Why does Gilead tell you to take Zantac together with Epclusa?

[Jorah]

I've talked about getting off the pantoprazole (acid reducer) before and I have tapered off of it but my reflux is so strong (probably because the the rebound effect) and also because I have taken them for almost 30 years...this is why  I continue to take Zantac (a different type of pill) twice a day because the reflux is too strong ..I need to take the zantac and tums/gaviscon because the zantac alone is not enough.

For those who have started Epclusa may know that Gilead recommends taking zantac at the same time with epclusa. For me it didn't make sense because zantac will reduce your stomach acids within 1/2 hour of taking them ...and ..Gilead recommends a an acidic environment in your stomach..I don't understand this ..it doesn't make sense and the nurses of Gilead didn't know why and their pharmacists won't tell me because they can't release proprietary information....

I want to make sure I get the maximum effect from Epclusa but at the same time not go crazy with strong heartburn. Does anyone have more information? Shouldn't I take zantac 4 hours after the Epclusa?

Thank you very much

[lporterrn]

I have to get to an appointment so can answer this better later, but the short answer is because medications don't all release in our system at the same time. Taking the acid reducer medication at the same time as Epclusa means that you get the benefits of both since they release at different times. Also, I will track down the latest research, but I think they found that the other med you took is likely OK.

Bottom line - what you are doing is safe.

[Jorah]

I have to get to an appointment so can answer this better later, but the short answer is because medications don't all release in our system at the same time. Taking the acid reducer medication at the same time as Epclusa means that you get the benefits of both since they release at different times. Also, I will track down the latest research, but I think they found that the other med you took is likely OK.

Bottom line - what you are doing is safe.

Ok thank you, they may not release at the same time...but the zantac releases within 30 minutes and works for 12 hours...so the acid in the stomach is reduced ...........then the epclusa starts releasing ..I don't know how fast...but we know it takes 4 hours to be absorbed...but by that time the acid is reduced ..so you understand why I'm skeptical...

The Treatment nurse and the specialty pharmacist told me that I should get off the PPI and the H2 because they are not recommended. I know of the Ottawa hospital study that says that acid reducers don't change treatment outcome. I wish they all get get their "stuff" together and wished Gilead released information around this so patients can feel reassured instead of being mysterious.

I'm sure you may have additional info Thanks Lucinda 

[Lynn K]

Through testing they have determined this is the best way.

The Epclusa has passed from the stomach before the acid reducing effects of Zantac occur. The Epclusa does not remain in the stomach for 30 mins I am assuming the med is adsorbed into the blood stream through the small intenstines with the reduction in acid from Zantac following behind in place and time. This is my lay persons guess but anyway I am assuming the medical researchers examined this question in depth and this was their determination.

I make this assumption because of how specific the instructions are for the different classes of antacids/acid reducers.

[Jorah]

Hello Lynn,
The other day we were talking about this stuff and if you remember you posted this link that a PPI was supposed to be taken 4 hours after Epclusa? 
http://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf?la=en

Well..I'm looking at their epclusa monograph and its saying that the PPI should be taken together with food at the same time with epclusa. I'm not sure they know what they're doing...it worries me.  (table 7)  This is why I keep asking...
http://www.gilead.ca/pdf/ca/Epclusa_pm_english.pdf

[Lynn K]

Not entirely sure that is correct for a PPI there seems to be a difference between the prescribing info sheet and whatever the Canadian doc you have is.

The Canadian doc does not say at the same time or to wait it is mute on that point I am wondering if that was an oversight.

From table 7.3 on page 9

Coadministration of omeprazole or other proton-pump inhibitors is not recommended. If it is considered medically necessary to coadminister, EPCLUSA should be administered with food and taken 4 hours before omeprazole 20 mg. Use with other proton-pump inhibitors has not been studied.

So what I read is take the Epclusa with food then wait 4 hours before taking omeprezole (Prilosec).

However, Zantac is not a PPI it is an H2 antagonist. Per table 7.3 page 9:

"H2-receptor antagonists may be administered simultaneously with or 12 hours apart from EPCLUSA at a dose that does not exceed doses comparable to famotidine 40 mg twice daily."

http://www.medicinenet.com/script/main/mobileart.asp?articlekey=861

DRUG CLASS AND MECHANISM: Ranitidine is an oral drug that blocks the production of acid by acid-producing cells in the stomach. It belongs to a class of drugs called H2 (histamine-2) blockers that also includes cimetidine (Tagamet), nizatidine (Axid), and famotidine (Pepcid).

[Jorah]

What I'm saying is that they are giving 2 different types of information for the PPI's on the first link they say to have it 4 hours after the Epclusa and on the second link the same PPI is to be taken at the same time with Epclusa and food....

[Lynn K]

I made a couple of edits above

Your Canadian document does not say one way or the other to wait it does not say at the same time it says nothing which I do find odd. But the FDA approved document from Giliead does specifically state to wait 4 hours after taking Epclusa with food before taking Prilosec and that this has not been evaluated with other PPI's

Have you tried the Giliead help line? I would ask them about the discrepancy in the 2 instructions.

http://www.epclusainfo.com/contact-us

CONTACT US

For additional information about EPCLUSA or Onward™, call Gilead at 1-844-4-EPCLUSA (1-844-437-2587). For additional information about EPCLUSA Support Path®, call 1-855-7-MYPATH (1-855-769-7284).

Address

Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404

Phone

(650) 574-3000

[Jorah]

Thank you , yes the oversights worry me. That's why i'm worried about the zantac.
Friday evening, I doubt I'll find someone. Maybe Monday.

[Lynn K]

I am curious to hear what they have to say about this.

[lporterrn]

I am trying to lay my hands on the data I saw that basically found that this may not be an issue, or if it is, it is a small chance and not significant one. Can't find the data I really trusted. However, the U.S. Veterans Association has an excellent site that spells it out simply: https://www.hepatitis.va.gov/pdf/acid-reducing-meds.pdf

[Jorah]

Thanks for looking Lucinda, I don't find the discrepancy in the US and the Canadian monograph reassuring. This VA site you posted is also not correct, Gilead recommends 40 mg of famotadine or equivalent twice a day. The VA site recommends double that: 300mg of ranitadine twice a day which is very high the usual dose is 150 mg twice a day. But thanks again for looking...

I am trying to lay my hands on the data I saw that basically found that this may not be an issue, or if it is, it is a small chance and not significant one. Can't find the data I really trusted. However, the U.S. Veterans Association has an excellent site that spells it out simply: https://www.hepatitis.va.gov/pdf/acid-reducing-meds.pdf

[lporterrn]

Jorah - please be patient with me when I ask this - I am not sure that I understand what is confusing. The VA, plus the US, Canada, and European Epclusa monographs all say to take H2-receptor antagonists (zantac) either with Epclusa or 12 hrs apart. 

RE the VA dose recommendations: Medicine is based on evidence with a subjective application about what that evidence means. If I understand your situation, the dose recommendations are less important in your particular case since you are concerned about Epclusa's efficacy more than whether you find the right dose of acid-reducing medication, right? What is indisputable is the timing of when to take the medications - that is determined by a more rigorous method of lab-based inquiry rather than clinical trials. The dose discrepancy doesn't call the source into question - it is just the determination of the group of people that put those guidelines together. It doesn't mean that one is right or wrong - it is still safe. As patients, we tend to want universal agreement, and when we don't get it, we don't feel safe. However, I think there isn't any cause for concern other than we patients just worry.

Hope this helps.

[Jorah]

Thank you Lucinda, the main thing I worry about is that the Epclusa will not absorb well with the Zantac. (Epclusa needs an acidic enviroment to be absorbed the zantac within half an hour changes removes acidity) I find Gilead's information conflicting and Gilead will not clarify after I tried to ask. The nurses at the Epclusa info site know nothing about this, their pharmacist won't talk to me.

I also worry that in their US monograph they say to wait four hours before taking a PPI (acid reducer)  so it can be absorbed, but on the Canadian Monograph it says to take the PPI TOGETHER with Epclusa This last information makes me even more worried...doesn't make sense...makes me think they don't know what they're doing...I know I'm taking ranitadine and not the PPI but I find it worrysome   (it wouldn't be the first time a pharm company made a mistake)

I'm not happy with this, this may be my only chance to take these pills, its not that I'm taking an asprin, that I can pick up everyday...I want the Epclusa to work 100%....

On the VA site I'm only pointing out that the doses of ranitadine are not common the max a day is 300mg  not 600mg. (i just wonder if they know what they're posting?) But Its not important ..the main and right information should come out of Gilead.

Thank you 

[Lynn K]

For the PPI, on the Canadian document I did not see any timing referenced it did not say to take at the same time nor did you say to wait it just said to take Epclusa with food while the US prescribing information sheet did specifically said to wait 4 hours after taking Epclusa with food before taking a PPI.

I thought you also intended to continue taking your PPI (proton pump inhibitor) pantoprazole? A PPIis notan acid reducer it prevents the formation of acid thus the term "inhibitor".

As far as H2 antagonists like Zantac those should be taken simultaneously with Epclusa I believe all the documentation is in agreement on that.

[Jorah]

I would love to go back to the PPI, my pharmacist said that I was better off on the H2 than the PPI because it had less acid reduction. I wish the Doctors would have told me this months ago so I could have the time to try to get off of them(if I can), not a week prior to treatment.

This is what the Canadian document says:
Proton-pump inhibitor doses comparable with omeprazole
20 mg or lower can be administered with EPCLUSA when
EPCLUSA is administered with food. (page 15)

http://www.gilead.ca/pdf/ca/Epclusa_pm_english.pdf

The US document says to take it 4 hours latter.    Amazing...

For the PPI, on the Canadian document I did not see any timing referenced it did not say to take at the same time nor did you say to wait it just said to take Epclusa with food while the US prescribing information sheet did specifically said to wait 4 hours after taking Epclusa with food before taking a PPI.

I thought you also intended to continue taking your PPI (proton pump inhibitor) pantoprazole? A PPIis notan acid reducer it prevents the formation of acid thus the term "inhibitor".

As far as H2 antagonists like Zantac those should be taken simultaneously with Epclusa I believe all the documentation is in agreement on that.

[Lynn K]

My point was that while the  prescribing information sheet is very specific and uses the word "simultaneously"when describing how to take and a H2 antagonist, but meanwhile in the instructions for the PPI there's not a specific time frame mentioned in the Canadian instructions.

I don't take "can be administered with Epclusa when Epclusa is administered with food" to mean at the same time. To me it is not specific as to the timing which is very different from the very specific timing mentioned for antacids like Tums and H2 antagonists like Tagamet. This does seem to me as though it may have been an error in the Canadian instruction to not mention the 4 hour wait.

Although it is concerning that is not clear on that issue of timing the dosing for a PPI between the 2 sets of instructions, as you are not intending to continue with your PPI while on treatment for you the point is moot.

[lporterrn]

Since the Zantac recommendations are identical in the US, Canada, and Europe, that may be a good fit for you now, assuming the Zantac works. Note that the U.S. and Europe drug profiles are identical and the only difference with the Canadian is that IF you take the PPI and Epclusa together, take it with food.

[Jorah]

I'm still using the Zantac, I need many tums and antacid to compliment the zantac. Will see if to continue or go back to the PPI. Also spoke with a Gilead US pharmacist, he agreed with my concern about taking the Zantac and Epclusa at the same time, but thinks maybe in the studies it worked out ok. (didn't know for sure)Whatever

I also spoke to him about the discrepancy between the Epclusa and PPI's in regards to the US monograph and the Canadian and he was surprised. Didn't know why..
I just hope a bunch of Canadians are not taking the drug the wrong way...
Will also talk to Gilead Canada to hear what they have to say.