Numbers of SVR's / relapses / breakthroughs

This topic has 28 replies, 9 voices, and was last updated 9 years, 2 months ago by emilio.

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8 September 2015 at 4:10 pm #1208
dointime
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@dointime
Hello Dr Freeman,

I am new to this board so let me start by saying that I applaud your work to help all of us with hepC. I wish that there were more of you out there.

I note that for your successes you publish 2 PCR’s which show that this person has become UNDetected. While this is encouraging and does prove the antiviral activity of the Mesochem drugs, we know that SVR is the only real measure of successul treatment for hepC. So would you be willing to post the numbers that you are obtaining from the Mesochem drugs regarding SVR12 / relapses / breakthroughs? It would also be helpful to know for those patients their hepC profile, ie. genotype, cirrhosis or not, treatment experienced or not and which drugs already experienced. Also the treatment drugs used and the duration of treatment. Also any adverse events with the side effects. All anonymously of course.

I think that this would be very helpful for those of us considering using the Mesochem drugs. I realise that it is early days and maybe too early for the SVR’s to be coming through. However a table of running totals would at least give us some insight as to the efficacy and safety of the Mesochem drugs.

Many thanks for your consideration,
dointime
9 September 2015 at 10:16 am #1212
emilio
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@emilio
Hey DT

It’s all relatively new here so most of us lining up are assessing the research data from elsewhere. I’m planning to have my daclatsavir tested on arrival not because I don’t trust the company, it’s to assure others that the supply chain can be trusted. Met you years ago on medhelp when I was doing a roche trial, you were big weeks weren’t you on the old stuff? I did 63 to no avail. Em
9 September 2015 at 7:29 pm #1214
dointime
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@dointime
Hi there Em,

63 weeks, whew! I didn’t do big time, it just felt like it after 2 crushing breakthroughs. I am a naive optimist no more when it comes to the hepC virus. I think it is a very good idea that you are getting your Dac tested. What kind of place have you found to do that for you and what test(s) will be done?

Well, hope you stick around and let us know how you are doing. I am unfortunately teetotal but I’ll toast an apple juice to you when I hear about your SVR,

All the best,
dointime
10 September 2015 at 1:50 am #1215
Dr James
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@fixhepc
Before letting the first patient take any medication we did a lot of testing to make sure the medication was both an accurate copy and also free of impurities. Unless the drug companies have faked the data it’s reasonable to expect similar results.

We are tracking people in exactly the way you describe (with additional things like batch numbers and medication testing results) so with time will have some pretty valid stats on this, but at the moment we don’t have enough data. Currently we have only seen 1 case where the patient has been non zero at week 4, but in a sample size of n < 100 the margin of error is +/- 10% Real cure is when you not only get to zero, but some decent period after stopping the medication remain at zero. Relapse represents not really being at zero, but rather being so low we can't measure at the end of treatment. Most relapses will happen within 12 weeks of finishing treatment http://cid.oxfordjournals.org/content/49/9/1397.full

We could set up an open data collection poll that people could use to add their personal data and then generate some graphs. While public crowd sourced data can be manipulated it would be interesting to see.

YMMV
10 September 2015 at 11:35 am #1218
emilio
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@emilio
I now recall that you were doing vertex while I was doing the roche PIs. I’m thinking you are US or UK based and if so what is your understanding of government policy on accessing the APIs and bringing them home? Yep I’m rearing to go again (naive) maybe but I won’t won’t stop till it’s done. I’m back after playing emu for 5/6 years. Em
10 September 2015 at 4:04 pm #1224
dointime
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@dointime
Em –
UK government policy! I can’t speak for them but I can say that my doc practically made the sign of the cross when I mentioned the Indian generics, so I never got the nerve to say anthing about the Chinese APIs.

Dr Freeman –
I very much appreciate the detailed information that you have provided so far. I wish we had somebody here in UK doing the pioneering work that you are doing. Unless I am willing to simply sit and wait till I develop advanced liver disease, it is DIY for me here at the moment I’m afraid. So all the information that you can supply is invaluable in helping me make informed choices as to my risk of doing nothing versus the risk of doing something, for example using the Mesochem APIs or the Indian generics – always supposing that I can obtain either.
On the question of an open data collection poll I am not sure, for the reasons that you have stated.

Best wishes,
dointime
11 September 2015 at 6:10 am #1229
emilio
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@emilio
DT – Very cheap accomodation down here, we would be more than happy to accommodate. Depends on how quick you wanna tx and the additional 2K in airfares? Em
11 September 2015 at 2:27 pm #1233
dointime
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@dointime
Emilio – what a lovely response, you are so kind. I want to tx in the next year. Not knowing how the Harvoni situation will pan out in India has been making my options uncertain. Also, this new information on the comprehensive testing that Dr Freeman has done on the Mesochem drugs is a game changer in my opinion, putting the Mesochem drugs more or less on a par with the Indian licensed generics, if both are indeed identical to the brand name.

One thing is certainly appealing about Tasmania – we are coming into the cold dark winter here in UK while you guys are approaching your summer. hmmm….
That alone has got to be worth the airfare!
11 September 2015 at 2:56 pm #1235
emilio
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@emilio
Hey DT – I’m thinking that you’re liver is holding up ok so you have a some time. Yeah I was looking closely at Harvoni or Sofosbruvir/Simprevir combo prior to happening upon James. Lol I’m about 1500kms north of Tassie so you would certainly know summer, hot and dry love it. Tasmania is something special though and we’re planning a trip down there soon.

That’s the great thing about GP2U, visits are Skyped, scripts, referrals and documents placed in your personal folder for easy access.

The offer is always open DT. Em
11 September 2015 at 3:09 pm #1236
dointime
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@dointime
Hey Em,
My liver is ok but I have a lot of fatigue which is really putting a dent in my quality of life. The more I learn about the service that James is providing the better it gets. It is so far ahead of anything that is happening over here that I am feeling I am living in a 3rd world country. Just to find out that better and affordable medical care is possible has been a huge tonic.
I am so glad to hear that you are working with James and that you are getting your shot at SVR. For some of us the wait has been very long and harrowing.
DT
11 September 2015 at 4:24 pm #1238
emilio
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@emilio
Hi Dointime

Well without this option I’d be heading to India down the track. In Australia the new drug combos have been recommended to be placed on the PBS subsidisation list, however I’m not sure that the Government is that keen, particularly in this fiscal environment but hey they may surprise all of us. I’m not banking on it though! So in a few weeks I will commence my sofos/daclats combo for 12 weeks and like you I’m not as confident as others, been there done that. I think once you relapse it’s hard to be 100% positive.

I’m convince that with daclatsavir I won’t need ribavirin however, I do think I should be considering an additional 6 weeks maybe, just to be sure? Anyway I’ll make that decision at week 4. Previously my VL hovered around 3 to 4 million so I’ll just have to reassess at week 4. In saying that though the clearance rates at 4 weeks for both daclats and ledip are pretty damn impressive. I did considered doing sofos/daclats/ledip combo but there’s just no research on doing 2 NS5As? One would think more is better but I just couldn’t consider doing this blind. Em
11 September 2015 at 5:13 pm #1240
dointime
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@dointime
Em,

I find that really interesting Em. For myself, I don’t feel I want to risk a 12 week duration without riba, even though for my hepC profile the AASLD recommends it. I read the Gilead trial results for ION2 and Sirius, which are the trials most interesting for me, and it seems clear that for 12 weeks I could expect <100% but for 24 weeks it would almost certainly be 100%. The 12 weeks with riba option would for me probably also be 100%, but based on previous experience the riba would give me a repeat of the rash from hell, which I don't fancy. Like you I am favouring the sof/dac combo rather than the sof/led combo.

Therefore, as there seem to be no safety issues with the 24 week option, even for cirrhotics, I am going for that if I can get it. I don't care if it is more than necessary. The recommendations are meant to be for everybody but each individual has to look to their own circumstances. I do wonder if more doctors would be willing to prescribe 24 weeks if it were not for the swinging price of the drugs and the fact that their hands are tied. I wouldn't do 2 NS5As either, for the same reasons as you. The thing I am not sure about is how good an indicator it is to be UND or not at week 4? So because I am not sure I would just carry on to 24 weeks regardless. Do you know of any research which can tell us more about this? My thinking around it has been to have a PCR before EOT and in time for the results to arrive before EOT. IF I were not UND at that point then clearly I would carry on, but if I were UND then what would I do? I'm not sure.

I am genotype 1b
no cirrhosis
treatment experienced with Telaprevir (NS3 protease class)

I would be most interested to hear how you go with your tx.

Best,
DT
15 October 2015 at 11:53 pm #2302
Rlh
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@rlh
Hi dointime, just joined and reading through everything . I think we have very similar profiles in regards to hepc status. I’m type 1b, relapsed after 1 year of peg interferon rab. And 2nd go 6 months of peg, rab. And telaprevir first 3 months. Achieved SVR 4 both times but relapsed.
I notice in your blog you say with dac and sof for 12 weeks svr 12 after treatment could be achieved. The American Association for liver disease also recommends dac/sof for 12 weeks.
Reading through the open label trials treatment for previous treatment failure dac and sof seems to be used for 24 weeks and or rab.Am I missing something.
Relapsers are more likely to have genetic variants which dac seems to be better for.
I am now 4 weeks into sof India and dac mesochem. I am trying to figure out if I need to extend to 24 weeks.
Mesochem is getting a little difficult now so must make a move
16 October 2015 at 1:37 am #2312
dointime
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@dointime
Hi Rlh,
If I read you right, I think you are getting confused between previous treatment with a NS3 protease inhibitor and previous treatment with sofosbuvir and an NS5A.
Leftover NS3 variants do not influence the outcome if you are doing sof/dac tx.
NS5A variants do, either baseline or leftover, and were identified as a major cause of relapse in the Harvoni trials.
I don’t know if dac copes better with NS5A variants, that would be a question for the doc.
Good luck,
dointime
16 October 2015 at 2:03 am #2313
Chester
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@chester
When I got my 4 week VLs the nurse assessed my chance of relapse against a checklist that included:

1. Whether or not an early responder (early responder defined as UND at 4 weeks)
2. Genotype
3. Treatment experienced vs treatment naïve (my understanding was treatment experienced referred to previous interferon based treatment)
4. Degree of cirrhosis

As I can tick all these off (UND, 1b, naïve, f3/4) and she said if it comes back we can just hit it harder for longer, I chose not to extend Sof/dac/RIBA beyond 12 weeks. And I’m an optimist.

Ultimately, should I have to retreat, I figure no matter what they do, the generics will continue to be available somewhere in the world and I’ll fly anywhere and crawl over broken glass to get ’em if I have to.
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