Yes Cruzan,
You are GOOD!
Responding to treatment great!
on your way to UNDETECTED!!!
Mike

Hi DT,

Thanks for the great explanation about the genetic markers. I am IL28B CT and I hadn’t fully realised the impact that these two little letters could potentially have on the outcome of interferon based treatment. Mid last year the Dr at the liver clinic was still recommending interferon with very little discussion about success rates and certainly nothing about the genetic marker which I just happened to see in a blood result.

It really is so important to keep yourself informed which is why this site and all involved in this adventure are so fantastic.

Cheers
Coral

Anyone giving someone interferon at this time shoud have to take it as well.
In jail.
M

From Gilead Page:
HARVONI was administered once daily by mouth in these trials. Sustained virologic response (SVR12) was the primary endpoint and was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment.

Thank you, Enkel, for pointing out (post#7415 on this thread and some other posts on other threads) that SVR12 is, apparently, not limited, as I had previously thought, to being HCV RNA undetected at 12 weeks after the last dose of treatment. Thanks also for backing this up with the quote above from a Gilead document which states that the definition of SVR12 used for the ION clinical trials into Harvoni (sof/led) was being below the LLOQ (Lowest Limit of Quantification) at 12 weeks post EOT (end of treatment). I assume that if this is the meaning of SVR12 used by Gilead in the ION trials it must be a meaning which is accepted not just by Gilead but also by the wider medical and scientific community.

It seems to me, if my understanding is correct, that, potentially at least, being below the LLOQ is not quite the same thing as being undetected at 12 weeks post-EOT (although clearly it includes being undetected at 12 weeks post-EOT). Is this correct? For example, does being below LLOQ for this purpose include being LLOQ, which would constitute relapse and failure to attain SVR12.

Another thing that puzzles me about this more lenient definition of SVR12 is that if someone achieves UND at EOT but then their VL test comes back

Hi,

maybe a ‘bit off topic’ but what about the possible outcome of never achieving a SVR?

From what I have read, it appears that HCV’s symptoms, and I hope damage, is limited during treatment. For me I need 24 weeks and finish the first 12 weeks on my birthday! Feel better on DAA’s then before when not on them, but there is the chance of still no SVR.

Being the product of warehousing due to Interferon not working previously I have had to watch my liver being bounced around, a dismal pastime not enjoyed by myself or the medics that have helped me for that matter, over many years. The liver is now scarred and sported a 4.9cm tumour for a while as well.

If no SVR, my questions are:

1. say another tumour decides to keep company with my liver, is staying on DAA’s likely to be some part of palliative treatment?

2. if the liver stays okay but the bug is not eradicated fully with the likelihood of coming back in the millions post treatment, is staying on DAAs something that medically could be indicated? Maybe delay another HCC if one is on the cards?

3. if the DAA’s cannot always get into the upper reaches of my liver’s scar tissue and there then is a reliance on my immune system finishing of what’s left, does this put Interferon (just before and a bit after EOT) back on the table?

Yours

J.

P.S. didn’t mention the costs, but think of the windfall Gilead could make if people such as I were on DAA’s indefinitely; they would need to lower the cost though, but I don’t think their bean counters have enough sense to think that way and I think they would put gouging before profits just to be sociopaths.

Sabrecat,

I can’t directly answer your questions but here’s what I know.

Q2
In the days of interferon it was also thought of that people who did not reach SVR might be put on a ‘maintenance dose’ indefinitely to protect their livers until a cure came along. It was tried but without much success. I don’t see why it couldn’t be tried with the DAAs too.

Q3
Again in the days of interferon, it was thought that there might be a reliance on the immune system to finish the job and get to SVR. For a while it was theorized that svr would not be possible without interferon, for this reason. So when the first svrs were achieved without interferon it really revolutionized that thinking. It was then theorized that if a person became resistant to all DAAs then interferon would once again become their only option. I don’t know how it goes from here. We’ve had an ‘arms race’ with bacteria and antibiotics which the bacteria are on the verge of winning. We are just starting an ‘arms race’ with viruses.

There was a guy on medhelp who had HCC. He got a liver transplant and he got to SVR with the DAAs. The most important thing about his story was that he had a fantastic medical team at the transplant liver centre who got him through all kinds of complications. Hopefully it will not come to that for you, but that’s what you need if you don’t get to SVR.

dt

Hi Sabrecat,

Being in a similar health and treatment situation to you can I just say that I have every confidence that we will both achieve SVR and remain so.

Particularly given our incentives, both cash and health wise, to be dosage compliant throughout our treatment. As my specialist said “…..at this point I usually give patients a lecture about taking the meds as directed but in your case I guess we can skip that!”
I have also stocked up on vitamins B12 & D and made an appointment this week with my GP for tests just to see if I need an initial shot to get me back up to optimum levels.

Any further tumours need to be found and treated as soon as possible for the best prognosis so make sure you are getting checked as regularly as possible. While your occurrence was at least 3 years ago, if it was me I would be talking with my specialist about three monthly scans while on treatment and a period after even if I needed to pay for some myself.

For others who may fail to achieve SVR, while not an expert, my thoughts are that staying on treatment with DDAs is not likely to be optimum. As Paul said, they would need to determine why they failed via testing and then look for alternative treatments such as Velpatasvir instead of Daclatasvir or possibly a three way treatment using Simeprevir (speculating with these suggestions)
There is also discussion that for some Gt3 patients, Interferon plus a couple of DAAs throughout treatment may work well but I know in my case Interferon has basically been ruled out for retreatment due to my IL28B status.

Thanks Hamilton

So not yet but SOON – I can live with that

I’m looking forward to when I can unleash the UNDECTED montage in the party room.

Congrats to your result, especially after failed previous Tx, onwards to SVR for you!