Hi Charlie, congrats on finishing your treatment, that`s great news!!   

Wonderful that you`re still undetected too and that you`ve been free of sx! Thanks for sharing your good news, it`s looking very promising for you as you`ve responded so well.  

Keep in touch, and we`ll keep our fingers crossed for 3rd time lucky... onwards to SVR!!!! 

Hi Charlie,

Congratulations on finishing your treatment !!!  SVR is just around the corner. 

SuziQ

Oct 27, 2014 completed 24 weeks treatment.  Undetected from week 6.  Down to 2.5 prednisone still for the Nplate shots.  No real side effects post treatment either.  Now onto SVR, fingers crossed.  3rd times the charm hopefully!

VL <15 at 3 weeks/4 days.  All Liver function tests 100% normal every one of them.  Next VL on July 10th.  No side effects at all now.  Feeling great.  

Went in for my ITP treatment (NPlate shot) and asked for Liver Function test.  Everything for the first time since I was a teenager are in the Normal range!  Will find out VL etc next Thursday.  Feeling great and some fantastic news.  Week 4 is Wednesday.

Thanks so much Susiq. I just stopped all supplements this week after reading the forum only 2 weeks in so I hope it helps. Fever I am pretty sure from tapering off Prednisone.  Haven't had for 2 days.   

Hi,

This is a direct quote from a personal note from a  friend who did the trial over a year ago.  She has been SVR about a year and was VERY pleased with her trial and result. This is a recent note from her concerning supplements. It does not really address your concerns, but thought you might like to hear input from someone who used the same meds.

[ hi there! my trial was with GS 7977 ( sofosbuvier, sovaldi) and
bristol myers BMS 790052 (Daclatasvir ). So far nothing has been able
to beat it. They are back in a Phase 3 trial for Geno type 3's, and I
believe The Daclatasvir is in FDA for approval. My doctor plans to
use the combo off label once approved.

Anyway, to answer your question about supplements the answer was no.
As a matter of fact we had to stop all supplements for 3 months prior
to the trial. The main reason being if something were to go awry it
was important to know that the drugs were causing it and not the
supplements or combination there of. Doctors haven't studied
supplementation and are really quite unfamiliar with them. Most are
text book trained and test result oriented. There are just too many
unknowns with alternatives including potential interactions, risk,
and so on. Best to keep it clean for ultimate results. I did beg for
my magnesium for constipation and he did allow it on an as needed basis.]

I don't recall that she mentioned side effects back when she was on the trial  I do recall that everyone in her group reached SVR.

I am the one Jill mentioned that was not allowed certain fruits during my Merck trial.  I am still UND 19 weeks post trial.  24 week SVR will be on July 1st.

Lots of luck on your new treatment!  It was considered THE BEST until Gilead backed away from BMS. So glad you were able to get it under compassionate care.  My Merck combo won't be available until 2015. It has also been very successful.

SuziQ

-- Edited by suziq on Thursday 29th of May 2014 01:21:40 PM

I understand exactly what you mean about the Prednisone, I`ve had to take a course of it a few times in the past when I`ve had a bad bout of asthma...it can make you feel quite strange!  Sounds quite likely that the fevers were due to the reducing dose then. 

Thanks so much.  I was all over the place when I first posted moving too fast and I'll blame that as well on the Prednisone.  :)  Nothing significant today.  I took the prednisone on its own this morning.  Waited a few hours then did the Solvadi and Daclatasvir, no fever to speak of so I'll do that from now on and see how it goes.  Hopefully Friday I can cut back to 10mg.  

Hi again, Charlie,

Thanks for giving us the information about how you obtained Daclatasvir, I must say I`m impressed with how quickly your approval came through via BSM for compassionate use, as well your insurance for Sovaldi.  No wonder you`re so pleased!  Good to hear that your LFT`s are looking better and the jaundice gone, and let`s hope the fevers disappear when you`re off the Prednisone.

By the way, I`ve joined your post from the Clinical Trials section to this thread so that the comments are all in one place, now we know what your situation is regarding the drugs.  Best of luck!

Thanks so much will have a look now.  Regards,

Charlie

Hi Charlie:

There was another member here, named Jim, who was in a clinical trial in early 2012 using Sovaldi (back when it was called PSI-7977) and Declatasvir.  He also pulled the Riba arm, as I recall, although some of the trial participants were on only the S/D combo.  He had just come off the Incivek triple therapy and was a non-responder. 

Jim attained SVR with this combo and with very few side effects.  He stops by here now and then.   Jim actually kept a journal of his experience and I'll bet if you search "PSI-7977" it will pop up.  If you can't find it give a holler and we can help.  

Sounds like you are in excellent hands and are doing quite well.  Best wishes for the remainder of your tx and onto SVR!

Thanks guys. Good luck Charlie!

My Hepatologist at Johns Hopkins put in for compassionate use when my liver function tests went haywire and I became jaundiced.  That is it really.  Took about 6 weeks for approval and approval from insurance company for Solvadi.   Very very happy to be approved and on the treatment.  I am also taking NPlate for ITP which I have had since a child and tapering off Prednisone as well as the NPlate starts to work so alot going on.  Talked to Hepatologist and Hematologist and both the HepC treatment and NPlate should not cause fevers.  Tested for UTI today, negative so I can only assume my morning fever is due to the Prednisone taper the sooner I am done with that part of my daily regimen the better off I will be I imagine.  I am no longer jaundiced by the way and liver function tests looking much better! 

Charlie

Hey Malcolm,

i was curious about that too and found this information on it. I hope this helps.

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/02/WC500160499.pdf

http://www.clinicaltrials.gov/ct2/show/NCT02097966

Tig

Hi Charlie,

Like Jill, I thought you were on a Clinical Trial. It's very interesting you were able to access Daclatasvir, as it's not FDA approved. Over here, when a drug is not approved, it can only be used in strict Clinical Trials, with a special approval. Could you tell us how you were able to obtain daclatasvir from BMS? Cheers.

Thanks for that info, Charlie.  The Sovaldi and Daclatasvir combo has done very well in clinical trials with high success rates for tx-naive and tx-experienced patients, and you did well to get onto this programme.

Bests of luck with your first viral load test in June, hopefully this will be 3rd time lucky for you! 

24weeks treatment.  I just took medication minus vitamin and my morning smoothie addition of Spiru-Tein (which I forgot until I started my morning routine).  I appreciate the advise.  This is my 3rd treatment program and I am very confident in the outcome of this one looking forward to next appointment in June. 1 pill of each daily. 400mg and 60 mg

Charlie

Thanks for explaining about that, Charlie, that`s very interesting.  I assumed you were on a clinical trial because you posted in that section, and because we haven`t had any previous members who were getting Daclatasvir through their compassionate use programme.  How many weeks will you be on the treatment, if you don`t mind me asking, and are you taking one pill a day of each drug?

People here who are taking Sovaldi are reporting various sx and like all treatments it does seem to vary from person to person. They are taking it in combination with other drugs though, for example ribavirin, with or without the addition of interferon, and also we have members who are doing an `off label` tx of Sovaldi and Olysio.  I know that coming off a course of Prednisone can cause side effects which is why you have to taper it off gradually, and it must be confusing for you trying to work out what is causing the fever.  At least it doesn`t last long and it sounds like you`re doing well. 

Do keep in touch and let us know how it goes! 

Thanks Cinnamin Girl. I am not on a clinical trial actually. I have received the Daclatasvir From the drug company on compassionate use. So my insurance covers the Solvadi and drug company sends the Daclatasvir   I think I will just stop the vitamin starting today just because less I take the better I would imagine. 

Will hopefully hear back regarding the SX and thanks for replying!

C

CharlieC wrote:

---

Also reading thru another topic on supplements should I just stop the multi-vitamin?  (New Chapter, 40+ every woman's One Daily Multi).  My doctor is aware that I am taking the multi-vitamin and nothing was mentioned.  Nothing was mentioned about the VitC or fruit either for that matter?

Thanks for any input.

---

Hi Charlie, whether or not to take the multi-vitamin is a difficult question for us to answer really, especially as your nurse or doctor has told it`s ok to carry on with it.  As you`re on a clinical trial though I think I`d leave it out for the duration of the trial just to make sure that your blood tests are as `clean` as possible.  You probably don`t need it anyway as long as you`re eating a good healthy diet.  I have noticed that other people on various clinical trials have been advised not to take any supplements, including vitamins.  

Grapefruit juice interferes with the metabolism of some drugs and that is why people on clinical trials are often advised to avoid it, as well as other acidic fruit.  Here`s a link to an article that explains more about that...

 http://hepatitiscnewdrugs.blogspot.co.uk/2011/01/grapefruit-juice-dangerous-medication.html

I did notice that someone who was on a clinical trial last year which included Daclatasvir was told to avoid grapefruit, oranges and pomegranates, so it could be worth avoiding any acidic fruit while on your trial, or at least asking your trial nurse or doctor for advice.  Here`s that thread, from the `Clinical Trial Participants` section...

http://hepcfriends.activeboard.com/t52581025/real-daclatasvir-or-placebo/

Best of luck, and I`m sure people with experience of Sovaldi will comment on your flu-like side effects.

Have not been able to find anyone taking Solvadi and Daclatasvir combo on the forum but my question is more towards the Solvadi side effects I think.

The last 4 mornings about an hour after I take my pills (which include the 2 pills for HepC treatment and, right now, 15mg of Prednisone (down from 20mg last week so tapering off), vitamin K (I have ITP and have a weekly shot of NPlate as well) and a multiple vitamin) I have been getting a low grade fever.  It does not last long at all, about 1/2 hour - 45 minutes.  After the fever breaks I feel fantastic and continue with my day.  This Wednesday will be my 14th day on the HepC treatment. 

Solvadi can cause flu like symptoms I saw, tapering Prednisone can cause a fever as well as the Nplate so not sure why this is happening could be any of the 3 I imagine.  Anyone taking the Solvadi have anything at all like this happen.

Also reading thru another topic on supplements should I just stop the multi-vitamin?  (New Chapter, 40+ every woman's One Daily Multi).  My doctor is aware that I am taking the multi-vitamin and nothing was mentioned.  Nothing was mentioned about the VitC or fruit either for that matter?

Thanks for any input.

Hi Charlene,

Welcome from me as well. With the ITP, you are lucky to avoid Interferon, and your drug combo is excellent. To my knowledge, only one Forum member did a trial of those drugs, with Ribavirin. He achieved SVR and had virtually no side effects. Cheers.

Hi Charlene,

Welcome to the forum! We do have some members on this trial and I'm sure they'll chime in soon and introduce themselves. I'm so glad you've found the forum. There are so many good people here willing to share info and an often needed shoulder on those rough days during treatment. You are indeed on a great combination and the success rates have been very impressive. If you can't find what you need by browsing, be sure to use our search function at the top of the page. You are always welcome to ask any questions that come to mind on the various threads. Please take advantage of the new members section and share a brief introduction. If you would like to add some personal data to your signature line, like mine or many others, it helps us to know a little of your history and your treatment protocol, etc. I look forward to hearing about your progress and hope you share your news going forward! Good luck!

Tig

Hello.  Glad to have found this forum.  This is my second day on Daclatasvir/Solvadi combination.  I have heard such fantastic things about the combo and was wondering if anyone out there is on the same treatment now or has been.