TOPIC: Query: 8 week protocol

Hi Everyone,
I am wondering if anyone out there has information on or experience with the 8 week (vs. 12)protocol for genotype 1(b).Would love to hear any stories.

Thanks a lot,

Hi Honker

I am on Sof/Led for 12 weeks (Genotype 1b) as recommended by Dr Freeman so I can't really comment on 8 weeks v 12 weeks. My stats are pretty much the same as yours. I'm sure Dr Freeman would be able to answer your query or other forum members more knowledgeable than I am in that area. Finish my treatment in about 10 days. I was undetected at 4 weeks but won't be having another test done now until post four weeks off treatment. Sides very minimal (insomnia). Good luck with your treatment. Cheers Lynne

That's great Lynn. How time has flown and glad you can see the finish line. Hopefully, I will be right behind you. What are you going to do when it is finished? Just curious how you will celebrate.

I am going to have a holiday, destination unknown at this point. Not overseas or anything though, can't afford that Had a dreadful couple of years.......my husband lost most of his right lung mid 2014 due to a huge infection (called a bulla) which went undiagnosed for at least 12 months. He was incredibly unwell and is still trying to get his stamina and health back on track. My best friend lost her son to cancer in the same year and then low and behold last year in March I was diagnosed with Hep C.......talk about killing a whole Chinese nation! Anyway enough doom and gloom.....have been able to work all the way through my treatment and as you say I am on the home stretch. The three months have gone by very quickly.......and I'm sure yours will too

Honk....Your numbers look pretty good. No personal experience yet, but I asked Dr Freeman about the 8 week Tx
because my VL is currently under 6 mil. That is the figure for the 8 week treatment per Gilead's recommendation.
The cure rate between 8 and 12 weeks is 4%....94 vs 98. Someone can correct me if I'm wrong (my memory is not
as good as it used to be.)

Dr F recommends 12 weeks. He said for another few hundred dollars, why take the chance. Personally, I will cross
that road when I come to it in week 8. Good luck.....e.

My take is this: Say there are 100 people here treating for 12 weeks. Two will relapse according to the data that indicates a 98% success rate. If that rate is 94%, that means six will not reach SVR or 3 times the number who treated for 12 weeks. For less than $300-$600, why risk that? If there were terrible side effects, maybe.
A big decision.
Mike

Another point to consider which I've mentioned elsewhere is that I suspect part of the push for 8 week treatment is a desire to save on medication costs for large treatment groups. To use Mike's figures and in very simplified terms:

100 patients X 12wks = 1200wks treatment costs with 2 patients requiring retreatment @ 24wks = 1248wks total cost

100 patients X 8weeks = 800wks treatment costs with 6 patients requiring retreatment @ 24wks = 944wks total cost.

Now, call me a cynic if you like but which looks more appealing to a government or insurance company?

But for self funders like ourselves there is no opportunity to spread the costs if we happen to fail treatment so as others have pointed out, for a few hundred bucks more we can do the full 12 weeks.

Of course there are possibly other reasons to opt for shorter treatments like easier medication compliance, less monitoring?, and potentially less side effects.

Lynne-Francis-facebook wrote:
Sending love to you
What a resilient and strong woman you have had to be x
Ariel

Goodness Lynne, you really have had a very rough and trying couple of years. Great to hear you're near EOT, wishing you and your family all the best towards healing and good health

Hi Lynne,

You've had a lot of challenges packed into a very short time. Hopefully the end of Hep C will be the start of good and healthy times ahead for you and your family.
Coral

Hello Honker,

1b is the genotype of choice (if choice was an option).

Here are the overall stats for Sof/Led

Sofosbuvir Ledipasvir

NAIVE
default: svr: 97%, trials: ION-1 98% (142/145) ION-3 96% 96% (165/172) Aggregate 96.8% (307/317)
gt1a: default: svr: 97%, trials: ION-1 98% (142/145) ION-3 96% 96% (165/172) Aggregate 96.8% (307/317)
gt1b: default: svr: 99%, trials: ION-1 100% (67/67) ION-3 98% (43/44) Aggregate 99.1% (110/111)
F4
default: svr: 97%, trials: ION-1 97% (32/33)
w12: svr: 97%, trials: ION-1 97% (32/33)
w12riba: svr: 100%, trials: ION-1 100% (33/33)
w24: svr: 97%, trials: ION-1 97% (31/32)
w24riba: svr: 100%, trials: ION-1 100% (36/36)
FAIL
default: svr: 94%, trials: ION-3 94% (102/109)
w12: svr: 94%, trials: ION-3 94% (102/109)
w12riba: svr: 96%, trials: ION-3 96% (107/111)
w24: svr: 99%, trials: ION-3 99% (108/109)
w24riba: svr: 99%, trials: ION-3 99% (110/111)

These don't show GT1 8 week results, but ION-3 does:

www.hepatitisc.uw.edu/page/treatment/clinical-trials/61

Now if you look at slide 5 you see 94% and probably go - ick!

But if you look at slide 6 you will see that of the 215 people in the 8 week arm only 2% (2/123) with viral load < 6 million failed versus 10% (9/92) who had higher viral loads.

On slide 9 you will see that 18% had NS5A RAVs at baseline (of who the vast majority still got to SVR)

Not shown in the slides are the SVR rates comparing 1a and 1b in ION-1 and ION-3 but the upshot of that was that 1b is a little more responsive than 1a

With 1b, treatment naive, non cirrhotic, Viral load < 6 million 8 weeks Harvoni offers 98-99% cure rate. Treating past that point is probably a waste of time and money because by 8 weeks the chances are a patient is cured. The last 4 weeks might help somebody in that remaining 2%, but for most patients they don't need it.

That said for ~ $500 USD I would take the full 12 weeks myself for peace of mind, but if finances are an issue and you're treatment naive, not cirrhotic and have a VL < 6 million 8 weeks is not a bad option for both GT1a and GT1b.

Sounds like a challenging time. Glad that things have turned out well for you on the TX Lynne and that you live virus free.

Hi Gaj,
I was thinking more about not taking any more of the drug than necessary for health reasons. But have decided to go ahead with 12 weeks, belt and suspendser. I start tomorrow. Down the hatch!

Cheers
Kathy

Thanks Dr. Freeman. I think I could do with 8 but will do 12 for POM.

Knock the beast down.
Kick it to death for 8 weeks.
Then keep kicking for another 4, just to make sure its doesn't jump up and bite you in the ass.
If you get tired, kick with your other leg for a while.
Good Luck!
Mike