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TOPIC: Viekira RBV Failure - Retreatment

Viekira RBV Failure - Retreatment 1 year 4 months ago #11664

  • J. Eugene
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New to the forum – have been reading and following the activity here with great interest.

Contracted HCV (genotype 1a) back in the late 60’s – diagnosed some 20 years later. Went through over 28 months of pre-pegylated interferon therapies including ribavirin – no success.

Two biopsies and recent FibroSure results show a score holding at the upper edge of F1-F2 – I am very fortunate. AST/ALT scores historically ranged in the 100/140 range or higher. With these numbers – I was able to wait for availability of the new DAA treatments.

Tried to get my insurance carrier to cover Harvoni when it was released – no dice – numerous attempts and paths tried. Was waiting for the generics overseas when my GI called and informed me that AbbVie had a coupon for their Viekira Pak – a free 12 week trial. Can’t really explain in words how it felt when I got the news.

Followed the directions to the letter – had a contract nurse from AbbVie checking my progress. Started with a low VL of 500k (guess my immune system has been waging a decent battle over the years – was in the millions). Went to undetected at two weeks – and held throughout treatment. AST/ALT dropped to 13 and 11 - the best I have seen in some forty years. It was looking good.

Had my blood drawn for the SVR12 near the holidays and shortly received the sad news that my VL had returned – to multiples of the start point. Sad news indeed. Curious to note that when my previous INF/RBV therapies failed – the suppressed VL also rebounded with a vengeance.

Using the AASLD/IDSA guidelines for retreatment – "deferral of treatment" is indicated in my case (due to minimal liver damage). If cost/price were not an issue – there would likely be a recommendation for retreatment.

What the lab tests do not show is the debilitating fatigue that has worsened over the years. The impact on my quality of like is driving me to look for alternatives.

I had the HCV Drug Resistance Testing performed by LabCorp (Monogram Biosciences). There are three separate tests covering NS3/4A, NS5A and NS5B with currently approved DAA medications. Some detail on their site here:

http://www.monogrambio.com/content/hcv-drug-resistance-testing

Since my insurance may not cover this, I checked ahead on the self-pay price. The three tests required are each priced at $690 USD here in California. A bargain really at less than two days of retail Harvoni or Viekira treatment expense (I was expecting a number in the thousands).

Test results were available in three weeks – and mine confirmed an NS5A resistance to both ledipasvir (Harvoni component) and ombitasvir (Viekira component). The drug resistant associated variant (RAV) detected for both was Q30R (a somewhat common RAV for GT 1a patients that have failed current DAA therapy from my reading).

The good news in my case is that no RAVs were detected for NS3/4A or NS5B – most importantly for the former. According to the AASLD guidelines – this allows for the possibility of my retreatment with currently approved drugs – specifically simeprevir (Olysio) and sofosbuvir (Sovaldi) with the probable addition of ribavirin.

However – the price here is breathtaking.

The recommendation “for patients with cirrhosis or other patients who require retreatment urgently” calls for a 24 week regiment with ribavirin. I did a quick check on retail prices.

Olysio (150 mg capsules) Qty. 28 $23,000

Sovaldi (400 mg tablets) Qty. 28 $28,000

Combined price of treatment (24 weeks – excluding ribavirin) $306,000

Fortunately – since I haven’t progressed to cirrhosis – I might be able to get by with 12 weeks of therapy according to my gastroenterologist. However – there is no doubt that my health insurance provider would deny such retreatment (even at the reduced prices they pay for these drugs).

This leaves me a few options:

Deferral of treatment (watchful waiting).

Enrollment in Clinical Trials.

Medical Tourism. Have just begun to look into this seriously. Availability of sofosbuvir seems well documented. Simeprevir appears to be more difficult to obtain from my reading. Have done a search here but have not yet made any inquiries.

My hope is to acquire a 24 week supply of these medications in the near future. If need be – I can travel abroad. I do have some past understanding of the U.S. FDA/DEA/Customs regulations regarding importation (was trying to acquire Roche’s Pegasys before the FDA approved it here – different issues to be sure). Need to do some more reading on this I suppose.

Would appreciate any thoughts here in developing a plan.

Thanks in advance for your help – and for all the good work you folks are doing to make these life saving medicines available to those who suffer.

John
GT 1a (~1968)
Diagnosed Non A/B ’85 – HCV ‘89
Rebetron INF/RBV 17 months 2000 – Failure
Infergen INF/RBV 11 months 2002 – Failure
Viekira Pak + RBV 12 weeks 2015 – Failure
VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k
Resistance Tests – NS5a Q30R
SMV/DCV/SOF + RBV 24 weeks 2016
VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT
SVR4 and SVR12 Undetected
Last Edit: 1 year 4 months ago by J. Eugene.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11665

  • Vororo
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Hi John, and welcome to fixHepC! You have quite a story there!

Here is a quick first answer - book an on-line appointment with Dr James Freeman on GP2U. He will give you the best possible medical advice and most probably advise you on the best way to source a generic treatment (most probably Sof+Led for Gt1a). I suspect that previous treatment failure on Vikerapak will not be an issue, but I am not a medical doctor. Dr James is now a world expert who you can trust unconditionally.

Here's the link: gp2u.com.au/

Even if you do not see his name there, do not despair. He will no doubt add some appointment slots as soon as he is available.
Diagnosed Jan 2015: GT-3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11666

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yep, best thing you can do is get that consult with Dr. Freeman. Then you can just order whatever you need thru fixhepc for a relatively modest cost and get it shipped to your door, like most everybody here has done. You don't need to travel to get it, hundreds of people in usa and other countries have had it mailed to them. If you WANT to travel though, you can do that too, its what I did, and I had no issue coming back thru customs.

I have kept hearing about v pack failures, it seems to be an inferior treatment from all the relapses I keep hearing about.
GT 2b; since 80's, no prior tx, sofosbuvir and daclatasvir compounded from API's at Kingswood Pharmacy in Sydney, started tx nov 6,2015, undetected at 4 wks, UND at 8 weeks, UND at 1 week after EOT, UND at 4 weeks after EOT and UND at 8 weeks after EOT. " I feel GOOD!! I knew that I WOULD!"
Last Edit: 1 year 4 months ago by 2b.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11668

  • Gaj
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Welcome John,

That is a long journey but it appears you have done some good research into your next options. There has been discussion of availability of generic Simeprevir fixhepc.com/forum/media-news/225-merk-s-...r.html?start=18#8395. My understanding is that it is available though somewhat expensive compared with the other generics (but nothing like the price of branded product). As with the others, I would also suggest making an initial appointment at gp2u.com.au/ with Dr Freeman to discuss your options.

If you are unable to find any available appointments with him then an email directly addressed to him via This email address is being protected from spambots. You need JavaScript enabled to view it. should assist.
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17

And I couldn't wait to get on the road again
On the road again, on the road again!
- with apologies to Willie ;)
Last Edit: 1 year 4 months ago by Gaj.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11670

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Hi, Did I see your post on HepMag? Anyhow, you have found the answer to your recent setback. Sick people who come here don't leave that way.
Simple as that.
Mike
This email address is being protected from spambots. You need JavaScript enabled to view it.
forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11682

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I don't have much faith in Viekira Pak. A friend of mine refused a free trial due to reports of death among cirrhotic patients, he's Gt1a, F4.
Good luck with new treatment. I'm sure with your RAV information now at hand a suitable course can be found. Dr Freeman is da bomb!
M 61yo HCV+ ~ 30 yrs Gt1a F2 VL 223,000 ALT 54 AST 42 Tx start Sof/Dac 17Dec15.
SVR4 at 7Apr16 ALT 22 AST 22
SVR12 at 9Jun16 ALT 23 AST 25
Melbourne, Australia
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11742

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Thanks kindly for all your replies.

After trying to arrange an appointment on GP2U without success - I forwarded an email as Gaj suggested. Will be looking for a reply with great anticipation.

As to Viekira Pak - I have read the FDA warning that was issued subsequent to my treatment. Since my hepatic status has not progressed to cirrhosis, the risk of liver injury in my case was minimal. Administered under the new guidelines - Viekira Pak appears to be relatively safe and very effective.

Given the choice - I would have chosen Harvoni - if only to avoid the additional ribavirin (which I historically tolerate well). But in the end - my treatment with Harvoni would have likely failed as well - as shown by the presence of the NS5A Q30R RAV in my subsequent resistance tests.

So I have taken the first small steps towards retreatment - starting with my first post here. Will certainly post again as things progress.

Have to believe that I will find a way to finally beat this.

All the best.

John
GT 1a (~1968)
Diagnosed Non A/B ’85 – HCV ‘89
Rebetron INF/RBV 17 months 2000 – Failure
Infergen INF/RBV 11 months 2002 – Failure
Viekira Pak + RBV 12 weeks 2015 – Failure
VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k
Resistance Tests – NS5a Q30R
SMV/DCV/SOF + RBV 24 weeks 2016
VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT
SVR4 and SVR12 Undetected
Last Edit: 1 year 4 months ago by J. Eugene.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11747

  • Vororo
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Hi John,

According to this review paper,

www.ncbi.nlm.nih.gov/pmc/articles/PMC3961994/

Gt1a people with Q30R variants should be responsive to Daclatasvir rather than Ledipasvir. So if this is all correct and I understand it properly, it looks promising for you. Generic Sof+Dac is readily available through the buyers club:

fixhepc.com/getting-treated/how-to-do-it/buyers-club.html

Compared to 3x$690 for the pre-treatment tests that you mentioned, you almost can't lose by just going ahead and trying it for real ($1400).
Diagnosed Jan 2015: GT-3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11755

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Thanks Vororo for posting that study – I certainly can use every thought on this.

I actually tried to decipher that article awhile back – it does appear that daclatasvir is well studied and effective when paired with sofosbuvir.

Current AASLD guidelines for retreatment in my case specify the simeprivir/sofosbuvir + RBV mix. And my GI here agrees with this. Note that this also shows-up on FixHepC’s HCV Decision Support Tool – referencing AASLD guidelines and the COSMOS study.

Unfortunately – daclatasvir was not included in the NS5A drug resistance testing I had performed – most likely since it is relatively new. Certainly – the labs will include it in future testing.

Will discuss this and all options with Dr. Freeman – however – I am somewhat worried about this next step. It seems that retreatment after DAA failure may have consequences – and the choice of medicines has to be made very carefully. Found this ….
__________

“One concern is that failure of a regimen that contains an NS5A inhibitor (ledipasvir in Harvoni, ombitasvir in Viekira Pak / Viekira) may result in the emergence of NS5A-resistant virus that can take up to 96 weeks to disappear.

NS5A inhibitors may have some activity against these variants, but further treatment with an NS5A inhibitor could result in higher-level resistance if hepatitis C is not rapidly suppressed. Adding an agent of a new class could increase antiviral activity.”

http://www.aidsmap.com/Treatment-intensification-with-sofosbuvir-permits-cure-after-failure-of-previous-HCV-treatment/page/3014995/
__________

The next step looks challenging.

Cheers

John
GT 1a (~1968)
Diagnosed Non A/B ’85 – HCV ‘89
Rebetron INF/RBV 17 months 2000 – Failure
Infergen INF/RBV 11 months 2002 – Failure
Viekira Pak + RBV 12 weeks 2015 – Failure
VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k
Resistance Tests – NS5a Q30R
SMV/DCV/SOF + RBV 24 weeks 2016
VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT
SVR4 and SVR12 Undetected
Last Edit: 1 year 4 months ago by J. Eugene.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11765

  • Vororo
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It can be difficult to separate the marketing from the medicine. Also, the numbers of people in those relapse studies are very small (22 or 25), so it is hard to get anything concrete back out. Mostly, Merck, BMS, and Gilead do not cooperate. So a study by Merck about relapse will most probably not include the possibility of re-treatment by a molecule from Gilead or BMS or Abbvie. If you look at the wiki pages for Daclatasvir (from BMS) and Ombatisvir (from Abbvie), the two molecules look quite similar ("me-too" drugs?).

en.wikipedia.org/wiki/Ombitasvir
en.wikipedia.org/wiki/Daclatasvir

Probably one is better than the other. But there is no way Abbvie will publicy admit it. And resistance to one does not automatically imply resistance to the other, as they will each block the NS5A binding site in a slightly different way. So if one didn't work, you're probably still good to try the other, along with sofosbuvir (a very effective polymerase inhibitor) which is a "new" one relative to your previous treatment (as per the advice of "adding an agent of a new class").

Anyway, I'll shut up now, and let you and the Doc figure out what is really the best way to go...

Cheers,
Diagnosed Jan 2015: GT-3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.
Last Edit: 1 year 4 months ago by Vororo.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11769

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Welcome John and thank you for sharing. You are in the right place and people here will help guide you to the right info/resources and plenty of support on top of that :)

Get that appointment with Dr James and you will be on your journey to better health and healing #love #flower

Good Luck :+1:
QLD Australia ☀️
G3a HCV 35 yrs Tx naive
Started Sof/Dac 13/01/16

Dec '15
AST 70
ALT 89
GGT 124
Fibroscore 8.5
F1-F2
13 Feb'16 VL UND #woohoo!
AST 24
ALT 26
GGT 50H
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11774

  • Price
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You're a previous interferon non-responder. I think it was silly to treat you for 12 weeks

P
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11775

  • Price
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You can lower your viral load before starting your next treatment by eliminating carbohydrates from your diet. Hep C is glucose dependent so taking its glucose source lowers viral load (Carbs turn into glucose).

This study proves it....


Microbiol Immunol. 2011 Nov;55(11):774-82. doi: 10.1111/j.1348-0421.2011.00382.x.
Inhibition of hepatitis C virus replication through adenosine monophosphate-activated protein kinase-dependent and -independent pathways.
Nakashima K, Takeuchi K, Chihara K, Hotta H, Sada K.
Source
Division of Microbiology, Department of Pathological Sciences, Faculty of Medical Sciences, Kobe University Graduate School of Medicine,
Abstract
Persistent infection with hepatitis C virus (HCV) is closely correlated with type 2 diabetes. In this study, replication of HCV at different glucose concentrations was investigated by using J6/JFH1-derived cell-adapted HCV in Huh-7.5 cells and the mechanism of regulation of HCV replication by AMP-activated protein kinase (AMPK) as an energy sensor of the cell analyzed. REDUCING THE GLUCOSE CONCENTRATION IN THE CELL CULTURE MEDIUM FROM 4.5 to 1.0 g/L RESULTED IN SUPPRESSION OF HCV REPLICATION, along with activation of AMPK. Whereas treatment of cells with AMPK activator 5-aminoimidazole-4-carboxamide 1-β-D-ribofuranoside (AICAR) suppressed HCV replication, compound C, a specific AMPK inhibitor, prevented AICAR's effect, suggesting that AICAR suppresses the replication of HCV by activating AMPK in Huh-7.5 cells. In contrast, compound C induced further suppression of HCV replication when the cells were cultured in low glucose concentrations or with metformin. These results suggest that low glucose concentrations and metformin have anti-HCV effects independently of AMPK activation.

P
Last Edit: 1 year 4 months ago by Price.
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11777

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Price wrote:
You can lower your viral load before starting your next treatment by eliminating carbohydrates from your diet. Hep C is sugar dependent so taking its sugar source lowers viral load (Carbs turn into sugar).

This study proves it....

Your advice is based on a profoundly ignorant understanding of the paper you quote. You have no idea of what you are saying and you are being reckless publishing such recommendations.

The paper you quote proves nothing of what you claim.
G4, F4, cirrhosis.

Thank you to Gilead, Michael Sofia, and the terrific folk at FixHepC for making this adventure possible.

YEAR..... ALT..... AST..... GGT... FERRITIN........................................
2009....... 210..... 215..... 953..... 1400........... (Bad health, stupidity)
2015....... 60....... 45....... 150..... 360............. (Improved diet and health, FixHepC treatment)
2016....... 20....... 24....... 25....... 156............. (SVR 12)
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Viekira RBV Failure - Retreatment 1 year 4 months ago #11780

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A.L.
Actually, Dr Freeman agrees that a ketogenic diet will drop viral load.

P.
Last Edit: 1 year 4 months ago by Price.
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