Sofosbuvir/Sovaldi Approved

[Willy50]

Sofosbuvir/Sovaldi just approved by the FDA shortly after Stock market close Friday

http://finance.yahoo.com/news/u-food-drug-administration-approves-211900093.html


U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C

– Sovaldi Approved for Use in Genotypes 1, 2, 3 or 4 –

– High Cure Rates (SVR12) and Shortened, 12-Week Course of Therapy for Many Patients –

– First Ever Oral Treatment Regimen for Genotypes 2 or 3 –

– First Regimen for Patients Awaiting Liver Transplantation to Prevent HCV Recurrence –

[GrammyA]

Hey - by the way I do not live far from you... Champaign IL!

[heart_in_the_keyes]

Me too.......that sounds GREAT.  Will let you know.  Know it was just something that the FDA approved Jan. 2014 and the first class at our university/med center in Indy was mid-Jan. So I am to be in the February class.  

[GrammyA]

I am 1b w/cirrhosis doing my third attempt.  Doing Off Label SOVALDI and OLYSIO ONLY!!!  No Riba- no interferon!  My body did not like those drugs at all so no more for me.
I am in my 5th week of taking just these 2 pills a day and feel absolutely FABULOUS!  Lots of energy and none of the horrible side effects that I had the 2 attempts prior.  IF ANYONE has had issues with interferon or Riba with failed treatments they really need to consider this dynamic pill duo!!  I go in this friday to do labs again and they will check the viral load at that time.  I believe the virus will be gone with that lab draw.  My 2 weeks lab actually showed ALL my blood levels to be better then they have been in over 20 years..... every single reading was in pure normal range!  I hope you will be on only these two drugs and you too will see how different this treatment is!  Best of luck! (only 12 weeks total and I am in number 5 so life is good)

[heart_in_the_keyes]

Good question Jimmy...I get all paperwork and class instruction on the 20th....will let you know but what I am being told their is a combo of pills....no shots.  Halleluiah!  Am getting ready to email lady whose husband started same program last month and see what she has to say.....her husband had a transplant a couple of years ago and then his new liver got cancer and he still had active HCV.  He kicked the cancer and is now waiting for another transplant but, like me, would like to get rid of the HCV prior to transplant.....

Will let you all know what I know and find out in the next couple of weeks...but think this is the one:

Genotype 1 or 4 SOVALDI + peg-interferon alfa + ribavirin 12 weeks
------------------------DOSAGE AND ADMINISTRATION----------------------
*   One 400 mg tablet taken once daily with or without food. (2.1)
*   Should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC. Recommended combination therapy: (2.1) HCV Mono-infected and HCV/HIV-1 Co-infected

* SOVALDI in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible. (2.1)

* Should be used in combination with ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first. (2.1

So I have really no idea exactly what combo I will be on....We'll see.....I do hate that riba though...years later still dealing with light sensitivity, residue rashes and thinned hair that will never be what it was....last time on riba I couldn't even walk out in the sun...thought I had some type of vampire reaction to the sun....my skin would just burn even through shirts....just in the last couple of years have I been able to tolerate the sun but never like my previous sun bunny self.

Oh well...if it's not one thing it's another...just keep a positive thought and have a sense of humor and keep plowing ahead.....what do I have to lose at this point....if I'm going out I'll damn well go out fighting.

[JimmyMose]

i wish you success with your planned treatment.

Just to clarify, will you be taking Sovaldi plus Ribavirin for 48 and not interferon in pill form?    

S/S combo?  sofosbuvir/sovaldi  generic/brand name for the same drug.

[heart_in_the_keyes]

That was my biggest concern but pre or post have to get rid of HCV...if its post I am back in the picture of HCV affecting my new liver...my doc thinks I can tolerate the pill form...hoping...will see.

Would be good to see responses on this S/S combo from those who had adverse reactions to interferon....early posts look good so far but being specific a interferon non-responder...(chills, fever, muscle problems)  due to adverse reactions would like to hear.  Also had adverse reactions to riba....(skin, hair, light sensitivity).

Nan.....you and your husband a have been through a journey....hang in there....

[nan535]

My husband who is post transplant  is starting treatment as soon as his red blood cell count improves. He is interferon ineligible so they are putting him on Sovaldi and Ribavirin for 24 weeks.  He went through hell on triple treatment when he developed ESLD pre-transplant and had to stop treatment at 5 weeks.  
I may be wrong but I believe the preferred treatment for your genotype 1 as you await transplant is Solvaldi plus Ribavirin for 48 weeks or until transplant whichever comes first.

I did not know interferon comes in pill form.  Based on his prior experience, I know there is no way my husband would do this treatment  if interferon were involved.

Good luck
Nan

[heart_in_the_keyes]

Hi...am approved for sofosbuvir/sovaldi......start in a couple of weeks...geno type 1...am non responder on several interferon/peg and riba trials...also was ok'd for triple and then Gilead and then taken off prior to first pill due to decompensation of liver and the ESLD stage I am at.  I am on transplant list with MELD of 12, ESLD Stage 4 moderate level.  They are trying to rid HCV prior to tp.  Cautious about the interferon which always made me sick previously but doc believes I can tolerate in pill form.  Will see.  Wish me luck.... Only warriors win the battle.  Will still have to have the transplant due to the decompensation but rather not deal with the HCV after a liver transplant. For all of those out there who are not cirrhotic....thank god and good luck to you ridding yourself of HCV.

[hepc4Sandi]

This is all good news tho, I am genotype 4, just found out I have it 4 months ago, but have had it since the 1970s probably. Starting the 3 meds this Friday, have no idea what my liver status is, tho blood panel is good and viral load is relatively low (192,000). Hoping I will dodge the cirrosis and cancer bullet. Does the liver recover after the solvaldi treatment? Can it repair itself up to a certain point?

[3xlucky]

As far as I know I do not have cirrous yet. But my doctor
Did say that with the scarring on my liver it was getting there and I should do the trial. I had only just completed six months before and with two Gilead drugs and interferon plus RIBA was not looking forward to another round. This treatment was not As bad. No sides from sofusbuvir and the usual from interferon and RIBA. But hearing I was Undected at 4 weeks (maybe 3) not sure as was only tested at 2 then 4 and knowing it was only 12 weeks made it more bearable. I would imagine the results will be posted soon as most of us should be coming up on six months post treatment early next year.

[nan535]

I know exactly where you are as my husband was there when he found out he had Hep C in Dec. 2010. One difference is he had esophageal varices.
He tried the triple treatment with Incivik  when it came out. I can only describe it as brutal for him. He became so anemic he needed blood transfusions and he almost went into kidney failure. So he stopped it at 5 weeks.  We're not sorry he did it though because he remained undetected for the virus  for 8 months until he got his transplant.  Then sadly  the virus showed itself again.

His doctor is planning to put him on Sovaldi plus Ribavirin for 24 weeks (no inteferon) in January. God willing it will be successful  Perhaps this is an option for you.

So I agree with your doctor based on my husband's  experience.  Interferon is risky for you.

Nan

[pooh55811]

Can-do-man posted this thread:

http://www.medhelp.org/posts/Hepatitis-C/US-Patient-Assistance-Program-/show/2058689

It tells you about the financial assistance that Giliad is making available. Might be worth the read for some people.

[GrammyA]

My Hep Dr. wants to do the 2 new drugs without the Riba and Interferon…. small problem that the cost is about $100,000 for the 12 weeks and he is not sure if we can get my insurance company to cover it.  We are going to submit it and see what happens…. so stay tuned.  Yes, this is the best solution for me and NO I do not have that kind of money.

[sunru]

You might try contacting a doctor/department who refers patients for treatment.  I have am HMO so it is quite different.

[scratchinghead]

Does anyone know what the treatment code is for this procedure? You know, the one that is used by insurance companies? I phoned my insurance company to ask if they covered Sofusbuvir/Sovaldi and the guy said "huh? what is the treatment code".

So just wondering if anyone knows, or if they know where I could find this out. I am figuring this might help more people than just me.

[sunru]

Thanks for posting your tx history and especially your most recent 12 weeks Sfsbvr, Inf, Rbv trial.  I've had no luck at all with two failed attempts with Interferon based tx in the past. I saw my hepatologist today and a few protocols were recommended and one of them was the 12 week tx plan that you were on which to me seems like the one I would go for since it is only 12weeks. It sounds like those of us 1a's and early cirrhosis it has to be a triple bullet with at least one of the new DAA's in order to attain SVR.  May I ask, was it pure torture? Or what stage fibrosis do you have? My hepatologist said it is important to try to get tx started with Sofosbuvir right away due to the cirrhosis. So she recommended a few different options to kaiser today.  3xlucky, thanks again for sharing your experience with us, it is really inspiring.

[Diamando6]

Thanks, friends, very much, for all valuable informations.
I also want to congretulate to 3x lucky, as I will try my luck also for third time, (but dont know when), ok, anyway those are encouriging news, that you are now SVR, after two failed therapies. You seem just like my case. I believe if this is as I can see the prescribed for geno 1 Sofo+interf+riba, but, willy said, that is possible without interf. I realy hate that stuff. , meaning, very difficult to bare the symptoms, ..at least for me. I was really happy hearing, that there was a treatment option without interferon.
All I know is that I will accept probably that too., but I will open discussion about all oral therapy.  
God bless you all!

[nan535]

Thanks for sharing that article. As an educator, I particularly enjoyed the fact that the person who is responsible for this new drug started out as a poor student with reading problems. Now he is helping to save lives!
Amazing!

I do have one critique and that is that the author writes that doctors are not screening for Hep C because they don't like questioning their patients about  sex and drug use. My husband got the disease from blood transfusions in 1979. She missed the opportunity to educate people about this more likely reason for their infection. I had unprotected sex with my husband for 30 years before we knew he had the virus and am negative for the Hep C virus. So the likelihood of getting it from sex is, in my opinion, is very small.

Otherwise, a great article.

Nancy

[Jeff88]

An interesting article on sofosbuvir invention.

A Better Treatment for Hepatitis C

http://www.newyorker.com/online/blogs/elements/2013/12/a-new-treatment-for-hepatitis-c.html

[nan535]

As they say "third times the charm".  Looking great for you.

Wishing you all the best in finally attaining SVR.

Nan

[3xlucky]

I want to comment on this as I finished a trial with sosfb and interferon and RIBA 4.5 months ago and I am undetected Since week 3 or 4. Treatment was 12 weeks. Prior non responder to two interferon treatments and a Gilead trial last year with another two of their drugs. I know one other person on this site who is also undetected. I will not be classified SVR until my six month draw at the end of January but very hopeful. Although the trial has not posted results according to my research site they are very hopeful for this combination until non interferon drug combo comes along for geno 1a non responders like me.

[nan535]

So glad to see you back posting. Hope you are healing and feeling well.

Thank you for posting the info on Sovaldi.
  Unfortunately, my husband is back in the hospital  being treated for UTI and HE. We just found out a year and a half after transplant, his new liver has progressed to cirrhosis,. The pathologist said that the scarring is 50% result of the bile duct damage he sustained from the hepatic artery blockage and 50 % due to Hep C reoccurence.
    The reason I am posting this here is his doctor just told us today that the plan is to get him healthy and then after the holidays, start him on the Sovaldi in combination with ribavirin for 24 weeks.  He is genotype 1a/post transplant, had to quit triple treatment with Incivik after 5 weeks so he is interferon ineligible. (No way would he do it again anyway).
     Needless to say, this has been a rough few days. But he told his doctor today, he'll do whatever he needs to do...what an incredibly strong man he is.

Nan
"* SOVALDI in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible. (2.1)"

[JimmyMose]

Sofosb + Simeprevir has not been approved yet.  You should search the forum for Sofosbuvir Simeprevir trials and/or post a new topic if none answers your 2questions.

Posted earlier SOVALDI
------------------------DOSAGE AND ADMINISTRATION----------------------
*   One 400 mg tablet taken once daily with or without food. (2.1)
*   Should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC. Recommended combination therapy: (2.1) HCV Mono-infected and HCV/HIV-1 Co-infected

Genotype 1 or 4 SOVALDI + peg-interferon alfa + ribavirin 12 weeks
Genotype 2 SOVALDI + ribavirin      12 weeks
Genotype 3 SOVALDI + ribavirin      24 weeks

* SOVALDI in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible. (2.1)

* Should be used in combination with ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first. (2.1)

* A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease. (2.4, 8.6)

There are some trial results for the recommended uses above in the FULL PRESCRIBING INFORMATION
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

[Diamando6]

Hello there,
I am a little bit confused about the data. I am a potential patient , for the third time to try to kill this virus , once and for good (hope so). I would like to know, what are the results of the study , are they better with Sofosb + Simeprevir, without Inf and riba. I thought , that was the option, all oral therapy? Or am I wrong? Please enlighten me!