Aa
Sofosbuvir/ Ledipasvir
Has anyone heard when Sofosbuvir and ledipasvir fixed-dose combination might be available?
Lynn,
I thought I read in the information that they were looking for candidates with all stages of Cirrhosis, mild, moderate, severe, and pre-/post-transplant. I am going to email the trial information to my hubby's hepatologist, who is at UW Medical Center in the Transplant Senter. UWMC is connected to Harborview. I know that she has him on the contact list with the study coordinator at Harborview, but maybe I can ask her to look specifically into this one. On the trial info sheet, it doesn't say that it's at Harborview. It says it's being run by Gilead, so I assumed perhaps at one of their labs.
Let me know if you hear anything else Lynn.
Feel free to PM me if you like.
Advocate1955
I thought I read in the information that they were looking for candidates with all stages of Cirrhosis, mild, moderate, severe, and pre-/post-transplant. I am going to email the trial information to my hubby's hepatologist, who is at UW Medical Center in the Transplant Senter. UWMC is connected to Harborview. I know that she has him on the contact list with the study coordinator at Harborview, but maybe I can ask her to look specifically into this one. On the trial info sheet, it doesn't say that it's at Harborview. It says it's being run by Gilead, so I assumed perhaps at one of their labs.
Let me know if you hear anything else Lynn.
Feel free to PM me if you like.
Advocate1955
Hi thanks for finding that
Yes that is being run here in Seattle at Harborview. I had been in contact with the study nurse coordinator and the Doctor in charge of the study just before the holidays.
Fortunately or in the case on this study unfortunately I am not sick enough. They are looking for Pre transplant child b and c and post transplant a, b, c
I am child A so I don't qualify. If I had one more point I would be child b.
Really that is what motivated me to post in the first place as it looks like I will have to wait for it to be available by prescription.
Harborview said I should keep calling every couple of weeks to see if they have something I could qualify for.
Thanks again
Lynn
Here is the trial identifier:
http://clinicaltrials.gov/show/NCT01938430
Advocate1955
http://clinicaltrials.gov/show/NCT01938430
Advocate1955
I did see a clinical trial through Gilead that is recruiting here in Seattle. It is for sofosbuvir and ledipasvir. It's not at either of the hospitals, it's through Gilead. I found it on clinicaltrials.gov. I've emailed them, but I haven't received a response. It is an open, intervention oriented, Phase II trial, and it will include previously treated and treatment naive Cirrhotics at all stages of Cirrhosis. Thoughts?
Advocate1955
Advocate1955
Great! My husband is supposed to start later this month. I could not be happier for you. Best of luck for a sustained SVR soon.
Nan
Nan
Started Sovaldi & Ribavarin today!!!!
Got HepC in the late 70's...
Happy Happy Joy Joy!!!!!
Got HepC in the late 70's...
Happy Happy Joy Joy!!!!!
Hi I did 10 weeks treatment rib/interferon/boceptivir until 10 days ago when my specialist advised I come off of tx as I was not coping with the sx. I could cope with the flu.symptoms.the tiredness, the aches and pains but then I started to suffer panic attacks all day every day for the last couple of weeks. I was ending up in A & E most days or calling the paramedics. I felt I was going crazy. I would hAve had to do this for 48 weeks. I am in the UK and does anybody know when the new drugs will be passed over here. For the record I am s 65 year old female, genotype 1a f3 fibroscan diagnosed last year and had the disease for perhaps.40+ years. Help
COMMUNITY LEADER
I agree with your doctor. You don't want to risk decompensation if you are close to it on a treatment that you don't respond to. Interferon based treatments only make me ill, they don't drop my viral load even 1 log.
I was lucky enough to treat in a trial with Sovaldi and ribavirin only for 48 weeks and I became undetectable within a week. Sovaldi stops HCV replication in its tracks and the side effects are minimal compared to interferon based treatments. Being undetectable for that time allowed my liver to stabilize so my MELD score drop considerably.
I wouldn't worry about the virus causing so much liver damage that it will "get rid of you". Although decompensation and its complication can be challenging, many of the complications can be managed with medication and when you will need a transplant it will be available to you as it is for the big majority of ESLD patients.
Remain pro-active and try to stay one step ahead of your liver disease with your doctor. Remember the odds are better than ever that hep C infected people cirrhotic or not can clear the virus permanently before it destroys the liver.
Hang in there!
Hector
I was lucky enough to treat in a trial with Sovaldi and ribavirin only for 48 weeks and I became undetectable within a week. Sovaldi stops HCV replication in its tracks and the side effects are minimal compared to interferon based treatments. Being undetectable for that time allowed my liver to stabilize so my MELD score drop considerably.
I wouldn't worry about the virus causing so much liver damage that it will "get rid of you". Although decompensation and its complication can be challenging, many of the complications can be managed with medication and when you will need a transplant it will be available to you as it is for the big majority of ESLD patients.
Remain pro-active and try to stay one step ahead of your liver disease with your doctor. Remember the odds are better than ever that hep C infected people cirrhotic or not can clear the virus permanently before it destroys the liver.
Hang in there!
Hector
I totally agree with what you are saying Hector.
My personal less educated guess was by next Christmas 2014.... hopefully. Your estimate is more optomistic than mine so I like your timeline
My Dr in Seattle won't treat me with interferon because of concers that I could go into decompensation. Also I was a null responder to interferon/ribavirin so the newest unapproved therapies seem to be my only hope of getting rid of the virus before the virus gets rid of me.
Thanks
Lynn
My personal less educated guess was by next Christmas 2014.... hopefully. Your estimate is more optomistic than mine so I like your timeline
My Dr in Seattle won't treat me with interferon because of concers that I could go into decompensation. Also I was a null responder to interferon/ribavirin so the newest unapproved therapies seem to be my only hope of getting rid of the virus before the virus gets rid of me.
Thanks
Lynn
COMMUNITY LEADER
Great post Lynn! Thanks for passing the information along. Such a coincidence you asked the question! Ha ha
The article mentions "Hepatitis C affects an estimated 170 million people worldwide". This is very exciting what it will do for these people and how it will effect the UNOS program in years to come.
Hang in there Lynn! I hope the best for you :)
Randy
The article mentions "Hepatitis C affects an estimated 170 million people worldwide". This is very exciting what it will do for these people and how it will effect the UNOS program in years to come.
Hang in there Lynn! I hope the best for you :)
Randy
Todays news I am sure we will hear more:
Gilead to seek okay for combo hepatitis C pill in Q1
http://finance.yahoo.com/news/gilead-seek-okay-combo-hepatitis-162147627.html;_ylt=AwrTWfywzLFS8ywApw_QtDMD
Dec 18 (Reuters) - Gilead Sciences Inc, based on favorable new clinical trial data, said it will seek U.S. approval in the first quarter of 2014 for a once-daily tablet containing two new treatments for hepatitis C.
The company previously said it would seek marketing approval in the first half of next year for the combination tablet, which would pair Gilead's recently approved Sovaldi (sofosbuvir) and its experimental drug ledipasvir.
Feeling Hopeful :-)
Gilead to seek okay for combo hepatitis C pill in Q1
http://finance.yahoo.com/news/gilead-seek-okay-combo-hepatitis-162147627.html;_ylt=AwrTWfywzLFS8ywApw_QtDMD
Dec 18 (Reuters) - Gilead Sciences Inc, based on favorable new clinical trial data, said it will seek U.S. approval in the first quarter of 2014 for a once-daily tablet containing two new treatments for hepatitis C.
The company previously said it would seek marketing approval in the first half of next year for the combination tablet, which would pair Gilead's recently approved Sovaldi (sofosbuvir) and its experimental drug ledipasvir.
Feeling Hopeful :-)
Thanks Hector
Yes that is the data I have been looking at.
I have been on the phone with Harborview Medical here in Seattle. Right now the only study here is for pre transplant Child B & C and post Transplant Child A, B. C
NCT01938430 "Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant"
So as you said I don't qualify. I'm too well to be sick but too sick to try any interferon based Tx
My Hepa Dr said I am right on the line between compensated and decompensated. I just started seeing her this last year, moved up from my Gastro I had been seeing for a while.
So just sitting here hoping for a study or the drugs becoming available before I get any worse.
Thanks and congratulations again on your transplant!
Lynn
Yes that is the data I have been looking at.
I have been on the phone with Harborview Medical here in Seattle. Right now the only study here is for pre transplant Child B & C and post Transplant Child A, B. C
NCT01938430 "Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant"
So as you said I don't qualify. I'm too well to be sick but too sick to try any interferon based Tx
My Hepa Dr said I am right on the line between compensated and decompensated. I just started seeing her this last year, moved up from my Gastro I had been seeing for a while.
So just sitting here hoping for a study or the drugs becoming available before I get any worse.
Thanks and congratulations again on your transplant!
Lynn
COMMUNITY LEADER
Earlier in 2013 Gilead had a projected time line of 2015 for interferon free, all oral treatment. I don't know if there has been any modifications to that timeline since then.
Now is the time in the evolution of hepatitis C treatment when all the transition treatments will be coming to market. The ones that include either Ribavirin or Ribavirin and peg-interferon along with a DAA.
Olysio (simeprevir) and Sovaldi combined is interferon and ribavirin free. But it's use would be off label. It would be up to the transplant center to decide if they would use this combination for those who didn't respond to interferon based treatments.
The LONESTAR trial results are very impressive to say the least for cirrhotics!
LONESTAR: Sofosbuvir/Ledipasvir With or Without RBV Produces High SVR12 Rates in Patients With Genotype 1 HCV, Regardless of Previous Treatment Experience or Cirrhosis
Source: 2013 Annual Meeting of the American Association for the Study of Liver Diseases*
Summary of Key Conclusions
• Overall SVR12 rate 97% with sofosbuvir/ledipasvir with or without ribavirin (RBV)
• SVR12 rate 97% in treatment-naive patients without cirrhosis treated for 8 or 12 weeks
• Among treatment-experienced patients with previous protease inhibitor (PI) failure:
• SVR rate 98% with 12 weeks of treatment
• SVR rate 95% in cirrhotic patients
• Regimens well tolerated
• No treatment discontinuations due to adverse events (AEs)
• No grade 3/4 AEs in RBV-free arms
FYI: Child's A IS compensated cirrhosis and a MELD of 7 is minimal (6 is the lowest MELD score possible). Most US transplant center won't list a patient with a MELD score less than 15 because if a person was to have a transplant with a MELD score less than 15 they would be more likely to die after the transplant than if they didn't get a transplant. Of course in reality no one gets a transplant with a MELD score of 15. If this is accurate assessment of your cirrhosis your cirrhosis is still in its early stage. But having grade 3 varices and banding for varices indicates extensive portal hypertension. Only your hepatologist with all the data can say how extensive your cirrhosis truly is.
Decompensated cirrhosis means the liver can no longer maintain all of its function and thus the complications occur. Decompensation is diagnosed when a patient has obvious ascites many times requiring paracentesis, bleeding varices, jaundice, and other serious complications.
Why not look to get into a Sofosbuvir/Ledipasvir trial. Have you asked your transplant center if they know of any local trials?
Best of luck to you.
Hector
Now is the time in the evolution of hepatitis C treatment when all the transition treatments will be coming to market. The ones that include either Ribavirin or Ribavirin and peg-interferon along with a DAA.
Olysio (simeprevir) and Sovaldi combined is interferon and ribavirin free. But it's use would be off label. It would be up to the transplant center to decide if they would use this combination for those who didn't respond to interferon based treatments.
The LONESTAR trial results are very impressive to say the least for cirrhotics!
LONESTAR: Sofosbuvir/Ledipasvir With or Without RBV Produces High SVR12 Rates in Patients With Genotype 1 HCV, Regardless of Previous Treatment Experience or Cirrhosis
Source: 2013 Annual Meeting of the American Association for the Study of Liver Diseases*
Summary of Key Conclusions
• Overall SVR12 rate 97% with sofosbuvir/ledipasvir with or without ribavirin (RBV)
• SVR12 rate 97% in treatment-naive patients without cirrhosis treated for 8 or 12 weeks
• Among treatment-experienced patients with previous protease inhibitor (PI) failure:
• SVR rate 98% with 12 weeks of treatment
• SVR rate 95% in cirrhotic patients
• Regimens well tolerated
• No treatment discontinuations due to adverse events (AEs)
• No grade 3/4 AEs in RBV-free arms
FYI: Child's A IS compensated cirrhosis and a MELD of 7 is minimal (6 is the lowest MELD score possible). Most US transplant center won't list a patient with a MELD score less than 15 because if a person was to have a transplant with a MELD score less than 15 they would be more likely to die after the transplant than if they didn't get a transplant. Of course in reality no one gets a transplant with a MELD score of 15. If this is accurate assessment of your cirrhosis your cirrhosis is still in its early stage. But having grade 3 varices and banding for varices indicates extensive portal hypertension. Only your hepatologist with all the data can say how extensive your cirrhosis truly is.
Decompensated cirrhosis means the liver can no longer maintain all of its function and thus the complications occur. Decompensation is diagnosed when a patient has obvious ascites many times requiring paracentesis, bleeding varices, jaundice, and other serious complications.
Why not look to get into a Sofosbuvir/Ledipasvir trial. Have you asked your transplant center if they know of any local trials?
Best of luck to you.
Hector
Thanks rpooo
I have been reading the same info.
I am anxiously waiting on this treatment to become available.
I am Genotype1A null responder w/ a diagnosis of early cirrhosis in Jan 2008. I have since had banding for grade 3 non-bleeding esophageal varicies and have subclinical ascities (only detectable on ultrasound i.e. scant acsities). Still considered a Child A and a MELD 7. Haven't been able to figure out if I am compensated or decompensated but I am surely on the line I would think.
The Dr's wont treat me with interferon anymore due to concerns I could go into full decompensation and with Telaprevir the stats don't look good in my case anyway.
Just wondering if anyone has heard when they might start the approval process. Hoping I can get treated before I truly decompensate. I am sure there are many others like me
Lynn
I have been reading the same info.
I am anxiously waiting on this treatment to become available.
I am Genotype1A null responder w/ a diagnosis of early cirrhosis in Jan 2008. I have since had banding for grade 3 non-bleeding esophageal varicies and have subclinical ascities (only detectable on ultrasound i.e. scant acsities). Still considered a Child A and a MELD 7. Haven't been able to figure out if I am compensated or decompensated but I am surely on the line I would think.
The Dr's wont treat me with interferon anymore due to concerns I could go into full decompensation and with Telaprevir the stats don't look good in my case anyway.
Just wondering if anyone has heard when they might start the approval process. Hoping I can get treated before I truly decompensate. I am sure there are many others like me
Lynn
COMMUNITY LEADER
Published Nov. 1, 2013
http://www.ncbi.nlm.nih.gov/pubmed/24209977
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62121-2/abstract
INTERPRETATION:
These findings suggest that the fixed-dose combination of sofosbuvir-ledipasvir alone or with ribavirin has the potential to cure most patients with genotype-1 HCV, irrespective of treatment history or the presence of compensated cirrhosis. Further clinical trials are needed to establish the best treatment duration and to further assess the contribution of ribavirin.
http://www.ncbi.nlm.nih.gov/pubmed/24209977
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62121-2/abstract
INTERPRETATION:
These findings suggest that the fixed-dose combination of sofosbuvir-ledipasvir alone or with ribavirin has the potential to cure most patients with genotype-1 HCV, irrespective of treatment history or the presence of compensated cirrhosis. Further clinical trials are needed to establish the best treatment duration and to further assess the contribution of ribavirin.
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It is the responsibility of pharmaceutical companies seeking to market a drug in the US to test it (trials/studies) and submit evidence (resulting data) to the FDA proving scientifically that the drug/treatment is safe and effective. A team of FDA physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's New Drug Application (NDA) containing the data and proposed labeling and then the FDA votes to approve or disapprove of the drug being distributed and use by the public.
So what this article is saying is that Gilead expects to submit an NDA to the FDA for Sovaldi/Ledipasvir treatment "in the first quarter of 2014 ". So for us we can expect that the treatment will be available about 9 months after the date that Gilead files for approval (the NDA) of the treatment.
For example:
The new Sovaldi/peg-interferon/ribavirin treatment that has now been approved by the FDA recently for treatment of genotype 1 patients had its NDA submitted this year on April 8, 2013. It then took until December 6, 2013 for FDA approval. So we can expect it will take about 9 months for approval and then some additional time for insurance companies to cover the new treatment, doctors to learn how to treat with it and for the treatment medicine to be available locally to doctors and patients as we are now experiencing with the currently approved treatment.
I hope this helps to set expectations for treating with this treatment to a realistic level. In other words the treatment won't be available in the near future (more likely in the fall or winter of 2014) and to plan accordingly.
For those people with cirrhosis who may be near decompensation they should have a discussion with their hepatologist if they will be treating soon and choose the best treatment that is available to them based on the timeline of their liver disease and not wait for something that may not come in time and then have their liver disease progress to the point of not being able to treat and needing a liver transplant to continue living.
Cheers!
Hector