Another Harvoni Relapse

[tmf2]

Finished Harvoni 7/7, 5th week in still detected 8th week undetected three weeks post EOT detected. AST 156 ALT 302 up from AST 37 ALT 40. I am stage 4 Cirrhosis with a Child score A treatment naive. Treatment was 12 weeks Harvoni.  My hopes are dashed. My doctor is attempting to get me approved from my Insurance for 24 weeks of Harvoni possibly with Ribavirin. Is this the best course of action and if they do not approve should I try for the  Viekera Pak ? Depressed worried and confused.


Dennis

[Corey]

Ugh!  I am so sorry!  I can't pipe in on the best course of action from here.  I am Stage 3/4 and was approved for 24 weeks of Harvoni from the start and crossing my fingers that I will get to SVR12. 

Don't get discouraged.  Seems like lots more options in the pipeline than there were 5 years ago.  We have come a long way since interferon was the only option!

[gnatcatcher]

Dennis, how I wish Harvoni had worked for you!  Since I'm not qualified to answer your question, I hope you can get a second opinion from another hepatitis expert who may know of other courses of action to consider.

[Lynn K]

Harvoni is actually 2 drugs Sovaldi and Ledipasvir. Ledipasvir is the same class of drug as one of the drugs used in Viekira Pak Ombitasvir they are both a NS5A inhibitor and unfortunatly there would be cross resistance issues.

The most current recommendation (revised Aug 7th) from the AASLD treatment guidelines for a patient like you



"Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).

For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.

Rating: Class IIb, Level C

 

For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.

Rating: Class IIb, Level C"

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

I relapsed last year after treating for 12 weeks with Sovaldi and Olysio. It was later recommended a petient with cirrhosis should treat for 24 weeks with that combo which is the likely reason I relapsed. That was hard news to hear I had so much hope.

On May 4th I finished 24 weeks of Harvoni. We added Ribavirin later so I was on ribavirin for 15 of those weeks. On July 28th I received my 12 week post results and I was still not detected believe it it can happen for you too

So sorry to hear of your relapse best of luck to you going forwards.

Lynn

[dragonslayer]

>>three weeks post EOT detected.<<

Dennis, what was your viral load at 3 wks post treatment?

[sickpuppy]

I'm in the same situation. Not relapsed, yet, but I am also on 12 week Harvoni + Ribavirin. I am also a CPT B not A, so even worse.

This post makes me depressed.

However, I don't know if you had Ribavirin added. That seems to increase chances for cirrhotics. I did become undetected 12 weeks into treatment, so I'm hoping that's a good sign, but all the studies show it isn't good nor bad, so I really don't know.

In any case, Harvoni re-treatment is not an option. I'm really sorry. I'm worried about that too. If you fail Harvoni as a cirrhotic on 12 weeks, you don't have any other options. You now have resistance to NS5A and/or NS5B inhibitors, and all the current and future drugs seem to focus on that. The SVR rates are much lower if you would try a re-treat, and even if you would like it, I don't think your insurance would approve it.

One of your hopes is a NS3 inhibitor, which Gilead is developing (but with low SVR rates so far).

However, your best hope is this: http://www.achillion.com/ACH3422

Pray this comes on the market soon. It's NS5A/NS5B and NS3/4 inhibitor and has insanely high SVR rates. Seems very promising.

[tmf2]

>>three weeks post EOT detected.<<

Dennis, what was your viral load at 3 wks post treatment?

3 Million

[tmf2]

I'm in the same situation. Not relapsed, yet, but I am also on 12 week Harvoni + Ribavirin. I am also a CPT B not A, so even worse.

This post makes me depressed.

However, I don't know if you had Ribavirin added. That seems to increase chances for cirrhotics. I did become undetected 12 weeks into treatment, so I'm hoping that's a good sign, but all the studies show it isn't good nor bad, so I really don't know.

In any case, Harvoni re-treatment is not an option. I'm really sorry. I'm worried about that too. If you fail Harvoni as a cirrhotic on 12 weeks, you don't have any other options. You now have resistance to NS5A and/or NS5B inhibitors, and all the current and future drugs seem to focus on that. The SVR rates are much lower if you would try a re-treat, and even if you would like it, I don't think your insurance would approve it.

One of your hopes is a NS3 inhibitor, which Gilead is developing (but with low SVR rates so far).

However, your best hope is this: http://www.achillion.com/ACH3422

Pray this comes on the market soon. It's NS5A/NS5B and NS3/4 inhibitor and has insanely high SVR rates. Seems very promising.

Well I understand about possible resistance NS5A and B, and appreciate your input. My Herpetologists  went ahead and requested 24 weeks Harvoni possibly with  Ribavirin so I guess it up to the insurance company at this point, if they deny we will deal with it another way. I guess my way of thinking even though SVR rates are much lower it is better then sitting around hoping for next best thing to come along when your C4, any small chance of a cure is worth taking at this point aside from interferon.     

Interesting article about re-treatment with Harvoni.

http://www.hepmag.com/articles/Harvoni_retreatment_2501_27162.shtml


Dennis

[Bixter]

So sorry to read about your relapse, Dennis. People who relapse after 12 week Harvoni have a cure rate of 46% with retreatment  with Harvoni for 24 weeks. But since Harvoni was your first tx, maybe Sovaldi/Olysio would be a better choice? I thought that was the recommended tx for some one in your situation? Maybe check for Q80K polymorphism if you are 1a.

Here's some info:
http://www.hepmag.com/articles/Olysio_Sovaldi_2501_25501.shtml

[Lynn K]

current AASLD Guidelines for retreatment 

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



Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).

For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.

Rating: Class IIb, Level C

 (note this next paragraph was just revised 8/7/15)

For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.

Rating: Class IIb, Level C

Data on the retreatment of patients for whom prior treatment with ledipasvir/sofosbuvir has failed are very limited. In a pilot study, 41 patients with and without cirrhosis who did not achieve an SVR with 8 weeks or 12 weeks of ledipasvir/sofosbuvir were retreated with 24 weeks of ledipasvir/sofosbuvir. SVR12 rates varied according to the presence or absence of NS5A inhibitor RAVs. Among 11 patients for whom NS5A inhibitor RAVs were not detected, SVR occurred in 11 of 11 (100%); in contrast, among 30 patients for whom NS5A inhibitor RAVs were detected, SVR occurred in 18 of 30 (60%). Importantly, NS5B inhibitor RAVs (eg, S282T) known to confer decreased activity of sofosbuvir were observed in 3 of 12 (25%) patients for whom the retreatment regimen was not successful. Similarly, in the OPTIMIST-2 study in which patients with cirrhosis were treated with simeprevir and sofosbuvir, the presence of NS3 RAVs, namely the Q80K polymorphism, led to a decreased SVR rate in patients with HCV genotype 1a infection. SVR occurred in 25 of 34 (74%) patients with HCV genotype 1a and the Q80K RAV and in 35 of 38 (92%) patients with HCV genotype 1a without the Q80K RAV. Based on these data, retreatment for patients for whom an NS5A inhibitor-containing regimen has failed should be considered in the context of retreatment urgency and the presence or absence of RAVs to inhibitors of NS3 and NS5A. Further, based on limited data, RBV is recommended as part of all retreatment regimens for patients in whom prior treatment with NS5A inhibitors has failed. Although no data exist, consideration may also be given to the addition of PEG-IFN to the retreatment regimen in patients who are eligible for this agent; PEG-IFN will have antiviral activity regardless of the RAVs present.

[Lynn K]

How about 24 weeks of Harvoni with interferon and Ribavirin just pull out all the stops assuming you can tolerate the interferon. Many have made it through interferon treatment

[tmf2]

Just to keep folks updated I notified my Hep Doc on the latest guidelines for relapse with Harvoni. He stated my progression and reaction to the treatment was good until several weeks after EOT thus he believed no resistance was present.
Later in the day his office called and stated that they were requesting info on labs that test for resistance-associated variants and will see if my insurance would pay for this testing. The results of the test will determine what action to take and they would contact Gilead on appropriate treatment protocols. With no resistance he will retreat with 24 weeks he believes.  I'm thinking if the testing is favorable for Harvoni
my insurance would cover vs without testing.

Dennis

[gnatcatcher]

Dennis, thanks for keeping us updated. I'm glad your hepatologist is working on getting the information needed to move forward in the way that's best for you.

[tmf2]

Got the word from Cigna Pharmacy that my insurance denied another round of Harvoni. I've not relieved the official letter of denial yet stating the reasoning. I called the Dr and was told they were still waiting on approval from my insurance for the resistance testing which costs 7k, So it looks like Im in a holding pattern with a cirrhosis of the liver with a 3 million viral count.

Dennis

[gnatcatcher]

Dennis, how I wish you didn't have to endure more waiting because of insurance company foot-dragging! Are you able to put the uncertainty aside long enough to partake of life's ordinary daily pleasures?

I'm sure I'm not the only one on this forum who feels bellicose just reading about the obstacles your insurance company is putting in your path. While I hope it will not become necessary, I find myself trying to think of ways you might be able to get free or low-cost legal help if that is what it'll take to get your insurance company to behave humanely.

Gnatty

[tmf2]

Well I got the denial letter for 24 weeks retreatment of Harvoni but as of yet have heard if they will grant me the resistance test.

The letter states:

"Based on medical records submitted and medical review the proposed treatment of harvoni to treat Hepatitis C does NOT meet the plans criteria for medical necessity, as there is an indication of prior treatment of harvoni or viekira pak. Incurred claims for these services/supplies will be denied. This notification of non-covered services/supplies is a pre-service adverse benefit determination. The covered person or that person's authorized representative may have the right to appeal this adverse benefit determination. Pleas refer to the enclosed appeal procedure for additional instructions.....Claims Dept"

As I side note nothing was enclosed about appeal procedure as the letter states and I received this on 8/29 when I knew about the decision via the pharmacy on 8/24.


Dennis

[gnatcatcher]

Dennis, I just read some useful info by Rosie13 in another thread. She managed to reverse a denial by getting Gilead and an organization called the Patient Advocate Foundation to go to bat for her. Here's the direct link to her post:
http://forums.hepmag.com/index.php?topic=3046.msg27496#msg27496

[slats1056]

Dennis, Keep after it Man & don't give up!!!! Stay after them like a Bull Dog. If they keep closing the door , kick that S.O.B. in or pull the hinge pins. Good luck & keep after it. Most Docs up to date on Hep C have someone on staff or contacts to help deal with the problems . I was so lucky it only took seven days from application to having the meds. in My hand. I really feel guilty about all the other people that are getting the run around due to insurance companies & big business. As I have posted before this is about Health Care & the rich getting richer.
 Chin up and kick some ass!

[gnatcatcher]

Dennis, the editors just posted a link to an article that contains contact information for the Patient Advocate Foundation and a description of what it does to help. Here's the link to the article: http://www.hepmag.com/articles/2512_20506.shtml

[tmf2]

Well my Insurance company denied both the Resistance testing and the retreatment of Harvoni. To appeal I must write a letter to urge medical necessary. Hmmm...I don't really know where to start with this letter any clues? They have documentation of my cirrhosis. Is that not a medical necessity? Has anyone wrote one of these? I'm asking my Doctor to type up a letter to submit along with mine.


Dennis

[gnatcatcher]

Dennis, along with the cirrhosis, your AST and especially your ALT (302!) have shot up, indicating your liver is under great duress. I'd put that in. It's excellent that you're having your doctor to submit a letter, too.
   You can pursue several routes simultaneously:
1) Appeal the insurance company's denials via your letter, your doctor's letter, resubmission of all relevant lab results, and anything else their procedure requires.
2) Contact the Patient Advocate Foundation for advice and assistance (see my post earlier today for the link).
3) if you live within 100 miles of a law school, see if there's a Law & Medicine professor or a professor who teaches health law and contact that person for suggestions on how to get your insurance company to pay. Or contact the nearest office of Legal Aid. If they can't help, they may know of a lawyer who'd be willing to fight your denial pro bono ("for [the] good," meaning they won't charge you).

If steps 1-3 don't do it, there's a fourth option -- going to the media: getting a sympathetic local reporter to write a feature article on your situation, which shines a glaring public light on your insurance company's inhumanity.

Rooting for you,

Gnatty

P.S. If you aren't already reading the "Hepatitis C Research News & Studies" section of these forums, please do. The editors post all sorts of information that can be crucial to you and the rest of us.

[tmf2]

Thanks gnatcatcher I.m finished with my letter the Doc is just going to give me the info lab tests etc to submit. I did find this in one of your links about retreatment and Im sending them this also::

Recommendation for re-treatment for genotypes 1a from the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA). -  8/17/15

Sec 18. Options for retreatment of patients with HCV genotype 1 whose previous NS5A inhibitor–containing regimen failed.
:
•   For patients without an urgent need for treatment, deferral of retreatment is recommended pending the availability of additional data. (III-C)
•   For  patients  with  cirrhosis  or  an  urgent  need  for retreatment,  testing  RAVs  which  confer  decreased susceptibility   to   NS3   protease   inhibitors   (e.g.,Q80K) and to NS5A inhibitors should be performed using commercially available assays. (IIb-C)
•   For patients with no NS5A RAVs detected, retreatment with a daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir  (400  mg) with RBV for 24 weeks is recommended. (IIb-C)
•   For  patients  who  have  NS5A  RAVs  detected  but do  not  have  NS3  RAVs  detected,  treatment  with sofosbuvir   (400   mg)   and   simeprevir   (150   mg) with RBV for 24 weeks is recommended. (IIb-C)
•   For patients who have both NS3 and NS5A RAVs detected,   referral   to   a   clinical   trial   is   recommended. (IIb-C)





Reprinted from IDSA

 

[slats1056]

 Dennis , Good luck to You ! We are all rooting for You. Stay proactive with Your approach and keep You chin up. I can't give You all the good advice & tech, info., like some of the others but I can be one hell of cheerleader for moral support!!! The old pea brain don't work like it used to, But it looks like You have Your stuff together pretty good, These days i have the attention span of a GNAT ( sorry Gnatty!) Keep plugging & stay positive, POSITIVE THINKING MAKES FOR POSITIVE RESULTS!!!!!

[BDK]

Hi Dennis - I am so glad you are appealing.  I hope you're appealing for the variant test as well as for the further treatment.  Now, if you get denied again, please please then request that your case be sent out for an external medical review - sometimes called an independent medical review.  The details of this will be included in the denial letter (if you are denied again - let's hope not.)  My feelings are that the insurance companies tend to automatically dish out denials to our first request and to our appeal, but once you've had 2 denials, you can go for the external review.  This has to be done by a board certified gastroenterologist (sometimes 1, sometimes 30, and they are independent of the insurance company.  I suspect that these independent reviewers perhaps lean more in our favor.  If you do go that route, that's the time to send the reviewer (or the company they review for), a copy of all your records, appeals, latest tests etc.  Good luck!

[Joe NM]

It's true that your hepatitis C can become resistant to NS5A inhibitors (in Harvoni, this would be Ledipasvir). YOU CAN STILL BE CURED, and there's multiple options out there depending on what, if any, resistance your HCV has developed, SO GET RESISTANCE TESTING DONE! Often, even when you don't clear the virus on Harvoni, you won't end up with this resistance, and can just take the Harvoni a second time (hopefully for a longer duration, if your insurance allows it). Depending on resistance testing, your doctor might say it's best to re-treat with Viekira Pak/Ribavirin, which is a combination of different medications from Harvoni. Also, around the end of this November Merck is coming out with its genotype 1 combination therapy, Elbasvir and Grazoprevir, which has a 2nd-generation NS5A Inhibitor. Or sometimes Simeprevir (otherwise known as Olysio) and Sovaldi can be a good option. But again this all depends on resistance...SO GET RESISTANCE TESTING DONE! This isn't always the easiest thing, as not every lab has this capability and not every doctor knows about it, but any Infectious Disease or Internal Medicine specialist should be able to order this and point you to a lab to get it done.
Hope that helps!

[tmf2]

Well my appeal was denied again ! The denial letter states they are not an insurance company but a third party administrator for claim processing of services for  self funded plans (Employer and member funded. Its my wife health care plan as shes a county worker. They state "Resistance testing were paid buy the plan" and that "explanations of benefits dated 9/25 were mailed to me"...I don't know what they are talking about I never have been tested for Resistance and my Doc told me they refused to cover it. The letter goes on to say I'm not to be considered a medically necessary and that the drug cannot be experimental/Investigational as defined by the plan. It states I have the right to appeal this matter further to the Review  Committee designated by the Plan Administrator. It clearly sates no Harvoni or Viekira Pak.......... Cirrhosis @ Stage 4 I feel like I'm on a raft in the middle of the ocean stranded.


Dennis
 

[Scoutdoy]

Dennis, make a copy of the letter or better yet call them and ask them on what date was the test done that the plan paid for because you would like the results, when they can't find them...ask them for a lab they paid because you need to get the results or have it redone because they obviously lost the results that your insurance company paid for

Scout

[gnatcatcher]

Dennis, I'm sorry the "system" continues to place burdens on you. Good to know that you are married -- it helps to have a local support system of family, friends, clergy -- whatever network you have available.

Besides Scout's idea, I have one suggestion. The county being self-insured is similar to the university that covers our household: the employer chooses a company (in our case Anthem BCBS) to administer the plan (and, in our case, a different company, CVS/Caremark, to handle prescriptions, even though Anthem usually works with ExpressScripts). CAN YOUR WIFE TALK TO THE APPROPRIATE STAFF MEMBER IN THE COUNTY'S EMPLOYEE BENEFITS ADMINISTRATION OFFICE? That person should be able to clarify exactly how the process works for employees and their families who get health insurance through the county. (I've done the equivalent here, and the benefits person has given me facts and advice that have saved me much time and trouble.) Then you'll know how to prepare the best case for the Review Committee.

Gnatty

[tmf2]

First thank everyone for the needed support as I'm not getting much on my end. Gnatcatcher the wife is doing that as I type. I called Allegiance and they will look into the resistance test mess. She believes both Harvoni and testing was denied, but she will get back to me this afternoon to let me know. Cigna Specialty Pharmacy wants to fight for me getting the drug....strange but Ill take all the help I can get at this point. I have 60 days to appeal, this is a second level appeal to a review board locally. Oh and I forgot Allegiance the administrator of the plan outsourced to a third party called Propeer in Fla to see if it was medically necessary and the Doctor at Propeer wrote 4 pages stating that due to Harvoni for re-treatment was Experimental/Investigational and not necessary  they recommend Allegiance deny my claim.

Allegiance just called stated they believe the resistant testing will be covered according to our health plan. Well I'll least get that done and hope they pay for it while I'm figuring how to navigate my second level appeal.



Dennis   
 

[gnatcatcher]

Hooray -- the door is open a crack, maybe even two! (1) Resistance testing will be covered. (2) Propeer's doctor's recommendation denies only a specific course of treatment: another round of Harvoni. In other words, Propeer's doctor has left open the possibility of approving some other course of treatment. Here's where Joe NM's advice about other possible treatments comes in handy. I hope Joe NM and others will supply specific advice about proving medical necessity when requesting one of the very new treatments.

That Cigna Specialty Pharmacy wants to fight for you is terrific! A similar thing happened to me: the specialty pharmacy my hepatologist prefers to use did a lot on my behalf even though my health coverage meant it was CVS/Caremark that got paid for providing my medicine.

The pieces are starting to fall into place. Keep up the good work and persistence!

Gnatty

[tmf2]

Didn't waste any time  getting to the Doctors office at 9 this morning and had the test done. Doc says he hopes no resistance will be found as he thinks 24 weeks
Harvoni will do it. He stated I cleared mid treatment and he followed the 12 week
protocol which has changed in August for people with cirrhosis. Do you think a result of no sign of resistance will strengthen my appeal much?  I have until Nov 11 as a deadline for the appeal. The testing is $1400.00 for folks wondering.

Dennis

[gnatcatcher]

Dennis, I'm very glad to hear you got the resistance test done. Thanks for letting us know the $1.4k cost. Given that your insurance now says it will cover it, I hope you copay is reasonable.

Could you please elaborate on your doctor's statement that the protocol has changed in August for people with cirrhosis? I've just looked on Gilead's web site for Harvoni, and the latest prescribing information there still says "Treatment-naïve with or without cirrhosis: 12 weeks."

Like you, before starting Harvoni, I was treatment naive with cirrhosis (F4 according to the FibroScan) and Child score A. I'll finish Week 10 when I take the next pill less than an hour from now, so if your doctor is saying that last month the protocol changed to more than 12 weeks for people in our situation, I would have to move quickly to try to get my insurer to extend my treatment without a hiatus. If your doctor is saying something else, I'd like to understand it better.

Last night I was at a local information session on hepatitis treatment. (I would have asked the Gilead rep who was there about a possible change in the Harvoni protocol if your latest forum post had existed before the session.) I got to speak to a rep. from the specialty pharmacy that helped me even though my prescription had to go to CVS/Caremark. The rep said that it's not unusual for one specialty pharmacy to help someone get approved for treatment even though the person's benefits dictate a different specialty pharmacy -- this specialty pharmacy actually has staff for that purpose. Who woulda thunk?! So perhaps Cigna has staff for that purpose, too.

Rooting for you,

Gnatty

[gnatcatcher]

I just called Gilead and spoke to a nurse. There have been no changes to the Harvoni protocol. In August Gilead did make some changes to the Sovaldi prescribing information, and of course Sovaldi is part of Harvoni, but the nurse said those changes did not affect recommended treatment lengths for Harvoni.

Dennis, getting back to your situation, Joe NM's post indicated that if the resistance test shows no resistance, your doctor's treatment idea is feasible. Joe NM also suggested other valid treatments. I don't know if it is appropriate in the appeals process for your doctor to include a willingness to accept either the longer Harvoni regimen or a different treatment that is appropriate for you. Perhaps Joe NM or someone else with appeals expertise will weigh in on that question.

Best of luck with the appeal.

Gnatty

[Joe NM]

Yeah usually you can retreat with Harvoni, the doc's I've heard from usually say 24 weeks, that with cirrhosis it can just take longer for the medication to absorb into the liver, and everybody's different, so 12 weeks just might not have been long enough for you. If for some reason Harvoni re-treatment isn't appropriate, like I said the new Merck drugs coming out at the end of November are something a lot of people are looking forward to.

Though I'm not a doctor and this isn't medical advise, just anecdotal, my clinic isn't prescribing Viekira Pak/Ribavirin to people with advanced cirrhosis anymore...three people decompensated in the same week, and it's not FDA indicated for that kind of situation anyway...has a 'boosted protease inhibitor' which can be rough on the liver. We only prescribed it to these people because they had Express Scripts, which won't approve Harvoni for initial treatment. All three survived and are now beginning a 24-week treatment with Harvoni---they didn't develop resistance to the NS5A inhibitor in V-Pak, thank goodness (which is a wonderful drug, I don't mean to knock it! Can just be iffy with people who already have decompensated cirrhosis or are close to it)

[Joe NM]

Also, best of luck with this process, you're doing an amazing job and are really inspiring me to keep going to bat for clients at my clinic!

[Lynn K]

Hi Gnatty

I believe Dennis's doctor was talking about the AASLD HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C UNIQUE PATIENT POPULATIONS: PATIENTS WITH DECOMPENSATED CIRRHOSIS which was updated August 7th

http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-decompensated-cirrhosis

Recommended regimens for patients with genotype 1 or 4 HCV infection with decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C) who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma.

Daily daclatasvir (60 mg), sofosbuvir (400 mg), and low initial dose of RBV (600 mg, increased as tolerated) for 12 weeks is recommended for patients with HCV genotype 1 or 4 with decompensated cirrhosis.

Rating: Class II, Level A



Recommended regimen for patients with genotype 1 or 4 HCV infection with decompensated cirrhosis who are RBV intolerant or ineligible.

Daily daclatasvir (60 mg) and sofosbuvir (400 mg) for 24 weeks is recommended for patients with decompensated cirrhosis who are RBV intolerant or ineligible.

Rating: Class IIb, Level C

There are also updates to:
RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed

and skipping down to patients with cirrhosis who failed Harvoni (but there is much else new updated Sept 1st):



Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).

For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.

Rating: Class IIb, Level C

 

For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.

Rating: Class IIb, Level C

For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time.

These are the current recommendations for treatment naive from the AASLD also dated Aug 7th

http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection

INITIAL TREATMENT OF HCV INFECTION



Several options with similar efficacy in general are recommended for treatment-naive patients with HCV genotype 1a infection (listed in alphabetic order; see text).

Daily daclatasvir (60 mg*) and sofosbuvir (400 mg) for 12 weeks (no cirrhosis) or 24 weeks with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) (cirrhosis) is recommended for treatment-naive patients with HCV genotype 1a infection.

Rating: Class I, Level B (no cirrhosis); Class IIa, Level B (cirrhosis)

Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for treatment-naive patients with HCV genotype 1a infection.

Rating: Class I, Level A

Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) and weight-based RBV for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis) is recommended for treatment-naive patients with HCV genotype 1a infection.

Rating: Class I, Level A

Daily simeprevir (150 mg) and sofosbuvir (400 mg) for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis without the Q80K polymorphism) with or without weight-based RBV is recommended for treatment-naive patients with HCV genotype 1a infection.

Rating: Class I, Level A

*The dose of daclatasvir may need to increase or decrease when used concomitantly with cytochrome P450 3A/4 inducers and inhibitors, respectively. Please refer to the prescribing information and the section on HIV/HCV coinfection for patients on antiretoviral therapy.


Best to all
Lynn

[gnatcatcher]

Thanks, Lynn. Glad I can count on you to clarify things. These last few days, I've had information overload and sleep underload -- at least it's not brain fog! -Gnatty

[tmf2]

Update..... My test came back bad news ....Q80K polymorphism and N5SA resistant. So here I sit waiting with Cirrhosis for some type of new meds. The Doc said he was calling U of Washington to see what is available for trials... I said anything but Interferion. Now what at least I'm not compromised ....yet !


Dennis

[Lynn K]

Dang sorry to hear this news Dennis. Are you in WA state? I live in Auburn.

Yes unfortunately with both testing positive that was the suggestion in the AASLD to look for a clinical trial

Best of luck to you and hang in there

[Scoutdoy]

Dennis, sorry to hear about your test results. With technology the way it is, your gonna get cures, it might just take a little longer. I wish you the best of luck and am confident that you will find success



Scout

[gnatcatcher]

Dennis, you can be looking for clinical trials, too -- sometimes a patient uncovers a suitable one that the doctor misses. If you are able to travel, you wouldn't have to limit yourself to trials at the U of Washington, although participating in a trial close to home would of course be easier.

I can't imagine that any clinical trial would involve interferon (INF). Now that direct-acting antivirals (DAAs) are on the scene, that's where the progress is. According to a hepatologist who gave a talk a few weeks ago, from 2014 on, the regimens are INF-free. That hepatologist mentioned that researchers and doctors still don't understand how interferon works, and INF monotherapy had only a 16% success rate. INF with Ribavirin (RBN) had a 35% success rate, and pegylated interferon (Peg-INF) with RBN had a 44% success rate. As soon as a combination regimen could be developed that needed only one of those two old medicines, Peg-INF was "shown the door" and RBN was what was kept. Harvoni already has two drugs in it, so the idea of a single pill that combines two DAAs has become the standard to meet or beat.

While you and your doctor are looking for a suitable trial, you can be doing health-positive things. What activities make you feel most fully alive? -- please make it a high priority to do them often. Do you have any gloomy friends? -- please stay clear of them. Fine-tune your health habits (liver-friendly diet, exercise, etc.).

And now comes the suggestion that may make you want to hit me over the head, so let me give you the background. In 1981, when I felt extremely depressed about how my life was going, the inner "silent voice" of wisdom told me to make it a daily habit to write down one thing for which I was grateful. I immediately replied that I would be lying. The inner "silent voice" of wisdom told me, "Do it and it will become true." And so it has . . . .

Gnatty

[tmf2]

Lynn K..I reside in MT now plan on moving in 3 years when the wife retires to Oregon

gnatcatcher, for the past three years I jog 3 times a week 7 to 8 miles weight lift the other three days with one day off a week. I eat healthy had no  fast food in 3 years. I guess that is what upsets me the most I'm doing all I can do but feel powerless over my liver and HCV. The only "bad" thing I do is smoke an occasional cigar. Otherwise very disciplined.

I wish I knew more about what’s coming out someone said a new drug end of November. The Doc never mentioned   a possible Olysio/Solvadi combo wonder why.Maybe not effective in my situation.

Dennis

[gnatcatcher]

Dennis, kudos to you for all you do to stay as healthy as possible. The Universe does not seem to be holding up its end of the bargain. I hope the jogging and weight lifting at least give you some measure of pleasure.

RE: November -- Here are the two most likely posts in these Hep Forums:
http://forums.hepmag.com/index.php?topic=3135.msg26209#msg26209
http://forums.hepmag.com/index.php?topic=3209.msg29214#msg29214
Unfortunately, the first is for GT3, and the second is speculative.

So I've done some Googling and have found the following webcast on the web page of the International Antiviral Society-USA:
HCV Genotype 1 Infection: Initial Treatment and Retreatment
Kristen M. Marks, MD
Airdate: 2015-09-09 09:35
Expiration date: 2016-09-21
Length: 49 minutes, 50 seconds
Presented by Management of Hepatitis C Virus in the New Era: Small Molecules Bring Big Changes

I haven't yet had a chance to listen to it, but it might be useful. Here's the link:
https://www.iasusa.org/content/hcv-genotype-1-infection-initial-treatment-and-retreatment

Gnatty

[Lynn K]

Here is a link to the clinical trials web site

https://clinicaltrials.gov/

Also there are groups that can provide transportation for you to other locations for treatment free of charge. The is a group called Angel Flight West that has volunteer pilots that will fly you from Montana to Seattle for treatment as often as you need to go. It is by small plane but they also provide some tickets for regular commercial flights on some occasions.

https://afids.angelflightwest.org/flight-request?keyword=angel%20flight%20west&gclid=COr-yu2TnsgCFUSRfgod_noEpw

in case this helps at all

Lynn

[tmf2]

Just an update.  I contacted a hospital in Seattle about trials. The trial coordinator told me that  I would have to be available in Seattle every two weeks to moniter how I was responding to the trial meds. I told her that Seattle was over 500 miles away and that would be really hard for me to do finacially and otherwise. I questioned about trials closer to where I live she said she would email me of anything available....I've yet to hear anything from her. In the meantime I did schedule an appointment with the liver and transplant doctors in Dec at the same hospital to see what if anything can be done to help me and possilby plead my case for a trial that possibly can be coordinated closer to my location. At the very least be seen by a real liver specialist vs my local gastroenterologist that appears not to be very aggressive concerning my Harvoni failure.


Dennis

[gnatcatcher]

. . . I would have to be available in Seattle every two weeks to monitor how I was responding to the trial meds. I told her that Seattle was over 500 miles away and that would be really hard for me to do financially and otherwise. . . . I did schedule an appointment with the liver and transplant doctors in Dec at the same hospital to see what if anything can be done to help me and possibly plead my case for a trial that possibly can be coordinated closer to my location. At the very least be seen by a real liver specialist . . . .

Dennis, glad you're being proactive about seeing a real liver specialist. If the specialist is involved in a study for which you qualify, he or she may be able to set things up so that your local gastroenterologist handles some of the every two weeks' monitoring, or at least can be a back-up monitor in case weather prevents Angel Flight West from flying you to/from a monitoring session for free. I trust you have thoroughly checked out the Angel Flight West link (and sub-links) that Lynn K sent you. It is a terrific organization.

Gnatty

[BillT]

I'm really sorry to hear this Dennis.Keep fighting the fight and don't up.I don't know what to say but you're getting good advice from some of the others here.I'm still a newbie at all the new things that have come out but I try to read something everyday.Keep the faith.

[Cal]

Hi,
I am slo glad you posted again. I found a trial of only 30 people so it's nit a recognised one yet, but it's from EASLEY re resistance and re treating.

http://www.natap.org/2015/EASL/EASL_69.htm

Cal 

[Lynn K]

Just an update.  I contacted a hospital in Seattle about trials. The trial coordinator told me that  I would have to be available in Seattle every two weeks to moniter how I was responding to the trial meds. I told her that Seattle was over 500 miles away and that would be really hard for me to do finacially and otherwise. I questioned about trials closer to where I live she said she would email me of anything available....I've yet to hear anything from her. In the meantime I did schedule an appointment with the liver and transplant doctors in Dec at the same hospital to see what if anything can be done to help me and possilby plead my case for a trial that possibly can be coordinated closer to my location. At the very least be seen by a real liver specialist vs my local gastroenterologist that appears not to be very aggressive concerning my Harvoni failure.


Dennis

Hi Dennis

Please check out an organization called Angel Flight West here is a link:
https://afids.angelflightwest.org/flight-request

Angel Flight west is a team of volunteer pilots who provide transportation free of charge to patients. You should give them a call and see if you qualify. 888-4-AN-ANGEL (888-426-2643).

They fly into small local airports and bring patients and also family members to say for example Boeing Field in Seattle they also have Earth Angels to transport you to a hotel or to your appointment.

Flights aren't guaranteed especially in the winter months but they also have some seats available on Alaska Air also free of charge.

Might be an option you hadn't considered

Best to you
Lynn

edit
ok I guess it helps to read the whole thread lol but I still think you could consider this as an option.

The jacket I am wearing in the picture is from Angel Flight West.