User

Welcome, Guest. Please login or register.
April 19, 2024, 05:36:44 pm

Login with username, password and session length


Search

Forums Index

Stats

Members
  • Total Members: 6307
  • Latest: golfer
Stats
  • Total Posts: 55125
  • Total Topics: 4851
  • Online Today: 102
  • Online Ever: 1314
  • (June 22, 2016, 05:23:42 am)
Users Online
Users: 0
Guests: 76
Total: 76

Welcome

Welcome to the Hep Forums, a round-the-clock discussion area for people who have Fatty Liver Disease, Hepatitis B, C or a co-infection, their friends and family and others with questions about hepatitis and liver health. Check in frequently to read what others have to say, post your comments, and hopefully learn more about how you can reach your own health goals.

Privacy Warning: Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.
  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.
  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.
  • Product advertisement (including links); banners; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from the Hep Forum Moderators.
Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.
« previous next »
Pages: [1]   Go Down

Author Topic: Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option  (Read 10857 times)

0 Members and 1 Guest are viewing this topic.

Offline J. Eugene

  • Member
  • Posts: 3
Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option
« on: February 23, 2016, 07:00:28 pm »
Thought that I would share some of the things I have learned in the past months.

Since receiving the sad news that my 12 weeks of treatment with Viekira Pak and ribavirin failed to achieve SVR12 – I have researched other options.

The AASLD/IDSA guidelines for retreatment (linked below) have been covered on this forum in some detail.  A common step before proceeding with retreatment is testing for drug resistance associated variants (VAR’s).

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

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.  Each of the three tests required are priced at $686 here in California.  A bargain really at less than two days of Harvoni or Viekira treatment expense (I was expecting a number in the thousands). 

Test results were available in three weeks – and mine confirmed a 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.  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 is breathtaking.

The AASLD 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 – I haven’t progressed to cirrhosis so I might be able to get by with 12 weeks of therapy according to my Gastroenterologist.  Even then – 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 a few options.

Deferral of treatment (watchful waiting). Have many years of experience with this. 

Enrollment in Clinical Trials.  Have already tried to get onboard one (kindly referenced by folks here).  Will likely continue searching for one that accepts me.

Medical Tourism.  Have begun to look into this seriously.  Availability of sofosbuvir produced in India is well documented.  Simeprevir is not so easily obtained from my reading – but still available at a fraction of the Olysio pricing in the States.

By simply looking at my HCV history and current test results – the first option seems the obvious choice.  What doesn’t show is the debilitating fatigue that is with me every day.  It truly affects quality of life enough for me to take action now. 

When asked about the side effects experienced during the 12 weeks of Viekira and RBV – I can say that I honestly felt better during treatment then I did before and certainly after.  The medication successfully pushed my viral load to undetectable within two weeks and my liver function test results were better than I had seen in some 40 years.

Once therapy stopped – my viral load quickly returned with a vengeance.  Interesting that I had experienced similar VL rebound results with the previous failed interferon based therapies.

So – will be pursuing options.  Checking ClinicalTrials.gov periodically.   Renewed the passport – I need to get away more anyway.  Will check in again.

J.     
Logged
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, SVR12 and SVR24 Undetected

Offline sapphire101

  • Member
  • Posts: 238
  • "Stop worrying and start living"
Re: Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option
« Reply #1 on: February 24, 2016, 12:31:24 am »
Fantastic job on posting all your research J. Eugene and all your documentation will certainly help others who find themselves in need of re-treatment.

Are you certain of insurance denial for re-treatment?
The pharmacy/insurance scene is in constant change now. Rules today may be different next month.

My opinion? Don't settle for watchful waiting - go for clinical trials or the medical tourism choice just as you have outlined.

Please keep us updated on your progress and thanks again for getting all this information posted.
Logged
Sapphire101
Genotype 1a Fibrosis level 1
Viekira Pak with ribavirin 12 weeks
Pre treatment  VL  1.7 million, AST 45 ALT 65
EOT VL not detected, AST 21 ALT 21
12 week SVR not detected,24 week SVR not detected.
Cured! Class of 2015

Offline Philadelphia

  • Global Moderator
  • Member
  • Posts: 1,157
  • It only looks like I know what I'm doing
Re: Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option
« Reply #2 on: February 24, 2016, 04:49:03 am »
Agree with sapphire - go for anything you can. And see if you can get treatment through your insurance co while you are researching other options.

My thoughts are with you.
Logged
CURED SVR24  Class of 2015
Wk 12 post EOT 30.11.15: ALT 14 AST 22 GGT 22 VL UND
Week 19 07.08.15: ALT 17 AST 23 GGT 25
Week 12 18.06.15: ALT 21 AST 23 GGT 28
Week 8 25.05.15: ALT 23 AST 27 GGT 30 VL UND
Week 4 20.04.14: ALT 30 AST 36 VL 40
Treatment start 23.03.15: ALT 137 AST 185 VL 342,600
Cirrhosis Child-Pugh A, Genotype 1a - Viekira Pak + riba 24 weeks
Total failure interferon/ribavirin/boceprovir Mar 2013
https://www.hepmag.com/blogger/grace-campbell

Offline jakas

  • Member
  • Posts: 265
Re: Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option
« Reply #3 on: February 24, 2016, 08:25:12 am »
Generic sofosbuvir availability and India market pricing as of 30 January 2016
Marketing Company Brand
name
Gilead Licensee Manufacturer Printed price,
USD*
Market price,
USD*
1 Mylan Pharmaceuticals
Private
Limited
Sovaldi N/A Gilead Sciences $305 $305
2 Biocon Cimivir Yes Hetero Laboratories Limited $307 $215
3 Dr Reddy’s Laboratories Resof No Hetero Laboratories Limited $308 $215
4 Abbott India Limited Viroclear No Hetero Laboratories Limited $323 $192
5 Hetero Healthcare Limited Sofovir Yes Hetero Laboratories Limited $299 $185
6 Zydus Heptiza SoviHep Yes Natco Pharma Limited $306 $185
7 Cipla Limited Hepcvir Yes Hetero Laboratories Limited $306 $169
8 Mylan Pharmaceuticals
Private Limited
MyHep Yes Natco Pharma Limited. $306 $163
9 Emcure Pharmaceuticals
Limited
Spegra No Natco Pharma Limited $306 $154
10 Ranbaxy Laboratories Sofab Yes Hetero Laboratories Limited $306 $154
11 Natco Pharma Limited Hepcinat Yes Natco Pharma Limited. $306 $149
12 Strides Arcolab Limited Virso Yes Natco Pharma Limited. $306 $108

*Printed prices were obtained from bottle labels. Market prices are based on community procurement costs in Northeast India. Prices in
other locations and through other suppliers may differ. All prices are for one 28-pill bottle and in approximate USD (1 USD=68 India)

YES= LICENCE FROM GILEAD
THE First price is as on label but you can negotitate a cheaper price which is the second price
source:
https://testandtreathepatitisc.files.wordpress.com/2014/11/31-jan-2016-indian-generic-sofosbuvir.pdf
« Last Edit: February 24, 2016, 08:29:44 am by jakas »
Logged
M/57 yrs.
Contracted (Unknown) 10-20-30 yrs back ??
Treatment Naive
Geno 1a&1b
VL  17+ million
ALT 200+, AST 170+
Fibroscan F4 ( 26+ kpa ) on 8th Dec. 2105
Started Tx 11th Dec.2015 ( 12 wks. Gilead Harvoni)
7/1/2016 :Viral Load|<25 UND.
23/1/2016: ALT 34 , AST 35, ALP 143
8 week NO labs done
EOT:03.03.2016 ( 84 pills eaten )
ALT 26, ALP 124, BIL .54
V/L <25 UND E.O.T.
4 weeks E.O.T. V/L UND::: SVR 4
SVR 12 and  SVR 24 on 16/8/16
Fibro 24.5kpa 23/05/16
SVR 63 05/17
Fibro 17.03.2020 kpa 6.3

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option
« Reply #4 on: February 24, 2016, 06:20:20 pm »
Hi,
Generic sofisbuvisofosbuvir and ledipasvir or Daclatasvir APIs can be in your hands for under $2000 for 24 weeks straight from the company that supplies Incepta-Beijing Mesochem. Never heard of a bad experience, either quality or delivery, and I know of hundreds here in the U.S.
Get well.
Mike
Logged
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline General Hamilton

  • Member
  • Posts: 5
Re: Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option
« Reply #5 on: March 29, 2016, 10:53:53 pm »
Very interesting post! Thank you for the resistance links!
Logged

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option
« Reply #6 on: March 30, 2016, 12:54:16 pm »
Excellent and thorough info for all of us.  I'm on day 36 of Harvoni, so I don't know if I'll need this info, but I am glad you posted it for when I get to that nail-biting EOT phase.  Thanks again, FT
Logged
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Viekira Failure (GT 1a) – HCV Drug Resistance Testing – Retreatment Option
« Reply #7 on: March 30, 2016, 01:45:50 pm »
EASL is in a few weeks, and with that comes the latest data. You can see if there are any posters on RAVs and treatment with velpatasvir/sofosbuvir, which is due to be approved 6/28 - since it has a low resistance profile, it may be the best choice - since you did the footwork, you have a good case for insurance coverage

Also, you didn't mention Zepatier as an option - you can find a list of the polymorphisms on Zepatier's package insert: file:///C:/Users/lucinda/Downloads/zepatier_pi%20(10).pdf
Logged
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter
Pages: [1]   Go Up
« previous next »
 

© 2024 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.