Relapsing after Harvoni

[katmakiah]

Hi.

I finished 12 weeks of Harvoni In May, detected<15 at 4 weeks, undetected at 12 weeks, EOT. I was so happy! Then 12 weeks labs in August shows a viral load of 1.53 million. Symptoms are coming back.

So I called Support Path, and asked about time frame for retreating and they said to ask the doctor. I asked if there was someone at Gilead I could talk to. She said, yes, and put me through to Gilead Medical Information. Nice lady. I told her my theory about virus trapped in scar tissue getting loose as my liver got better, and she said, it made sense, but she couldn't say that was the case, for sure. Then she said, there is no time frame for getting retreated. She said someone from Gilead would contact me per my relapse, for more information.
The number to call is 800-445-3235, when the options start press 2. When the next options start, press 6.

 I am genotype 1A, previously treated, with possible cirrhosis, diagnosed F4 Feb 2011. We spoke for about 20 minutes. I told her I had relapsed and my theory was this. I cleared the virus at 4 weeks, was still clear at 12 weeks. But when my liver began to heal, some virus that was caught in or behind scar tissue got back in action. She said, that made a lot of sense, and also said there is no protocol time wise for retreatment, no waiting period necessary.

I'm looking for others who have relapsed since EOT, especially those in the trials.

[KimInTheForest]

Hi katmakiah. I am so sorry to hear that Harvoni did not cure you. Were you undetected at any stage during treatment or at End of Treatment? Or was your only viral load test at 12 weeks post-tx?

Your theory about virus being trapped in liver scar tissue is interesting and something I had not thought of. Another possibility I keep reading about is that lymphatic tissue can act as reservoirs for HCV (since the Hep C virus is lymphotropic as well as hepatotropic). And that these reservoirs can be the cause of some cases of relapse or apparent resistance to treatment.

One article is here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848137/

Another here:
http://www.ncbi.nlm.nih.gov/pubmed/11819700

And then there is the issue of some people carrying a genetic mutation making them resistant to certain treatments. I believe some HCV patients are actually getting this genetic testing done to determine whether a certain treatment is likely to be effective for them.

I am also wondering, since you are F4/cirrhosis and previously treated without success, perhaps 12 weeks of Harvoni alone was simply not enough. I believe in that scenario the recommendation is 12 weeks of Harvoni+ribavirin or 24 weeks of Harvoni alone. But others here may correct me.

Fortunately there are a lot of drugs in the pipeline now. You will have another chance at something! Do keep us posted on your situation.

Kim

[katmakiah]

Thanks Kim, yes, I was undetected when I finished treatment. So it coming back was a real blow.

4 weeks labs
https://www.youtube.com/watch?v=5jsi1vTb3iE

12 final test
https://www.youtube.com/watch?v=Hi3fUmJO-1w

[dragonslayer]

>> I believe in that scenario the recommendation is 12 weeks of Harvoni+ribavirin or 24 weeks of Harvoni alone. But others here may correct me.<<

Yes, Kim, you are right...  Gilead guidelines, Im pretty sure, say for treatment experienced with cirrhosis, 24 wks should be given.

Kat, that 12 wk post treatment youtube was brutal, especially following on the heels of the 4 wk on-treatment one which was so positive.   Its a real heartbreaker  for sure.  But as many people here who have failed prior treatment will attest, you WILL be retreated and cured..  Just hang in there...

[katmakiah]

Thanks, DragonSlayer. Since I posted I have read that the relapse "new" viral strain may be resistant to Harvoni. I guess I would need to find that out first. And I'm thinking there are new drugs in the pipeline.

The guidelines for cirrhosis are 12 weeks for treatment naive and 24 weeks for relapsed from interferon/Ribavirin.

The good news is, right after I made that 2nd video, the strangest thing happened. All the anxiety, the battle, the stress, the fear, they all melted away and I was left with a feeling of peace, calm and assurance that all is well in my world, and that this happened for a reason.

Since I was diagnosed I have tried to stay healthy with alternative treatments and while they did reverse extra-hepatic symptoms, they could not destroy the virus. So I'm back doing what I do best: Eat right, and stay healthy with exercise. But it's better now that I no longer feel scared of relapsing. Been there, done that....next!

[Lynn K]

Hi Kat
So sad to see you have relapsed I had the same experience last year when I relapsed after 12 weeks of Sovaldi/Olysio I was so hopeful and then I was crushed.

I was just checking the current AASLD recommendations for your situation they have a recent update about half way down highlighted in yellow.

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

"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."

"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."

For me I believed had I treated longer I probably would not have relapsed last year and I believe the same for you.

My doctor initially only prescribed Harvoni so I started on a 24 week treatment but after I read some stuff I asked my doctor about adding ribavirin. Not that I really was looking forward to treating with ribavirin but felt for my best shot at cure I should. My doctor agreed and said we probably should have just started with both meds so I took ribavirin for 15 of the 24 weeks and am now SVR 12.

The problem is the ledipasvir is in the same class of drugs as some of the components of Viekira Pak so that won't work for you.

Hang in there something will come soon to help

Hugs to you
Lynn

[katmakiah]

Thanks Lynn, that http://www.hcvguidelines.org/ site is the BEST!

It actually covers those who relapse from the new drugs, Harvoni and Viekira.