Hep C Discussion Forum

Harvoninme · Senior Member

RE: Surprised by rough time with sides.

Rubye · Senior Member

That makes sense Tig. Thank you.

Tig · Admin

ISIS,

Thanks for posting that update Matt provided on the rec for the additional 12 weeks on this protocol. It's an ever changing regimen. I would like to know what the real world results are for those F4's that completed 12 weeks after those trial results were released. Perhaps you have those numbers? Thanks!

Tig

Tig · Admin

I wanted to add that they likely used the first mention of Undetected under the Standard Range as their Reference range or what a normal/virus free result would say and the second reference was your result. When they can't find a quantitative number below their reference range, 12 in your case, they list it as undetected. But again, this new assay was still sensitive enough to say there was a weak positive presence of viremia. Confusing but it's nice to know that your 8 week results were indeed undetected!

Tig

Isiscat2011 · Guru

Hi Rubye:

It sounds like the side effects hit you pretty hard. I'm sorry to hear that but glad things have improved. Good idea to ask the doc to submit the preauthorization request and then you can decide when the time comes; that will keep your options open. A month from now you could have your fighting spirit back.

Tig · Admin

I answered this on the other thread. This is a new one for me! It does indeed say undetected and weak positive on Week 4! However your Week 8 is IMO definitely undetected. Congratulations!

Tig

Rubye · Senior Member

This is the 8-week results --

These results are most likely suggestive of either the absence of HCV viremia or the presence of low-level HCV viremia at or below the assays lower sensitivity limit of 12 IU/mL.

Component	Standard Range	Your Value
HEP C PCR, QUANT	Undetected, Undetected - See Below IU/mL	Undetected

Rubye · Senior Member

Looks like I lied. :)

Seriously, here is a copy of my 4-week lab --

The HCV specific signal was above background, but below the linear quantification range of 12 IU/mL. This result is likely due to a very low-level HCV viremia below 12 IU/mL.

Component	Standard Range	Your Value
HEP C PCR, QUANT	Undetected, Undetected - See Below IU/mL	Weak Positive

Tig · Admin

Hey Rubye,

i have never heard of a viral load test coming back reading both undetected <15 and "weak positive". Was that quoted to you or was it written on the actual lab paperwork? If it was on the lab report, I would like to see how it was stated if you can post a copy. That's a new one for me and just doesn't make sense.

Tig

Rubye · Senior Member

I understand the necessity of treating for the extra 12 weeks, but I think I am kind of depressed because I've lost my fighting spirit. Regardless, I will ask my doctor tomorrow for the new 12 weeks. Has anyone else who has cirrhosis received the new extra 12 weeks since FDA approval of Sovaldi and Olysio?

Actually, I was maybe undetected at 4 weeks as my viral load results read "undetected, <15, weak positive" but this last one at 8 weeks said only "undetected". Both quantitative. This test confuses me because how can I be undetected and weak positive at the same time.

Part of what is emotionally defeating for me is I've lost a lot of hair and my gums are receding with a couple of teeth having serious gum and bone loss. A lot of this was before tx and from the HCV but it seems to have gotten worse with the S/O and I keep telling myself that soon enough I'll be off tx and hopefully these things will stop. So, facing another 12 weeks make me a bit apprehensive.

Isiscat2011 · Guru

P.S. When you watch the video you will hear one of the Hepatologists say "So, there are either 1 in 4, or 1 in 5 cirrhotics, who will need retreatment [after relapsing on the S/0 12 week protocol]." When you state it that way the argument in favor of 24 weeks seems fairly compelling.

Isiscat2011 · Guru

Welcome Rubye:

Some "real world" results of the Sovaldi/Olysio combo have surfaced and the most comprehensive analysis I've seen was contained in a video in which 4 Hepatologists are discussing this very subject. Here is a link and it is definitely worth viewing before you make your decision not to try to extend your tx duration (courtesy of Matt):

http://s318638489.onlinehome.us/files/aasld2014/

Real world results for cirrhotics @12 weeks ranged between 76% and 86% as I recall, depending on the study. So roughly an 80% SVR rate with 12 weeks. This is why the FDA approved and recommends 24 weeks S/O for cirrhotics.

Your call, but please consider also the amount of time and energy that will go into retreatment (which will be for 24 weeks) if you are in the unlucky ~20% and it may not be easy to get retreatment even for cirrhotics. I like to see everyone get the best possible odds for SVR and for cirrhotics it is essential.

You are actually quite fortunate to be a late comer on this combo so you have the benefit of some real world SVR rates with which to make your decision. The retreatment merrry-go-round is not a good place to be and with a longer tx duration you are much less likely to experience it.

Even adding another 4 weeks, or whatever you can get, might be well worth it. I noticed you did not reach UND until week 8 and, while there are no absolute rules about this yet, I have heard Hepatologists say they like to continue tx longer when it takes longer to reach UND. This stuff is still trial and error.

Best of luck to you!

Tig · Admin

Hi Rubye,

Welcome to the forum, I'm glad you found us! Congratulations for doing so well on your course of S\O, that's an excellent combination and we've got members that have done very well and are enjoying SVR!

I'm including a link to some data on the success rates of your protocol. The success rates for both 12 and 24 week therapies are extremely close. Many people feel better as treatment progresses and the body adjusting to the medication is certainly possible. It did for me but I was on an entirely different protocol, so little in common with yours. Just be thankful for the improvement and I hope you do finish the last 4 weeks. Your chance for success has never been better! Good luck and do stay in touch!

http://www.hepmag.com/articles/Olysio_Sovaldi_2501_25501.shtml

Tig

Rubye · Senior Member

I'm in my 8th week of Sovaldi/Olysio and up until a week ago I was very miserable with mostly nausea and fatigue - to the point where I considered quitting tx around week 4. My doctor gave me some Zofran and that helped immensely and kept me going. For some reason, a week ago I started feeling much better but I have no idea why. Perhaps my system has adjusted to the meds after 8 weeks. Or perhaps it is because I have become undetected and all my labs are now those of a healthy person. At 4 weeks I was <15 and then at 8 weeks it said only "undetected".

Since Sovalid and Olysio are now approved for those of us with cirrhosis for 24 weeks I've considered asking for that extra 12 weeks but am so tired of being sick that I really think I'll take my chances with only the 12 weeks.

Also, I am far from a small person as I am 5'9" and weight 185 lbs. Not exactly proud of it but just to let you know that larger people can also be made miserable by these drugs. :)

LC · Senior Member

Sorry you've been sick Rudiroo. I can usually tolerate bananas, toast, applesauce, Stouffers mac and cheese in the little red cups. I wouldn't worry about a few pounds either during treatment. Hope you are starting to feel a little better!

Peter M · Veteran Member

It's amazing how different we all are! The Sovaldi and Olysio increased my appetite to the point my family was worried that I was eating way too much. Everything looked and tasted good. I particularly became fond of raw organic pastured cheese with a granny smith apple that I took with the Sovaldi and Olysio. Fortunately some energy came back to me and I was able to walk some of the extra calories off but I still managed to gain five pounds on the treatment.

I think I hate nausea almost more than anything. Some where I learned that lying flat with my feet higher than my head sometimes helps.

Although I am 'cured' I still have some residual effects from cirrhosis, tendinitis, stiffness, higher than normal blood sugar, and some insomnia. Over all I feel Wayyy better.

Good luck Rudiroo...do whatever you can to deal with the nausea and hang in there. SVR makes a huge difference and when you're there, this will all be behind you and you won't have to worry about dying from liver disease.

Isiscat2011 · Guru

Hope you feel better soon, RudiRoo. I'm certain that size can make a difference in side effects. In Japan the dosage for Olysio is adjusted downward for a smaller frame. Women were hit harder by anemia on the triple therapy too.

I have always wondered why the same dosage of a medicine could be given to a 100 lb woman and a 200 lb man?? As I recall you are very tiny so it seems like that could certainly play a role in your sx.

Isiscat2011 · Guru

shadow10cats wrote:
have you heard of a gizmo called "yonanas"?
http://www.amazon.com/Yonanas-901-Deluxe-Cream-Silver/dp/B00532A6YK/ref=sr_1_1?ie=UTF8&qid=1416783985&sr=8-1&keywords=yonanas

I am a sucker for kitchen gadgets and appliances and had never heard of this one. I took your recommendation and ordered it. Arrived today! Now I just have to freeze some fruit and it will be ready to try out. Oh, the things I find exciting these days. biggrin

RudiRoo · Senior Member

Thanks to you all. Everyone here is so kind.

When I called Janssen and Gilead to get approval to take the zofran & tramadol, the nurse at Janssen wanted to know my height and weight.

I'm thinking about all the drugs that used to be tested on men and then had to be dose adjusted for women after they got FDA approval. I learned when birth control pills came out the estrogen dose was so high it gave women breast and ovarian cancer. It seems like women get more sides during tx but I have seen some men too. I wonder if size is relevant?

Bj, back in the day those frozen bananas were my ice-cream. I made them in my nutra bullet. They work great for a lactose intolerant belly - which I recently learned hep C can cause. Just too nauseas to even think about that kind of thing right now. Living on lemongrass & ginger tea, and toast the last couple days.

2willy u made me laugh - I feel like a walking problem myself right now.

Greg, I build websites and had to redo a simple procedure so many times i'm laugh at myself while i screw up!

Thanks Isis i think about you every day and hope for you and matt to get ur tx soon. Like NOW soon!

A cool thing, (yep, that was a pun) Gracie, is I discovered that smelling tiger balm helps the nausea!

Jlynch - six times, oh you poor duck! I will cease all whining immediately.

SVR to all!

2willy · Senior Member

Ye been there and out of possible 22 side effects I had 19 and a few personal problems, used ensure sometimes just to keep up strength, it is a hard go but benifits of beating virus comes, for me a year after treatment, it seems like 2 steps forward and one back, but that is better than 1 step forward and 2 back with the virus, hang in there if an old fart like me can survive you will get through this with this forums help, take care

shadow10cats · Senior Member

have you heard of a gizmo called "yonanas"? It's a counter top size unit that takes frozen fruit and turns it into a yummy sherbert like treat. I'm always skeptical about these types of gizmos - often they are junk or a pain to use. I had heard good things about this one and saw it on sale at Home Depot a couple years ago for $39 (cheapest model is $49 at full retail price) - so I decided to give it a try. I LOVE IT. My boyfriend is the "master" of the yonanas machine and in minutes we can have a treat that is both easy on the stomach and good for you. The basis is of course bananas that you freeze after they have ripened to where the peel is turning black. Those black spots means it's getting over-ripe but also that the banana is becoming really nice and sweet. You simply peel them and freeze until use. You then let them thaw just a bit. You want them frozen but not so hard the machine can't mush them up. We add frozen organic wild berries: strawberries, blueberries, raspberries - and in literally a few minutes out comes this yummy sorbet / sherbert / ice cream treat. I can eat a huge bowl of this on almost any day regardless of how awful I feel. It's very healthy & low fat. There's a bunch of recipes depending on your personal tastes but I recommend trying organic berries, especially since we have compromised immune systems and the wild blueberries have a lot of anti-oxidants that certainly can't hurt! You can get it on sale now on Amazon. There are 2 or 3 versions above this but this one is all I've ever needed.

http://www.amazon.com/Yonanas-901-Deluxe-Cream-Silver/dp/B00532A6YK/ref=sr_1_1?ie=UTF8&qid=1416783985&sr=8-1&keywords=yonanas

beingsassy · Senior Member

Hi,

I'm sorry you're having a rough time. My first few weeks on sovaldi/riba were easy but got worse near the end. I thought about quitting but sure am glad I stuck it out. Try to stay hydrated and get rest. If you can, take a day off work now and then just to take care yourself. I usually eat healthy but the last part of the tx I ate whatever I could. I did gain some weight but wasn't as worried about that as much as I was with the hep c. Right now just take it easy on yourself. If you gain weight you can lose it later. Eat whatever is the healthiest option that you can right now and don't worry too much. Your hashimotos is possibly making thus tx harder for you but these are side effects from the meds as well. I was working and doing a class on statistics during my brain fog days. It wasn't easy but I kept my job and passed the class. I did take a day off here and there just to rest and try to concentrate. You know best what you need right now so listen to your inner voice and realize that this will pass, maybe not soon, but it will pass. Take care of yourself and if you need a day just to cry or slerp, take it. Praying for you

gigi

JLynch30 · Senior Member

This is my 6th time on treatment and I had a rough first day, but I am feeling great the last few days - this too may pass for both of us - but hang in there!

Gracie · Guru

Nothing tasted good to me either. I kept cans of meal replacement drinks and had them for lunch, cereal for breakfast... It was tough with the incevik as we had to eat. Headaches are the Pitts when your not use to them. I rubbed tiger balm on my forehead and temples which helped. Trudge on through... It will be done soon enough. Feel better! :)

Groupergetter · Guru

Hi Rudi, sorry you're having a rough time with the tx. I had frequent headaches on the S/O but they seemed to decrease at treatment went along. I tried to take as few other meds as possible while on tx. My doc prescribed ativan/lorazepam to help with sleep though I only took it occasionally. Also said I could take otc pain reliever for the headaches but I didn't take this often. Sort of just coasted thru day to day. Yes I had and have increased problems with the thought process (brain fog) as well. Difficult to perform my job at high level.

This will pass, you will get SVR, and all will be well. smile Hoping and praying for your success.

Isiscat2011 · Guru

Sorry, I posted the data for HARVONI side effects and you are on S/O!! I can see it is going to be hard to keep up with the various protocols as more come out. I'll leave the data up for anyone on Harvoni. The side effects of S/O should be similar but also include the rash and itching. There were a number of people here who had some hard days on the S/O combo. You are not alone.

I noticed you have some autoimmune issues as well and that could make tx a bit harder. Feel better. :)

Isiscat2011 · Guru

Hi RudiRoo:

I'm sorry you are not feeling well. We hear so many glowing reports about how easy the tx is, and compared to the old protocols I'm sure it is, but many people have side effects. Some of the more common side effects include headaches, fatigue, nausea, insomnia, and diarrhea. Make sure to stay well hydrated, get some exercise, but plenty of rest also. I also tried zofran which worked really well for nausea but could induce headaches. You might want to try eating soda crackers and drinking ginger ale.

More people are reporting mental sides like feeling spacey and a kind of brain fog. IMO, those are due to the meds rather than the HCV suddenly acting up. You may just have to accept that you won't be able to function at 100% at all times during tx, and try to take it easy on yourself. I don't like to sugar coat things because I like people to know what to expect. I appreciate your letting us know too.

Just so you will know that what you are experiencing is not unusual here is some clinical trial data on the typical side effects:

Table 2 : Adverse Reactions (All Grades) Reported in > 5% of Subjects Receiving 8, 12, or 24 Weeks of Treatment with HARVONI

	HARVON I8 WEEKS N=215	HARVONI 12 WEEKS N=539	HARVONI 24 WEEKS N=326
Fatigue	16%	13%	18%
Headache	11%	14%	17%
Nausea	6%	7%	9%
Diarrhea	4%	3%	7%
Insomnia	3%	5%	6%

Laboratory Abnormalities

Bilirubin Elevations: Bilirubin elevations of greater than 1.5xULN were observed in 3%, < 1%, and 2% of subjects treated with HARVONI for 8, 12, and 24 weeks, respectively.

Lipase Elevations: Transient, asymptomatic lipase elevations of greater than 3xULN were observed in < 1%, 2%, and 3% of subjects treated with HARVONI for 8, 12, and 24 weeks, respectively.

RudiRoo · Senior Member

I read so many happy accounts prior to starting treatment even though I was nervous, I thought it would be easier. I've been trying to stay positive but I'm kinda crumbling a little here. Not riba/peg crumbling but it's not easy either.

Wondering now if my small stature is accounting for the unrelenting nausea? Also headaches and struggling to think clearly. I can only eat plain, carby foods like sugar cookies, toast, crackers, corn chips. A far cry from my normal low carb high veg diet. I made a plate of broccoli and had a stare down with it but I lost. I felt like crying at the grocery today because everything made me want to throw up and I couldn't think of what to buy. Tomorrow is day 28 and I've gained 4 lbs from eating like this.

I was taking benydryl for nausea but the doc gave me zofran which was very $$ and is super bitter and makes me gag. She gave me Tramadol for headaches which causes constipation and I think is just making the whole thing more dramatic. Neither of them seems to work well. My last day is January 19th and right now it looks really far away. I need to work but my brain is really sucking at solving problems, which is what I do.

Hep C has given me lots of extra hepatic troubles and I'm really wondering if that has something to do with this also. I see so many people that just breeze through the treatment I have to wonder what's wrong with me that this is happening? I remember when I first started on this board someone else mentioned they didn't have the easiest time either but I can't remember who.

I'm trying to focus on the good - my bilirubin was down this week, the itching is gone, I've been able to sleep, no riba/peg only 12 weeks, very high chance of success and how incredibly fortunate I am to even have these drugs and a chance for a new life!

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