TOPIC:

Is "Gane" a New Zealand word for "Limbaugh"....with no test results, sounds like a lot of familiar "wind", imo

So enough results are in, and out of embargo so now I can say what I was dying to say at the time, well actually.....

Generic Sofosbuvir + Ledipasvir delivers damn good SVR rates and we repeated a trial Professor Gane did (26/26) with Sof+Led+Riba in GT3 and got 13/13 = 100% SVR - please don't get excited this was in treatment naive low fibrosis GT3 only and the +Riba was essential.

Here is the data: fixhepc.com/forum/media-news/914-easl-sl...-4-svr4-overall.html

It is all good news James. It is all a great comfort.
Thanks for your time taken to report to us. I am about to read the other posts, Cheers from Ariel.

Thank you Dr. J, but I was wondering if you think it's OK to not have the Ribas with the Sof/Dac meds for my War Vet friend, G.T. 3a 2nd liver transplant. Had failed Ifn/Riba tx in past.

He's on the PBS orals, under the care of his specialist, but I don't think they are really "caring" enough.
He has been on it for 2 weeks now ( Sof/Dac no Ribas)& he is SO tired and kind of "out of it" most of the time.
He going to be on it 24 wks.

He's not meant to have another blood test 'till week 4.
Does anyone think he should be getting checked more often?

Surely they'd want to check his rejection drugs are working ok with the tx??!!

I do feel sorry for him, why is everything such a hassle, why wouldn't they just check him more often, why do we have to hassle them.
Surely they should just monitor him more closely?

WHY aren't more doctors like DR. Freeman??

Can anyone tell me if it's normal to feel VERY TIRED from the drugs?

x

CJ wrote: Thank you Dr. J, but I was wondering if you think it's OK to not have the Ribas with the Sof/Dac meds for my War Vet friend, G.T. 3a 2nd liver transplant. Had failed Ifn/Riba tx in past.
x

Hi CJ,

hope things go well for your friend and I think that having people that care about him like you has already made him better in his heart.

The RIBA bit on top of sof/dac is something I have an interest in and have two lines of thought.

First it may assist?

Second, I could not cope with it when used with interferon - do I want to make my life miserable on the way through this treatment?

Some of my rationale for treatment given the past HCC is that another HCC can come along for many reasons, and at least feeling better in the mean time is well worth the treatment.

I think this is al individual and something doctors get paid the money to sort out with the individual patient .....


Yours

Jeff.

Can anyone tell me if it's normal to feel VERY TIRED from the drugs?

My observations are:

1) The closer people are to the edge the longer it takes to drag them back
2) The usual 1 week "a bit under the weather" on treatment initiation is more like 2-4 weeks in cirrhotics
3) Cirrhotic viral loads, enzymes and bilirubin take longer to come good, and platelets take even longer

The reality for some people is that treatment arrives too late to drag things back, and transplantation will still be required.

I have one patient like that. He was in ICU when we started treating him 6 months ago, and has no viral load, but his liver was/is so shot he's now on the transplant list. Without generics he would have been on the casualty list.

James-Freeman-facebook wrote: So enough results are in, and out of embargo so now I can say what I was dying to say at the time, well actually.....

Generic Sofosbuvir + Ledipasvir delivers damn good SVR rates and we repeated a trial Professor Gane did (26/26) with Sof+Led+Riba in GT3 and got 13/13 = 100% SVR - please don't get excited this was in treatment naive low fibrosis GT3 only and the +Riba was essential.

Hi Dr Freeman

I'm currently on Sof/Dac 12 wk tx...about 7 weeks in. I'm in the process of making the decision to extend a further 4 wks..should I be
Adding RIBA to the mix?

There's a bit of evidence that Ribavirin produces a scant few % points improvement in SVR in 12 week treatment for both GT1 and GT3, but there is also evidence that extending the duration adds more % points.

There is nothing to guide taking it at the end of treatment. What often happens is that it gets taken until the sides get to bad then stopped. The big problem is we don't exactly know how it works.

You don't say if you're GT1 or GT3 in your signature. In your favour is low starting viral load, F0 and womanliness.

If you're paranoid and losing sleep over things a few extra weeks of Sof+Dac 4-6 or even 12 does deliver slight improvements in SVR.

The duration is a case of diminishing returns. Each extra week adds less and less extra SVR and you have to draw the line at some point.

Thank you for quick response.

I'm GT3...

If you were GT1 I would say don't worry. With GT3 a few extra weeks are not a bad idea for many people, but you are really at what should be the "very easy" end of the spectrum.

I'd expect you to SVR with 12 weeks but if you're tortured with worry and can arrange it adding 4 weeks would not hurt and adds a little insurance.

Thanks so much Dr J ,

That makes sense, around 3 to 4 wks feeling knocked about if cirrhotic,

We are keeping a close eye on him & my hubby organised a carer for him to keep his little place clean & make sure he's ok when we can't be there, so all fingers crossed.

x

James-Freeman-facebook wrote: If you were GT1 I would say don't worry. With GT3 a few extra weeks are not a bad idea for many people, but you are really at what should be the "very easy" end of the spectrum.

I'd expect you to SVR with 12 weeks but if you're tortured with worry and can arrange it adding 4 weeks would not hurt and adds a little insurance.

Dr James,
Thanks for clarifying the above..

If an additional 4 weeks adds a little insurance for success...I'm there!!!

James-Freeman-Facebook wrote:

So enough results are in, and out of embargo so now I can say what I was dying to say at the time, well actually.....

Generic Sofosbuvir + Ledipasvir delivers damn good SVR rates and we repeated a trial Professor Gane did (26/26) with Sof+Led+Riba in GT3 and got 13/13 = 100% SVR - please don't get excited this was in treatment naive low fibrosis GT3 only and the +Riba was essential.

Here is the data: fixhepc.com/forum/media-news/914-easl-sl...-4-svr4-overall.html

Isn't Slide 11 – headed “SOF+LDV+RBV for GT3(Ed Gane 2015)” - a double-edged sword for Prof Gane?

It praises Prof Gane's research by reproducing his results on the use of LDV plus Riba for GT3 (although, in passing, most GT3-ers would, I imagine, prefer SOF + DCV without Riba to SOF + LDV with Riba).

But, on further reflection, it's apparent that this result has been largely, if not completely, achieved through the use on Redemption 1 of the very unlicensed LDV from China and Bangladesh, which Prof Gane has been at pains to warn the world – first in his NZ radio interview, then in his NZ TV interview and again in his piece in the NZ patient group mag - may be substandard and ineffective.

As far as I know, Prof Gane has not withdrawn or qualified his previous remarks about the possible inefficacy of unlicensed ledipasvir or at least of some types of unlicensed ledipasvir.

It's true the Redemption 1 results are at this stage only preliminary and, because of the timeline, are mostly SVR4 not SVR12. Also the EASL slides do not state the precise provenance of the unlicensed ledipasvir used in the trial– was it, for example, buyers' club Chinese Mesochem LDV or Incepta's Twinvir or Beximco's Lesovir-C or some combination of these and, if so, in what proportion? The former could be remedied by the publication of the SVR12 results when they become available. Disclosure of the latter could be very informative and relevant given the uncertainty about the precise scope of Prof Gane's comments.

It seems to be me that some sort of resolution of Prof Gane's thesis about unlicensed ledipasvir would be desirable and that Redemption 1 is the best placed trial to do this. If Prof Gane proves to be right then he needs to be congratulated for alerting the world to the possible dangers of unlicensed ledipasvir or at least of some types of unlicensed ledipasvir. But if he proves to be wrong then perhaps he should be given the opportunity to correct or qualify his previous comments - because uncorrected and unqualified those comments have the potential to be not only damaging to the unlicensed generic industry but also needlessly distressing to those patients who have used unlicensed ledipasvir.

Gane needs to clarify his remarks. He made a very vague attack against generics from Bangladesh. But research shows generics from Bangladesh are made from API's from China.

Interestingly, Gilead admits some of it's ingredients are API's from China. So I challenge Gane to come forward with the origin of the Gilead "superior" API's. Because I say that "perhaps" Twinvir and Harvoni are made from the same API's.

Is this prof concern valid, since all the Api are made in third party factories

Or do Gilead produce their own Api?