Hep C Discussion Forum

Cinnamon Girl · Guru

RE: Sofosbuvir Looking for Info on - Anyone who Participated in Clinical Trials etc

shadow10cats · Senior Member

And here I was so sure it was because of the color of your hair!

Let's all wish / pray / dance naked under the moon.... for a real cure in the new year - (where the side effects aren't worse then the disease)

Happy Holidays to You & Everyone

Cinnamon Girl · Guru

Hi BJ, I chose that user name because it`s the title of one of my favourite songs by Neil Young! wink

shadow10cats · Senior Member

I see why they call you "cinnamon girl" - pretty! :)

Cinnamon Girl · Guru

Hi Shadow10cats, and a warm welcome to the forum. I`m glad you found us, and don`t worry, you`ll find everyone here is friendly, helpful, and non-judgmental, so you can feel free to express yourself and ask any questions you have.

I`m also surprised by you doctor`s opinions about prescribing Sovaldi without intereferon for genotype 1`s. In the full prescribing information issued by Gilead there is a statement that 24 weeks of Sovaldi + ribavirin can be considered for certain categories of patients with genotype 1 who are not eligible for interferon, although in general interferon will be required and it will be for 12 weeks. There seems to be quite a lot of confusion around this subject at the moment and it will be interesting to see what happens.

In your position I agree that it would be sensible to wait until interferon-fee treatments become available, and if you`re not happy with your doctor you could consider looking around for someone else who you`ll be able to feel more confident about. Best of luck!

AngieV123 · Senior Member

I did read somewhere that genotype 1s can do the sofosbuvir without interferon but the treatment duration would go from 12 weeks to 24 weeks instead. I am not sure if it changes the SVR rate for geno 1s but it is worth asking your doctor about if you want to treat now vs later.

Matt Chris · Guru

Hey Shadow10cats

Welcome to the forum from me as well. You are making a wise decision in waiting for the Sofosbuvir that has other DAA's in included especially with your liver status. Perhaps your Doctor was over zealous without doing the research.

By the way you have decribed your past treatments your to be commended on taking responsibility for your own health, it's something that we all should learn to do.

Hope you can stick around, we could use your insight.

matt

shadow10cats · Senior Member

Thank you for such quick, informative & FRIENDLY replies.

There have been forums that I've tried out with some really hostile people. God forbid you should talk about waiting or trying alternative therapy or just various supplements & methods to keep your body as healthy as possible in the interim. One forum was basically a dictatorship where this ga, who had been on it for a long time, controlled the discussions & if you went against the norm you found yourself booted off the site!

So hopefully folks on here are open to discussions and even if we have a difference of opinion we can agree to disagree but continue to have open dialog and share information. After all, when all is said and done that's really why these forums are here - to share information and support each other.

I do think I'm going to wait. My dr. said that if I tried the sofosbuvir/ribavirin now and stopped or failed that this combo, for whatever reason, did not cause the virus to mutate and you could re-do the same drugs later when they add the 3rd drug mentioned below to it. However, after some thought I decided that if I tried this and failed or stopped I most likely am going to be sick, run down, feeling side effects etc and not really prepared to start another regime of therapy even if it has a 100% cure rate. It would just be too much. So why not wait and be healthier and stronger and take a drug combo that has a better chance of curing me. That sounds like a reasonable decision don't you think?

I am a bit puzzled and concerned however that my Dr., who is supposed to be one of our local "authorities" on HepC, is touting Sofosbuvir with just ribavirin for Genotype 1 (24 wks) and is making it seems as tho sofosbuvir was approved for just this reason. If I had not researched it on the FDA's website for myself I would have gone along. However, as I learned it was really for types 2 on, an only really for G-1 when used with interferon which I simply won't do. Thank goodness we have the internet so we can find out things for ourselves. But I am really not happy that he is doing this because it's misleading. I plan to call him and let him know I'm waiting and tell him why. Then I'm going to research and see if there's another dr. in my area who is qualified & recommended for Hep C patients. (Albany, NY) (there's been other things that have caused me some concern so maybe another dr. would be best)

suziq · Senior Member

Hi Shadow 10cats,

The info from Mallani is right on. I am 79 and have REALLY waited to treat. I am currently on the Merck combo that Mallani mentioned and have been undetectable since week 4. It is in Phase 2 clinical trials now and will need to do Phase 3 trials during the next year. So there will be an opportunity to do that clinical trial in the near future. Cinnamon Girl just posted about faldaprevir and that looks like a good combo in the near future.

This forum has such a lot of info and great bunch of people. You can get all the info you need before making any decision about treatment-- It has a section on clinical trials that has info from people who are doing/have done clinical trials. And the News section has info on clinical trials as well.

Welcome!!!

SuziQ

mallani · Guru

Hi shadow 10cats,

Welcome to the Forum. You're doing the right thing by asking questions, as it pays to be as informed as possible before embarking on treatment.

Sovaldi is obviously a great drug, but for the Geno 1's, it would pay to wait until it can be used with another DAA ( w/wo Riba). Gilead have an effective NS-5A blocker in Ledispavir, which will be combined into a single pill with Sovaldi. This will probably be approved in late 2014, and have SVR rates close to 100%. With your history I would avoid Interferon, and, as you say, Sovaldi plus Ribavirin is a poor option for Geno 1.

AbbVie have a good triple DAA combo, which will also be approved in 2014.

Merck's MK-5172 and MK-8742 are getting close to 100% SVR in Trials, but will be lucky to be approved by late 2014.

We have Forum members doing Trials with the above drugs. To my knowledge, nobody was on the Sovaldi/ Peg/Riba Trial. If you're only Stage 1 Fibrosis, you can afford to wait until the dust settles. Cheers.

Larry2384 · Member

I did not participate in the clinical trials although I signed up and my doctor's assistant never bothered to submit my application and I missed the deadline. I have searched the internet for months looking for people who participated in these trials to get further information about but I could never find anything. It seemed as if Gilead had silenced everyone from speaking but who knows.

I opted to try Sovaldi as soon as it became available and got the call last Friday that it had hit the pharmacy shelves. I think I am first one in city to get.

Anyway, I have completed 3 days of taking Sovaldi and Ribavirin combo to treat genotype 2b. I have had HCV since 1974 and it is becoming more active the past few years. I had a biopsy 3 years ago and was still only in stage one and my liver doctor told me that inflammation was the only immediate concern. However, things have been changing recently with my red and white blood count and have developed type 2 diabetes too. Therefore I decided to jump on this new treatment since it is all oral and because my wife has fantastic health insurance that is paying for. Hopefully they won't carve me out after they get a look at the bills that are imminent. Sovaldi costs $1000 per pill and ribavirin isn't exactly cheap either.

Anyway, after 3 days, I have experienced no side effects whatsoever and I am truly thankful and relieved for that. Supposedly my chances for a SVR and cure are very good but only time will tell. My understanding is that the treatment for genotype 1 is 90 days but also includes peg interferon. At minimum, the gen 1 regimen is a lot shorter than the typical 12 months and they say the chances for success are better. Only time will tell.

shadow10cats · Senior Member

Just saw my Dr today & he was all excited about the new "game changer" - (ya right I thought). He told me about the FDA approving Sovaldi (sofosbuvir) with Ribavirin & he could get me on it today if I wanted. He was way more excited about it than I was since I'd be the one who'd be feeling like crap for 6 months! I've been researching this info and now I have questions.

First, a little about me: I am a 59 yr. old female. I don't smoke & stopped any drinking 12 years ago. I love to mountain bike, hike, snowshoe, canoe, take photography, an animal activist, funky clothes nut, Scorpio, Finn-Swede-Italian. I was diagnosed in 2004; Genotype 1, Grade 2, Stage 1 with a viral load over 12 million. My liver functions were perfectly normal.

I briefly tried the old regime of Peglated Interferon/Ribavirin in 2007 where I lasted less than a month taken off due to a very bad reaction to either the Lexapro, Interferon or both. In 2011 I tried the new miracle drug Telaprevir. I lasted a whopping 2 weeks this time! I simply could not eat and I threw up anything I did get down. The first 10 days I lost almost 10#, and considering I only weighed 103# when I started, my Dr cut it short. I do know folks who stuck it out & today they are clear & running marathons. However, for me it was a total flop. Personally, I dont know who the genius was that thought up a drug that had to be taken with fat in order for it to work when the folks taking it would be so sick that eating could be almost impossible. I tried so hard to stay with it after all, I thought cheesecake, Ben & Jerrys, peanut butter it would be a breeze! Funny how quick your favorite treats can turn against you. So here I am, 10 years later & still waiting for a cure that will work for me. And the older I get the harder it is, the less healthy I am & the less fight I have left in me. Thing is, my liver is still quite healthy & my last biopsy I was actually a Grade 1 / Stage 1 - better than my 1st biopsy in 2004! I do have to get ultrasounds now of my liver every 6 months because I am now in that age range where cancer is a risk. And, I am very sympthamatic - I have extreme fatigue, joint pain, I miss a lot of work. My outdoor activities, especially this year have really taken a hit - it takes me longer and longer to get going & I'm always playing catch up. So I want this out of my system so I can hopefully get my life back before I'm too old and decrepit!

Getting back to this Sofosbuvir. My Dr told me it was approved for Genotype 1 with just ribavirin but when I was reading about it online it said this was for types 2 & 3 and 1 still needed the interferon. There was a short sentence stating it could be "considered" for patients with type 1 who are interferon ineligible but didn't expand on that at all.

-Can anyone provide more info on using this treatment for type 1? Effectiveness, Side effects, ability to work, etc?
-Did anyone participate in the clinical trials of this combo? How was it? What are the side effects really like?

I am a little skeptical to try something just out, especially when the 2 drug combo isn't really for type 1 & the cure rate is only around 78%. Later this year they expect to add a 3rd drug to this regime (w/o interferon) that is supposed to increase the cure rate to almost 100% (Ledepivir?? I can't read my drs writing)

Also interested in any info on other non-interferon / non-ribavirin treatments such as:
- Daclatasvir This is a drug from Bristol Myers that in combo with Sofosbuvir (Gilead) has like 100% cure rate but because they are competitors they won't work together
- Daclatasvir & Asunaprevir: tested in Spain with great results

You can simply never have too much info when it comes to decisions about your health & I stopped putting my health, my life in drs hands a long time ago. I learned the hard way that you have to play a huge role in making sure you are doing what is best for you.

Thank you in advance for any information. Happy Holidays to All!

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