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I have been trying to get in A trial at Baylor since my harvoni relapse, i called them all the time.... so i know it takes hard work and persistence to make something happen... well with that fibrosis level I would have been really worried also!!!  It was great you got in that vosevi trial... I have another friend in canada that relapsed following harvoni but i think she is set up to do vosevi now... i think..... In 2011 my biopsy said i was between a 1 and 2... when i had a fibroscan in 2015 i was a 5??  Is it possible that my fibrosis reversed when i was clear of the virus for 3 months.. or is the fibroscan not accurate... or did that just get the biopsy pieces from a bad liver area... who knows?!?!?!

so glad you cleared the virus!!!!  I to have had the virus since about 1971....

Had i not worked hard, persisted and positioned myself well after doing a lot of sussing, I would not have been as lucky as I was to succeed in getting one of the very fews seats for my Vosevi trial. So lucky I was to get in my trial, as my "standard" Canadian options (in my Province) were extremely restrictive/limited as far as ever being able to recieve the best treatment available to me as a GT3a (via the regular medical system we have up here).

I would have been forced to do sof/riba 24 weeks as my first treatment, if I failed that. then "perhaps" that would be the only way for me to "qualify" in my Province for them to "allow" me to do sof/dac (an iffy eventuality) as a re-treatment (sof/dac, which was still not even fully approved/available for use - sof/dac at that time had long been quagmired, well-stuck in the Provincial approval limbo process for a very, very long time)!

In the event that my Plan A (my trial) did not pan out, I too did much info digging and prepping for my "back-up" Plan B (obtaining my own out-of-country meds if I had to) - it's worse for us in Canada in that there is no such thing as "mail-order" drugs from out-of-country for us (not allowed, can be confiscated at Customs), the powers that be have that avenue stymied - they do not make it easy for us! - I would have had to physically make a trip and and pick drugs up from out of country - ensuring careful steps/details/preparations/plans were followed as far as "how and who" scripted the drugs, and then, actually "starting" the course out-of-country, before returning to my country with script records in hand, some of the work and precautions I would have had to take to ensure that Customs would not be able to confiscate my drugs upon my return to Canada. Trip/costs/stress i could not easily afford. But, we have had at least one brave/determined Canadian fellow here (in similar circumstances to me, with a poor limited drug choice being offered to him) who had to do just that! He had to do the work and go out of country to get what he best needed - he was glad he did but it was not easy.

For some of the other folk who got their out of country drugs (if that was not hard enough in itself), it was the "after" that was harder, getting their own docs in their own countries to cooperate, assist, continue treating them/follow them through on the treatment.

Sofa/riba for 24 weeks was definitely below my "Plan C". Sof/Vel (Epclusa) was not yet easily available via out-of-country and of course nor was Vox (still in trial).

I was very lucky I got my sof/vel/vox (Vosevi) trial when I did. I really did not want to wait any longer, nor be forced to get drugs out of country and all that might have entailed until I was cured via that route. I was horrified with the reality that I had unknowingly been carrying the virus since the 70's (40++years) and that it had been playing havoc with me all that time. In the last 6 month period, of spinning my wheels "waiting" to see what treatment I was going to succeed in wrangling up for myself, my Fscore went from F3 to F4. I would ALWAYs encourage ANYONE who has a low Fscore to get as early a treatment as humanly possible - it's not just their cure but their "insurance" against the other/extra unwanted gifts HCV bestows upon us along the way. The eariler the cure the better I believe.

The Canadian and non-Canadian fellows and gal i know who obtained their out-of country drugs did experience some assorted (and differing) challenges. But, they made it work.

For a disease everyone says they want to see wiped off the face of the earth ASAP, they sure do not always make it easy for us to do so!

I cannot fathom how everyone in the US makes insurance work! Sorry about your knee thing, quite an ordeal, for sure. C.

We have had (at least) 2 members here that stand out in memory (there have been others) who were forced by circumstance to go and obtain their own drugs out of country, Epclusa, and as well as another 2 getting Daklinza the same way - they found parts of that journey an arduous feat (in varying degrees) when you read through every post they made on the site, but ultimately for them, worth the hard work and effort invloved in the end, and for them some of the costs and other unavoidable difficulties they encountered were justfied. Their work, to "orchestrate" and organize getting their out-of-country drugs this way, paid off, not only because they were cured, but because it got them cured sooner, with more ideal drug regimes, than the alternate regimes were that were being offered to them at home. Getting otherwise unobtainable drugs, out of country, not only solved their most pressing obstacle (insurmountable assess), but made it possible to have a choice for the best drug suited to them. They had been faced with waiting, or, being offered lesser regimes first in their own countries. 

I only mention their stories, so you will not think that getting out-of-country drugs and doing them at home will necessarily be "easier" than getting them through regular routes at home. Some of the best regimes that exist for you, are already right here, already available here, available to be prescribed for you, right in the US, if you could get access to them here.

How much work is involved, either way?, (when comparing how hard it will be for you to procure US drugs or how hard it will be to procure Indian drugs)? I think that's a very good question to suss fully.

How much work was it to phone Gilead to verify if Epclusa/Vosevi was a "possible" drug suited to you after a GT1 Harvoni failure? Probably as much work as it would be to link in/search/phone Gilead to also inquire if they happen to have any Vosevi drug subsidy plan to offer you. Or the same work involved to suss out if Abbie has a drug subsidy plan. Worth exhausting these home avenues, no? 

Some found it difficult to gain full cooperation of their docs who did not like to see pts getting their own drugs from other countries and bringing them back to be followed stateside  - yes, for sure, you would have to run that out-of-country scenario by your new doc when you see him (if some local access avenue does not pan out for you before then).

What is catastrophic insurance anyway?? What kind of things are you covered for or not covered for?? 

Shouldn't packing HCV for 40 years and failing Harvoni once kinda qualify as catastrophic. At least it does to my way of thinking. 

I so much look forward to hearing more from you on your good steadfast quest and progress. C.

(Man, I can't spell worth beans!)

So glad you had some labs 6 months ago. 

Just hate to see you packing HCV for 40 years.

Maybe generic drugs in the future from India would costs less. Maybe same drugs right here, right now, in US (via big pharma's various discount plans) would make it affordable. I wouldn't know, I've never investigated what these big pharma subsidised deals are through Abbie or Gilead.

I have heard of others here tho who have received cost-subsidized drugs direct via big pharma, and it sounded good to me. Tig has some various links to some of these company "deals' - maybe you have already seen those. 

What's the dif between getting the drug at low cost via a trial, or from pharma subsidising you, or buying it from India? Common denominator is low cost - but which method might give you opportunity for timelier/easier access.

I thank my lucky stars, every day, that I got my trial drugs (on several levels of great appreciation). 

I wish for you too, that you will find the drug best suited to you, and the easiest most affordable way to get it. :) 

I have had minimal fibrosis for all these many, many years!!  my blood work has always been good other than slightly elevated enzymes.  Vosevi is not the drug for me, harvoni gave me horrible headaches and I believe it led to my eventual knee replacement and that's a long story..  I refuse to live in fear when I have great bloodwork... I just had labs done about six months ago and the doctor wondered why I even came into the office since I take no meds...

So I will patiently wait for generic mavyret... no big deal.  My life is in divine order....  I am not going to spin my wheels and create undue stress for myself trying to change my insurance or pursue financial aid... that alone will make me feel like crap!

I thought about calling abbvie about the drugs but with the floods in Houston, I have not had time for anything
!!

I may get an appointment with one of the leading hepatologists here down the road (sussman at Baylor) and maybe I won't, not sure, I am contemplating it 

The bottom line is that I am not a "doctor" person , not a fan of big pharma either.... I will wait it out and see how my friends do that are treating with vosevi and Mavyret now or soon... I rushed into harvoni and it was a mistake... I should have done 12 weeks and the doctor's office didn't take care of that and I didn't know any better, and that may have not done it either... I had a bad experience with that treatment and the doctors office involved

Baylor tried to push invercek (sp) on me years ago and that really was a problem for people... and now off the market.  I refuse to rush into anything again

thank you for your concern!!   Connie

Hi angelseven,

Sorry to hear that the Merck 3682B trial you were hoping for did not pan out  - Ruz (NS5A)/Uprif (NS5B)/Grazo (NS3/4A) with or without riba, 16 and 24 weeks.

Tig's right, there are fewer trials out there nowadays. Some have ceased, prematurely, ones with good potential too, that were putting forward triples, which are thought may be more ideal for relapsers, some of these "contender" trials were containing their own new NS5B's in direct competiton with Gilead's NS5B (Sof), and, as well competing for the pan/triple market-share that Gilead's "Vosevi" for relapsers has already gained - Sof (NS5B)/Vel (NS5A)/Vox (NS3/4A).

There was one (it too has now been drawn to an early close) - Janssen's - Odal (NS5A)/Simi (NS3/4A)/AL-355 (NS5B).

I worry about your access to timely HCV re-treatment, and it comforts me none to hear you say you have "time", being that you have had decades- long HCV, and given your first treatment failed in 2014. 

It seems the largest impediment to you getting re-treated quickly is this restrictive "catastrophic" type insurance you have, and that you need to wait (what, 3 more years?) until your 65, when (before) you will be able to get better "medicare" insurance?? 

We all know it is better to be HCV-free sooner, than later, period.

I  expect costs are why you have been trying so well, and long and hard to procure another seat in a second trial. 

Time and costs can also ensue (waiting for "generics" to come along into being and to be "easily" available to you from other countries), unknown time and costs that you may not be able to afford either, depending on how it "might" work out.

I implore you, if you cannot change your insurance impediments, to enable you to get quicker treatment with a good triple, ideal for relapsers, like Vosevi is, that is already available on the market in the US (or possibly a double that also already exists in the US - such as Abbie's "Mavyret" - Glec (NS3/4A)/Pib (NS 5A), that you think might be a choice for you), then I hope at the very least you are having your liver frequently assesed (if you have you have no other choice but to keep waiting). If you wish to consider doubles like Mavyret, then know Zep too, like Mavyret, is also a NS5A (elba) and a NS3/4A (grazo), but they may opt to add riba to Zep, depending.

It would be good to know what your RAV's are, especially if you are looking at doubles, (RAV's, being perhaps a lesser important consideration with a triple like Vosevi), to know which drugs are best suited to you, and to know which drugs you should be hoping for. And, it would be VERY good to know exactly where you are at via regular hepatic assessments, bloods/fibroscans/abd. ultrasounds to keep tabs on your liver statuses and Fscores. Do you happen to have any current labs/fibroscans/Fscores/ultrasounds? I would hate to see you creeping into F3 or more, by giving it untreated opportunity. These things (as you know) have great bearing on how soon treatment should be happening. (In an aprox 6 months period I went from F3 to F4).

The Vosevi triple is already here (now more easily available to you, right here), in the US, and being that it is near teflon to baseline RAV's, it could be an good choice for you, if your lack of insurance was not holding you back from it.

I know you were not wanting to do riba (should it have come up as being as being a third component to add to some NS5A/NS5B double, to make a triple for you as a relapser). In the 16 week or 24 week Merck trial you were just looking at, you might have been offered the arm which contained riba as a  fourth drug. And, you also seemed reluctant to want to do Sof (NS5B) again, period, as you think that was the cause of your headaches while on Harvoni - Ledi (NS5A)/Sof (NS5B). If you read ALL the drugs that we have been talking about here, (Merck/Abbie/Gilead) you will not find one of their various regimes that does NOT say headache may be a potential side. Sof alone may not have been to blame for your headaches while you were on Harvoni. Even the sof-free regimes (which you seem to want to consider first or exclusively, to avoid sof) if you read their potential sides - headaches are listed there. You said at one point you would really just prefer "a whole new dif class of drugs" than what you failed on, trouble is, the most common "classes" being offered ARE the NS5A's, NS5B's and NS3/4A's - you already did 2 of these classes on Harvoni - the Ledi (NS5A)/Sof (NS5B). True, you have not done a NS3/4, (yet), that class may be "new" to you - but the thinking out there is that a triple (like Vosevi) containing all three of these classes of drugs IS effective for relapsers. Even the Merck trial you were just considering contained all three of these "classes", it's Uprif is a NS5B (like Sof is a NS5B), except they may have also added riba to your trial arm.

Keep your radar on, and turn all stones, don't restrict a regime in error, and don't just settle for more waiting for out-of-country generics or medicare, conditions may merit earlier treatment, and, perhaps you can make other situations occur (insurance?) that would get you good treatment sooner, than later. Ask Gilead about their own Vosevi financial assistance plans that they may be able to offer to you, if anything can be offered to you. If you are stuck on the Mavyret double, then phone Abbie too and ask them about their assistance as well. Worth a try, at least you will know if there is any chance of a financial path that way or not. Do a thorough reading, especially about RAV's for relapsers (and drug sides), to compare Vosevi to Mavyret - with a NS5A/NS5B failure (Harvoni) the 5A RAV's tend to persist the longest and every regime contains 5A's (thus some of the reasoning behind why re-treatment of relapser's with triple classes are doing well), 5B RAVs tend not to present the same persistnce thus why sof can be used again in a triple re-treatment.  C.

The trials have been scaled back considerably. There are so many quality approved treatments now, the Big Pharm R&D dollars are going to other illnesses.

Maviret/Mavyret is an excellent treatment. Indian pharmaceutical companies are responsible for saving a lot of lives. Big Pharm could do a lot more by following their lead and provide the same opportunities here. Someday, maybe...

Stay in touch and let us know what you hear.

thanks!!!!

I tried to get testing for rav's but my hepatologist office was not cooperative at all... i even printed up the tests from quest lab.... anyway, i am done with them now!!  I could apply for financial assistance but this Merck trial is suppose to happen in 6-8 weeks.... if that doesn't happen i could always wait for generic form on vosevi!!  Low fibrosis and good blood work means i don't have to rush!!

the Merck trial doesn't have a riba arm, so it must be time frame difference!!  I don't think it is the same trial she posted.... is it possible it has not been listed??

Honestly, i am probably not working hard enough at examinig this new treatment.... i know 1 guy that did it with riba after relapsing after harvoni, he had no sides.... what do you think about the Merck trial without riba?

i need to turn over more stones for sure but my life is getting ready to be very busy with stuff!!!

thanks for your continued input!!!

I just don't want to take anything with sovaldi it it,  i had horrific headaches with harvoni!!!!  I don't have to be in a rush to treat with .5 fibrosis and real great blood work other than slightly elevated liver enzymes. I hope the Merck trial happens, i would like to do a whole other class of drugs.. thanks for all your info!!  I will check out the vosevi board, keeping an open mind,  i will see how the relapsers do on it!!

i have not called Gilead but other people have and it appears that the treatment is good for all relapsers regardless of resistance.  Their wording was very confusing and they certainly could have done a better job with it. Thanks so much for getting all this info because if the Merck Trial doesn't pan out I may go this route if I can get financial aid. Although I have to say I had horrible headaches with harvoni so I am hoping for the Merck trial.  Also I understand that Vosevi will be available in about a year in generic form.

My friends Dr (my friend from the facebook relapse group) called Gilead and they confirmed the information that you related!!!

Thanks again for all your help with this matter!!!

Peace,  Connie

Thank you Tig, there are many of us that are ready the info from Gildead differently, i am just gonna give them a buzz next week... i will keep you updated.

It is nice not to have to be in a rush about retreating!!!!

peace,  connie ( angelseven)

Hi angel7,

I can understand why you could read it differently. That's a great idea!, you said you were going to phone Gilead to ask for the interpretation, please do let me know what they confirm for you. Clarity and getting to the bottom of things IS important.  C.

https://www.projectinform.org/hepc/vosevi-frequently-asked-questions/

Good link regarding vosevi!

No , it says the treatment could not contain a ns5a inhibitor which harvoni does!

"genotype 1a or 3 who were previously treated with a Sovaldi (sofosbuvir)-containing regimen that did not include an NS5A inhibitor"

Harvoni does include a NS5a inhibitor so it is not for me and it doesn't matter anyway cuz in am not doing it!!  But iot will be important for other people  so I am going to call gilead to make sure I am not losing my mind over

Tig , I also see what you are pointing out and it is very confusing....

There are two bulleted points that are a bit strangely worded. The reference you quoted does state those previously treated with Sovaldi (NS5B) and not including an NS5A would not qualify. But the first point, and I'll post the section, states those that failed any treatment that included an NS5A inhibitor, which is Ledipasvir in your case, would be a candidate. Had you treated with say, Sovaldi and Riba, you wouldn't be a candidate. They don't make this stuff easy to understand, that's clear!

-------------------------------INDICATIONS AND USAGE------------------------- VOSEVI is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, velpatasvir, an HCV NS5A inhibitor, and voxilaprevir, an HCV NS3/4A protease inhibitor, and is indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have (1, 2.2, 14):

• genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.

• genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. o Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.

Hi angel7,

That's great, that you have been in such good constant contact with the trial people, all along, and that you ARE definitely on the list! Looks good!

I have to beg to differ tho, you said ... "high deductible marketplace plan which is pretty useless so I would never get any meds paid for and there isn't anything out there for me at this time, even the new combo just released is not for me (vosevi, if you have done harvoni and you are 1a, it is not for you" ...  Sorry to hear about your insurance, that does put a huge barrier up, BUT unless your doc knows something very specific about your particular failure, RAV's/ resistances, I would argue Vosevi IS a VERY effective regime. Ask your people again about Vosevi, and why they have suggested to you (if they have) that it would not be suitable for you - the Vosevi triple was designed for people just like you, in your "needing re-tretament" situ.

Has your doc actually said - you cannot take Vosevi and I would never request it for you? If so, why? But, like you say, if Vosevi was applied for, perhaps your insurance would still be a barrier, unable to afford the deductables? BUT, if Vosevi IS for you, then how MUCH would you have to pay for it?? Maybe poke around a bit and confirm this, and ask Gilead about their "coupons". Tig has links to Gilead for this kind of info. (See "Payment Assistance" link in Tig's sig. line, when you get a phone number ask specifically about help for those wishing to get Vosevi - ya never know.) But it does look like your ship is coming in with this trial, it's just what the trials drugs will be and for how long - nice to have a choice or a plan B).

eew, ouch, orthopedic work - makes me shudder. Sorry for your very long year. C.

Tig,  thanks for the link, although she says there is no riba so who knows... situations change all the time with these clinical trials so I will just have to see what happens!!!  I don't even see Houston listed on their list of clinical trial sites...

Peace,  connie

Hi angel7,

CON-GRAT-U-LATIONS!!!! After all your searching and a long wait, and your prior disappointment - you must be thrilled to know this trial has arrived in your area.

Did they actually contact you, call you in, phone you? - TELL you? that you were actually going to be enrolled in the trial (for sure), or does that still have to be sorted, to see if you qualify?? Do you have to go through some formalities first.

You say you will "know more" in a couple weeks? You must have an appointment to see them then, in a couple weeks? Maybe pre-trial blood draws? I hope so, if you have not been seen by them yet.

I am still not sure which is your trial (when I look back).

But it does look like MK-3682B is a combination of 3 drugs - Grazoprevir (NS3/4A), Ruzasvir (NS5A), and Uprifosbuvir (NS5B). Trials were listing arms of 12 weeks of GZR/RZR/UPR with riba, or, 24 weeks of GZR/RZR/UPR without riba, but I am not sure of your trial yet.

This is a very interesting triple, extremely effective in the earlier Crest trials. No sof used as the NS5B, they are using this new Uprifosbuvir as their NS5B!

Gee, I hope you are "IN", and that you will not be offered riba (additionally), as I know you wished to avoid it.

It sounds so good, so close, very promising for you! You deserve this. I sure hope you get in on this one. All my fingers and toes are crossed for you. If not, do not be devastated, they have just come out with Vosevi as well, also a very excellent choice for the prior experienced. You have a back-up plan B. 

Please do keep us posted on every little detail as you can. We are all ears!  C.

Well, i don't have all the details yet but i know another guy that did this trial with riba... he is svr now.  Believe me there are people that relapsed after harvoni.  I will post after i get more information which will be a couple weeks.

One thing i know for sure is that there is no riba11

Thanks for your encouraging words!!

well, I have been waiting patiently for over a year for this Merck trial and it looks like it is finally going to happen at Baylor in Houston texas... yipee

thanks Suzie... i rememeber you had some stomach problems, it was probably the riba?? Anyway you are free of the virus!!!

Hugs,  connie

WTG, Mr. In-The-Know ... how you find all this stuff amazes me ... always most helpful and relevant information. 

D