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Avatar universal

I was not cured on Harvoni 12 week treatment. Why?

I have HCV Genotype 1A, non-cirrohtic chronic and was not cured on Harvoni 12 week treatment.  My insurance has denied treatment for Zepatier since they say it is not medically necessary.  What next?  Appealed decision and then still denied.
11 Responses
683231 tn?1467323017
Hi

Unfortunately you likely have resistance factors called RAV's either NS5A or NS3 or both

The recommendation for those who fail Harvoni treatment who do not have cirrhosis or otherwise in urgent need for treatment from the Americian Association for the Study of Liver Diseases is:

"Recommended for Genotype 1 HCV NS5A inhibitor Treatment-experienced Patients
Recommended regimens are listed in groups by level of evidence, then alphabetically.

Deferral of treatment is recommended, pending availability of data for patients with HCV genotype 1, regardless of subtype, in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed, who do not have cirrhosis, and do not have reasons for urgent retreatment.
Rating: Class IIb, Level C"

There are new treatments coming so for those who don't need treatment immediately  you can wait for the next medicine or see if you can find a clinical trial for harvoni failures you could participate in.

I treated 3 times with interferon based treatment and was a null responder. I was waiting for the arrival of telaprevir but while I was waiting I was diagnosed with cirrhosis. When telaprevir was finally approved the doctors would not let me take it because of my cirrhosis and because of my prior treatment I would likely fail anyway.

I was waiting from 2008 until 2015 with liver cirrhosis believing I would die from liver disease before any new medicines would save me.

Time is on your side only about 20% of people over 20 years will develop cirrhosis it took me 30 years of infection before I did and not everyone even develops cirrhosis.

I know it is tough but hang in there your time will come.

Good luck
Lynn
1 Comments
Lynn, I hope you  have found a treatment!!!
Avatar universal
Thanks for your response and the time you put into it.
17919786 tn?1461404324
Hi flyinlynn,

One of my friends father have the same problem, reappear virus 3 months after completion of Harvoni. I want to know can we do testing of resistanc3 factors called RAV called NS5a or NS3 or both. Thank you so much in advance.
1 Comments
Yes, there is a deep sequencing test for RAVs. Quest in the US does it. It has about an 80% accuracy rate.
Avatar universal
Can you try Sovaldi, Olysio and ribavirin?
1 Comments
After having RAV testing that will determine the best course of action per the AASLD guidelines. I don't think of hand that Sovaldi and Olysio plus Ribavirin is on the list of recommendations for Harvoni relapse. Actually if the resistance testing showed as a possibility Harvoni for 12 weeks plus Ribavirin is one of the retreatment recommendations.
Avatar universal
Finished 8wk HARVONI last month n scared to death that I may have relapse since I never told anyone afraid maybe has it n now me again n tht the ins may not recover for a 12 wk treatment idk I'm just scared joint pain nauseous stomach hurts n liver side achy
1 Comments
Have you had any post treatment testing? I failed 12 weeks of Sovaldi and Olysio and was later approved for 24 weeks of Harvoni but don't worry about not getting covered for additional treatment just yet. Your odds of being cured are very high.
Avatar universal
Sorry ment to say Husband
683231 tn?1467323017
Keep appealing.

From what I understand once you have 3 denials you can appeal to your states insurance commissioner. I assume you don't have any liver damage so the recommendation of the AASLD is to wait for better treatments. Does your doctor have any recommendations? Is your doctor a hepatologist or at least a gastroenterologist experienced in treating patients with hep c?

Also another option could be to go to clinical trials . Gov and see if you can get into a clinical trial your doctor may be able to help you find one.

When were you tested post treatment and what was your post treatment viral load. Have you had a second test to confirm relapse? I recently heard of one person who was told they relapsed and it turned out to be a lab error.

I have also heard of people who were weakly detected at end of treatment and even 4 weeks post but when tested at 12 weeks post they were virus free and still are 24 weeks later.

Hoping you may have had one of those occurrences lab error or weakly detected post treatment and could still be cured. Best of luck to you.
1 Comments
like the last pos to this for you
6708370 tn?1471490210
What does your doc say?

Is there a local support group who you could enlist as your advocates?

Treatment is so hard. It should not also be a nightmare of bureaucratic redtape

Good luck and keep us posted on your progress
Avatar universal
This is one of my fears with trying the Harvoni, since I've done 12 TX and have not yet, made it to SVR. I did clear using the Sovaldi, Inter., Riba, but, unfortunately, on my 3 mon. post TX viral load, I had relapsed. I am wanting my doctor to check me for resistance factors, such as the RAV and the other one for Protease Inhibitors, BEFORE I agree to doing any more treatments. They cost so much money and it's hard enough to arrange payment for these things when you don't have cirrhosis, so I want to make sure I'm doing the right thing by pursing doing Harvoni., or wait another year and try for the newer pill that just got FDA approved. That drug that has Harvoni in it+another drug w/it. (can't remember the name of the newer drug without going back and looking it up. Anyhow, I am so sorry you didn't clear on the Harvoni! Susan400
1 Comments
Hi, Susan400.

Have you been tested for viral escape variants (mutations)? When you treat and relapse, it can be because the virus mutated to a type that is resistant to the specific meds you took. If you have treated with harsh broad-spectrum antivirals like INF/RBV and have not cleared the virus entirely, it is a possibility that you now have viral escape variants in your liver that are even harder to kill than the original virus. So you need to be extra-careful what further Tx you do, as some meds, even new ones, may not be effective on the viral variants you now carry (if you did relapse due in part to virus mutation), and some meds cause the creation of escape variants more than others. Even with a drug that is potentially effective against the variants, you may need to take it longer than the normal protocol says because it may not be as effective on the variants as on the original virus. These are all important factors to consider. Your MDs need to be aware of them. If they aren't, perhaps you need to consult with other MDs. The subject of treatment, relapse, and virus mutation is complicated. Not all MDs understand it, and not all drug companies and insurance companies are willing to tailor Tx regimes to specific cases, nor run the risk of potential failure with unorthodox Tx regimes. Do as much of your own research as possible. Don't forget that your interests and those of MDs, drug companies, and insurance companies are not exactly the same.
6708370 tn?1471490210
It would be so sweet to check in one day and read that you had achieved SVR, Susan.

Can't tell you what to do but I cleared with Harvoni + Riba and I have cirrhosis. Treatment was not a piece of cake but nothing like the treatments you endured

Good luck and keep us posted!
1 Comments
I agree , wish you all to be free of this. Something will come that will work, look how far the drugs have come now from 10 yrs. ago!  I was dx in 07, and a lot of people on this site said to wait for the newer drugs to come up. And I did wait because the side effects that people were having were awful.  So today is my 2cnd pill of Zepatier.  So far I just feel weird. But I also cold turkeyed off my evening wine, so I am feeling that too.
Something good will come for you, I know it will.
Avatar universal
Thanks, Mike for the comment. YES, I have spoken with the gastro/liver doctor who is following me about my desire to be tested for the resistance. I have just about insisted upon it, although he's being a P.I.A. about agreeing to it. His ideas are, 'well, it's not going to change what my recommendations are for your future treatments'. My comment is, "well, I'm not sure I will agree to any future treatments UNTIL I am tested for resistance. I don't know if you remember, but, I have been exposed to protease inhib, with the Telaprevir and I had null response w/that + Peg(was in a trial so No Riba randomization). Then, I had relapse after initially clearing, on the Sovaldi+Peg+Riba x 12 wks. That was actually 2 yrs ago that I was on that treatment. Anyhow, I've been hesitant to do anything else after 12 treatments unless or until I get resistance testing.  Susan400
3 Comments
I think your position is the right one. And I frankly don't care for the sound of what your MD is telling you. Why is he unwilling to vary the Tx according to your specific case? That doesn't sound like an elightened and helpful approach. Rigidity and orthodoxy are the hide-away of the frightened and ignorant.

Do you remember a Medhelp member named Gauf, who went through almost as many Tx's and relapses as you and finally SVRed thanks to a Tx regime cooked up by him and a helpful, pro-active MD specifically for his case?

Since many of the new meds have few if any side effects, it seems to me that it should be possible to mix and match and come up with a combination that's going to work for you. I Tx-ed with Sovaldi + Olysio, which you may recall was never approved (it was called "off-label", remember?). Well, there are a lot of off-label combinations that haven't been trialed for your specific situation. If you can find an amenable MD, maybe you can devise your own Tx like Gauf did.

It's worth some thought, don't you agree? And if you can't convince your present MD to keep an open mind, and to comply with your very reasonable demands for pre-Tx resistance testing, maybe it's time to look for a new MD.
After re-reading my comment, I may have been mistaken about S+O never being approved. I seem to recall now that it finally was. Of course, that was over a year ago and so much has changed. Or has it?
I agree Mike, I switched doctors 3 x. I finally found one that gives a hoot!!!
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