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29837 tn?1414534648

Harvoni Side Effects Anyone?

I ask this because overall, I don't feel much, but this morning I woke up with a headache, which is very rare for me. I believe one of the side effects can be a headache. I also notice my hands slightly shaking since starting Harvoni. Anyone experience this? Just curious as to what others are going through.

I know this is a new type of treatment, but it would be helpful and put people at ease if others are experiencing the same effects. Otherwise, people could freak out and think something worse is happening to them. Something worse than watching a Justin Beiber video if that's possible...

Magnum
98 Responses
317787 tn?1473358451
Hi there! I have read that headaches are very common on Harvoni.  I am not sure if I read this in the prescribing information
I will try to find some information, Take Care
317787 tn?1473358451
I just cut and pasted this from the RXlist website so you could quickly see the statistics on side effects.  I hope this helps you.

SIDE EFFECTS
Clinical Trials Experience

The most common adverse reactions ( ≥ 10%) were fatigue and headache in subjects treated with 8, 12, or 24 weeks of HARVONI.

Table 2 lists adverse reactions (adverse events assessed as causally related by the investigator, all grades) observed in ≥ 5% of subjects receiving 8, 12, or 24 weeks treatment with HARVONI in clinical trials. The majority of adverse reactions presented in Table 2 occurred at severity of grade 1. The side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs.

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.

2059648 tn?1439766665
Drink lots of water.  Headaches can be associated with not drinking enough weather.  Very important on treatment to flush your system.  More important than watching a Justin Beiber anything. : )
2059648 tn?1439766665
weather=water

Seems my transmission to the forum ends up with different words. hmmm.
Avatar universal
My GI is in the process of trying to get me approved for Harvoni.  What is everyone taking to help with the headaches?  I've heard so many conflicting comments on this site.
Avatar universal
conflicting comments seems to be the norm re: this disease. I am happy to see the topic started as I will be starting treatment soon and I too have heard headaches. I am one of those "health nuts" sad that is what we are called who , after reading for months and years, does coffee enemas and other things (ozone) to keep my immune system modulated . I will have to see if I can do this while on Harvoni,, This is a confusing thing to navigate and it has taken me years to find what works for me and so it goes. When I started coffee enemas and I was NOT exited about it, my fatigue decreased significantly and my anxiety did as well. So,,, my lab is my body.. maybe I will now be thrown out of the room. They do say WATER to keep the headaches at bay,, keep posting.
29837 tn?1414534648
Yes, the headaches. This is nothing I'm whining about, instead just curious as to whether others on Harvoni are experiencing this. Funny I should even bring this headache complaint up because here's a log I kept while I was taking a triple treatment which almost killed me. I was one shot of Interferon per week, Ribavirin at 1200mg daily and Victrelis at 2400mg daily, in other words, one shot per week and 18 pills per day. I went from 3.2 million viral count, down to 300 in 16 weeks. The only problem was that treatment of this magnitude should have been stopped at 12 weeks if I did not clear. My doctor and I agreed to go another month in spite of the agony and torture because I had already failed four treatments. Here is a log of side effects I kept. I now am NOT whining about a simple headache.

SIDE EFFECTS: Cough for 6 weeks, probably due to acid reflux from pills. Lack of energy. Diarrhea. Sleep depravation. Constant medicinal taste in mouth. Salty taste on right inside of mouth about ½ hour after pill taking, which lasts for 5-10 minutes. Short fuse temper. Feel hot at times. Itching in calf areas of both legs and back. Red bumps breaking out on my forearms. Mouth is very dry at night. Distended stomach the last 3 weeks of treatment (month 5) sleep deprivation worsened the last month (month 5), averaging 2-3 hours nightly. Some hair loss. Ribs on right side hurting a few days after stopping treatment.

Magnum
317787 tn?1473358451
Hey there, there is no way anyone could ever think you are whining.  You are just looking for help.
You have been through so much already, several treatments as well as a transplant.
Puleeze, no one thinks you are whining, you are just looking for information :)

Hang in there, I, and everyone else is rooting for you :)
Oh the information I cut and pasted above was from the trials.  I am trying to find real time sx's
Take Care
Dee
317787 tn?1473358451
Hi I don't know if you would be interested but I found a person's blog who has been treating with Harvoni for about a month.  I thought it might help you.
Take Care, Dee

http://blogs.hepmag.com/kylejacobs/
29837 tn?1414534648
Thanks. I will look into it. Yes, the side effects are extremely minimal at best. Another15.5 months to go on this treatment should be no problem. If I can withstand a transplant, 5 failed treatments and have no transplant complications after 11.5 months, something tells me this is a walk in the park in comparison.

Magnum
29837 tn?1414534648
I meant to say another 5.5 months of treatment to go.

Magnum
29837 tn?1414534648
Still getting morning headaches from Harvoni. As I mentioned before it is very rare for me to get a headache. The last time I had a headache was when I was digging weeds in my front yard flower bed and had my dog Delta next to me. She was a pit bull but of a very gentle nature. Anyway, she was sitting there on the grass next to me. After a while I turned around and she was gone.

I started freaking out because I didn't know where she went. So I called her several times and finally she came from the backyard of my neighbor, who has a swinging gate so when you open it, it swings back into the closed position on its own.

I couldn't believe my eyes, she came to me with a dead rabbit in her mouth. It was all full of dirt. The neighbor had three kids and each one had a pet rabbit. I didn't know what to do, so I took it in the house and washed and shampooed it and blow dried it to fluff it up.

I went into their backyard and noticed a hutch with two other rabbits in it. I figured it had escaped. So I took it and put it back in the hutch. That weekend I was picking almonds off my tree in the front yard and the neighbor was cutting his lawn.

He shut off the mower and came over to me and told me "you know, when my wife went to feed the rabbits before we took the kids to school, she noticed one of them had died. We buried in the back yard, and when we got home, it was back in the hutch again".

I didn't say anything and did all in my power to not laugh. My headache went away later.

magnum
317787 tn?1473358451
Oh my gosh!  That is so funny.  I am laughing so hard my husband is asking if I am watching a comedy
Thank you so very much
Dee
29837 tn?1414534648
Laughter is not only important, but necessary in what most of us are going through. I'm glad you had a good laugh. I was not laughing when it happened. Quite the opposite, I was extremely upset, but later relieved and laughed myself when the neighbor told me what happened. Apparently my dog dug it up. They do have much better olfactory glands then we do and can smell things we never can.

Magnum
Avatar universal
Magnum, hilarious !

Yep, 2 days in Tx, Harvoni and nothing unmanageable yet :)

-5 hrs after 1st dose, felt a pretty funky head, tingling & perception off. About hour later top half of head, headache( not bad, def there. Slept well.
- woke up w/headache today, 3/4 gallon of H2o & it went away. Felt overly awesome till about 2p. ( still hydrating) & headache returned w/ some inability to focus eyes.
- still there midnight.

Not surprised by headache but vision thing a bit strange, anyone have this? Could be fatigue of some sort?

So only 2 days in & tx naive, hoping to adjust! At least see 1 letter, not 3 on a slant :)

I Don't ever take Tylenol or Advil, see a lot of posts saying tylenol, but w/ liver disease doesn't make sense.

Anyway, would also like to know consensus, in case ache does get nasty.my pharma/nurse said Advil, but GI issues & ? anti- inflammatory w/ meds.

Hope yours go away, same way they came.... fast!

Dee, as always, thanks for input~

Thx again for rabbit tail - laughter best med

Randy

317787 tn?1473358451
Hi I wanted to come back to say I know it could not have been funny when it happened, it had to be horrific at the time.
I think that a lot of times our worst experiences become funny after a while.  You gotta laugh or you will cry :)  When something bad or frustrating is happening I try to tell myself that some day it might be funny.  Some days that is the only way I can get through it :)
I hope you are doing better.  I have been reading about others treating with Harvoni on Lucinda Porter's blog and while some are having little to no sx, others are having headaches, fatigue, some even experiencing nausea, swollen lymph nodes, etc.
Of course everyone is different.  You are in my thoughts, I am rooting for you
Dee

Rbeth, you are so sweet, thank you :)
29837 tn?1414534648
It's been 5 weeks since starting Harvoni and not only am I getting the morning headaches, but also I seem to have some blurry vision and watery eyes. I'm taking a Kleenex and wiping my eyes on a regular basis. Have you or anyone here on Harvoni experiencing this?

I spoke to my optometrist who is scratching his head about this. The eyes also feel irritated. He lifted and inspected under the eyelids and saw nothing. There may be some correlation between the headaches the irritation of the eyes. I will contact my transplant doctor and ask if this may be a side effect of Harvoni. I have to keep trying until I find and answer. As my father once told me "Where there's a will, I want to be in it".

Magnum
Avatar universal

Hey magnum!  Sorry your still having headaches & blurry, teary eyes!  In fact, I am still getting night headaches, not every night, getting better. I took a little trip to ER last Wed. because BIG headache, blurry vision & twitchy :/ had me check my blood pressure(ALWAYS real low) it was 145/90. Thought maybe electro's were whacked. They were fine. Doc dx'd hypertension & tremors. Ok?... I talked to hepa & added a dose of verapamil(take for fast HR) anyway, took about 4 days & starting to come down. So, although a SFX, it seems my headaches were connected to increase in BP( not normal symptom of HPB)

So, I'm sure you probably have, but if not, keep an eye,(no pun) on your blood pressure. It might just be Harvoni headache, wondering if you have dry eye, they tear & burn. Certainly your eyes can be affected from headaches & possibly past Tx's.... did you have that?

Anyway, blink a lot (or wink a lot:), drink a lot(of course), & warm wet cloth over eyes helps. Hope it's as simple as that for you! You're still so young, me too, so dry eye may not be it, but I hear there are drops that replenish.

Curious to know what transplant doc thinks! Keep posted...

Did optometrist not even see sclera under your lids? Lol and your father was a smart man!
Btw, try to stay away from pad, PC, phone a lot, hard on eyes & head. I'm at least 6-8 inches from mine... Duh!
All best,

Randy
Avatar universal


;) sleep is also replenishing for eyes, so sleep blessed friend... maybe you'll get back to Fergie dream......
Avatar universal
Any vision problems with Harvoni out there?
Avatar universal
    I 'm getting ready to start the Harvoni has anyone had weight gain  or loss ? Any hair loss at all . Thank you   Janice Simmons
Avatar universal
Just took my 6th pill. Initially, the first 3 pills or so, caused mild indigestion and an hour or two later, headaches. These felt different than ordinary headaches but since I take my pills in the evening, I simply went to bed and they were gone in the morning. On day 3, I took a couple Advil. Day 4 went by without any indigestion or headaches. I thought I was past the period where the body gets used to the drug but on day 5, I got mild angina in the evening for several hours. This caused more anxiety than the pain was worth. Today, day 6, I had another bout of angina in the morning and then again for another couple hours in the evening. I'll call the doc's office about it tomorrow. I'm a pretty healthy guy and have not felt fatigued at all so I continued riding my bicycle to work. Perhaps the effort didn't mix well w Harvoni? Who knows. I'll follow up when I hear back from the doctor's office. Googling around, I didn't see any connection between Harvoni and angina so maybe this is unrelated?
Avatar universal
The second week of treatment with Harvoni my vision was so blurry I count read letters and typing as a joke. Dry eye - occasionally. I posted a comment about all my symptoms and the fact that my doctor's nurse seems to believe that no one else has any negative side effects- Worst thing is the fog I'm in from about 2-3 hours after taking the pill. I take it at 6 am as I work early and still have trouble sleeping all night.  
Avatar universal
First dose this morning.Nausea and fatigue also profuse sweating.I haven't heard of anyone else having a problem with sweating.
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