Author Topic: Wait for Epclusa or start Solvadi/Ribavarin? Thoughts?? (Read 22911 times)

debbieCA · « **on:** August 19, 2016, 10:05:33 pm »

Thank you to everyone who responds to these questions. You all are amazing! I would really appreciate any advice from those who have experience as I am new and even though I know we each have different circumstances I might learn something from others. Here is my background. I am 52 yrs of age, a healthy female and was just diagnosed with Hep C last month. No symptoms. No other major medical problems. I don't drink, smoke, and eat pretty healthy. I would guess that I contracted Hep C 25+ years ago. I am a Genotype 2 with mild scarring (F1-F2) no cirrhosis. My insurance just approved Sovaldi/Ribavarin for 12 wks and was going to start ASAP because I wanted to get rid of this. After reading about Sovaldi/Ribavarin I see many people have experienced side effects e.g. fatigue, headaches, insomnia, muscle weakness, anemia, extreme mood swings. Some have adverse symptoms post treatment including hair loss or suffer from symptoms after they stop treatment. I don't see many people claim not to have any side effects. I corresponded with my GI doctor to ask if Epclusa was an option. My understanding is that Epclusa has less side effects. He advised that Sovaldi/Ribavarin is the standard of care, Epclusa would not get approved and they both have similar side effects and I might not have ANY. After my Sovaldi/Ribavarin was approved I thought I would write to my doctor again to see if we could try Epclusa because I am really scared about the side effects. He again told me that Epclusa would not get approved - I see his point about insurance approval as this new drug is not on the preferred list, but he also said that side effects are similar and I may not have ANY! That strikes me as an odd statement given what I have read about Solvadi/Ribavarin. I want to start treatment, but admit I am super scared. I asked if I could delay he said a few months won't hurt. Not sure if I should delay treatment. I realize the progression of liver disease is slow, but wondering if it can move from F1-F2 to advance scarring and cirrhosis in 6 months or a year? I have heard it moves faster the older you are. My question is are the side effects for Sovaldi/Ribavarin worse than Epclusa? And, does anyone have experience or think it is worth waiting or fighting with insurance to approve Epclusa or do you know how quickly it will become the norm to authorize? My doc says they won't authorize, but hasn't tried? Also wondering if I may be naive about this disease, meaning maybe I should be thankful there is finally a cure and the insurance approved. Talking to the doctor again next week, but welcome your opinions and expertise. Thank you in advance for your incredible support!

crabby old guy · « **Reply #1 on:** August 19, 2016, 10:56:13 pm »

Hi Debbie,
Welcome to the club of people beating the beast. You found this site before starting so that's a good start. I guarantee that within a day or two a lot of people will respond. A few people have done a lot of research and I sometimes think they know more than some docs. I don't know anything about Epclusa, ribavirin is part of my txt for 24 wks but I lucked out and my doc said I could stop the riba after 20 because of sides. My user name says it all. Good Luck which ever way you take.

debbieCA · « **Reply #2 on:** August 19, 2016, 11:31:40 pm »

Thank you! I love your username... that is so original. I might steal that because I feel like a crabby old gal and I haven't even started yet! I am hopeful and optimistic about being cured. So many other people have had this for decades without any hope and treatments that are much worse. I know I am blessed, but yet still uneasy about treatment. $:-\$ Thanks and I hope others weigh in. These are tough decisions.

Lynn K · « **Reply #3 on:** August 20, 2016, 12:06:39 am »

Hi I have threaten several times including having ribavirin on 3 treatments.

I developed ribavirin induced anemia every time I was taking it. But not everyone develops any side effects from riba.

While the anemia was not super fun I did survive. Even went on a quick 5 day business trip to Italy while on treatment.

I was followed closely since diagnosed with hep c. I had liver biopsies every 5 years. With each biopsy I progressed fron F1 to F2 to F3 and finally F4 but it did take me 10 years to go from F2 to F4 ages 40 to 50.

So not really answering your question just relating my experiences.

Personally I would treat sooner rather than later certainly you don't want to risk cirrhosis.

If you can't get Epclusa ribavirin isn't a lot of fun but it is doable and you might be one of those without noticible sides.

Good luck
Lynn

KimInTheForest · « **Reply #4 on:** August 20, 2016, 12:11:31 am »

Hi Debbie. And welcome! According to this chart (https://www.hepmag.com/basics/hepatitis-c-basics/hepatitis-c-treatment-naive-recommendations)...

the 2 standard treatments for treatment naive Geno 2s without cirrhosis such as yourself are:

Daklinza+Sovaldi
OR: Epclusa for 12 weeks

Sovaldi + riba is no longer even recommended for Geno 2 because with the newer Daklinza there is no need to use riba in your situation. I did 12 weeks of harvoni+riba (Geno 3). And in retrospect, I might be better off now, 1 year post-treatment, if I had not burdened my body with ribavirin. But many people on the forum have done the riba and recovered from the riba side effects quickly with no problems post-treatment.

Epclusa is brand new, so I don't know if anyone knows much about side effects (apart from those who got it in clinical trial,w hich I think some people here did).

Why not ask your doctor for Sovaldi+Daklinza instead of Sovaldi+riba. See what he says.

best,
kim

debbieCA · « **Reply #5 on:** August 20, 2016, 12:25:45 am »

Hi Kim - Thanks for your expertise here. Very interesting. I thought Sovaldi/Ribavarin was for G2. I am so glad you pointed out the link with the Daklinza + Sovaldi and Epclusa. Very strange this doctor is prescribing the Sovaldi/Ribavarin. I haven't been super thrilled with my doctor to be honest, but that is another story and trying to figure that out. I am definitely going to ask and look up the medication you noted.

debbieCA · « **Reply #6 on:** August 20, 2016, 12:32:48 am »

Hi Lynn -

Thank you for relating your experience. I have been wondering how long the disease takes to progress and your response gives me some perspective. I think I know that treatment sooner than later is the right thing. It is just so new and as you can see from Kim's response the doctor may not even be prescribing the right medication. I appreciate having some frame of reference and thank you for sharing!

Debbie

Lynn K · « **Reply #7 on:** August 20, 2016, 12:39:34 am »

Yeah I agree with Kim my bad to not check current recommendations of AASLD for your genotype glad she caught that.

Is your doctor a gastro or an infectious disease specialist? Any chance you could see a different doc? Or just put up with this one to get it done

As far as my 10 year from F2 to F4 individual results can vary as well just to add that disclaimer

debbieCA · « **Reply #8 on:** August 20, 2016, 12:51:21 am »

Hi Kim -

Quick question. When I selected your link below I can see Daklinza + Sovaldi would be for me - G2, naive, no cirrhosis.

https://www.hepmag.com/basics/hepatitis-c-basics/hepatitis-c-treatment-naive-recommendations

However, when I went to the link below to read about side effects it treat genotypes 1 and 3 which doesn't seem to be in line with the treatment naive recommendations.

https://www.hepmag.com/basics/hepatitis-c-basics/hepatitis-c-treatment-side-effects#daklinza

My goodness. Very confusing. Help!!!!
Debbie

Lynn K · « **Reply #9 on:** August 20, 2016, 01:03:47 am »

Check this the AASLD treatment guidelines updated in July 2016 they are the treatment recommendation authority

http://www.hcvguidelines.org/full-report/initial-treatment-box-summary-recommendations-patients-who-are-initiating-therapy-hcv

Genotype 2 Treatment-Naïve Patients Without Cirrhosis - Recommended

Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 2 infection who do not have cirrhosis.
Rating: Class I, Level A

Genotype 2 Treatment-Naïve Patients Without Cirrhosis - Alternative

Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is an Alternative regimen for treatment-naïve patients with HCV genotype 2 infection who do not have cirrhosis.
Rating: Class IIa, Level B

* The dose of daclatasvir may need to increase or decrease when used concomitantly with cytochrome P450 3A/4 inducers and inhibitors, respectively. Please refer to the prescribing information and the section on HIV/HCV coinfection for patients on antiretoviral therapy.

debbieCA · « **Reply #10 on:** August 20, 2016, 01:08:33 am »

Hi Lynn -

I just saw your post. I am going to read. Regarding your question about the doctor he is a GI not infectious disease. So far, I am not to impressed. He ordered lab work. Sent his treatment plan to the specialty pharmacy and have only corresponded via the web/portal. My plan is to schedule to discuss this instead of the back and forth and get a read on him. I mean it seems crazy to not have a conversation and start treatment. Also looking to schedule with another GI or Hepatologist, but having trouble getting in. I will make a decision once I see him and get a feel or like you said put up with it so I can be treated.

Totally understand the disclaimer! Just nice to have a point of view from others who have experience. I am a newbie - 30 days!

Reading your other post around AASLD treatment guidelines right now.

Thanks!
Debbie

debbieCA · « **Reply #11 on:** August 20, 2016, 01:37:26 am »

Hello Again Lynn -

Thanks for sharing this site. Go figure the AASLD site...would have never known!
You are all a Godsend! Here is what I think both you and Kim are saying.

Sofosbuvir (400 mg)/velpatasvir (100 mg) is the same as the Daklinza with Sovaldi that Kim noted in her post.
The Sofosbuvir (400 mg)/velpatasvir (100 mg) is the Epclusa

So here is my takeaway. I should be asking my doctor why he is recommending the Sovaldi/Ribovarin. Hmmmm....I was wondering about this doctor from the start as you read from my last post, but didn't want to go on a rant about him. Need to figure this out. Appreciate your help and Kim's too!

Thank you again!
Debbie

P.S. Very difficult to spell or remember the names of these medications/drugs! By the time I am done I will be an expert! LOL

KimInTheForest · « **Reply #12 on:** August 20, 2016, 01:48:43 am »

One thing to remember is that ribavirin has been a standard for a long time. Daklinza and Velpatisvir are both quite new. Those guidelines are updated almost monthly it seems because of the new drugs coming out the pipeline all the time. Unless a doctor stays on top of these rapid changes, he/she will be recommending ribavirin, thinking that is still the standard. Also it is possible, that insurance company will only cover the cheapest (or whatever it has a pre-existing deal on), which may be sovaldi+riba and nothing else for Geno 2. But it is still possible to fight that and insist on the less toxic combos that do not have riba. It is also possible to buy 12 weeks of sovaldi+daklinza generically for $1,500 USD via the redemption etrials through fixhepc.com. But if you can get the medication you want domestically, and covered by insurance, that is preferable.

kim

FutureThinker · « **Reply #13 on:** August 20, 2016, 01:08:21 pm »

DebbieCA, there is no good reason, with your history and GT, to have to take ribavirin, except lack of motivation on your doctor's part to fight, and the insurance company's monetary bottom line. The treatment he is recommending is what your insurance is willing to pay for -- the Daklinza and Epclusa are much more expensive ----- but also with a lot less risk of side effects. My insurance co made a deal (as many did) w/ the maker of Viekira Pak and for my GT, it would have required the addition of the riba. I did not want to take the riba unless I absolutely had to, and fought my insurance co's 2 denials by taking my appeal to my state insurance board. They overturned the denials and I completed my Harvoni treatment in May w/ literally little to no issues. In this day and age, there is no good reason to take riba if you do not have to, as we have much safer and tolerable drugs available now. They are just quite expensive.

So, I chose to fight for the option w/o riba. This is a personal decision, but read carefully on the riba sides. In my discussions with my hepatologist, I was told 30-40% will develop anemia. That was too high a percentage for me to go that route if I did not have to. Of course, there's another 60-70% that will not develop anemia, but my feeling was to avoid any extra issues w/ my health if I could. Just be sure you are comfortable with which ever treatment you go with! FT

Lynn K · « **Reply #14 on:** August 20, 2016, 07:40:20 pm »

Daclatasvir AKA Daklinza was developed by Bristol-Myers Squibb while Epclusa is a fixed-dose combination tablet containing sofosbuvir and velpatasvir.

debbieCA · « **Reply #15 on:** August 22, 2016, 11:45:57 am »

Thank you Lynn & Kimmin -

I appreciate you pointing me in the right direction on these drugs. I think I am becoming clearer on this battle between pharma and insurance.

I may reach out later with questions as I learn more this week.

Best,
Debbie

debbieCA · « **Reply #16 on:** August 26, 2016, 01:18:18 pm »

Hi Future Thinker

Thanks for your response.

I think you validated my suspicions regarding insurance, and doctors. I learned a lot this week. On the insurance side it was confirmed both treatment plans for my G2 are not on the list. As for the doctor he thinks the ribavarin Had more side effects because of the Inferon. I think your right about the Anemia and don't want to be the thirty percent!

I have a referral to a hepatologist early September. Let's see what she thinks.

Thank you for weighing in with your experience!

Debbie

crabby old guy · « **Reply #17 on:** August 26, 2016, 01:52:59 pm »

Debbie,
Glad to see your waiting, my exp with riba was pretty crappy, I've been off work for 10 wks because of another medical issue which is good because I would not be able to do my job. (Brain fog-Insomnia-weak and exhausted all the time.) Its been 22 days since the doc had me stop the riba and finally had 3 nights of decent sleep, brain fog is still there and still feel weak. 7 more days to go!

Lynn K · « **Reply #18 on:** August 26, 2016, 02:47:30 pm »

Hi Debbie

While treatment with interferon and ribavirin was difficult for me even when I last treated with Harvoni for 24 weeks and ribavirin for 15 of those weeks I did experience ribavirin induced anemia and had to dose reduce from 1200mg to 1000mg which did improve my hemoglobin level enough so I was able to continue. After I finished treatment my anemia did resolve immediately so that was a good thing.

Can't believe your doctor thinks ribavirin is not an issue. While not everyone develops anemia as was already said about 30% do. There are also other less common sides like a ribavirin induced rash nicknamed ribavirin rash that for some was bad enough to have to discontinue treatment. I never had ribs rash the 3 times I have taken riba just anemia.

Anyway hope you get it all sorted out soon good luck

FutureThinker · « **Reply #19 on:** August 26, 2016, 02:55:32 pm »

Hi DebbieCA -- Glad I could be of assistance in your quest for a safe, tolerable and effective treatment. I was basically in your shoes during my treatment decision-making. This whole thing boils down to money, unfortunately. I'm glad to hear you're getting a second opinion and hope that one proves to be better for you! Keep on fighting!!! It will be worth it. Take care and let us know how this goes -- FT

dragonslayer · « **Reply #20 on:** September 07, 2016, 03:52:00 pm »

Lynn, thanks for that AASLD link.. I note there is no mention any longer of 8 wk Harvoni treatments for lower viral loads in treatment naive patients without cirrhosis. Wonder if Gilead removed it, or the FDA, or if results with 8 weekers were not living up to the trials.

Interesting!

andrew j · « **Reply #21 on:** September 07, 2016, 07:23:00 pm »

Yes, dragon.

There is a post somewhere here, collecting results from those who have been treated with Harvoni - and it indicates that most of the people who have relapsed have done so from 8 weeks of treatment.

8 weeks shouldn't be prescribed if 12 is indicated, just to try to save money.

Maybe a subject for another thread ...

Lynn K · « **Reply #22 on:** September 08, 2016, 12:43:27 am »

Hi Dragon didn't notice that while copy cutting and pasting. I will have to take a second look

Edit:

Ok the 8 week is still mentioned in the prescribing information as a note

https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

* HARVONI for 8 weeks can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pretreatment HCV RNA less than 6 million IU/mL [see Clinical Studies (14.2)].

dragonslayer · « **Reply #23 on:** September 08, 2016, 08:50:47 am »

Ok, Thanks Lynn.. I just didnt see it in the boxes contained in the link.... I see its still being offered though for patients that fit the criteria.

>>There is a post somewhere here, collecting results from those who have been treated with Harvoni - and it indicates that most of the people who have relapsed have done so from 8 weeks of treatment.<<

Andrew, that post youre referring to.. .Is that the thread that was accumulating results from within this forum? Or was it reflecting the results of a study... Trials showed 8 wk results to be very good; they showed relapse rates to be almost identical between 8 wk and 12 wk groups.

andrew j · « **Reply #24 on:** September 08, 2016, 08:32:23 pm »

It was from within this Forum, dragon.

I'll see if I can find it again.

dragonslayer · « **Reply #25 on:** September 08, 2016, 09:04:02 pm »

Quote from: andrew j on September 08, 2016, 08:32:23 pm

It was from within this Forum, dragon.

I'll see if I can find it again.

That's ok, Andrew... Ive seen it before.. It cannot be used to establish a relapse rate, however, because the sample is so unrandomized and meets no study criteria.. I believe this was stated by a moderator at the time to keep people from jumping to the wrong conclusion.

Lynn K · « **Reply #26 on:** September 08, 2016, 11:05:19 pm »

yes just anecdotal reports not a scientific sample and the clinical trial data and also later reports does support the use of 8 weeks for some patients

andrew j · « **Reply #27 on:** September 09, 2016, 07:38:05 pm »

There is a new posting on this very subject on the main storyboard.

dragonslayer · « **Reply #28 on:** September 09, 2016, 08:48:23 pm »

Andrew, can you provide a link? Dont know what you mean by 'main storyboard' and didnt see it on the home page.

Thanks.

***Edit***

Found it:

https://www.hepmag.com/article/excellent-hepatitis-c-cure-rate-just-eight-weeks-harvoni

andrew j · « **Reply #29 on:** September 09, 2016, 10:32:36 pm »

The Homepage. The Homepage!
Blimey - I need to get out more.

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Author Topic: Wait for Epclusa or start Solvadi/Ribavarin? Thoughts?? (Read 22911 times)