodating Reduced Renal Function On DAA Therapy


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RE: About Accommodating Reduced Renal Function On DAA Therapy
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Another tiny tidbit found regarding the NOT frequently seen reductions of sof in DAA treatments (due to renal insufficiency.) This excerpt was found in some reccomendations coming out of the "Liver Summit" - The Elita Consensus - in a section looking at LT patients with renal failure needing DAA's.

Recommendations - post-transplant phase 

·         25.

SOF requires dose adjustment when the eGFR is below 30ml/min. Although no firm recommendation can be made on the extent of the dose adjustment,6 SOF administration every other day is currently used with an acceptable risk/benefit ratio. Although tolerability and efficacy of GZR/EBR are satisfactory in patients with renal insufficiency, their use is not recommended after LT due to major DDI with many IS. This is also true for the 3D combination. GRADE II-3.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



Guru

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Waduya figure Tig, some of will start cracking our sof tabs in half? hee hee  Hardly. I would want every blessed molecule of that sof in me!

I wish I could post the whole article, and the million other semi-related references (studies) it included, but I cannot, it's a "sign-in" thing I think. I hoped the blue links (3, 23) would open, but they do not. So, I will (at the bottom) type the info or links for these 2 references and anyone interested can google the studies up.

I recall our buddy who did the ½ dosing of sof, and we were all alarmed, a bit confuddled and fretting for him (initially) of course. There were variables in his case, the largest of those being his poor renal function, he actually had quite a few disadvantages going against him! He also had to access his drugs out of country and mostly had his care decisions being made by an out-of-country doc. Was the out-of country doc's call right or wrong? - not my decision, who am I to judge, but I know at least one state-side doc who was not pleased about the whole treatment decision thing.

When we (then) read through the Gilead sof info, it did (and does) spell out how full dosages were safe even for those in fairly advanced stages of renal failure, and, there are also another million studies showing that, so, was the out-of country doc right or wrong in our particular fellows case?  ... well, Mr. so and so, congratulations, I am pleased to inform you, you are und after your full dosings of sof/dac, your liver is great!, but sorry, your prior failing kidneys are fried now, and you need to go to dialysis ... Maybe that was that docs thinking - I have no idea. Even with the unusual ½ dosings (every other day) of sof, our guy did endure a full 24 weeks of treatment (by design), both the "every other day sof" and the "daily dac" for 24 weeks - so, he did have a fair bit of saturating, given the 24 week course length. Who gets 24 weeks of anything anymore! He was und at 6 weeks - I can only say that that speaks to the powerful nature of good Gilead drugs. Over on this side of the pond it was consider off-label use for sof.

I tell you Tig, this girl would want full doses of sof thank you very much, me, who was scared shatless that I pulled the short "trial" straw -  only getting 8 weeks of a triple therapy, when I wished for 12, or 16, or better yet 24 please!! I still can't shake loose that "more must be better" safety syndrome!

These references (3, and 23) are only picked out of a much greater number of studies (references) that were pooled, where they were looking at (in totality) many aspects of using sofa-based DAA's on those with varying stages of renal failure. Not many studies are found on sof ½ dosing. So, in honour of our guys odd win, I posted what I stumbled over. Oh they just study everything, don't they, or, I guess they should!

I only twigged on to these two, as they served to partly satisfy my ongoing curiosity about that foreign doc's decisions to half sof-dose our buddy. At the time, we could only assume it WAS a kidney sparing measure that over-rode standard practice (in that doc's book anyway).

Of the very many studies that were pooled in this article, the article did comment that some studies were not considered of "high quality".

In regard to just these two references (3 and 23) the article did mention ... "Nineteen patients in two studies[3,23] were treated with half-dose sofosbuvir and four of them failed to reach SVR12" ...

Only 19 people (combined) - and only (about ) 80-ish % (more or less) reached SVR? (but, you would have to read these studies to glean all the study and pts. parameters, for all reasons for failures - some of these poor folk had more going on than just HCV, and many were tied to a dialysis machines!

Safety, efficacy and tolerability of half-dose sofosbuvir plus simeprevir ...

www.journal-of-hepatology.eu/article/S0168-8278(15)00394-3/abstract

1.      

by BK Ram - 2015 - Cited by 39 - Related articles

Jun 18, 2015 - September 2015 Volume 63, Issue 3, Pages 763-765 ... Hepatitis C (HCV) is a leading cause of chronic liver disease worldwide and its ...

 

Download Images(.ppt) - Journal of Hepatology

www.journal-of-hepatology.eu/article/S0168-8278(16)30010-1/ppt

Journal of Hepatology. Volume 65, Issue 1, Pages 40-47 (July 2016). DOI: 10.1016/j.jhep.2016.02.044. Copyright © 2016 European Association for the Study of ...

 

 

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

Tig


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Where's the beef? wink  Did they provide any SVR rates? I'm curious what the failure rate was and the RAS profile following treatment. Any additional data on that? Creatinine or GFR results during and after Tx?

Gilead won't like knowing half doses of Sovaldi are adequate... no



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Tig

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Guru

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This had come up quite a times before in conversations, consideration of renal function while on DAA's, how to save work for the kidneys if they are not functioning up to par before you start DAA's. Zep has been highlighted, but we had one member here (in what seemed unusual, at first, at the time) who had been put on a regime of full dose dac and half dose sof. It was a bit of a curiosity, so, we had a search for studies about it or for others who had reduced sof, and DID find some reference to this "reduced" practise, but mostly, we surmized that it was a kidney-work sparing measure, due to the fact that this particular fellow did have less than par kidney funtion. He was well-cured BTW, and seemed to be fairly well followed by the doc who prescribed this designed regime for him. I just (now) happened to stumble across some further references to this "half dosing thing", so I post this snippet now, just in case anyone is interested, and only because we had not found too much on the subject back then. C.

 

... stage 4-5 CKD patients were on dialysis. Sofosbuvir-based therapies were used in seven studies.[3,4,18,19,21-23]Notably, Bhamidimarri et al.[3] described their treatment strategy of simeprevir and half-dose sofosbuvir (200 mg once daily or 400 mg every other day) in 15 HCV genotype 1 patients with stage 4-5 CKD. Desnoyer et al.[23] also included four patients with their treatment strategy of half-dose sofosbuvir (400 mg three times a week) plus daclatasvir or ribavirin ... 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

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