G-3 relapsed after 24 weeks of sovaldi + RBV

[geno333]

I have genotype 3, and was excited about treatment with sovaldi + RBV for 24 weeks. Sadly, I relapsed right after treatment ended, with a viral count of 7 million. What are my options now? Looks like there might be a chance if I repeat treatment for 12 weeks but add PEG this time .. although that's not specifically outlined in the AASLD recommendations (they only address retreatment when PEG fails, but say nothing about when sovaldi fails), so I'm afraid the insurance company won't go for it. Any ideas or experiences? Thank you!

[FreedomMK]

I have genotype 3a and I've failed treatment twice (RBV/Interferon in 2003, and RBV/PegInterferon in 2012).

I'm currently on a clinical trial with 16 weeks of RBV/MK3882b (MK3682b is a combination of grazoprevir, MK3682, and MK8408). I'm hoping for the best, but I think my chances would be better with another arm of the trial, 24 weeks of MK3682b without RBV for 24 weeks.

So far the results of the testing the new Merck drugs (grazoprevir, elbasvir, MK8408, MK3682) have resulted in a slightly better rate of SVR without RBV added.

RBV is useless with the new drugs in my opinion - it just raises my bilirubin causing an annoying itch and lowers my hemoglobin and RBC count, causing me to lack stamina (tire easily) and eventually gain weight from lack of exercise.

I have experienced no side effects from the MK3682B, and my viral load dropped rapidly when I started treatment. The MK8404 component is like an advanced weapon of war against Hep C.

I think you should try the clinical trial of the new triple drugs like MK3682b, it has shown to be more effective against genotype 3 than most of the other treatments.  But go for 24 weeks without RBV.

[FreedomMK]

Is it possible to edit a post? I made a couple of errors in the post above I'd like to fix. 8404 should be 8408, and the second "24 weeks" should be deleted.

[SurfsideGal]

Thanks Fret, I think you are right.

[fretboard]

That's right, that's what I would do, except I dont think you'll really need the riba.  Looks like there's two tx's for geno 3 and the weakest tx is the sofosbuvir with riba, jmo.

    Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 3 infection who do not have cirrhosis.
    Rating: Class I, Level A

http://www.hcvguidelines.org/full-report/initial-treatment-box-summary-recommendations-patients-who-are-initiating-therapy-hcv
    
    

[SurfsideGal]

Sorry to hear about your relapse. You might ask the doctor about adding dazlinka to the sovaldi and ribavirin. The Ally trial shows a 91% SVR for genotype 3 treatment experienced patients. Although they did not look at previous sovaldi relapsers as far as I know. But it might be worth a try for you.

[Wizard64]

I've just received the same EXACT results, 24 weeks of sovaldi + RBV, was undetectable at 30 days and throughout treatment, only yo get tested for SRV12 and discover a viral load of 7,000,000. It's a drag and I go back to the GI on two weeks to see what's next....

[Jake571]

Hi BobA4

I'm so sorry to hear you relapsed! I am GT-3 and I had a SVR 12 with the Solvaldi plus Riba after 24 weeks of treatment. I relapsed sometime between 13th and 16th week post treatment. I'm currently on week 14 of 24 with Harvoni plus plus Ribavirin. This treatment is harder for me as far as side effects go but I'm happy to be on it!! I will keep everyone everyone posted how this treatment works. My last day of treatment is July 3d 2015

[Jazmine6]

Wow I had pretty much given up hope on Harvoni but I'm going to definitely bring it up to my doctor now.  Fingers crossed for everyone with G3 also.

[BobA4]

Recently finished Solvaidi wth Ribivirin 24 weeks. Also had isolated Cirrhosis .genotype is 3-a. I let the hep c go to long and about 25% of the liver is hardened. I relapsed with a viral load of 4.3 million. I feel ok doing my daily routine but for how long?

[Drewmich]

What did the doctor you saw say about  geno 3's who achieve SVR12.  Whats the chance of relapse after that?  Thats the boat I'm in.  Do you or anybody out there know of anybody (G3) relapsing after getting an SVR12.

Thanks,
Andy S.

[AWorriedMom]

I am so sorry to hear about your relapse. I'm sure you are aware that with these new drugs genotype 3 patients are more likely to relapse than patients with genotype 1, 2, or 4. I attended a talk by Dr. Ira Jacobson tonight. He is a hepatologist at Cornell. He said the biggest problem now is what to do with geno 3 relapsers. I do not think Viekira is the way to go. Talk to,your doc about Harvoni and Ribavirin for 24 weeks. Even though it is not approved for relapsers some people have had their insurance companies pay for it. Hang in there....so many things are happening so fast something is sure to help soon.

[Livelife777]

Geno.  Wow I'm really so sorry that you relapsed esp after 24 weeks.  As Pooh has said, it wasn't the water and it wasn't your fault.
Won't reiterate the good advice you've been given but will say that Interferon is NOT the way to go.  With all the new meds coming out the Pharma Co are engaged in a battlefield and willing to bend somewhat for a piece of the action. I do believe a good Hepatologist will be able to help you maneuver thru the landlmines and find a working solution.
I do believe also that you should move quickly.  As previously said, you don't want or need to slip into the Cirrhotic Catagory with all its complications and implications.
I rather like the Duke idea.  I traveled 3 hours to see my Hepatologist without question.  It was so worth the effort and outcome.
Wish you well
.....Kim

[Jake571]

Hi geno,

I'm sorry it took so long to get back to you! I should have pointed out to you in my last comment that I have compensated cirrhosis and that I'm working with a transplant center who recommended  Harvoni plus Ribavirin for 24 weeks for GT-3. I previously have failed  Sovaldi plus Ribavirin 24 weeks and also Interferon and Ribavirin 24 weeks.They told me that it is being used in Europe. It was not an issue getting it approved by my insurance company. Best of luck to you! I hope this treatment becomes an option for you!

[Mattsmom218]

I am so sorry for the bad news but hang in there my friend. You are only about 3 hours from Atlanta. My hepatologist is one of the top in the country. Norman Gitlin, MD with Emory University Hospital. He is with Atlanta Gastroenterology. They do lots of clinical trials as well. He is brilliant! Best of luck to you and God Bless. There is a cure for you, it is right around the corner!

[alico222]

If your fibroscan is 6.8 check that,...
It's low and you can wait for GS 5816 ... Next year maybe.
I'm only saying wait... If that is your fibroscan score!!!

Viral load goes up after treatment... Crying shame and annoying but there it is... Can't be helped.
Anyway this GS 5816 looks like the magic bullet and is good for geno 3,,,,!,,,

All best.
So sorry the 24 week failed... Makes me very nervous about it esp as you said you took it by the book and it didn't work...!

[pooh55811]

Duke University is involved in trials so you may be able to get Harvoni and Riba through a trial there. The woman who I quoted in my above post was in a trial at Duke. In addition, the Hepatologosts at university medical centers know how to navigate the insurance obstacles. I am sure they would know how to get you on Harvoni and Riba.

You had another question in one of your posts and that was about waiting to treat and how long to wait. Personally, I would not wait. I would seek out competent care now and try to get treated soon.

You really do not want to wait until you progress to Cirrhosis. Not only is it harder to cure the Hep C when one has Cirrhosis, Cirrhosis also brings its own problems and risks.  In addition, once you develop Cirrhosis you are at much higher risk for developing Hepatocellular Carcinoma and you will need every 6 month monitoring (Ultrasound/MRI) for the rest of your life. So you really do not want to develop Cirrhosis if you can avoid it.

Here is something I found:

"Genotype 3: Future Treatment Option"

"Future Treatment Options for Patients with HCV Genotype 3: Given the suboptimal response rates, high cost, long duration (greater than 12 weeks), and ribavirin-associated toxicities when using the recommended 24-week course of sofosbuvir plus ribavin, a variety of direct-acting antiviral
combinations are being studied currently in phase 2 and 3 clinical trials for genotype 3 infection. Whether patients will be able to achieve SVR12 rates greater than 90% without ribavirin as part of the regimen remains to be seen, particularly in cirrhotic genotype 3 patients. None of the regimens listed below are recommended or FDA-approved for the treatment of genotype 3 infection
.
Ledipasvir-Sofosbuvir:
In the ELECTRON-2 trial, 51 treatment-naive patients with genotype
3 HCV were randomized to receive ledipasvir-sofobuvir (n = 25) or ledipasvir-sofosbuvir plus ribavirin (n = 25). The study included patients with cirrhosis, but only 15% of the genotype 3 patients had cirrhosis. In the treatment arm that included ribavirin, 25 (100%) achieved an SVR12, compared with 16 (64%) in the arm without ribavirin. In a separate study, investigators used a 12-week course of ledipasvir-sofosbuvir plus ribavirin for 50 treatment experienced patients with genotype 3 HCV, incluing those with cirrhosis. Overall, SVR12 was
achieved in 82% of the patients, including 89% in those without cirrhosis and 73% in those with cirrhosis. Although these data suggest some efficacy with this regimen, its comparability relative to the standard of care is not established and neither the FDA nor AASLD have approved its use for genotype 3 patients.

Daclatasvir: This pangenotypic NS5A replication complex inhibitor is currently in phase 3 trials. The phase 3 ALLY-3 trial enrolled 152 patients with genotype 3 infection (101 treatment-naive and 51 treatment experienced). All patients received a 12-week course of the oral regimen of daclatasvir (60 mg once daily) plus sofosbuvir (400 mg once daily). Overall, SVR12 was achieved in 90% of the treatment-naive patients (97% in those without cirrhosis and 58% with cirrhosis) and in 86% of the treatment-experienced patients (94% in
those without cirrhosis and 69% with cirrhosis).

GS-5816:
This ldquo;next-generation” investigational NS5A inhibitor has the advantage
over ledipasvir in its pan-genotypic activity. Data from the open-label phase trial ELECTRON-2 was presented at the 2014 AASLD meeting and demonstrated high (96 to 100%) SVR12 rates with the combination of sofosbuvir plus GS-5816, with or without ribavirin for 8 weeks in treatment-naïve genotype 3 patients without cirrhosis. Another open-label trial examined the efficacy of 12 weeks of sofosbuvir plus GS-5816 (no ribavirin) in treatment-naïve patients without cirrhosis with genotypes 1-6 and included 54 patients with genotype 3 infection; the SVR12 rates for the genotype 3 patients were 93% in both treatment arms (GS-5816 at 25 mg or 100 mg). These preliminary data included small numbers (n=27 in each arm) but suggest that sofosbuvir plus GS-5816 may provide a shorter and potentially ribavirin-free option for genotype 3 infection. ASTRAL-3 is a phase 3 randomized controlled trial currently enrolling patients with genotype 3 infection to either sofosbuvir plus ribavirin (24 weeks) or the fixed-dose combination of sofosbuvir/GS-5816 (12 weeks).

Paritaprevir-Ritonavir plus ABT-530:
A phase 2 trial is examining a 12-week course of the paritapreivr-ritonavir plus the investigational NS5A inhibitor ABT-530, with or without ribavirin in treatment-naive patients with genotype 3 infection."

http://www.hepatitisc.uw.edu/pdf/treatment-infection/treatment-genotype-3/core-concept/all


PS: The amount of water you drank would have nothing to do with the relapse.

[geno333]

Jake and others, are there any technical resources to point my doctor to that support Harvoni plus ribavirin for 24 weeks off label? The only thing I found was the Electron 2 study, but that was only for 12 weeks. Also, what was your insurance company, and did you do anything special to convince them to conver it?  Thanks.

[keepingOnkeepingOn]

Have you checked into Abbvies vietra pak?

[flyinlynn]

Hi Geno

Sorry you have relapsed I am GT I with multiple failed attempte with interferon based treatments and relapsed after 12 weeks Sovaldi Olysio last year so I feel your pain.

Unfortunate currently GT 3 is now the hardest to treat group. In the Fission Clinical trial with treatment naive GT 3 treated for 12 weeks with Sovaldi and Riba only 56% made SVR 12.Similarly in th ePositron trial same meds same lenght of treatment 61% success. The Valance trial same meds but for 24 weeks the result was 95% for patients without cirrhosis.

However you have to keep in mind that clinical trial results often don't translate into real word results and as you said no point in second guessing now.

There was the Electron 2 study including GT 3 for 12 weeks with Harvoni plus ribavirin the result was 100% SVR 12 but that is currently not on label but some are using this treatment as mentoned above by  Jake571. When you feel ready you could ask you docter "OK now what?"

I am finishing 12 weeks with 12 more weeks to go on Harvoni and Riba.

Good luck hope you find your cure soon.

Lynn

[pooh55811]

PS to my above post:

I know Durham would be a drive for you but a lot of people have traveled in order to get good care. You could see the Hepatologists at Duke, have them do the initial work up and labs and tests, determine the best treatment and course of action, and see them as needed, but you could probably get your weekly and in between lab work done in Asheville so you would not have to drive to Durham as often.

I know I started out with a local GI but I switched to a Hepatologist in Minneapolis in the middle of treatment. It was worth the drive to get good care.

[pooh55811]

We had a thread here that listed good Hepatologists. One woman went to Duke for her care. Here is what she said:


Dr. Andrew Muir at Duke University Medical Center, Durham, NC, a very kind and compassionate person who really cares about people with Hep C.  He is the Clinical Director of Hepatology.  My care at Duke was top-notch. Here is the link to his page at Duke:

http://www.dukehealth.org/physicians/andrew_j_muir

[geno333]

Wow, didn't expect so many responses so quickly. Thank you! It's my first time here, and this is encouraging me to share more:

I've been carrying G-3 since I was six months old. I'm now 43! This was my first treatment, and it started 9 months ago: sovaldi+Ribo for 24 weeks. I had level three inflammation (no cirrhosis) when I started (I think the Fibroscan was 6.8). My vrial count has always been around 400,000, and liver functions generally slightly elevated. I never drank alcohol, and am generally healthy. I went by the book with this treatment. Never missed a dose. The only thing I can think of is that I generally don't drink much water, and didn't really focus on that in the treatment. I would say I drank a couple of 8 oz cups a day on average. Could that possibly have been it?

Anyway, what's done is done. My focus not is trying to decide what to do next. What's making consider pushing for PEG+sovaldi+Ribo for 12 weeks is that my viral count is now 7 million .. much higher than it ever was. It's like the strongest, best replicating viruses are the ones that survived! Does it actually work like that? My other concern is of course cirrhosis, and how that would make it even harder to treat in the future. I feel like I'm pushing my luck already having had the virus for 43 years!

So my question is, given my situation, would it be worthwhile to force myself to do PEG, and starting asking for it? Or should I just wait? And for how long?

The other important question: does anyone know of an excellent hepatologist in NC who's really close to the research, trials, ..etc.? I'm in Asheville, but could probably travel 2 or 3 hours for appointments.

Thanks so much for all your support!

[Jake571]

Hi,

I'm also a genotype 3 and  just wanted to post one suggestion. Ask your doctor about Harvoni with Ribavirin for 24 weeks. This is what I'm currently on. Previously I have failed Interferon with Ribavirin 24 weeks and Sovaldi with Ribavirin 24 weeks.  

Best of luck!!! Hope this helps!!

[patra_]

Geno:  Very sorry to hear of your relapse!  Also Gt3, and am now 9 1/2 weeks EOT, waiting for Week12 EOT Labs, so I do, indeed 'feel your pain'!

Bristol-Meyers, Squib has been working on a Dir Acting Antiviral, to be used with Sovaldi, and their tests have been focus on Gt3.  Thought that was going to be FDA approved in Dec but FDA referred it back for additional information, and I haven't heard anything recently.  I HAVE read, however, that the are working on a 3 drug combo pill (sort of the was Harvoni is) that will be sent for trials, so you might want to check with BMS to see if they are testing that and if you qualify.

Don't know how that is going, but thought I would mention it.  I have been following the BMS Med with high interest, IN CASE I relapse, and need additional tx.  Wish I knew more to tell you.

All I can say, is relax, take some 'down time' for yourself to deal with this, keep on with the hydration and liver friendly diet, and get in fighting shape to get back in the ring with that Dragon.  The Sol/Riba at the very least, gave your liver a break from the virus.  Soon there will be new meds for the knockout punch!

Praying for you.  Pat

[48weeks]

Sorry to hear this, like the others said keep yourself healthy and hopefully you can get onboard with one of the newer milder more effective treatments. I have a history of disappointment too.