Hep C Discussion Forum

mallani · Guru

RE: NSA3 - NS4A resistance clear and getting my sword olut again. But which sword?

Matt Chris · Guru

Hey Bills

Nice to hear from you again, best advice I can give is what I mentioned to Beacon.

Make sure you remind or ask your doctor the include a "Letter of Medical Necessity" with the prior authorization application.

matt

Isiscat2011 · Guru

Excellent news, Bills. Your diligence and patience have paid off. So glad to see your doc prescribed 24 weeks of Harvoni. The good docs know that getting it right the first time with the new DAAs is essential. You will finally be able to exit the treatment merry-go-round once and for all.

Good idea to get the labs/VL check out of the way before beginning the pre-authorization process. Some of the bugs are being worked out--docs know what the insurance companies are looking for-- and the process seems to be smoother now. It should be fairly seamless for you. Best wishes.

LC · Senior Member

Hi Bills! I quit posting for about a couple of years, and I'm sorry to hear you didn't hit SVR yet. I would bet it's coming soon for you though.

I started treatment finally on a 12 week AbbVie trial called TOPAZ II, and I'm a little more than 1/2 way on it.

Bills · Guru

Hello Again Malcom

I'm picking up back here because I pretty much followed your advice below. I was advised to wait by a 2nd opinion on the same lines you bring up. Now that we've entered the fist open door to Harvoni I'm really set on making it my 1st choice. My labs were taken waiting on viral load. Doc asking for the Full 24 weeks. I'll see what happens soon. I'm sure I have all reasons ( labs ) to be get Harvoini approval. I'm on the edge about the cost. I'm just tiring to leave to God as i understand him. My stressing over it will not change what happens. I see lots of great post from the ones just getting started I'm so excited to here them. Big difference to story we used to tell. So God willing. there will be a lot of thanks giving given this week. I'll be posting gratitude or attitude. But I'm always grateful to you Malcolm Jill Matt and many many more for all the support and solid advice that got me this far. I'm getting that sword sharpened.

Getting My coupon and waiting for the phone call

See you on train

BS

mallani · Guru

Hi Bills,

I think your new doctor has summed up the situation for you. Without knowing the exact state of your liver right now, it's impossible to predict how you will be in 6-12 months. If your platelets, albumin, bilirubin and prothrombin time are reasonable, you should be OK to wait.

You've had a hard time, and this treatment should be the last. That's why you should chose it carefully. By watching the Forum, you will get an idea of how the Sovaldi/ Olysio combo works ( better than the Cosmos results). As expected, the VL rapidly becomes Undetectable, but time will tell whether 12 weeks is long enough to eliminate all hidden pockets of virus. IMHO, Sovaldi/ Victrelis would give similar results and be cheaper.

Wait until you've got a choice between the Gilead single pill, the Abbvie combo and the Merck stuff. Treatment duration, and cost, will be more clear then and you probably won't have the Insurance hassles. Be kind to your liver and think through the options carefully. Good luck buddy.

Bills · Guru

Mallani,
You are correct about time to response, but that is now old data based on ifn based therapies. Probably correct for new treatments, but as far as I know to early to tell.
Remember that the COSMOS numbers were small, physicians are being asked to make decisions based on educated guesses with inadequate data. The new drugs and responses are dramatically changing the landscape and decision making. If you look at this forum January 1 vs today, it is overwhelming how many are now doing well on a combination that wasn't available 3+ months ago. Good news, but creates new uncertainties.

(Gator man said )My doctor was clear that any tx with ifn involved was not an option based on my prior experience. We discussed Riba as part of the Sovaldi/Olysio combo. Perhaps if I had not had aplastic anemia in the past and the COSMOS data being more definitive regarding the efficacy of adding Riba, he might have added it to the tx plan. His current trial has Riba and Riba free cohorts, so I could have been in either arm. So far, I can't say that I miss having Riba. If I get to 6 month SVR, we made the right choice-time will tell.

Gator ,

I wish you and all the people here doing the sovaldi/olysio success and SVR If I didn't have such recent bad luck I be on it myself. Agreed there was little data on the decision to add ribavirin to sovaldi/olysio. and still is up in the air about ribavriin and RVR. Time will tell

And Thanks Malcom,

The major thing for me is time, Will I stay where i am till ? 2015? For me just jumping in is too much time and money to take another chance. I would do sovaldi/olysi/ribavirin in a heart beat I'm not afraid of tough treatment or long treatment I'm concerned about the success of advanced cirrhotics / wear and tear and long term side affects i think I already have

For me " a three time relapse-er with over 72 weeks of Riba/ interferon in the mix " I'm done with that. The most sensible thing for me seems to be wait for Ledipasvir to be approved. It also ( may be ) the one FDA will run with and in turn insurance approval being one manufacture 1 Pill.

I'm definitely not the sharpest pencil in the box so I depend a lot on what I hear and whatever I can make of the confusing data out there. That's why I went for a 2nd opinion this time. I have a lot of faith in my long time Dr's in NY but with all the information ( right here ) It Doesn't matter where I go now. This group is in NJ 15 mins from my house by streets, no highways. No 45 min trips tolls and parking expenses.

This experience has. Forced me to examine whats going on for myself as well. I refuse to just take ANY doctors word on anything anymore. So many people just say yes to their doctors cause they don't know what or why they are taking drugs. ( this is not just about Hep c = all health conditions and surgeries ) I for one am not trusting anyone. "In the majority of council there is wisdom" We only get one body and life.

That's why I love this forum and all the great advice and support I've gotten here, As well as all the people I consider friends and fellow warriors in this fight.

We will see.

Thanks everyone.

BillS

I found this fourm to be the place I get more information about whats happing out here ( to Us ) than at my doctors office. Back to. We are all ju

Bills · Guru

Thanks for all this info

I just need to sort through this a little before I stick my foot in my mouth Be back soon

maddie · Senior Member

I was wondering how long the time must be in between one DAA tx. and if not cleared, then the next. Obviously not wanting to have to face such a scenario, but just wondering? Right now on the sovaldi/olysio for 12 weeks. Did reach UND by week 4 bloods but not week 2 bloods.

Gator Man · Senior Member

darkstar wrote:
Bills,
"Big fat liar." Please, IMHO you shouldn't blame the doc for the rapid change in the data. The answers to many of these questions is uncertain. I struggled as did my doc to decide about whether to add ribavirin to sovaldi/olysio.

Mallani,
You are correct about time to response, but that is now old data based on ifn based therapies. Probably correct for new treatments, but as far as I know to early to tell.

Remember that the COSMOS numbers were small, physicians are being asked to make decisions based on educated guesses with inadequate data. The new drugs and responses are dramatically changing the landscape and decision making. If you look at this forum January 1 vs today, it is overwhelming how many are now doing well on a combination that wasn't available 3+ months ago. Good news, but creates new uncertainties.

I selected my physician because of his involvement in the COSMOS trial. It was unclear last fall when a interferon free therapy would be available and thought that a specialist familiar with the trial might have more gravitas in getting an off label treatment approved by my insurance. Back in November, this was a major question.

While the numbers are small, my doctor did have first hand experience with COSMOS patients which we discussed regarding treatment options. If I was still in the F2-3 fibrosis range, he indicated that I could possibly wait for the new DAA combos later this year or early 2015. He was fairly insistent on me getting a liver biopsy done to his specifications versus a FibroScan, so that my fibrosis stage was accurately diagnosed.

My doctor was clear that any tx with ifn involved was not an option based on my prior experience. We discussed Riba as part of the Sovaldi/Olysio combo. Perhaps if I had not had aplastic anemia in the past and the COSMOS data being more definitive regarding the efficacy of adding Riba, he might have added it to the tx plan. His current trial has Riba and Riba free cohorts, so I could have been in either arm. So far, I can't say that I miss having Riba. If I get to 6 month SVR, we made the right choice-time will tell.

The "uncertainties" have to be decided considering each individual patient's health status, and unfortunately their insurance/economic circumstances.

Only a few more days of meds left to take. I am looking forward to getting this behind me and getting on with life. For many of us, this may be the first time we've been able to see the end of HCV. The last few months have certainly changed everything.

-- Edited by Gator Man on Friday 21st of March 2014 02:19:16 PM

Matt Chris · Guru

Hey Bob/Darkstar

You make a very valid point about the Cosmos Studies being very limited, I was surprised to learn how small the trial actually was not to mention the cirrhotic group.

Really this first group that we are seeing come through being treated with Sovaldi & Olysio will help establish some guidelines for the future. The latest figures show that Olysio is only getting about 10% of the market with it being prescribed more with Sovaldi in our forum members that with the SOC meds.

Again the backbone is Sovaldi it's what makes it all work, the Olysio adds another wall of protection and keep the Ravs under control. The crazy drug is Ribavirin because they still don't know what it really does and how it works. It just does, sounds stupid I know but ask any Doctor and they will babel on about it and not really explain much.

matt

darkstar · Senior Member

Bills,

"Big fat liar." Please, IMHO you shouldn't blame the doc for the rapid change in the data. The answers to many of these questions is uncertain. I struggled as did my doc to decide about whether to add ribavirin to sovaldi/olysio.

Mallani,

You are correct about time to response, but that is now old data based on ifn based therapies. Probably correct for new treatments, but as far as I know to early to tell.

Remember that the COSMOS numbers were small, physicians are being asked to make decisions based on educated guesses with inadequate data. The new drugs and responses are dramatically changing the landscape and decision making. If you look at this forum January 1 vs today, it is overwhelming how many are now doing well on a combination that wasn't available 3+ months ago. Good news, but creates new uncertainties.

Matt Chris · Guru

Hey Wayne

I think your pro active course is the correct one. You have a lot invested in your treatment and not just the money part. Hopefully your Doc agrees and can convince your insurance to go along. Not only do we have to do battle with HCV but also with the Insurance system. Remember though their is people achieving SVR with UND coming later so its not uncommon.

The longer we live with HCV the more we learn and understand its many varied ways. I would like to quit learning about it and move on but everything has it's time.

matt

mallani · Guru

Hi guys,

We've hijacked Bills's thread, but I'm sure he's interested.

RVR, or the time to become Undetected, was discussed at the recent APASLD Meeting. This is the single, most important indicator for SVR. With the old SOC, 4 weeks was exceptional, and most took 8-12 weeks. With triple Rx (Incivek and Victrelis), 4 weeks was used as the definition. With Sovaldi combos, Sovaldi is so potent that 1-2 weeks is now the expected time. Obviously, some patients achieve SVR without an RVR.

Even with an RVR, treatment duration for cirrhotics is uncertain. I have previously mentioned the compromised liver blood supply in cirrhotics. The thickening of the limiting plate between blood sinusoids and hepatocytes also interferes with access to the drug. With cirrhosis, there is a wide range of severity of these changes. Unfortunately, there will be no set rule, and cost may well see cirrhotics get the standard 12 week duration. For some, this will not be enough. Find an Hepatologist to discuss these concerns. Best.

OldenSlow · Senior Member

Matt Chris wrote:
(2) With Cirrhotic patients get as long of a treatment you can get, 12 weeks is average but 18 or 24 is better. The reason has to do with the time from when you reach UND status during treatment (sometimes explained as guided therapy) should be longer than 6 weeks from the time you reach UND . Example- if from the start of 12 weeks treatment if it takes longer than 4 weeks to reach UND you should consider extending treatment. In my case/trial I did not reach UND until week 6 but had to stop at 12 weeks because I was selected for the 12 week arm, I relapsed after 4 weeks. I requested to be extended but no luck. My new Hepatologist point is the most important time or weeks is the time or weeks of treatment after a patient reach UND status. He emphasized that this is the critical time period to prevent relapse.

Matt - This has been a concern of mine. In my case, VL's are scheduled at weeks 4/8/12 only. Week 4 showed an almost 5 log reduction but not UND. Should week 8 show UND (I'll know shortly), it could only be a guesstimate as to when undetected status was achieved. I guess I could assume it happened within the six week window, since I was so close at week 4, but wouldn't really know for sure. I have already mentioned to my doctor my desire to continue tx for an extra month, at least. Unknown at present how that is going to pan out. Any thoughts?

wayne

Matt Chris · Guru

Hey Bill

How are you doing man! Interesting Doctor visits, they both are looking out for your welfare.

Its encouraging that we actually have multiple choices (YES!) It's a funny coincidence but yesterday I had my first appointment with my new Hepatologist about the same basic issues.

What to treat with and when to treat? Though I am only a one time relapser it's that I've relapsed on Abbvies triple DAA which mades it even harder for a recommendation.

For me Bill and for most Cirrhotic patients my new Hepatologist and I agree on two points and I think they IMO apply to both of us.

(1) Solvadi (Sofodbuvir) has to be one of the drugs in the therapy because its the best DAA available. Its the back bone of any treatment. Like my Doctor said "anything in combination with Solvadi will perform well"

(2) With Cirrhotic patients get as long of a treatment you can get, 12 weeks is average but 18 or 24 is better. The reason has to do with the time from when you reach UND status during treatment (sometimes explained as guided therapy) should be longer than 6 weeks from the time you reach UND . Example- if from the start of 12 weeks treatment if it takes longer than 4 weeks to reach UND you should consider extending treatment. In my case/trial I did not reach UND until week 6 but had to stop at 12 weeks because I was selected for the 12 week arm, I relapsed after 4 weeks. I requested to be extended but no luck. My new Hepatologist point is the most important time or weeks is the time or weeks of treatment after a patient reach UND status. He emphasized that this is the critical time period to prevent relapse.

Having the new DAA's reducing the viral load quickly and steeply is the best indicator of a standard (12 week) shorter treatment. Thats why its important to get a viral load reading at the end of week two and week four.

So with this knowledge in mind my choice will likely be waiting for Gilead's combo Solvadi and Ledipasvir because it will cost a lot less for 18 or 24 weeks than Solvadi & Oylisio for the same duration and have a better chance to be approved by insurance. When I decide treatment again I want to have all my bases covered because IMO most cirrhotic people require longer treatment and do not want to wish I had gone longer.

matt

-- Edited by Matt Chris on Thursday 20th of March 2014 05:53:52 AM

OldenSlow · Senior Member

Hey Bills - I found myself on the horns of the same dilemma at the beginning of the year. Doctor was good about keeping me in the loop as to what was available and what was coming down the pike. It was my call and I chose to treat. Currently 2 months into the S/O/R combo and doing fine, though not a big fan of the Riba. Had I been a stage or two better off, cirrhosis-wise, I'd have waited. But it was time for me. No regrets. Best of luck!

wayne

mallani · Guru

Hi Bills,

Good to hear from you, buddy. With your history, you have a right to be cautious. How's the liver holding up? Probably OK, or you wouldn't be advised to wait.

If it was me, I'd wait for Ledipasvir to be approved. We need some final data, but probably Riba won't be needed with the Sovaldi/Ledipasvir pill. The recent APASLD Meeting suggested that 12 weeks will be all that is required for cirrhotics. I'd want to see figures.

I understand your desire to get it right this time. It's good that no antiprotease RAV's were detected, but I'd avoid the antiproteases and go straight to the big guns ( anti NS-5A and B).

Can you ask your doc to check for the S282T RAV? Cheers mate.

Bills · Guru

Hi All you great people here,

Sorry I have avoided coming on this because I was just looking and looking for a Trial to do / Whats new approved? I was getting to obsessed with when can I start TX again.

I'd love to hear some feedback on this.

To get this good news out of the way I got my doc to test for the resistance to Protease Inhibitors None , None , None with that was a suggestion to try the Sovaldi / Olysio/ Riba triple. After 3 failed attempts I've become sketchy about jumping right in. Got a 2nd opinion with another teaching hospitals hep treatment group Today.

Without telling the new doc the suggestion by my original doc. Gave him the whole 6 yr story about when I started. He suggested waiting 6 months, for the one pill no riba. Sovaldi / Ledasisvir/ Spell chec. Comment hard to treat people like you. did well the results of phase 3 are in the FDA hands. He says about 6 months it's out. Or coming up and out is the ABBIVE Combo. I can only say I trust his credentials and verbal involvement with the trials as a consultant. Unless he a big fat liar. another comment asked his assistant how many people do we have currently doing any combo with Riba thinking then said none. He said last 6 moths I stopped using it completely.

Disclaimer :::: I am in no way knocking any treatments anyone is on or thinking about. We are all different types and stages and there are many good things happening out there.

He was very patient to listen to everything before saying anything on what I should do. I also tried to explain how with all the enzymes and high markers the ones that show liver function are his main concern. regarding my function I'm safe and OK for now. So he only wants me to do the Gilead 1 Pill or the Abbive.

So why is my Orig doc suggesting now is the time and do the Sovaldi/Olysio/ Riba ? and maybe 24 weeks if insurance allows?

I'm very impressed with this new Doc and intend to investigate his credentials.

My gut says find out why the conflict in the 2 doctors. A strange thing they both know each other. Nobody said this was easy and for us treatment experienced relapses even the best out there is a delegate decision.

Again all credit to this group and the Gurus that direct to the best information out there.

Bills

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