Treatment on Harvoni

Mitzi, Good morning!

As always, follow your doctor's recommendation with treatment.

I have not seen anything regarding Harvoni and the need for increased water. Each treatment is unique. This one is quite new.

With interferon/ribavirin, increased water was recommended to my husband, themister, both times he treated. Riba sides, we were told, were the reason for the increased water.

With this new treatment, I have not seen the water increase recommendation. You are one of the early treating folks on our forum.

I am posting the US FDA patient info sheet. Please check in an let us know any side effects or issues during treatment so others can learn from you. I am so happy you will soon be Hep C free. Big Hugs

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HARVONI™
(har-VOE-nee)
(ledipasvir and sofosbuvir) Tablets

Read this Patient Information before you start taking HARVONI and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is HARVONI?
•HARVONI is a prescription medicine used to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults.
•HARVONI contains the prescription medicines ledipasvir and sofosbuvir (SOVALDI®).

It is not known if HARVONI is safe and effective in children under 18 years of age.

What should I tell my healthcare provider before taking HARVONI?

Before taking HARVONI, tell your healthcare provider if you:
•have liver problems other than hepatitis C infection
•have severe kidney problems or you are on dialysis
•have any other medical condition
•are pregnant or plan to become pregnant. It is not known if HARVONI will harm your unborn baby.
•are breastfeeding or plan to breastfeed. It is not known if HARVONI passes into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI may affect the way other medicines work, and other medicines may affect how HARVONI works.

You should not take HARVONI if you also take other medicines that contain sofosbuvir (SOVALDI®).

Especially tell your healthcare provider if you take any of the following medicines:
•an antacid that contains aluminum or magnesium hydroxide. If you take an antacid during treatment with HARVONI, take the antacid 4 hours before or 4 hours after you take HARVONI.
•carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®)
•digoxin (Lanoxin®)
•efavirenz, emtricitabine, tenofovir disoproxil fumarate (ATRIPLA®)
•elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (STRIBILD®)
•medicines for indigestion, heartburn, or stomach ulcers, such as nizatidine (Axid®), famotidine (Pepcid AC®), cimetidine (Tagamet®), ranitidine (Zantac®), esomeprazole (Nexium®), lansoprazole (Prevacid®), omeprazole (Prilosec®), rabeprazole (Aciphex®), or pantoprazole (Protonix®)
•oxcarbazepine (Trileptal®, Oxtellar XR®)
•phenytoin (Dilantin®, Phenytek®)
•phenobarbital (Luminal®)
•rifabutin (Mycobutin®)
•rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®)
•rifapentine (Priftin®)
•rosuvastatin (Crestor®)
•simeprevir (Olysio®)
•St. John's wort (Hypericum perforatum) or a product that contains St. John's wort
•tipranavir (Aptivus®) used in combination with ritonavir (Norvir®)
•tenofovir disoproxil fumarate (VIREAD®, TRUVADA®) used in combination with atazanavir (Reyataz®) and ritonavir (Norvir®), darunavir (Prezista®) and ritonavir (Norvir®), or used in combination with lopinavir and ritonavir (Kaletra®)

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take HARVONI?
•Take HARVONI exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
•Do not stop taking HARVONI without first talking with your healthcare provider. If you think there is a reason to stop taking HARVONI, talk to your healthcare provider before doing so.
•Take HARVONI 1 time each day with or without food.
•If you miss a dose of HARVONI, take the missed dose as soon as you remember the same day. Do not take more than 1 tablet of HARVONI in a day. Take your next dose of HARVONI at your regular time the next day.
•If you take too much HARVONI, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of HARVONI?

The most common side effects of HARVONI include:
•tiredness
•headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of HARVONI. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store HARVONI?
•Store HARVONI at room temperature below 86oF (30oC).
•Keep HARVONI in its original container.
•Do not use HARVONI if the seal over the bottle opening is broken or missing.

Keep HARVONI and all medicines out of the reach of children.

General information about the safe and effective use of HARVONI

It is not known if treatment with HARVONI will prevent you from infecting another person with the hepatitis C virus during treatment. Talk with your healthcare provider about ways to prevent spreading the hepatitis C virus.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use HARVONI for a condition for which it was not prescribed. Do not give HARVONI to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information about HARVONI, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about HARVONI that is written for health professionals.

For more information, call 1-800-445-3235 or go to www.HARVONI.com.

What are the ingredients in HARVONI?

Active ingredients: ledipasvir and sofosbuvir

Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The tablet film-coat contains: FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

ZelDDa,
I'm happy that you're finally getting the meds you need. This has taken a long time.

Mitzi, I have changed your subject line for you. Let me know if you want anything else. Happy to know you got your first pill down. You are on your way to being Hep C free!! Big Hugs

You'll save a ton of money if you use omeprazole, the generic version of Nexium/Prilosec. My docs prescribed 20 mg. and it works just fine.

Thanks, ppm guy. I addressed that today. I had the prilosec changed to the 20mg. The Nexium dioes work much better though. The bottom line is my insurance pays for the Prilosec, not the Nexium.

Day two on Harvoni has gone well. I dose every day at 4pm. The only change was my pulse rate. I take my blood pressure two or three times a day. My pulse is at 92. Spoke with my cardiologist today and was advised to contact them immediately if it hits 100 or higher. Blood pressure is good.

An ongoing problem I have been having is severe cramps in my legs at night. I am taking prescribed potassium, with magnesium, and zinc supplements. I am on HCTZ, twice a day. I am staying well hydrated. I did read that one of the symptoms of cirrhosis is severe leg cramps. There could be several causes for this so I am tracking it to discuss with my doctor on next visit.

Will continue to post throughout duration. Taking one day at a time with a positive attitude.
Mitzi

Okay, it's been awhile. I have had some issues and just couldn't post. I started Harvoni on February 9th of 2015. I didn't get headaches, insomnia, or nausea. I have always been regular with going to the bathroom. On the second or third day I noticed I was getting constipated. I ate foods to correct the problem. It did not happen. In the middle of this, I also fell and hit my right hip. I have intense pain in my groin, hip, and buttocks. Things got so bad, I called the doctor. He told me to get Magnesium Citrate, drink half of the bottle. If I did not go in an hour, drink the rest being a total of 10 ounces. I did not have pain and cramps like with Senokot or Correctal. Six hours later I finally had success! I have never felt pain in my life being impacted like that.

I have 2 MRI's and an Ultrasound scheduled for Wednesday to check for possible hernia and maybe a fracture. Needless to say, I am in a lot of pain right now. The Harvoni definitely has caused the constipation problem.

I will keep you posted once I find out what the problem is. Thanks for being here...
Hugs
Mitzi

mitzi, I am so sorry you fell and are in pain. Please let us know how things look with your tests.

You know, I have heard a few people are having some noticeable constipation with Harvoni. This is a new treatment and I am glad you are reporting your sides to the forum. I think reporting this to your specialty pharmacy would be a good idea. I spent some time looking around the world wide web and I see several reports of the same side effect. Most that do have sides see headache and fatigue. I am glad treatment a short duration. And Harvoni is so very successful. Big Hugs

Hi Mitzi, Great news on the 2 week VL. Undetectable is what we love to hear!

I have no ideas on the ascities, other than something to do with cirrhosis, possibly. What does your hepa say? I hope you figure out what is causing your pain soon. The CT scan should answer some questions. Please update as you can.

After your posts regarding constipation on Harvoni, I poked about the internet and did see some others with noted constipation, as I mentioned last time I posted to you. I am glad you are reporting that here so others following your treatment are aware. It looks like one of those missed side effects with this new treatment. I was surprised to see so many others report it. Take care of yourself. Big Hugs

Thanks for this post. Hope they find out the cause of your pain soon. Congratulations on undetectable. ... I'm starting Harvoni soon so this is good info for me. Keep it coming. ;)

It is always best to have a liver specialist, hepatologist, look after your care when you have cirrhosis.

It would be for docs to decide if you are compensated or decompensated, though the Internet definitions certainly suggest that. But don't give up the ghost yet...many who are properly treated can manage a long time with a poorly functioning liver...look at aziffle's posts. Orlando has a good program.

Day by day, my friend, day by day...sending good thoughts your way.

Mama Lama

Stay with it girl, you'll get there.

Thanks for your information. Wr have lots of members BUT there are so many who check the site who don't post themselves...true stories, success stories, and the things we learn over time truly help so many othersHuhs,

Ml