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Post Info TOPIC: Mavyret, trying to start treatment!!


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RE: Mavyret, trying to start treatment!!
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Thanks Angel, that is one of the best and most current treatment reads I have seen. RC



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 M-61 (3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017) On my way to SVR.    SVR-12. 3-13-18



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Here is a great link:

 

http://hepatitis.s3.amazonaws.com/2017/HCVelimination2017/CCO_HCV_Elimination_2017_Downloadable_Jacobson.ppt

you may have to create an account to view..... nice, concise slides regarding hep c and retreatment

 



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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Hi sleestak,

Glad to meet you. Don't think i read anything from you before, don't recall other posts? ... but glad you posted here all the same. Good sig line BTW, sorry about your prior bad luck with the first treatment, and sorry you had to do it again with Harvoni/riba, but so good you are cured up now. Glad to see someone else who reads trial data!

Yes, you are right about Glec/Pib (Mavyret) formerly ABT 493/450 being one our good new DAA's. It's attributes have been well documented in many trials since. Your example is quite an old one 2013/2014, but the merits and potentials of those old "Phase 2" trials justified the more recent/further "Phase 3"  trials, (Magellan) and ultimately brought the drugs coming to market recently.

This early "Phase 2" one you brought here was interesting though. It was just one of the standard required initial studies for dosage and effects and intensive RAV investigations all the pharmacuetical development companies must perform to prove their drugs, so many log drops over what period, etc., etc. This particular early "Phase 2" trial was for a very small group of subjects, had varied doses, and drugs were only consumed for a few days, and the subjects were ultimately intended to be cured on other drugs immediately following. 

But, the same good indications from these early Phase 1 and 2 results carried through to further Phase 3 trials and justified Mavyret being on the market today.

It was exciting to see the Abby Phase 1, 2, 3 trial results data, and Mavyret being brought to the market, just as it was exciting to watch Gilead's development of Epclusa and Vosevi proving themselves. With these very excellent additions to market we certainly have the best treatment choices available to us us nowadays!

There are some other links to the "historlcal" development of Mav in the site here - see  Abby's - Pan 8 week Glec/Pib  , but you will have to start at the earliest bottom post and then read up as the thread evolved and morphed toward the end. Also, there is more about Mav here (in their monograph) - www.rxabbvie.com/pdf/mavyret_pi.pdf - where much of all of the Abby trial data is synthesized, and, we have had a handful of folk right here on this site who were participants in some of the ABT493/450 trials.    

Recently we had been delving into how Mav (for relapsers) is being recommended for a prior NS5A failure, or for a prior NS3/4A failure, but NOT in a failure involving both a NS5A and NS3/4A - https://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/2017%20HEP%20Alerts/ClinicalThought/CT2.aspx

The newest DAA's that have to come to market are such a godsend. smile C. 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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ABBVIE MAVYRET ( glecaprevir/pibrentasvir )
ABT 493 ABT 530
3 day monotherapy

In addition to the improved antiviral activity, ABT-493 and ABT-530 maintain antiviral activity against common RAVs that often negatively affect the potency of other DAAs (68). In this study, the prevalences of NS3 and NS5A RAVs detected in baseline samples were similar to those observed in published studies (11, 14, 15). NS3 RAVs were detected in baseline samples from 50% of patients treated with ABT-493, with Q80K being the most common RAV. The presence of baseline NS3 RAVs did not appear to affect viral load declines during ABT-493 monotherapy. Among patients receiving ABT-530, 15% had baseline NS5A variants that, if present as variants with single amino acid changes, confer notable resistance to several NS5A inhibitors, including ombitasvir, daclatasvir, and/or ledipasvir, but not to ABT-530 (8). Viral load decline curves with ABT-530 monotherapy for patients with these baseline NS5A RAVs showed little difference from those for patients without baseline NS5A RAVs,, with the exception of patient 5. This patient harbored baseline RAVs at 3 NS5A positions and had a slightly smaller viral load reduction at the end of monotherapy, compared with the mean for the dose group; linkage of these 3 RAVs cannot be ruled out, based on the population sequencing performed. However, this patient achieved a sustained virological response at posttreatment week 12, following 12 weeks of treatment with the combination of ombitasvir-paritaprevir-ritonavir with dasabuvir and ribavirin (data not shown). Taken together, these monotherapy results underscore the potent antiviral activity of both ABT-493 and ABT-530 and suggest that the combination of these next-generation DAAs holds promise for more difficult-to-treat patients who harbor NS5A RAVs that are known to confer resistance to currently approved NS5A inhibitors, as well as for patients with cirrhosis. Based on the monotherapy data presented in this study and in vitro antiviral data for each compound, the combination of ABT-493 and ABT-530 has been advanced into phase II clinical studies with patients with genotype 1 to 6 infections, including patients with compensated cirrhosis.

http://aac.asm.org/content/60/3/1546.long

This combo being high barrier to resistance looks like a very effective salvage regimen for either NS5a or NS3/4a failures. I thought this would be a good thread to add this information to. Good luck with re treatment. 



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Age 54,  G1a,   F1,  12wks S/O 2014 - rlps ,  12wks Har/Rib 2016 - SVR 12 ,



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I am going to have to schedule an appointment with James Freeman in Austrailia over the phone or however he communicates to get more information on adding sof to the treatment... I can always get the generic form.. I need more details.  Apparently he has treated many, many people by adding sof to mavyret....I will keep working on it...

thanks for everyone's input, I am grateful!!

 

connie



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.

Tig


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I would not let sides (that can be managed) be the overall deciding factor in choosing what drugs will cure me.”

I would like to say I totally agree with that statement. The key word is “managed”. I remember back in the dark days of just a few years, the side effects caused a lot of people to fall out. Not to mention the relapse rates were higher. I know many of us treated multiple times and were still willing to retreat with the same nastiness. Why? Because treating and winning are that important. I always recommend it! 

These treatments are good and my money is on your success, Connie. Keep crossing the t’s and dotting the i’s! You’re getting closer all the time, that’s what’s important...



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Re: Possibe incidences of headache complaints (on Mav alone - just glec/pib, no sof) - http://www.rxabbvie.com/pdf/mavyret_pi.pdf

see section 6, page 6 and 7.

There are no stats available (that I can find) to indicate further the incidence of headache for if and when sof is added to glec/pib. I can only guess that the incidence of headache "might be higher" in that case (if additionally taking sof as well as Mav) or adding sof to another regime period, just based on all the other studies and monographs on the many different doubles/triples out there (all regimes with sof, OR NOT, seem to hold "some" potential for reported incidences of headache). Headache can be a common complaint with many anti-viral treatments, perhaps, generally, a higher incidence may be counted with the regimes that do contain sof.   

I would not let sides (that can be managed) be the overall deciding factor in choosing what drugs will cure me. 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Hi  Angelseven.  Im glad to see your looking into all your option. The second choice of treatment is important.   I would like to put in my 2cents worth. Its just my opinion. 

I like to think of the virus structure and make up as looking like a old wagon wheel. Or wagon wheel has 9 spokes, and without all the spokes in the wheel it will start to wobble and wont go round very well.Your first treatment took out two spokes so theoretically your wagon wheel should have fallen off. But like many of us for some reason the first attempt at knocking the wheel off the cart failes! You have been treated at two spokes with HARVONI the NS5A (Ledipasvir)and NS5B (SOF)   

So now its time to knock out a third spoke,the (3/4). This added to the NS5A and NS5B is one of the best ways to bust up all three spokes at once.  I think its about knocking off the spokes all at once, kinda like the fatel blow.  Its not really who makes the drugs, its what the drugs do to the spokes. 

You spoke of  adding SOF to your Mavyret treatment, that would take care of all the spokes so it should work.   Adding sof to mavyret is off label  And that has its own problens.  RC

 



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 M-61 (3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017) On my way to SVR.    SVR-12. 3-13-18



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Yes, my friend is a yoga/pilates/massage therapist and she had zero issues on Mavyret!!!  Now,  she is a real energy bunny!!  I was lucky to hook her up for the mavyret trial at Baylor as she had no insurance!!!  She was almost cirrhotic!! and she had low platelets!!

My harvoni headaches would sometimes start at 4 am and get milder as the day went on, they seemed to lessen some as the treatment advanced but I would have bad days.  I was given permission to take ultram which helped... I have never heard that it could have been the led component causing the headaches, always hear it was the sof... I took NO other supplements when on treatment.

I just found out that Quest labs has a patient assistance form to cover what the insurance does not cover for lab work... you might want to put his link in your files section:  https://www.questdiagnostics.com/home/about/corporate-citizenship/community-giving/assistance.html

I am going to have to call them to check on each specific test as they say some tests are not eligible, forturnately the gastro guy put the quest lab number by each test..

They are not doing any rav testing anymore, they say the meds are so effective it is not needed... And I have been told the rav testing is very expensive... my hepatologist after I did harvoni did not recommend it, I even took them specific tests from Quest and he poo pooed them.

The gastro guy I talked to says he is treating most of his patients with vosevi but it was fine for me to do mavyret due to headaches... now I will get the second opinion from the new hepatologist (still haven't heard from wayne about appointment, but I don't wanna bug him)  Maybe I should apply for Gilead patient assistance program also in case I decide on vosevi... I think I can live with the headaches and they seemed to get a little better with time but honestly by gut feeling was always to take mavyret..

Thanks for that slide information, I am going to check that out but I have to do Christmas stuff... LOL

Have a nice day,  Connie



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.

Tig


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I’m so glad you are both on top of this! The research on these issues takes on a life of its own. The use of these new combos, regardless of manufacturer, seem to be hugely effective. That’s the good news. Too bad it’s such a winding road to find the best approach. (Not telling you anything!)

Connie, have they determined or surmised what caused your headaches previously? Did you suffer from them throughout your last attempt? I guess either way, you’ll have to hope it was the Ledipasvir component in Harvoni that caused the issue. I like hearing your friend had such an easy time on Mavyret. It’s nice to know that these treatments are getting easier, as well as reliably effective.



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Too bad about St. Hope, but it was worth checking out, did you also exhaust any possible assistance from Gilead for Vosevi (just on the leaving-no- stone-unturned principal)? Nice your lab fellow is turning out to be so helpful. Ya, do ask your new doc (when you get there) about ALL your options and what HE feels is best for you. I wonder if he would do RAV testing on you to see where your RAV's lie at the moment, and, whether Il28B testing might at least reveal if you are a CC type. I was lucky (because of my trial) to come to know that I was a CC type, CC's may respond better to treatment than a TT for example. RAV's and these kinds of things may have a bearing on what to try and what to try first, but it seems so many docs are reluctant to do RAV's testing now, I have no idea what RAV testing costs! I was thinking your Harvoni was "by" trial, if so, then their trial data may contain your Il28B typing, and I do recall once you said something about a 80K? RAV, after Harvoni - so, did they do any RAV testing on you back then for the trial, and perhaps after you were finished? Maybe Dr. A can access your old trial data?, maybe not. Maybe he will feel he does not need to know this in order to pick a regime for you.

Hm, (below was just a big "blank" spot!), I cannot make the "slides" I wanted to paste below, show here! What I wanted to show you were a few specific slides, from that "downloadable slideset" (the prior link I gave you). Slide #23, 24, and 126 are about Vosevi and Mav. Mostly "comparative" data, as seen in how various drugs perform in various GT's. The slides show drug "activity" (how potent the drug is), you will see comparisons between Vosevi's 5A Vel to Mav's 5A Pib, and how potent Vosevi's 3/4A Vox is to Mav's 3/4A Glec, across various GT's. The comparison numbers do support the claim that the Vosevi triple is potent, especially for us GT1a's and 3a's. But this not to say there are not also wisdoms in considering Mav first over Vosevi (for the reasons discussed in our prior chats about drug regime choices).

If you can open the prior link ( 2017 Resource - Treatment Options ) and download the slideset, you will see the 3 specific slides I wanted to show you there. But, the entirety of the slidesets are educational.

 

Just a reference only -  to slide set #23

RE: VEL  ... Ref #6. Cheng G, et al. EASL 2013. Abstract 1191

1191 GS-5816, A SECOND GENERATION HCV NS5A INHIBITOR ...

www.journal-of-hepatology.eu/article/S0168-8278(13)61192-7/abstract

 

Just a reference only -  to slideset #24

RE: VOX ... Ref  # 4. Taylor JG, et al. EASL 2015. Abstract P0899

P0899 : Preclinical profile of the pan-genotypic HCV NS3/4A protease ...

 www.journal-of-hepatology.eu/article/S0168-8278(15)31102-8/abstract



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Wow, thank you so much for your explanation of things.  It is just too much for my brain to comprehend!!  I will ask the doctor .. Victor Ankoma-sey if he thinks Vosevi is the better option for me but I would really prefer mavyret as I had a friend that took it with no side effects but of course, one person is not much to base things on  You can look him up that doctor on line, massive experience and great doctor... The St. Hope thing is out, Wayne gossbee is helping me navigate things with dr. Ankoma-sey, I am waiting back to hear when my appointment will be.  Apparently his office staff is not the greatest but I can deal with that if I am prepared (from reviews I have read

I am going to continue to look for info on this info about adding sof to mavyret....

And yes I did focus in on the one sentence as the whole article was a lot to comprehend .... he he

Have a great day and I am so greatful that you can interpret these things for me

Connie/angelseven



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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In regard to Dr. Feld's comments, remember foremost, he gave a "case study specifically pertaining to re-treatment of a GT1a 5A (ledi) TE" (treatment experienced) pt., not a TN (treatment naive) pt. His example was a cirrhotic but a compensating GT1a who had relapsed on ledi/sof who was presenting for re-treatment. This was Feld's food for thought on the matter for the benefit of all who might read his thinking. He was expounding on the AALSD/IDSA recommendations, and the nuances in how the recs may be read and applied (in what these pts. should be treated with in the US, and why). The recs and guidelines do take into consideration the study data and suggest best practices.

You have to keep the WHOLE of his article in mind, and not just focus on a select sentence. The paragraph expresses, importantly, that careful deliberation has to be given to ensure best success, including compliance, interferences with absorbtion, and RAV's

..."Positioning Patients With Previous HCV Treatment Failure for Success 

With extremely high cure rates reported in clinical trials and replicated in real-world data, modern DAAs effectively cure the vast majority of patients infected with HCV. However, for a small minority of patients, treatment failure is a great concern. Before initiating HCV retreatment, it is important to evaluate why previous therapy failed. The key issues to consider include patient factors (eg, adherence, drug interactions that may have affected absorption) and virologic factors (eg, resistance). Careful examination of these characteristics will help to ensure that the same issues do not negatively influence retreatment. This is especially important because, for most patients, it will be difficult to treat a third time if 2 attempts are unsuccessful." ... 

Don't focus on one item in isolation ... if you read the whole of Feld's article, and ALL the other links I posted there as well (recs/guidelines), you will end up seeing why I narrow in on the importance of whether you are BOTH 5A and 3/4A experienced.

Because Feld was faced with only two regimes for his "particular" 5A relapsed GT1a case - using either, the higher SVR rate Vosevi (5A/5B/3/4A) OR the inferred "sub-optimal" SVR rate Mav (5A/3/4A), I can only assume that that is what Feld is referring to (to deliberate ALL aspects for success carefully - compliance/ interferences/RAV's) - not just prior experience - but, as per the recommendations, prior experience does play a big part here, because ... if you use Mav as the second treatment, and it fails, then you still have another option to go to (a third treatment) by going to Vosevi last.

I was trying highlight this before - let me try this way ... (pretend you had not done sof/ledi for your first treatment, but, had instead done and failed a 5A/3/4A containing regime), then Mav would not be a recommended choice for you for a second treatment (according to the recommendations) because you are already 5A/3/4A experienced. But, being that you did fail on a 5A/5B (ledi/sof) regime, then you can do Mav as a second treatment (as you are only 5A experienced from the Harvoni and not BOTH 5A and 3/4 A experienced). Then ... if you failed a second treatment with Mav, even though you would now be both 5A and 3/4A experienced (from the glec/pib), you would still have a further (third) treatment option (with Vosevi) as you are allowed to go to Vosevi after glec/pib, even though you are now BOTH 5A and 3/4A experienced from your second Mav treatment. Vosevi does not present a "no go" just because you are 5A/3/4A experienced, Mav does have a "no go" if you are both 5A/3/4 experienced.

Into the 90 percentile Mav will likely cure you as a second treatment, and still leaves you with the insurance that you have another third treatment option to go to, that being Vosevi, that boasts of an even higher SVR rate. (That's how I'm reading it anyway!)

Or, you could go for the gusto and see if a doc (who has deliberated carefully in all apsects of your potentials for success or failure) agrees, that the triple Vosevi, right off the bat, is the best (of the two recommended treatments) for you as a second treatment.

I am glad you are getting repeated feedback about the merits of sof (and triples such as Vosevi) and treatments that contain sof. Headaches can be a possibilty with any of these anti-virals and can be managed/mitigated/prevented, and avoidance of a sof-including treatment, based on this "unknown", should not dictate which combination of drugs holds the best chance of cure for you. I am not surprized to hear Dr. Freeman speaking of the added value/benefits of sof, like the sof the triple Vosevi already has in it. Many regimes have noted complaints of headaches, even Mav, without any sof in it!

To leave no stone unturned, to fully explore all your options, I would still exhaust any possibility of getting Vosevi, for free, in your home country.

Please do let us know if the St. Hope thing pans out.

Hope the visit with the newest doc is going to be a good one. Ask him if he thinks any RAV testing on you would tell him anything that would influence a regime choice decision. Did you say once you had some RAV testing done, 80K? It will be interesting to hear what the newst doc, that you will see next, says about adding sof to glec/pib, over just taking Vosevi, or over just taking glec/pib plain.

Keep up your good and thorough work. C.

Yes, I have scoured the "fixhepc" website site a few times and of recent found no firm specific recommendations from them about adding sof to Mav for relapsers (I am keeping in mind your particular parameters as a GT1a relapse for an example) - I would be interested to read that, if I could find pt's (in similar circumstances to yours), doing just that there! Send a link if you have one.

Here is a link to Australia's regular recs - http://www.hepcguidelines.org.au/ - see "Salvage" ... no Mav mentioned, but Vosevi and other regimes/triples "perhaps" being recommended and approved in future to be "allowed" to be dispensed on the "public" Aus 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Actually Dr. Freeman wrote that himself in a comment on our hep c relapsers and new treatment facebook page!!!

He said this:

On that link you have posted by the Doctor with the American association for the study of liver disease, he says only two treatments of DAA's .... what do you think of that?!?!?

here is that link:https://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/2017%20HEP%20Alerts/ClinicalThought/CT2.aspx.. Dr. Feld says this:

"This is especially important because, for most patients, it will be difficult to treat a third time if 2 attempts are unsuccessful"  ( not sure exactly what this means but doesn't sound good

I have to say you know a whole lot more than I do about all of the details with the treatments... I need to study up more.. The good news today is that Wayne Gossbee. link2labs (former liver ourtreach coordinator as the Med center in houston, also has worked with Dr. Freeman)   called me this morning and he is getting me into to see his hepatologist connection Dr. Victor Ankoma-sey who does a lot of research... He is going to see me without additional testing.. if he wants to do a few more labs that is fine with me but he said he would see me as is....  This was really great news to hear this morning!!  I will be interested to see what he thinks about adding sof to Mavyret... and I better start reading all this medication in more detail.. but I am very grateful you have given me the information you have,

 

Here is exactly what James Freeman said: " Hi Connie, the reality is that you are going to need Sof in your retreatment whether that is Sof + Zepatier, Sof + Viekira, Sof + G/P or Sof/Vel/Vox. Unfortunately, the headaches do come from the Sof component and will likely to feature for you. All forms of routine headache medication are ok and the headaches do appear vascular so increasing fluid intake helps. In patients who get migraines and have had headaches on Sof the migraine tablets help."  Then David Cowley also told me he is treating thousands this way

have you looked at his fix hep c facebook page... I feel negligent in not doing more research but I am a busy person.... I gotta get on it

I called to cancel all appointments with the gastro guy I saw Friday who said he would not write a prescription without all that additional testing... I called abbvie to tell them I am changing doctors and would get back to them

I am feeling much better about things now... I was advised today that the generic Mavyret will be available in the first quarter of 2018

thanks for your help .... Connie/angelseven



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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Hey Angel,

I was quite interested in your comments about Freeman, I have never read him talking about "adding" sof to Mav, if you have a link to that or if you tell me where you got that info from I would love to follow it up.  Like that new doc mentioned?, I have not found any old trials by Abby (Expedition/Endurance/Surveyor/Magellan) or otherwise, which explored adding sof to glec/pib, so far (but I will keep looking for you).

I have not heard any rumours that Abby is motivated to trial and compete with Gilead by making their Mav become a triple (by adding a 5B to it) like Vosevi's formula.

I am not surprized people would think of this tho, as in general, many people are being drawn to consider the values of triple's (5A, 5B, 3/4A's) as good re-treatment for relapsers who have failed various 5A regimes.

Being that Mav, 3/4A (glec) and 5A (pib), IS a "double", then by adding a 5B to it, it would "technically" become an (un-trialed) triple - no wonder people think of this, as there really is only one popular (approved) non-riba "triple-choice" out there for the 5A relapser-rescue market - that being Vosevi.

Vosevi is already the approved/trialed 3/4A (vox), 5A (vel), and 5B (sof) "triple" for relapsers. Mav is already the approved/trialed 3/4A (glec), 5A (pib) "double" for relapsers. Both Vosevi and Mav seem to have landed at an exclusive top of the US 5A relapser market.

In your situ, as you are only 5A/5B experienced from your first treatment, Mav "fits you" as a double for re-treatment. Mav would not fit you for a second treatment, if you were already both 5A and 3/4A experienced. The beauty of doing Mav (as your second treatment) is that not only is it effective for you as a 5A relapser, but Vosevi would still be available to you for a third treatment as there is no restriction with Vosevi as to being prior 5A/5B/3/4A experienced. 

Just re-iterating this for thought.

Good you are checking out that St. Hope thing, hope that pans out.

Please do let me know if you have a link to that Freeman thing. Thanks. C.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Tig, thanks so much for your positive reply!!!  I am really, really considering waiting.... I would like to add the sof with the mavyret to make sure I knock this virus out... and maybe there will be more info on that down the road.  Of course if I got a prescription for the mavyret I could add the generic sof myself but I will continue to mull this all over....

Have a great evening!!!



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.

Tig


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I think if your LFT’s, fibrosis score and most recent ultrasound are acceptable, you may benefit from waiting. From a financial viewpoint it sounds good. Discuss your interest in this with your doctors and see what they think. Then weigh the time, cost and risk. I’m on Medicare disability and on Blue Cross HMO Advantage plan. It sucks. Be cautious of the policies available. They cover costs, but their prescription programs are spotty and wrought with exceptions and tiered drugs. The higher the tier, the higher my copay. These DAA’s are in the highest tier of my plan. My copay would be 50%. A big savings, but I would have to rely on (hopefully) a payment assistance program to cover those extras. No way could I afford that myself. 

I‘m glad you are taking this seriously and doing your homework. I know you’ll get this figured out. Make the right choice this time and it’ll be the last time! Sometimes we are better informed than some of the people treating us. I’d like to think that’s improving. We’ll see.

 



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Yes, I got my viral load which is about 3 million... I would love to have all these test and for this reason I may have to wait til I am 65 to have my medicare with a great supplement and I won't pay for anything... I have one other option of a sliding scale institution called St. Hope Foundation... I may go in to see them.  They help with everything, patient assistance included... in the meantime I will wait to hear from my link2labs contact to see if his doctor contact will see me.

Yes, I should have waited to do bloodtests... of course I rushed it... LOL... as my contact that has worked with some of the best liver doctors said that would be all I needed... he implied gastro guys typically go overboard with testing....

If I have to spend to much more time on this... I will be waiting another year and one half to treat which actually may not be such a bad idea considering there is no data about adding sofo to mavyret but this is what dr. James freeman is saying is really needed for relapsers... maybe by that time more data will be available...

Peace ,  connie



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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You said 

... "I qualify for complete funding of Mavyret through the patient assistance program. I think that he was thinking he needed more testing for insurance purposes and my insurance does not cover the medicine at all so that is a mute point ... I send him a long message through the patient portal to see what he says about he whole situation.  In the meantime my link2labs contact is checking with his very close hepatologist that he worked with at the medical center to see what he thinks about all this.. I may be going to see him." ...

That's good, that you have already confirmed that Abby will pay for your drugs, for certain - has Abby already had you fill out their required forms, and shown you any steps you must complete? Good, (if it is true) that your new doc (in error) is ONLY asking you for more testing simply for  "insurance" purposes - but ... docs do and will want to satisfy themselves as well (for various good reasons) to know exactly what they are dealing with as far as your health, and, to satisfy whatever baseline testing guidelines they think they must meet. Most of what he asked you for (some items you mentioned HIV, U/S, fibroscan, fibrotest) are really quite ordinary common standard baseline testing and are not stupid tests for no reason, they help him assess you more fully/currently. The tests he asks of you may not be "just" for insurance purposes, they may be considered important safeguards for you, your doc and the drug co who will be giving you the drugs. 

I would have to disagree with you about the use of the word "MOST" in regard to people getting generics do not have to have these tests - it really does all depend on who you get for a doc, who you go through, what he wishes to have you tested for, if they are thorough and careful, if they have specific concerns for you, if they wish to complete certain assessement guidelines, they will ask for certain minimum things. Depending on who you use for a doc, you might be surprized what all you can be asked for (home OR abroad). They use their own good judgement, in addition to any minimum requirements they go by. You "might" get the "less" testing you seek, if you go doctor shopping, but maybe not much less tho - it's hard to say! Worth a try I suppose, if you say he ordered you so much testing you could never be able to pay for it all and he sticks to his guns? A fibrotest (or like), an AFP and other bloods should not have cost much, when it is coupled in with the same draw session you had, to provide your ALT/AST or liver profile panel (or whatever else you said you had done prior) to take with you to the new doc. 

It might have been more cost-saving to see the new doc first, have him give you a list of all the testing he wished done, then argue with him then and there as to what you could whittle down on testing during the appointment, and then go from there to the lab (or not), instead of bringing self-directed labs to him.

You may feel you are "all tested out" and that all you have had is sufficient testing, that you have done all that "should be" adequate for you, (according to your standards or thinking or to others standards of thinking), but the bottom line is that the minimum requirements for testing/assessing IS your treating docs call. Perhaps the new doc you just saw will be willing to leave out some testing - i would not know, but good, you wrote later to him, to ask him that.

Will be good if your new doc comes back and says yes, i agree with your thinking, and that he feels very comfortable that he knows everything he needs to know about you and requires very little further testing, that a 7 year old U/S imaging is OK and a 2 year old fibroscan will do. Then, this assessment period will be more affordable for you. 

But to me, baseline data is very important, and the more the better, as tests are merely just good guesses, best in combination with mutiple methods of assessing (the more tests you get, "layers" of testing), the closer you get to the most accurate guess at where you are at. You may be worse or better than you think, without multiple levels of testing backing up the guessing. Physical exams, including hx, labs, imaging, fibroscans are all standard tools and fare.

Regardless of when you end up proceeding with treatment, if I had long standing HCV, relapsed 2014, and subsequently remained untreated I would be wanting more than the one U/S (done 7 years ago) to know all is well with all of my internal organs (from GB, spleen/pancreas, to guts/liver/kidneys) and ensuring annual liver labs were VERY complete including AFP's, fibrotests (or some other forms of blood fibrosis testing) and an annual fibroscan, aside from other general chemistry/standard fare health panels to keep tabs on general health changes (kidney function/lipids), etc. These blood tests you just had done and the ones you had about 8 months ago (I am betting) covered "most" of the standard stuff, but if self-directed then perhaps not all what a thorough doc may have prefered to follow in you, or insufficient to use to assess you currently with.

This 2 year old fibroscan you have referred to, as being .5, do you know the what the actual kilopascal number was please? Did you get your VL back yet?

You might inquire of your new lab friend, how much RAV testing might be. 

Keep pulling angel, it sounds as though you are getting quite near! C.

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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The doctor had no preference between Mavyret or harvoni.  Since I had the horrible headaches with harvoni, he thought Mavyret would be a good option.

I didn't realize how much everything was going to cost until I spoke with my lab person who thought the additional requests for labs were really not needed.  For example, I just had a fibroscan the end of 2015 almost one year after completing harvoni and my score was really low..  and .5.  And since fibrosis-cirrhosis does not matter for the length of time of treatment, this test does not seem to be necessary... 'He had no interest in resistance testing. I provided him with an inch of paper with bloodwork, etc.

Most people take the generic meds without doing all the tests and honestly, I have about tested myself out in the last few years.

I qualify for complete funding of Mavyret through the patient assistance program. I think that he was thinking he needed more testing for insurance purposes and my insurance does not cover the medicine at all so that is a mute point

I send him a long message through the patient portal to see what he says about he whole situation.  In the meantime my link2labs contact is checking with his very close hepatologist that he worked with at the medical center to see what he thinks about all this.. I may be going to see him.

In 1 1/2 years I will have medicare with a supplement and can get all the testing I need!!

Thanks for your input



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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Nice the doc was nice.

Did you discuss the choices ... Mav versus Vosevi? What was HIS opinion?

Did you discuss with him that you feel you cannot afford a fibroscan or an abd. ultrasound or any further labs?

Did he say he WAS prepared to treat you, with one (or the other), or either, as soon as you had completed the testing he wanted?

When will you finish finding out whether you can get full or partial funding assistance from either of these drug companies (Gilead's Vosevi or Abby's Mav)? 

As a priority, you need to finish thoroughly exhausting every possible avenue to gain full/partial funding from Glilead or Abby TO KNOW which drugs you may be funded for.

Aside from the further (basic, routine, normally required), baseline data he requested from you (usually has to be within 6 months current for VL's, imaging and fibroscan/fibrosis ascertations) did you provide him a current AFP, any past RAV testing ...  or did you two discuss having AFP, RAV testing and any other missing bloods done, aside from fibrotest??

Why did you not already have a fibrotest/fibrosure test done, to take to him?? It is pretty basic necessary data. We do not know what bloods YOU chose to have done to provide to him. But I am not at all surprized that HE would want to be satisfied that HE knows exactly where you are at being that you presented with no curent fibrotest, no fibroscan for a couple years, and no U/S for about 6 years.

Did he tell you your 2015 fibroscan, and 2011 U/S was not "current"?

(To me) the tests DO matter, and, especially if that is what stands between you and treatment, and just as importantly, to follow many aspects of your longstanding chronic hep c health. 

Aside from U/S imaging, fibrosure, fibroscan and HIV what were the other "a lot" of tests he asked you for, that you and others think are too expensive and are unecessary?

If you have not discussed your lab and testing budget restrictions with this new doc that you saw today, then I would fully ascertain which (if any) of the tests he wanted you to have, that he would be willing not to do. You may just find quite a few docs, just like him, (home or abroad) ask for these tests to satisfy themselves and to meet with current assessment guidelines. Importantly ... what regime did he recommend for you, based on the limited info he had on you? Even more importantly, finish finding out what drugs you might be able to get, for free, from Gilead or Abby funding. C.

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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I loved the gastro doctor but he is asking for way to many tests that are really unnecessary. I just had a fibroscan in 2015 and he wants me to do another one and a  sonogram ... I had one of those in 2011... plus a lot of additional labs which are really not necessary according to my liver specialist contact person... it would all cost thousands of dollars with this current insurance police I have.. he wants a fibrosure... and it doesn't matter if I even have cirrhosis (in 2015 I was a .5 with fibroscan)  So I talked with the past liver outreach coordinator at the medical center and he is contacting a hepatologist he worked with to see what he can do... This other hepatologist  will not require all that additional testing according to my contact... I was also told by Dr. Freeman in Australia that he recommended adding sofosbuvir  to mavyret to increase chances of clearing... This doctor said there had been no studies on that so he could not do it.  Since the American Association for study of liver disease says you can not retreat after 2 relapses, I have got to make sure I clear the virus.  It might be beneficial to wait another year anyway in case more information becomes available..!!!

I will be waiting to schedule an appointment with Dr. Victor Ankoma-sey for second opinion and to hopefully eliminate all this extra testing.... here is an example of another test needed HIV... I had this some years ago and I have not been in a sexual relationship so how would I get hiv? no manicures or anything....

OK, enough said.. I may be waiting for generics!!!

I have left a message for the doctor to call to see if I can avoid all that additional testing... so I will see what he says.

Have a nice weekend , we woke up to 1 inch of snow here is sugar land, texas today outside of Houston!!!



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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Actually my doctors appointment is not until tomorrow but i had such headaches with harvoni that i was thinking the mavyret would be the better option... although the recommended treatment for harvoni failures is vosevi... better success rate in clinical trials.... and Dr.Feld also states that it is very difficult to treat for a third time if there is another relapse.... so now i am on the fence again and wondering if i should just wait to treat... I will see what the doctor thinks tomorrow... i believe i would still have a 91% chance to clearing the virus with mavyret... and several that failed retreatment with mavyret had cirrhosis... glad i found the article you posted.  I guess i havent dont enough research myself but it is all so complicated....

arghhhh..... connie/angelseven



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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Hey angel,

Well now! THAT sounds like very excellent news!smile

How did you like this new doc/facility you went to, all in all?

Did he order any further labs (or other additional tests) for you, something that he may be wanting done on you? (I am not sure how extensive the labs were, that you took to him).

Did he discuss both Mavyret and Vosevi with you? Did he voice an opinion on both?

Was he able to offer any further assistance/guidance to help you get the ball rolling with the funding? Does he play a part in that, or, is that end of it still all up to you?

It sounds like the appointment went really well, with a much more hopeful sounding outcome like that! What good hard work you are doing to get yourself lined up! biggrin C.

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

Tig


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That’s exciting news, Connie! Congratulations on the approval. I hope you don’t have long to wait. Once things are approved they tend to move fairly quickly. Let’s hope so. Make sure and keep us informed. smile



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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It looks like I will get the meds from the Abbvie patient assistance program... the doctor's office says they have others that are getting there meds at no cost directed from Abbvie so I am feeling much better now!!!  I hope to start the meds in a month if I am lucky!!!  I need to double check with abbvie though because they never changed my doctor's name... how they got my old doctor's name is beyond me as I never gave it to them!! I am going to make sure again tomorrow they have the correct doctor....

I will get medicare with a supplement in about 1 and 1/2 years!!!  Then things will be a lot better...

Yes, healthwell was on my list of people to contact for help.... they told me they do help folks after their pan funds have been exhausted but since my insurance covered nothing grants would not work for me...!!

Have a nice evening and thanks loads for your assistance!!!  connie



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.

Tig


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Have you contacted Healthwell? There are a number of organizations out there as you’re aware, but may have missed this one. I haven’t dealt with them personally, but the word on them has been positive. They help cover copays.

Healthwell Foundation

I have a Medicare disability policy (Blue Cross HMO) and its no better than your Bronze plan. I can’t move to a decent plan until I move to regular Medicare when I turn 65. None of these drugs are covered by them either. It’s on a tier that requires 50% copay. Most of us can’t afford anything close to that.

Just keep kicking in doors and seek the individual that knows how to work the system. It’s aggravating and I wish there was a better answer. One of these days, you’ll be pleasantly surprised by the call that tells you you’ve been approved! You shouldn’t have to wait for care, but since you’re stuck in a holding pattern, it’s fortunate you have a low fibrosis level and not fighting advanced disease. That alone is a blessing! Your day is coming...



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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I got most of my bloodwork back excluding viral load and my tests are as usual, everything normal except slightly elevated alt and ast... 2 points or so out of range.  My glucose was high but I had orange juice before I had lab work so that could explain that.... Now I am just waiting for my viral load test which takes a little longer to get back... I should have everything the doctor needs for my visit Friday... again I want to recommend link2labs on line... I paid 52.00 to get the bloodwork I needed plus the viral load test... (you get your first viral load test free and the others cost around 70.00) Just amazing prices if anyone doesn't have insurance out there or has cruddy marketplace insurance like I have (bronze plan)



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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RE: Mavyret, trying to start treatment without the proper insurance to cover the meds
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Looks like abbvie runs the same program gilead runs to give out free meds if your income is less than 100,000 a year... the first gentlemen I spoke with when I received the insurance denial letter from a company affiliated with abbvie (Proceed) gave me the wrong information therefore I spent a lot of time on trying to obtain information that was useless!! He gave me the name of three places to apply for grants. Well, grants only pay if you have some of your insurance paying but honestly no one seems to know that.  After speding hours on hold with PAN, I finally was given the correct information when I called Abbvie back.  They will file another claim for meds through Marketplace which will of course be denied.  Then the doctor has to fill out some information and send them the prescription, his information and my tax return to verify income, also my Medicaid denial (which is useless, it is quite obvious I cannot get Medicaid as I am 63 and caring for no children, the website won't even let me apply)   probably won't get a denial letter for weeks.... The good news is that eventually I will get the meds. Obviously I will not be expecting anything quickly...

Somehow people need to be advised of what to do if their insurance won't pay for the meds... I even contacted the Hep.mag and they were not helpful.... I will see how this all pans out and if it doesn't work out, well, I will take generics... At this point I am not sure about anything...

Actually for a relapse the meds are taken for 16 weeks....

LOL (in my dreams)  connie/angelseven



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.



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Mavyret, trying to start treatment!!
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I am trying to start treatment with mavyret as soon as I get the funding for the meds worked out... I will paste some info from another thread as to my journey in trying to retreat without the proper insurance benefits... LOL



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.

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