Author Topic: genotype 4 therapeutic options (Read 19775 times)

inaglasshouse · « **on:** October 14, 2014, 09:38:52 am »

Hello all, I'm new to this forum and I'm looking for informations about previous experiences and advice useful to my case.

I got HCV 35 years ago, genotype 4, presumably F3 stage, failed IFN/RBV treatment 10 years ago resulting as a non responder plus unmentionable sides.
I need to take a decision among the new therapeutic options since for me interferon is out of the question (the new coming Harvoni is out of the question too because ledipasvir doesn't work well with genotype 4).
Unfortunately there is little literature or studies about DAA therapies on my genotype because is rare, except for the now running campaign in Egypt.
I know this genotype is rare also in the US (I'm in Italy) but I'd like to ask if anybody in this forum has direct experience or knows about anyone under S/O therapy with genotype 4 and if it's working.
Anyway I think these are my options to date:

1) Sovaldi + Olysio 12 weeks
Pros: shorter course, about 20% cheaper than option 2
Cons: no literature at all, recommended as alternative choice by the European Association of Study of the Liver, but not by the American Association for the Study of Liver Diseases (why?)

from the EASL recommendation
There is no data with this combination in patients infected
with HCV genotype 4. Nevertheless, given the antiviral effectiveness
of both sofosbuvir and simeprevir against this genotype, it is likely that
the results of the COSMOS trial in patients infected with genotype 1
can be extrapolated

2) Sovaldi + Ribavirin 24 weeks
Pros: tested on field (87% SVR12), approved by both associations
Cons: longer course, about 20% more expensive, Ribavirin sides

3) Just wait, at least another year
Pros: more powerful, cheaper/reimbursed and tested molecules
Cons: increased risk of developing cirrhosis/HCC, one more year of lousy life.

Thanks in advance to those who will give me any helpful information or advice.

lporterrn · « **Reply #1 on:** October 14, 2014, 10:35:43 am »

Although I can't speak directly to your request, I want to add that there may be more data coming out at the liver meetings in Nov. Hep will highlight some of the news this. The abstracts are available on http://www.aasld.org/livermeeting/abstracts/Pages/default.aspx

inaglasshouse · « **Reply #2 on:** October 14, 2014, 12:24:30 pm »

Thank you Lucinda, I searched across the 1283 pages for genotype 4 and found a few related studies:
One on Harvoni (#240), maybe I was wrong about thinking it wouldn't be suitable for GT4, but the abstract is not clear at all to me, maybe I can't read scientific abstracts but it sounds like many patients ran away from the therapy and follow-up, this wouldn't be statistically meaningful (are they dead maybe?

. They will release more data on the conference anyway.
One on ombitasvir/abt-450 (#1928), but only F0-F2 patients, so why to make a trial?
One on the new Gilead's combo (#80) which should come after Harvoni.
One way or the other I'll have to wait..
(I know sometime I'm polemical and not yet on meds..

)

Regards and thank you for the site and the community.

lporterrn · « **Reply #3 on:** October 14, 2014, 11:01:40 pm »

Hi - I did a little research, and I am going to ask around. Yes, it does look like waiting is what you will be doing for now.

BattleTheBeast · « **Reply #4 on:** November 29, 2014, 06:35:06 am »

Hi Inaglasshouse,

Welcome and love your Forum Name!

I found a ton of information from 2014 here and there is some mention of Genotype 4 for you to check out. http://hepatitiscnewdrugresearch.com/approved-treatments-for-hepatitis-c.html

I am not sure if it's anything you haven't already found, you seem to be on top of things but maybe there's something that will help.

Hope you had a great Thanksgiving and wishing you the best!

~Mel~

inaglasshouse · « **Reply #5 on:** November 29, 2014, 08:49:09 am »

Thank you, Battle..hem in Italy we don't have Thanksgiving..but I'll keep the wishing for Christmas..hehe
Regarding the name, I know I am paleolithic but I have the feeling today really few make felt music, I mean it's always treated like a saleable product, I think it started all with the 80's hedonism and the DX7.

I'm reading basically all the relevant sites often, including clinicaltrials.gov.
I think at present my best option would be Harvoni, but there is only one trial based solely on a population of 20(!). Then it has been approved for genotype 4 in Europe but not in US.
How could I trust this?
There is another trial ongoing in France:
http://clinicaltrials.gov/show/NCT02081079
with a population of 80, but I can't find infos on how is going and probably they might already have results.
If anybody by chance knows anything about its outcomes please let me know.

badbradley · « **Reply #6 on:** December 11, 2014, 02:11:26 am »

Hey "in a glass house" ---Great album, Gentle Giant-A band way ahead of it's time. Got turned on to them in the 90's. Still diggin' it!
Been wondering about you. How's your search for meds going? Wish there were some options for you other than waiting but hopefully it won't be much longer. As you said, there aren't many geno 4's around these parts! A cure is in the near future for you brother! Best of luck.
Brad

inaglasshouse · « **Reply #7 on:** December 11, 2014, 11:17:56 am »

Hi Brad, I'm still waiting for plausible data release about Harvoni treatment on GT4.
All I have about my case is two studies, the Gilead one with 20 persons and an AbbVie one with patients < F3, and this is way too little to me.
I tried to find the email address of the manager of another French study without success. I think they should have already results by now, but it's not clear when the outcomes will be released.
Also, with my usual luck, Fibroscan doesn't work on me, and I'm not very keen to undergo a third liver drilling, I mean I'm at least on advanced fibrosis and I need to be cured for sure.
Furthermore, if at a certain time someone will say Harvoni is good, I'll have to persuade my doctor and pay out of pocket.
And sometime I get emotionally unstable..

Apart this I discovered that listening to Hiromi Uehara can alleviate the symptoms.
All the best.

BattleTheBeast · « **Reply #8 on:** December 11, 2014, 12:38:29 pm »

Have you read this? http://hepatitiscnewdrugs.blogspot.com/2014/11/european-commission-grants-marketing.html

I just found this open clinical trial that is recruiting:
https://clinicaltrials.gov/ct2/show/NCT02265237?term=hepatitis+C&cond=Genotype+4&cntry1=EU%3AFR&rank=3 which is Abbie

and here is a Merck one recruiting: https://clinicaltrials.gov/ct2/show/NCT02252016?term=hepatitis+C&cond=Genotype+4&cntry1=EU%3AFR&rank=20

Keep looking, maybe one of these will work for you but more news coming out every week!

Mel

inaglasshouse · « **Reply #9 on:** December 11, 2014, 02:22:08 pm »

Quote

Have you read this? http://hepatitiscnewdrugs.blogspot.com/2014/11/european-commission-grants-marketing.html

Sure, but I trust nobody when there are so many economic interests, how is in the US it's approved only for genotype 1?

Quote

I just found this open clinical trial that is recruiting:
https://clinicaltrials.gov/ct2/show/NCT02265237?term=hepatitis+C&cond=Genotype+4&cntry1=EU%3AFR&rank=3 which is Abbie

unfortunately not in Italy, and I'm not sure I'm cirrhotic even though in the neighbourhood.

Quote

and here is a Merck one recruiting: https://clinicaltrials.gov/ct2/show/NCT02252016?term=hepatitis+C&cond=Genotype+4&cntry1=EU%3AFR&rank=20

This one could be promising even though a total jump in the void..Should I take the risk?

Anyway I appreciate your effort of helping me, it makes me feel less isolated.
The problem is that sometime I see everything conjuring against.

BattleTheBeast · « **Reply #10 on:** December 11, 2014, 02:55:26 pm »

Please don't feel alone, you aren't but I know how easy it is to go down that road. I fight the isolation all the time. Just remember if we don't fight and advocate for ourselves no one else is going to. You hold the key inside and we are all here and ready to help in any way we can.

Mel

inaglasshouse · « **Reply #11 on:** December 11, 2014, 05:40:58 pm »

Thank you Mel, I know that.

BarbG · « **Reply #12 on:** December 23, 2014, 01:37:21 pm »

I am 4B, and a week in today on Harvoni. I was treatment naïve, but have probably been infected since 1981, and have a huge viral load.
My doctors and I decided to go for it, even though there are not a lot of studies, as you have discovered.
We are going to do a 2 week draw, so looking forward to lower numbers !

inaglasshouse · « **Reply #13 on:** December 23, 2014, 02:12:20 pm »

THANKS! Very encouraging reading this from you!
I'll have the first visit with my new doc on january 8, probably too soon to get your results in time, anyway it will be appreciated if you will post it. And I think 2 weeks is a very short period to get acceptable results, your doctor must be feeling on a roulette more than you

I'm optimistic about Harvoni on genotype 4, I read somewhere that genotypes 1 and 4 are genetically related.
And there is this chart:
http://natap.org/2014/AASLD/AASLD_76.htm
Look at the second hystogram, "Proportion of patients.."
It sounds like genotype 4 responds even better than 1, but the legend is wrong I believe.
Break a leg!

inaglasshouse · « **Reply #14 on:** December 23, 2014, 02:31:52 pm »

And just saw that Harvoni has been recently included by AASLD also for GT4 in US (previously only in EU)

BarbG · « **Reply #15 on:** December 23, 2014, 02:58:32 pm »

Thanks for that link. I am planning on responding well. I waited a long time for a treatment I thought I could tolerate, and so far the sides are pretty minimal. Fatigue-this has been my normal state for so long, I hardly notice the slight increase.
Headache-has lessened each day, not too bad at all.
Intestinal distress on day 2, but that has calmed way down.
Vision-funny spots a couple of times, and eyes seem a little sensitive to bright light.
I sure hope this is truly the "miracle drug".

inaglasshouse · « **Reply #16 on:** December 23, 2014, 03:31:24 pm »

Please keep me and all the others on the same boat (GT4) up to date.
I hope to take the same route soon.
Remember to drink a lot of water and to monitor blood pressure during the course.

Cure4life · « **Reply #17 on:** June 18, 2015, 04:51:31 pm »

Hi all. I am new to this forum but I thought I share my story with you in particular with those with GT 4 which is what I have. I was diagnosed with HCV GT4 F2 in December last year. We figured out that I probably contracted the virus 30 years ago whilst doing the military service during which I was part of a mass immunisation program where a gun needle was used. After the initial shock and panic attack I started researching treatment options for GT4. There aren't many I am afraid. I live in New Zealand where GT4 is almost non-existent and funded HCV treatment is mostly limited to interferon/ribavirin regimes. After discussing my case with a local liver specialist I decided to self-fund 12 weeks with harvoni. Although there is very little data on GT4 and harvoni, the very few trials I managed to find showed some encouraging results. With the help of a friend and some savings I had I bought 12 weeks worth of harvoni. My VL at day 1 of treatment was 84,000. At week 4 was 28 (not ideal) at week 8 it was detected <12 non-quantifiable . With only 4 weeks left of treatment and the lack of alternative treatment options, if harvoni didnt work, it was panic time. After consulting with my doctor and borrowing additional funds we decided to extend treatment for another 4 weeks so 16 weeks in total. We also decided to include ribavarin for the last 4 weeks. I finished treatment 2 days ago. Generally it was well tolerated specially the part without the riba. VL test in 4 weeks but I have to say I have the sneaky suspicion that the virus is back already. I have been experiencing symptoms like the ones I experienced before I started treatment so level of confidence is low. If this doesn't work I would have spent all my savings plus what I was so generously given by my friend for nothing. I am keen to know how other GT4 patients are doing and whether there are any new treatment options with proven success in GT4 cases.

Thanks for listening!

BarbG · « **Reply #18 on:** June 18, 2015, 09:33:14 pm »

I am undetected! Just had my 90 day draw, and both my medical team and I are optimistic that I will remain undetected.
I stayed a bit nauseous for a few weeks after completing treatment. Lost about 23 lb.
I seem to have worse fatigue; was really hoping I would feel better by now.
My eyes have remained a little light sensitive, and it seems as if my vision has changed (for the worse).
But I can handle these things!

BarbG · « **Reply #19 on:** June 18, 2015, 09:38:15 pm »

And my blood pressure went up slightly, but I normally have low BP.

Cure4life · « **Reply #20 on:** June 18, 2015, 11:20:57 pm »

That's great news and thank you so much for your response. The next 4 weeks until the next VL test will be stressful but knowing another GT4 has cleared the virus with Harvoni is very encouraging. What was the condition of your liver if you don't mind me asking.

Cure4life · « **Reply #21 on:** June 18, 2015, 11:35:45 pm »

Hi there you may wish to read my previous post and a response I received. There was more Harvoni GT4 trial result released at this year's liver conference in Vienna. Certainly they seem to be getting good results although the participant numbers are very low compared to the trials on GT1. Have you started treatment ?

BarbG · « **Reply #22 on:** June 19, 2015, 12:01:43 am »

My liver was in pretty good shape, mild fibrosis.

inaglasshouse · « **Reply #23 on:** June 19, 2015, 03:17:00 am »

Thanks for sharing your experiences with Harvoni.

It would be a pity a failure after your economic sacrifice, anyway there are studies showing you may be retreated a second time with a 24 weeks course, even this would mean robbing a bank, or going to shop in India.
Also, drug prices should go down in the medium/long period.
After all I think you have been treated in a correct way and your viral load looks good to me, remember that being detected a EOT sometime resolves in SVR.

About me, I managed to have 24 wks of Harvoni covered by public insurance and I'm on day 10 now.
During the last week I had flu-like symptoms, fatigued and lately I've been having the feeling of being stabbed in the liver.
I really hope all this means something like the immune systems starting to fight the virus, and the liver trying to regenerate, otherwise I will be screwed since I have cirrhosis.
First draw will be on day 17.

Best luck to everybody.

Cure4life · « **Reply #24 on:** June 19, 2015, 03:32:56 am »

Great to hear you are getting treatment. You will clear the virus for sure with 24 weeks treatment. I had liver pain on and off during treatment and I have read others have experienced it also so don't be too worried about it, no other major side effects so it will be an easy ride for you . Trip to India could be on the cards if 16 weeks wasn't enough for me !

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Author Topic: genotype 4 therapeutic options (Read 19775 times)