Oh, sorry you`re feeling so poorly, Nirmalee, but what a boost getting an UND result so soon into your tx...congrats!! 

Hope you start feeling better soon..keep us posted!  Jill x

Hi Nirmalee,

Wow, it sounds like you're really feeling awful. I'm so sorry to hear that. On the other hand, you got your first UND!! Yeah!!!! That's wonderful news and I hope brings you a bit of relief! Hang on to that good news and keep us informed on your progress! Good luck...

Tig

That is great! We will pray for continued success and that you feel better with each passing day!

One day this will just be a time in life to reflect on instead of worry about.

All the best to you !

Duane

Just got back from consultant - 2 week results UND!  Have a bit of jaundice but don't care!

Am  not well at all, I think this is because the chest and kidney infections I had did not clear up and are causing problems.  My GP tried to send me to the Acute Med ward today but I managed to persuade her against it as they don't know anything about these drugs and would probably end up killing me off.  Will keep you posted.

Nirmalee

Hi Nirmalee, definitely sounds like riba side effects to me too.  Eat when you can and what you can..don`t lose too much weight! 

Two weeks done and dusted!  Jill x

Dragonfly, 

Thanks for your posts and good luck to you. 

2 weeks in, feel pretty awful but that's the Riba I'm sure.  At least I'm losing weight!  I take the main drugs at night which helps me eat in the day, slight hair loss and weird aches and pains.  I am grateful for this opportunity.

Hi dragonfly:

I have high sensitivity to most drugs so I get weird side effects too.  There are always going to be side effects that aren't listed especially on new drugs.  Most side effects will be transient and not serious. If you feel like the weird things are serious, however, get medical help right away.  Even the "safest" drugs can be harmful to some people.  You already know this I'm sure.  

I think you are right to have confidence in this combo.  Granted, most of our information is coming from pharma (and I trust them as far as I can throw them) but Sovaldi has been in the US market for almost a year and so far it is still looking safer than any hepc drug we have seen before according to a few independent sources as well as people who have taken it. 

Hang in there!  

P.S.  Don't young people read Steinbeck?  Sheesh, what is the world coming to?  

Hey Dragonfly

Hang in there! Your combo has had great success, but you should always report any odd things to the trial doctors.

keep the faith

matt 

Hi everyone,

I have had a weird reaction to the new drugs but my GP told me that in the UK most of the trials have been on cute bunnies, mice and men.  I tried to make a joke about John Steinbeck but I think he was too young to understand!  I remain convinced that this is my best chance.

Hello again Nirmalee, thanks for sharing your photo, what a great time you must have had with your nieces at the Tower of London!  The ceramic poppies centenary installation must have been an incredible sight close up. 

Good to know you`re able to get out and about even with the nausea and hopefully that will ease up soon.  I`m sure your visit was well worth the effort!

Sounds like it`s going well.. keep in touch!  xx

Hi Jill,  The Riba is making me feel quite sick but I have excellent support from my partner.  I had promised my nieces that I would take them to the Tower of London last night (we know the Yeoman Warders) which probably was a bit optimistic.  We saw the poppies and they were able to go to the Beefeaters bar and have their pics with them and wearing their hats and gloves!  It was well worth feeling rubbish.  Even though it is early days I feel this is working, I now no longer have referred pain in my shoulder and the pressure from my liver is subsiding - I hope everyone who needs this treatment gets it.  Hang on in there.  Nxxx

Good for you! I started treatment yesterday and all oral treatment is not yet approved in the USA. My doctor told me that it is rumored to be approved here by the end of the year, but that there is no guarantee that it will be approved. He asked me if I wanted to wait for it.

I decided to start while I know that my insurance covers it. Sovaldi alone is $84,000 here and I don't know what the new drug would cost, but if it is expensive too there is no guarantee that my insurance would cover it.

All oral meds is certainly the way to go if available to you!

Very reassuring words from your consultant, Nirmalee  ""we are throwing everything we can at it"!

Apprehension about starting a new treatment and having blood draws done all on the same day is certainly enough to make you feel drained and a bit poorly, as well as the initial dose hitting your system.  How are you feeling now?  Keeping my fingers crossed for an easy ride! 

Thank you Jill, I'm taking it easy today as the combination of the tabs and the amount of blood he drew have made me feel a bit poorly.  In the words of my consultant - "we are throwing everything we can at it"!

I`ve just logged in to see how you were doing, Nirmalee...well done for taking your first dose!  I know you must have been feeling apprehensive  but you did it and you`re on your way now.  Even though you`re taking ribavirin again at least this will be a shorter treatment and the side effects should be so much easier for you this time around without the peg shots. 

Wishing you all the best of luck and do keep us posted with regular updates!  Jill x

I started this morning - am also getting Riba, it took me 2 hours to pluck up the courage to take them!

Tomorrow!

JLynch30 wrote:

---

I did a clinical trial 5 years ago with BMS interferon and ribravirin- relapsed

 

 I also just relapsed with solvaldi with those two.  

 

I am wondering if i will be elligible for the solvaldi - daclisivar in october???

---

 Hi John:

There is presently no evidence that Sovaldi can't be used repeatedly so medically the answer is yes.  The question will be whether your insurance company will pay for it. 

The combo that will be available in October is Sovaldi/Ledipasvir.  Ledipasvir is in the same drug class as Daclatasvir but different manufacturer (Gilead). 

I did a clinical trial 5 years ago with BMS interferon and ribravirin- relapsed

 I also just relapsed with solvaldi with those two.  

I am wondering if i will be elligible for the solvaldi - daclisivar in october???

Bills wrote:

---

Hi Jill 

I apologize for my passion here This subject is sensitive to me because. The Trial I was on  treatment failed and  I had continue another round with with Incivek when it was possible that I could have pushed for  Solvadi / Delatasvir  but Gilead canned it That's why I said if I'm reading this right, I tend to jump out at things.

And more appreciative that Nirmalee is getting such a great treatment.

---

Hi Bill, no problem and no apology needed either!  I well remember what you`ve been through and I was just providing the information to clarify what the the situation is with these new drugs over here in the UK.  You`re comments are always appreciated, as is your passion!

Hi Nirmalee, sounds like you had a wonderful holiday...just what you needed to prepare yourself for the next round!  This time it will be so much easier for you though than your previous treatments, and no shots to do!

Best of luck for Thursday, how exciting! 

On Thursday morning at 8.30 I go to see my consultant for him to sign a piece of paper and that will be me sorted!  We got back from Iceland late last night after a week of scrambling about on glaciers, lava flows and dangerous jeeps and seeing beautiful minke whales - I feel ready now.  Thank you for all your support. Nxxx

Bills wrote:

---

Hi Jill

Just read that article on the          

            Compassionate Use Program  http://clinicaltrials.gov/ct2/show/NCT02097966

This is the way it should be as a minimum world wide

In the US they ask 1. Whats your name 2. What insurance you have?  And it's not just Hep C it's almost everything from Cancer to a broken arm to a knee replacement. I always side with the underdogs. Whats right doesn't matter here is Money and stacking the deck for the rich and powerful. America should be doing better in this area.   LOL there I go again 

Good luck Nirmalee a Higher Power has seen your desperation 

Peace 

BS 

 

---

 I agree Bills, 

Hi Jill

Just read that article on the          

            Compassionate Use Program  http://clinicaltrials.gov/ct2/show/NCT02097966

This is the way it should be as a minimum world wide

In the US they ask 1. Whats your name 2. What insurance you have?  And it's not just Hep C it's almost everything from Cancer to a broken arm to a knee replacement. I always side with the underdogs. Whats right doesn't matter here is Money and stacking the deck for the rich and powerful. America should be doing better in this area.   LOL there I go again 

Good luck Nirmalee a Higher Power has seen your desperation 

Peace 

BS 

Hi Jill 

I apologize for my passion here This subject is sensitive to me because. The Trial I was on  treatment failed and  I had continue another round with with Incivek when it was possible that I could have pushed for  Solvadi / Delatasvir  but Gilead canned it That's why I said if I'm reading this right, I tend to jump out at things.

And more appreciative that Nirmalee is getting such a great treatment.

Anyway  I am on line for the one pill, I even asked for an Oct 10th Appt. but my doctors only in on Mondays LOL 

I am quite certain that Solvadi- Ledipasvir will do the trick and is my best option and thank God it's here very soon. every thing I have read and been told is this is almost as good / just as good etc. I'm counting days like I'm in Jail. 

I've been reading this last 18 months there were still many people here presented with the combos still using Riba and Intf.   And the partial Riba / Intf  did work for many here. Just such a drag about the side affects and unknown long-term use of interferon. We are all different G-Type and liver damage. It's a great day for all the newbees the worst is over.      And today is     HEP C DAY      GOOGLE  it there's lots of articles.

Thanks everyone and good luck to all in TX  hang in there 

BS

Ozzy had to be wheeled out on stage but as a real trouper carried on!

Isiscat2011 , thank U so much for Dac+Usunapr news!

I had no idea that this commbo is already approved in Japan. Great news!

Bills wrote:

---

---

    It's nice to hear ( if I read this right ) UK is approving the combo. 

 

---

Hi Bill, just wanted to mention that neither of these drugs have actually been approved in the UK as yet, and as far as Sovaldi is concerned it`s looking doubtful that it ever will be, but this combo is being made available within certain countries in the EU on a compassionate use program for the benefit of people in the most urgent need.  I`m assuming that is what Dragonfly will be doing, taking into account her previous tx history.  Here`s a link to that information...

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

Hi Sssveta:

I have no idea about pricing.  D/A has been approved in Japan.  Here is some information about it: http://hepatitiscnewdrugs.blogspot.com/2014/07/japan-approves-hcv-daklinza-daclatasvir.html

Here is some more information about what the drug manufacturer BMS is up to:  http://hepatitiscnewdrugresearch.com/daclatasvirasunaprevirbms-791325.html

Isiscat2011 , thank U for Your inform.

to your opinion: what will be the price of Dacltasvir ?

Do You know when combo Dac+Asunapr will be registered in Japan?

Hi Bills:

Gilead is the one in the news; they are spending the most to make sure of that.  "Any press is good press" so even when the news is complaints about costs, Gilead gets to respond "Yeah, but we are that good! That's why we can charge so much."  The public wants it even more!

If you want to find info about Abbvie, Merck, or BMS drugs you have to dig, because they aren't out front and center advertising.  But the bottom line will be what docs prescribe and what insurance companies pay for. 

We all know that the S/L one pill combo is scheduled for approval Oct.10.  From what I have gathered the Abbvie combo should be approved in December. BMS has filed for FDA approval for its Declatasvir/Asunaprevir combo, which will be two separate pills, and has also been FDA fast tracked.  It will probably be available by the end of 2014 or early 2015.  Mercks combo will come later, probably well into 2015 or 2016.  

So, by the end of 2014 and into 2015 docs are going to have some prescribing options because there will be the Gilead combo, the Abbvie combo, and the BMS combo.  Olysio will also be in the mix but it isn't likely to get much play.  The old standby Riba may still see some action for certain HCV populations. If the BMS combo is ONLY approved for use together (Declatasvir + Asunaprevir) then docs would have to go off label to prescribe Declatasvir + Sovaldi.   Off label is usually harder to get insurance approval for.   Also, docs may not get their first choice of tx if insurance companies opt for something cheaper that has similar efficacy profiles.

In summary, you could be waiting a while for the Sovaldi/Declatasvir combo in the US.  That's my take on the situation.  

Isiscat2011 wrote:

---

Congrats, dragonfly!  That combo should be very good.  I'd take it in a New York Minute!  

A member named Jim was on that combo plus riba a couple of years ago in a clinical trial (he SVRd with almost no side effects after being an Incivek/Peg/Riba non-responder).  He kept us updated by journaling his tx experiences.  I will find that thread for you if you are interested.  

Best wishes for a safe and successful journey!  

---

Hi Dragonfly,

Nice to see you around again and so happy for you, 

 I second this motion and me in a half a minute. 

I'm on line for the Ledipasvir Solvadi combo   in Oct       But if I had a chance to jump I'd be bouncing or if knew Declatasvir would be an approved combo I may wait more. 

Anyone who can get  Solvadi  Declatasvir jump right in. 

We have to go back to the reason Declatasvir & 7977 aka Solvadi was canned in the first place. " The Money " Greed  I still can't get over how Gilead got away with that. And it seems the insurance companies are on the Gilead team.  I'm glad we have good option. But ask any of us G1 who relapsed in the 18 months how it feels    It's nice to hear ( if I read this right ) UK is approving the combo. I see in a lot of cases USA does a lot of research and can offer choices I see one common thread here  " The Money "  The insurance approval, I can only Pray that somehow all of Hep C infected will someday be offered what we should have got 2 years ago.  And yes Jim has a great story Hi Jim 

Thanks for posting Dragonfly good luck and thanks for everyone else's input 

Yes, there are still Phase III trials going on.  She was probably on one of those.   

She must have been on a trial because she told me she was on the Sovaldi/Datclatisvir?

JIme wrote:

---

It's the best combo to date that I know of. I guess they are selling the drugs separately now. Gilead made their own version of Datclatisvir but it is not as good as the BMS original that you are getting. 

_________________________________________________________________________________________________________

Sovaldi is FDA approved but Declatasvir is not.  Gilead refused to work with BMS and opted to make its own NS5A inhibitor, Ledipasvir.   The Sovaldi/Ledipasvir one pill combo is scheduled for FDA approval October 10.  Meanwhile, on April 7, 2014 BMS applied for approval for a different combo: Declatasvir (an NS5A inhibitor) and Asunaprevir (a NS3 protease inhibitor).  The BMS combo is likely to be approved in late 2014 or early 2015.

The Sovaldi/Ledipasvir combo has gone through more clinical trials than the Sovaldi/Declatasvir combo and the SVR rates look fairly close. However, it is certainly possible that neither the Gilead nor the BMS combo will work as well alone as they would have together.  Only time will tell.  It is quite possible docs will begin prescribing Sovaldi and Declatasvir off label after Declatasvir is approved.  Much will depend on cost.

Interestingly, BMS is looking more to the European markets and has also already made a deal with Japan for the D/A combo. Europe may see more of the Sovaldi/Declatasvir combo than the US does.  I expect the US will also see more relapses since our market is profit driven while theirs is more health driven. JMO. 

yay dragonfly!!!! great news! & have fun on that trip!! 

It's the best combo to date that I know of. I guess they are selling the drugs separately now. Gilead made their own version of Datclatisvir but it is not as good as the BMS original that you are getting. Another friend of mine was on this combo too. She cleared the virus and just ended tx last week. First time in 35 years she has been free of the virus. She had a little dizziness after taking the meds for a few minutes, that was it. As you remember I had Zero sx during my tx with the same drugs plus riba. They said the riba did not make a difference. Everybody cleared with it and without it. It's an amazing combo. I'm so happy for you.

Btw, How was Ozzy?.....lol......

I hope you fair well in your endeavours.

 We are all in this together Keep your stick on the iceland "Red Green Show"

Thank you everyone for your support.  A whole new journey beckons and a new life begins! We are off to Iceland next week life is amazing and I'm so happy to have been given this.

Hey Nirmalee,

Good things come to those who wait. This will be a great combo hope you get into the best arm of the trial.

Keep us informed, it will be fun to have weekly updates

matt

Hi Nirmalee,

That's daclatasvir, a very good NS-5A blocker. Congrats- that's a great drug combo, and we'll be keen to follow your results. Cheers.

Congrats, dragonfly!  That combo should be very good.  I'd take it in a New York Minute!  

A member named Jim was on that combo plus riba a couple of years ago in a clinical trial (he SVRd with almost no side effects after being an Incivek/Peg/Riba non-responder).  He kept us updated by journaling his tx experiences.  I will find that thread for you if you are interested.  

Best wishes for a safe and successful journey!  

Hi Dragonfly, what great news!!  You`ve had a long wait for an opportunity to do an all oral treatment and it`s wonderful that drugs like Sovaldi and Daclatasvir are being made available in the UK and elsewhere in the EU for people in the most need.  This will be through the compassionate use programme from BMS I take it. 

Do you know yet whether you`ll be taking ribavirin too? 

So pleased for you...do keep us updated! 

I am so excited - the clinical nurse has just called me to say I can start meds.  Never thought that I would get this chance.  For everyone do not give up hope.