Author Topic: will our S/O post treatment please post results 4, 12, 24 EOT (Read 220635 times)

badbradley · « **Reply #300 on:** September 10, 2015, 11:26:34 am »

Hello Mollythedog, Sorry to hear of your relapse. It may be that with F3-F4 fibrosis you required 24wks of treatment. I'm wondering about your Ribavirin dose. Was that the prescribed dosage or was it reduced? Ribavirin is weight based dosing. I have not heard of anyone being on 400mg.It may be that Riba is a concern with transplant patients. I am not familiar enough with transplant to have an informed opinion on your treatment regimen or a retreatment strategy. As I understand, the AASLD Guidelines recommend retreatment with 24wks Sovaldi/Ledipasvir w/Ribavirin for 1a w/cirrhosis. With F3-F4 fibrosis, I would want to treat as if I had cirrhosis. You said you had F4 fibrosis at one point, I understand that to be cirrhosis. It may be because of the required Ribavirin that your Doc does not want to use that regimen. Again I am not familiar enough to have an opinion on his retreatment strategy but I have provided this link to AASLD Guidelines. I strongly advise familiarizing yourself with retreatment options. I relapsed onS/O 12wks also and my treatment team were going to let me retreat on a regimen that is NOT RECOMMENDED by AASLD because of cross resistance to protease inhibitors. My insurance was going to foot the bill for it. Viekira Pak. The treatment would most likely not have worked. I informed them of this fact and refused the medicine. Probably saved my insurance a bunch of money. Now they are denying me the meds that are recommended. 12wks Harvoni w/Riba.
I hope these guidelines help you. If you have anymore questions don't be afraid to ask. Best of luck. Brad

http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed

Perca05 · « **Reply #301 on:** September 10, 2015, 01:27:53 pm »

Hi all...
Just had my 12 week EOT results on Harvoni, and I'm still clear! Yay!
AST = 9
ALT - 16

Viral count undetected.

Will have another checkup in 6 months.

I now have one less thing to worry about in my life.

mollythedog · « **Reply #302 on:** September 10, 2015, 05:08:33 pm »

Hello Brad, thanks so much for your reply, I have been waiting for someone who knows how it feels after a relapse on the "miracle cure". I'm so sorry you still have to wait but it's worth it for the right treatment and not to go through relapse again. My doc said riba wasn't that important for me but he would halve the dose as an extra. I had F4 when the virus came back with a roar and a transplanted liver is more prone to stiffness. He wants to give 24 wks Sovaldi, Daklinza and Riba, probably more this time, as Daklinza is indicated for post transplant patients. Go back on 30th September. Not sure if you have to wait some time before retreating, do you know? Keep pushing for your therapy, you seem to know what you're talking about. How do you live, work, do everything without remembering you have this sword of Damocles over you head all the time? I'm such a happy easygoing person really, I don't want to lose that. Is it possible? Ps. I live in Italy. I'll check out the link. Thank you so much. Molly. I'll pray for you and all of us unlucky ones that we keep strong and don't ever give up.

badbradley · « **Reply #303 on:** September 12, 2015, 12:47:21 pm »

Hi Molly,
Adjusting to the news of relapse was a struggle for a time. I had to refocus my attention on retreating strategies so I didn't have the time or energy to dwell on treatment failure. It was one foot in front of the other and keep on keeping on and still is. The struggle now is getting retreated. They are pulling out all the stops and it is very frustrating and maddening at times. Insurance companies here are not quick to approve treatment due to it's extremely high price.
I try to keep this struggle separate from my work life and family life but it creeps in now and then.
As far as waiting to retreat, that is an interesting question. For your retreatment regimen you will not have to wait to retreat as the medicine in particular the Daklinza (NS5A), is a different mechanism of action than Olysio (NS3/4A) protease inhibitor. I'm not clear on weather or not testing for naturally occurring NS5A resistance associated variances is necessary. I do not think it is but again not sure.
For my retreatment....my Doc is trying to convince me to retreat on Viekira Pak which contains an NS3/4A protease inhibitor ( Paritaprevir ), therefore NOT RECOMMENDED by AASLD for retreatment after failing on a regimen containing another protease inhibitor, specifically referring to simeprevir (Olysio). He says that the resistant mutated virus will revert back to "Wild Type" in a year and therefore it will be OK to retreat on this regimen. It will be 1yr in Nov from end of treatment on S/O.
The problem is....I'm not buying into it. Even if it does "revert" back to Wild Type, I'm not convinced of the clinical significance of that. I already failed on that class of drug so why would it work the second time. Also, Paritaprevir, along with the other drugs in that regimen, are all "Low barrier to reistance drugs". I am well aware of retreatment strategies focused on "Different mechanism of action and a higher barrier to resistance".
So that is what I'm struggling with. It is more work for them to do the appeals etc. for the correct recommended retreatment regimen for my profile which is 12wks Harvoni w/Riba. I was denied once for lack of clinical information and denied Fibrospect and then denied fibrosure tests, which would give me the clinical info they are requiring. "Yay" right?
So I will be seeing my hepatologist in about a month and go from there but at this point, a new treatment team is looking like a good probability in the near future.
I hope you get your medicine soon and get retreated. I was so sure I had it beat being UD at 4 and 12 wks on treatment. I tested 12wks after last dose and discovered relapse. It is what it is but having to deal with this additional stress is challenging to say the least. This is why I strongly advise being informed on these new treatment drugs and the guidelines. Not all Docs are totally informed on these new regimens.
Stay positive and keep focused on staying healthy and gear up for the next round. You will slay this dragon.
Brad

mollythedog · « **Reply #304 on:** September 13, 2015, 12:23:45 pm »

Hi Brad, you sound so weighed up on clinical issues. I try by studying everything official and serious I can find. I studied your link. Below each recommendation there was Class A or B, Level 1, 2 or 3 what does it mean? They don't have the assays necessary for testing for resistances here in Italy. I quite suspect I have Q80k if S/O didn't work. Also I see Ledispavir is an NS5 a and b inhibitor whereas Daklinza is NS5a only. I am sorry it's so difficult for you to get retreated in the US. Personally I think that system stinks. Yes, it is hard to stop remembering every minute that this virus is trying to kill my transplanted liver. Started treatment at almost 6 million VL 12 weeks later 3 million. Like you during treatment I was UND at 4 and 12 weeks. I was and still am disappointed. I don't know if the tx time was insufficient or whether it didn't work due to resistance. I was tx naive. My doc is a specialist in both gastroenterology and infectious diseases, mainly HIV and Hepatitis. He's a very remarkable person, I have a great doctor patient relationship with him. He offered me retreatment immediately and in my situation I can't wait. Although I have no symptoms I must have cirrhosis by now with F3/4. Brad, what we need is inner peace, you are ahead of me, I too want to just work and carry on my normal daily life. I've developed a strange nervous habit of continuously pushing the air out of my chest, I know it's stress but I do it unconsciously. I wish you all the luck in the world and I pray that sooner than you know you're offered retreatment. Take good care everyone, thanks to all the kind people who want to give encouragement.

badbradley · « **Reply #305 on:** September 13, 2015, 01:36:01 pm »

Hi Molly
You are right that I am weighed up on clinical issues. That is because at some point I will have to retreat and if I have no other option, I will have to retreat on what is made available. My insurance companies' Pharmacy Benefits Manager "Express Scripts", has chosen Viekira Pak to include in it's Formulary and will not cover Gilead's Sovaldi or Harvoni.
So, I had to spend a lot of time researching to find out if in fact this regimen is a possibility and what my odds are of clearing the virus. Unfortunately, I have not found any evidence that this regimen is possible. In fact, everything I have read supports the AASLD Guidelines recommendations to not retreat on this regimen.
It is exhausting to say the least and it is inconceivable that I should have to convince my own treatment team that this medicine is not the treatment that is required.
I am sorry that I am not as encouraging as I could be. I did not post on the forum for a while because I felt I was a negative presence having relapsed. You will find plenty of encouraging people on this forum. It sounds like you will be starting treatment soon and I encourage you to stay involved on this forum.
Good luck on your next treatment. I will be looking for your posts. Take care.
Brad

mollythedog · « **Reply #306 on:** September 13, 2015, 05:34:31 pm »

Evening Brad, just wanted to say how important it is for me to speak to someone who knows what the problem is. My doc doesn't appreciate my knowing too much, I sense this, but he's just not used to it. I've been a medical/scientific translator for years and can easy understand everything I read about my disease. I think it's terrible that treatment teams are so unorganized and sometimes, let's be honest, incompetent. The problem here is that we're not updated, even most of the doctors don't speak English and work long hours, they don't have the time to study the latest updates and it's the pharmaceutical companies who step in and inform them on the specific drugs, each one working in the interest of their own company. Just one question, is daklinza a high or low resistance inhibitor? Is Ledispavir more potent? I too felt negative and although seeing success stories with my treatment made me happy for other poor sufferers, it only made me feel even more unlucky, an alien. I fully understand why you don't want another NS3 inhibitor, it's logical, but is Veikira so much cheaper? Have you called Gilead? I believe daklinza is even more expensive. I'm off to bed now, it's getting late. Keep your spirits high. God bless.

badbradley · « **Reply #307 on:** September 13, 2015, 08:21:42 pm »

Hi Molly
I have a couple of links for you. Regarding your question about Daklinza, it is a low barrier to resistance drug. I am not sure if it is more potent or less potent than Ledispavir but from what I have been reading it is showing very high cure rates when combined with Sovaldi, for your profile being a G1a High fibrosis, treatment experienced. There is information here that refers to Daklinza being used on patients that have failed earlier 1st generation protease inhibitors and results look very good. Some of this information as you know requires familiarizing yourself with some basic terminology but it is readable. I have learned enough to be able to understand fundamentals but the more you learn, the further it pulls you into the scientifics. Without a professor standing next to you explaining and answering questions, learning is limited. Anyways here are some links.

http://www.nejm.org/doi/full/10.1056/NEJMoa1306218

http://www.natap.org/2015/EASL/EASL_90.htm

http://www.ncbi.nlm.nih.gov/pubmed/24428467
http://www.natap.org/2015/EASL/EASL.htm

To answer your question about Viekira Pak being cheaper - yes currently it is on their formulary as their preferred choice of treatment and have struck a deal with Abbvie for a substantially reduced rate vs. Gilead's Harvoni or Sovaldi
Hope this is helpful.
You have a great chance of clearing with this regimen.
Brad

badbradley · « **Reply #308 on:** September 16, 2015, 10:27:05 am »

Hi Molly

Here is some info on Resistance.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3870547/

http://aac.asm.org/content/54/5/1878.full

http://www.natap.org/2015/CROI/croi_164.htm
http://www.hepatitisc.uw.edu/
http://www.researchgate.net/publication/236223417_Evaluating_the_Role_of_Macrocycles_in_the_Susceptibility_of_Hepatitis_C_Virus_NS34A_Protease_Inhibitors_to_Drug_Resistance

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3554180/

Hope you are doing well. Have a good day.
Brad

Also, another new forum member , chuck3a , has started a new thread " Sovaldi, Ribavirin, Daklinza, for 24weeks".

mollythedog · « **Reply #309 on:** September 16, 2015, 12:09:34 pm »

Hi Brad,

I've studied all the relative data contained in the links you sent me. The information has been extremely useful in understanding the medical scientific aspects off the new generation drugs. I have been able to understand my doctor's preference for Daklinza as opposed to Ledispavir. As a post transplant patient I must take proton pump inhibitor to protect my stomach from excess acid production due to the immune suppression drugs I must take daily to prevent organ rejection. Ledispavir has interactions with these drugs and is not fully absrbed. I hope your retreatment date is getting near, here, too I need approval and it takes time. I'm really working on not dwelling on my therapy failure, so disappointing. An acquaintance of mine started 2 days after me and is cured. Thanks for all the info. I don't plan on losing myself on forums but it is so nice to have met someone so far away and share experience. It's evening here in Italy and I must start cooking. (very important over here) . Take care and I look forward to hearing news of your retreatment.
Molly

sunrise · « **Reply #310 on:** September 23, 2015, 12:02:36 am »

Hey Molly,
I felt so awful when I just read this thread. My apologies for feeling positive you had beat it. Im thankful though you found Brad, he is so sweet , and really has done his homework huh!Hey Brad! Guess it is still the "waiting game" is still on. Hope you are well. I am still dealing with side effects. Best wishes for everyone, much respect for your courage... SunriseAnd I'd choose you; In a hundred lifetimes, In a hundred worlds, In any version of reality, I'd find… https://t.co/Ka7SDkTltJ

sunrise · « **Reply #311 on:** September 23, 2015, 12:05:15 am »

That last sentence is not my entry, so weird. anyway, take.care

mollythedog · « **Reply #312 on:** September 23, 2015, 10:48:23 am »

Hello Sunrise, thanks for your kind concern. Yes, it was so hard to digest. In just 5 days my bloodwork and liver panel were excellent. Stayed UND all through. Don't know at what point the virus came back but I felt great the whole time. I began worrying about 10 weeks post treatment, I had this niggling feeling that it hadn't worked on me. So I was quite impassive when my doc read the results. However, it took almost 2 weeks to stop the stress and paranoia, a lot of prayer. But I'm able to say that today I am calm and relaxed about the situation. I'll take either harvoni or sov and daklina plus RIBA either case, for 24 weeks. I read how hard it is for many to get insurance coverage for retreatment in the US and my blood chills. Here in Italy we're covered if we have F3/F4, have hcv recurrence after transplant or hcc already cured. I've no idea whether or not it will work. I've always considered 50/50% possibility, it's yes or no. Whatever, this monster has had too much of my life already and I don't want to give it another single day. I want to just carry on doing what I do, working, eating healthily, swimming, taking care of my family and doing all that's available to get cured. If it doesn't work, well, we'll cross that bridge when we come to it. If I get s/e this, I got none on Sov/Oly riba for 12 weeks, then I'll just take it in my stride. This is the result of prayer and meditation. Beats any treatment. If I have die from this, I'll frag this evil virus with to the grave !!! But I don't dwell on tomorrow anymore and that's a miracle for me. I follow the posts and I think its great to be able to write about your ups and downs in tx, your joys and sorrows, your success or failure and know that someone somewhere is getting something out for your experience. Brad has been great. He helped me through the initial shock and disappointment. My prayers are for all of you, we will get to the other side of the river sooner or later. Much love

Kate101 · « **Reply #313 on:** October 01, 2015, 04:11:24 pm »

Hello to all,

Just got my 12 week post treatment. Still negative! Feeling great. Anxiety and insomnia much better.
My WBC, RBC, AST, ALT and Glucose are normal again. Still a little fatter

My Platelets are low @ 114. Is this normal?

Treatment was rough on me but I am looking forward to the rest of my life now!

Kate101

slats1056 · « **Reply #314 on:** October 01, 2015, 04:15:23 pm »

Kate, The first day of the rest of Your life!!! Kinda like a second birthday! Great news on the undetected.

KimInTheForest · « **Reply #315 on:** October 01, 2015, 05:47:07 pm »

Quote from: Kate101 on October 01, 2015, 04:11:24 pm

Hello to all,

Just got my 12 week post treatment. Still negative! Feeling great. Anxiety and insomnia much better.
My WBC, RBC, AST, ALT and Glucose are normal again. Still a little fatter
My Platelets are low @ 114. Is this normal?

Treatment was rough on me but I am looking forward to the rest of my life now!

Kate101

CONGRATS on your new life, Kate !!!

kim

badbradley · « **Reply #316 on:** December 08, 2015, 11:38:55 am »

Quote from: badbradley on July 28, 2015, 09:21:04 pm

Hey Mel I am so glad you won this battle! I did not want to see you have to go through retreatment. You are a survivor. I am Happy for you!

My Retreatment journey has been anything but uneventful -
Feb. - Relapse
Apr. - Hepatologist recommends Harvoni/Riba 12wks
Apr. - Harvoni rejected, Viekira Pak approved (Express Scripts)
Cannot retreat on Viekira Pak -Protease cross resistance issues having failed S/O
May - Requested Harvoni, Request Denied (F3 - F4 fibrosis required)
June - Researched treatment strategies, etc. Request for Fibrospect
June 28 AASLD updates treatment guidelines to include retreatment for my profile
It is Harvoni/Riba 12wks (one less reason for a denial) Plan is to appeal denial, if second denial go to "My Support Path" and try my luck there.
July 1st - "My Support Path" cryteria modified - no longer providing medications for patients with insurance being denied by their providers for unmet payer cryteria, prior treatment failures,etc. etc.
Gastroenterologist says NS3 resistance variances will revert back to wild type in 1 yr. It is hinted that I retreat on Viekira Pak (probably to avoid hassles of appeals)
AASLD advises against this retreatment regimen for my profile
July 28 - Denied request for Fibrospect (considered experimental/investigational and therefore not medically necessary).

So this is where I stand on this 5th annual World Hepatitis Day!
GOOD GRIEF
Brad

So then a request for a Fibrosure test was put in and also denied but a liver biopsy was approved.
I did not have the biopsy. My Gastro wanted me to have another consultation with my Hepatologist so an appointment date was made for early Oct. SLOOOOW forward to Oct. - Visit with Hepatologist netted the original recommendation of Harvoni/Ribavirin 12wks. Waited for almost a mth and no call from anyone and it was day 176 of the 180 deadline for an appeal. Meantime I was encouraged by a forum member -MEL, Bless her heart, to contact Express Scripts. After many on holds, transfers, a couple of disconnects,1 hang-up and just determination and persistence, I was put into contact with a patient advocate at Accreddo. The appeal was made and in its final days of review and She tracked the status for me and was able to determine the day it would be decided. A couple days later she called me with the news that my treatment had been approved. I was in disbelief but grateful! She put in some faxes to my treatment team and with a few more typical snafu's I was finally notified by Accreddo of my delivery date. It was pretty exciting watching the processing of everything on-line. My Harvoni was processed on Thanksgiving morning. It was indescribably emotional! Noteworthy is that I have Anthem, BCBS - Express Scripts. 1 denial and 1 appeal and then approved, albeit significant downtime in between. Also no fibrosis documentation - insurance required F3 - F4.
I began my treatment, 12wks Harvoni/Ribavirin on Sun. Dec. 6 and I actually feel better than I have in months (knock on wood)! I am a 12wks Sovaldi/Olysio relapser.
Lots of frustration over the past months. I have been seeing quite a few approvals in recent days. Lets hope this is a sign that things are loosening up. It is helpful to share some details in your battle for treatment as it may encourage others to press on and be persistent. Do not take NO for an answer. It is unacceptable. Best of luck to all.
Brad

KimInTheForest · « **Reply #317 on:** December 08, 2015, 12:43:56 pm »

Congrats on starting retreatment, Brad! And good luck on your Harvoni+Ribavirin combo. That is the combo that cured me. (I wasn't a relapser, but was 3a, which is hard to treat.)

You have certainly been given the runaround.

best,
kim

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Author Topic: will our S/O post treatment please post results 4, 12, 24 EOT (Read 220635 times)