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Author Topic: BEST TIME TO TAKE TIVICAY???  (Read 1619 times)

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Offline cityboy

  • Member
  • Posts: 144
BEST TIME TO TAKE TIVICAY???
« on: March 08, 2014, 08:14:11 AM »
Will be switching from Reyataz Norvir Truvada to Tivicay and Truvada as soon as meds received. 

Normally take current meds at night since they make me sleepy.   Other than that have never had any side effects.

When is the best time to take Tivicay?   Any notable side effects?

Thanks

CB

Offline Matts

  • Member
  • Posts: 205
Re: BEST TIME TO TAKE TIVICAY???
« Reply #1 on: March 08, 2014, 10:45:39 AM »
I also will switch soon. I recommend the European VIIV Leaflet; it contains more Information than the original  one.
http://www.viivhealthcare.com/media/74706/EU_Tivicay.pdf

some excerpts:
Oral use: Tivicay can be taken with or without food (see section 5.2). In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see section 5.2). ..
 Absorption  Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.   
Food increased the extent and slowed the rate of absorption of dolutegravir.  Bioavailability of dolutegravir depends on meal content: low, moderate, and high fat meals increased dolutegravir AUC(0-) by 33%, 41%, and 66%, increased Cmax by 46%, 52%, and 67%, prolonged Tmax to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively. These increases may be clinically relevant in the presence of certain integrase class resistance. Therefore, Tivicay is recommended to be taken with food by patients infected with HIV with integrase class resistance (see section 4.2).

medicines called antacids, to treat indigestion and heartburn: Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. (See also Section 3). 
Calcium supplements, iron supplements and multivitamins:  Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it (see also Section 3).

Calcium supplements, iron supplements or multivitamins: Calcium supplements, iron supplements or multivitamins can stop Tivicay being absorbed into your body and make it less effective. Do not take a calcium or iron supplement during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.     Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Tivicay. (they reduce Tivicay up to 74%)

-You can find the "Undesirable effects" section under 4.8

tivicay/kivexa

Offline eric48

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Re: BEST TIME TO TAKE TIVICAY???
« Reply #2 on: March 08, 2014, 12:32:32 PM »
Other than that have never had any side effects.

Why do you change then ?

I hope you qualify for "with or without" food.

The info posted by Matts is more detailed than the aidsmeds drug page on this matter and indeed very useful

Cheers

Eric

Offline surf18

  • Member
  • Posts: 525
Re: BEST TIME TO TAKE TIVICAY???
« Reply #3 on: March 08, 2014, 03:42:57 PM »
I take it in the morning when I get up . I do not take it with food ,though I typically eat breakfast about and hour after I take it.

Offline buginme2

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  • Posts: 2,834
Re: BEST TIME TO TAKE TIVICAY???
« Reply #4 on: March 08, 2014, 04:08:45 PM »
TAKE IT ONCE PER DAY...THE REST IS GRAVY!!!

Offline lucinda29

  • Member
  • Posts: 3
Re: BEST TIME TO TAKE TIVICAY???
« Reply #5 on: April 15, 2014, 12:18:57 AM »
I took mine at night before I go to bed. Since it is only 2 pills a day, I took both around the same time each night before I go to bed. Try and see what works for you. The key is" to remember to take them at the same time each day, whether you decide to take them in the morning or at night".

Offline Bizkits

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  • Posts: 103
Re: BEST TIME TO TAKE TIVICAY???
« Reply #6 on: April 15, 2014, 09:25:55 AM »
I'm also about to start Truvada/Tivicay, once I've received them both, that is...still waiting on the Tivicay.

My doc told me it was okay to take with vitamins...hmmm, ok need to read that info and go talk to her...worst case scenario just take them at different times.

Also, she told me the time I take them can be a little flexible, like a couple hours here and there (say sleeping in on Saturday or staying out late if at night) as long as it is around the same time every day...is that true?
« Last Edit: April 15, 2014, 09:28:50 AM by Bizkits »

Offline Miss Philicia

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  • Posts: 23,880
  • celebrity poster, faker & poser
Re: BEST TIME TO TAKE TIVICAY???
« Reply #7 on: April 15, 2014, 10:03:13 AM »
Considering Tivicay is going to be marketed as an all-in-one HIV medication soon (though not with truvada) what's the point of this financial investment when you can't take it with a multi-vitamin, etc.? Seems a bit odd to me.
"Iíve slept with enough men to know that Iím not gay"

Offline Bizkits

  • Member
  • Posts: 103
Re: BEST TIME TO TAKE TIVICAY???
« Reply #8 on: April 15, 2014, 11:29:27 AM »
huh? How is Tivicay, as an integrase inhibitor going to be marketed as a all-in-one? Is that the epzicom/tivicay all-in-one pill they're talking about but is not available yet?

Offline AusShep

  • Member
  • Posts: 207
Re: BEST TIME TO TAKE TIVICAY???
« Reply #9 on: April 15, 2014, 12:41:25 PM »
I take mine in the AM due to the timing with any buffered meds, anti acids, vitamins, etc.  easier to wait 2 hours after my morning dose vs. 6 hours after taking anything else in the 6 hours before taking a dose in the evening.



Offline Miss Philicia

  • Member
  • Posts: 23,880
  • celebrity poster, faker & poser
Re: BEST TIME TO TAKE TIVICAY???
« Reply #10 on: April 15, 2014, 06:34:52 PM »
Is that the epzicom/tivicay all-in-one pill they're talking about but is not available yet?

Yes
"Iíve slept with enough men to know that Iím not gay"

Offline cityboy

  • Member
  • Posts: 144
Re: BEST TIME TO TAKE TIVICAY???
« Reply #11 on: April 15, 2014, 07:19:22 PM »
Just took an hour ago, feel a little zoned out and fatigued
Some abdominal pain.

Anyone else experience this?


Offline cityboy

  • Member
  • Posts: 144
Re: BEST TIME TO TAKE TIVICAY???
« Reply #12 on: April 15, 2014, 07:40:29 PM »
Thanks for the good iinformation


I also will switch soon. I recommend the European VIIV Leaflet; it contains more Information than the original  one.
http://www.viivhealthcare.com/media/74706/EU_Tivicay.pdf

some excerpts:
Oral use: Tivicay can be taken with or without food (see section 5.2). In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see section 5.2). ..
 Absorption  Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.   
Food increased the extent and slowed the rate of absorption of dolutegravir.  Bioavailability of dolutegravir depends on meal content: low, moderate, and high fat meals increased dolutegravir AUC(0-) by 33%, 41%, and 66%, increased Cmax by 46%, 52%, and 67%, prolonged Tmax to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively. These increases may be clinically relevant in the presence of certain integrase class resistance. Therefore, Tivicay is recommended to be taken with food by patients infected with HIV with integrase class resistance (see section 4.2).

medicines called antacids, to treat indigestion and heartburn: Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. (See also Section 3). 
Calcium supplements, iron supplements and multivitamins:  Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it (see also Section 3).

Calcium supplements, iron supplements or multivitamins: Calcium supplements, iron supplements or multivitamins can stop Tivicay being absorbed into your body and make it less effective. Do not take a calcium or iron supplement during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.     Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Tivicay. (they reduce Tivicay up to 74%)

-You can find the "Undesirable effects" section under 4.8

Offline AusShep

  • Member
  • Posts: 207
Re: BEST TIME TO TAKE TIVICAY???
« Reply #13 on: April 16, 2014, 10:27:06 AM »
Just took an hour ago, feel a little zoned out and fatigued
Some abdominal pain.

Anyone else experience this?

Nope...  But just switched to Tivicay ~3 weeks ago.  I'm usually having coffee fairly soon after my meds since I can be zoned out in the AM before the meds anyway...

Offline cityboy

  • Member
  • Posts: 144
Re: BEST TIME TO TAKE TIVICAY???
« Reply #14 on: April 16, 2014, 08:17:32 PM »
Two questions

Do multivitamins include all vitamins or true multis like Centrum?

Do antacids include H2 receptors like Zantac


I also will switch soon. I recommend the European VIIV Leaflet; it contains more Information than the original  one.
http://www.viivhealthcare.com/media/74706/EU_Tivicay.pdf

some excerpts:
Oral use: Tivicay can be taken with or without food (see section 5.2). In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see section 5.2). ..
 Absorption  Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.   
Food increased the extent and slowed the rate of absorption of dolutegravir.  Bioavailability of dolutegravir depends on meal content: low, moderate, and high fat meals increased dolutegravir AUC(0-) by 33%, 41%, and 66%, increased Cmax by 46%, 52%, and 67%, prolonged Tmax to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively. These increases may be clinically relevant in the presence of certain integrase class resistance. Therefore, Tivicay is recommended to be taken with food by patients infected with HIV with integrase class resistance (see section 4.2).

medicines called antacids, to treat indigestion and heartburn: Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. (See also Section 3). 
Calcium supplements, iron supplements and multivitamins:  Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it (see also Section 3).

Calcium supplements, iron supplements or multivitamins: Calcium supplements, iron supplements or multivitamins can stop Tivicay being absorbed into your body and make it less effective. Do not take a calcium or iron supplement during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.     Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Tivicay. (they reduce Tivicay up to 74%)

-You can find the "Undesirable effects" section under 4.8

Offline AusShep

  • Member
  • Posts: 207
Re: BEST TIME TO TAKE TIVICAY???
« Reply #15 on: April 16, 2014, 09:12:52 PM »
Two questions

Do multivitamins include all vitamins or true multis like Centrum?

Do antacids include H2 receptors like Zantac

Multi-vitamins like Centrum can't be taken with Tivicay.  I checked that out myself and verified with my pharmacist.  Anything containing aluminum, calcium, iron, magnesium or sucralfate (ulcer med) needs to be 2 hours after taking Tivicay, or 6 hours before (again that's why I take Tivicay in the morning, 1/2 dose multivitamin and zinc in the evening)

Zantac doesn't show as a problem on a drug interaction checker, but I'd verify with your Doctor or Pharmacist if you plan on taking them close together.  Antacid is probably a warning based on calcium.




Offline cityboy

  • Member
  • Posts: 144
Re: BEST TIME TO TAKE TIVICAY???
« Reply #16 on: April 17, 2014, 08:02:40 PM »
Thanks, that helps. 


Multi-vitamins like Centrum can't be taken with Tivicay.  I checked that out myself and verified with my pharmacist.  Anything containing aluminum, calcium, iron, magnesium or sucralfate (ulcer med) needs to be 2 hours after taking Tivicay, or 6 hours before (again that's why I take Tivicay in the morning, 1/2 dose multivitamin and zinc in the evening)

Zantac doesn't show as a problem on a drug interaction checker, but I'd verify with your Doctor or Pharmacist if you plan on taking them close together.  Antacid is probably a warning based on calcium.

Offline Bizkits

  • Member
  • Posts: 103
Re: BEST TIME TO TAKE TIVICAY???
« Reply #17 on: April 21, 2014, 10:00:28 AM »
I just started taking Truvada/Tivicay last Thursday as my first regimen ever. The pharmacist told me to stop taking zinc supplements period. She said there's a small amount of zinc in multi-vitamins which isn't a huge deal but to stop the extra. She also said it would be best to take multi-vitamin apart from tivicay, as has already been mentioned.

I have been taking the Truvada/Tivicay in the morning and maybe have noticed a very teeny bit of gastric upset...like a small bloating/gas-like feeling but it goes away within an hour or 2 and really is not bad at all to begin with. No other effects at all. :)

Offline AusShep

  • Member
  • Posts: 207
Re: BEST TIME TO TAKE TIVICAY???
« Reply #18 on: April 21, 2014, 01:29:29 PM »
I just started taking Truvada/Tivicay last Thursday as my first regimen ever. The pharmacist told me to stop taking zinc supplements period. She said there's a small amount of zinc in multi-vitamins which isn't a huge deal but to stop the extra. She also said it would be best to take multi-vitamin apart from tivicay, as has already been mentioned.


IDK...  The detailed drug guide doesn't say anything specifically about zinc, but it is a polyvalent cation; but so is potassium, and it doesn't say not to eat a banana with breakfast...  I'm taking 50 mg 12 hours apart from Tivicay, but good catch, I'll verify low zinc supplement with my doc in addition to my 1/2 dose multi.

The detailed info shows a 1/3 reduction in Tivicay efficacy if taken at the same time as a multi.  But even Maalox, which reduces efficacy 75% if taken together, is down to 20% two hours later, the minimum recommended wait.  Hopefully after 12 hours there's no impact at all.


Quote
Medications containing polyvalent cations

(e.g., Mg, Al, Fe, or Ca)
Cation-containing antacidsa or laxatives Sucralfate
Oral iron supplements Oral calcium supplements
Buffered medications

TIVICAY should be administered
2 hours before or 6 hours after taking medications containing polyvalent cations.

Offline cityboy

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  • Posts: 144
Re: BEST TIME TO TAKE TIVICAY???
« Reply #19 on: April 24, 2014, 01:35:57 PM »
Off Reyataz/Norvir/Truvada taking Tivicay/Truvada going on 2nd week.

These are the noticeable differences for me:
 
No fatigue or any effects after taking Tivicay so far (only first couple of days
   felt some abdominal pain and gas, that is gone now)
Stools are solid again
No more bloated feeling
Energy level is still great, but feels more evenly paced through the day.
Less dehydrated
Breathing feels clearer.






Offline Matts

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  • Posts: 205
Re: BEST TIME TO TAKE TIVICAY???
« Reply #20 on: May 17, 2014, 05:08:08 PM »
A FDA update for Tivicay:
You can take multivitamins and supplements with Tivicay if You have a meal at the same time, otherwise as before:  2 hours before or 6 hours after taking supplements containing calcium or iron.

"... Additionally, in section 7: Drug Interactions, Table 5 Ė the following was added regarding co administration with oral calcium or iron supplements, including multivitamins containing calcium or iron: TIVICAY should be administered 2 hours before or 6 hours after taking supplements containing calcium or iron. Alternatively, TIVICAY and supplements containing calcium or iron can be taken together with food."

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm397765.htm

the rest of the update is incomprehensible for me:)
tivicay/kivexa

Offline AusShep

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  • Posts: 207
Re: BEST TIME TO TAKE TIVICAY???
« Reply #21 on: May 17, 2014, 08:36:40 PM »
Thanks Matt, good info.

I just picked up a refill today, and of course the new info isn't on the sheet yet; and since I don't exactly read those inserts every month, nice to see the update here.

Offline survivor703

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  • Posts: 104
Re: BEST TIME TO TAKE TIVICAY???
« Reply #22 on: May 18, 2014, 10:42:59 AM »
Quote
A FDA update for Tivicay:
You can take multivitamins and supplements with Tivicay if You have a meal at the same time, otherwise as before:  2 hours before or 6 hours after taking supplements containing calcium or iron.

I take the same regimen... and I usually take my two pills around 1:15pm daily.
I take any supplements at night before bed though, just to throw caution to the wind. The science says we should be safe though, as also evidenced by the recent FDA update provided by Matts.

Quote
IDK...  The detailed drug guide doesn't say anything specifically about zinc, but it is a polyvalent cation; but so is potassium, and it doesn't say not to eat a banana with breakfast...  I'm taking 50 mg 12 hours apart from Tivicay, but good catch, I'll verify low zinc supplement with my doc in addition to my 1/2 dose multi.

In regards to the aluminum, calcium, iron, magnesium and other electron deficient cations, these particular atoms, when in solution, causes the pH to change. These act as BrÝnstedĖLowry acid/bases. The active in tivicay, (4R,12aS)-N-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide requires a fairly acidic pH to be absorbed properly. If the pH is out of this range, this molecule, a typical carboximide (amino carbonyl), will become protonated and loose the capacity to hydrogen bond. This will effect pk values, causing for much less absorption.

But here's the good thing... the pH of the stomach is usually buffered around pH=1-5 or so. So that means that it will resist big changes in pH. This translates to the fact hat in order to get the pH of the stomach to change, you'd need to take a WHOLE LOTTA calcium in order to get the pH up even a bit. I believe in vitro studies showed that the absorption was much less in the presence of such cations. In vivo is a different story, however.

ViiV has probably provided some research to the FDA that supports this, and as a result, the label has changed (or will be changing soon), and that's good because to be quite frank, it's very wise to take calcium with tenofovir (usually prescribed with tivicay in the form of truvada), due to the possibility of bone density loss.

But I think I'll still take mine at night, just because I'm used to it, and I don't want to commit to taking food with it, otherwise I would have gone with complera  ;)
... I pop my fish oils and calcium/D3 just before bed, and will continue to do so.
« Last Edit: May 18, 2014, 10:45:24 AM by survivor703 »
02/14/2012 Diagnosed (Happy valentines day)
02/15/2012 CD4 502 21%, VL 69,134
04/10/2012 CD4 607 22%, VL 60,893
10/08/2012 CD4 615 15%, VL 155,981
03/01/2014 CD4 340 17%  VL 65,689
05/05/2014 1:18PM EST Started Truvada + Tivicay
06/03/2014 CD4 620 20% VL 30 (almost UD!)
Next Labs 08/2014

Offline Matts

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Re: BEST TIME TO TAKE TIVICAY???
« Reply #23 on: May 25, 2014, 06:20:40 PM »
Thank You Mr. Survivor for the info, it was interesting. GSK has delivered a proper study:


"Calcium and Iron Supplements Lower Dolutegravir
 Levels When Taken Between Meals
 
 
 
   15th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy, May 19- 21, 2014, Washington, DC
 
 Mark Mascolini
 
 Calcium supplements taken with dolutegravir between meals lowered dolutegravir exposure by one third. Iron supplements with dolutegravir between meals approximately halved dolutegravir exposure. Supplements did not have this effect when taken with dolutegravir with a meal, or when dolutegravir was taken 2 hours before the supplement.
 
 Antacids containing high levels metal cations significantly cut levels of dolutegravir, a 2-metal-binding integrase inhibitor, because of chelation. Current prescribing information recommends taking dolutegravir 2 hours before or 6 hours after cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.
 
 To learn more about calcium and iron supplement interactions with dolutegravir, GlaxoSmithKline researchers conducted an open-label four-period crossover study in healthy volunteers, half of them randomized to take 50 mg of dolutegravir with a calcium supplement (1200 mg of calcium carbonate) and half randomized to take the integrase inhibitor with an iron supplement (324 mg of ferrous fumarate).
 
 Study participants took these agents in a four-step sequence: dolutegravir alone fasted; dolutegravir with a single dose of calcium or iron fasted; dolutegravir with a single dose of calcium or iron with a moderate (about 30%) fat meal; and dolutegravir fasted 2 hours before a single dose of calcium or iron. At least a 7-day washout separated each period.
 
 Twelve people taking calcium and 11 taking iron could be evaluated. There were no grade 3 or 4 adverse events and no serious adverse events. Only one drug-related adverse event occurred--grade 1 nasal congestion.
 
 Taking dolutegravir with a calcium supplement fasted lowered dolutegravir area under the concentration-time curve (AUC) 39%, maximum concentration (Cmax) 37%, and 24-hour concentration (C24) 39% when compared with dolutegravir alone fasted. Taking dolutegravir with an iron supplement fasted lowered dolutegravir AUC 54%, Cmax 57%, and C24 56%. Neither calcium nor iron affected dolutegravir concentrations when the supplement and the integrase inhibitor were taken together with a meal or when dolutegravir was taken 2 hours before the supplement.
 
 "Dolutegravir and calcium or iron supplements can be co-administered if taken with a meal," the researchers concluded. "Under fasted conditions, dolutegravir should be given 2 hours prior or 6 hours after calcium or iron supplements."
 
Reference
 
 1. Song I, Borland J, Arya N, Wynne B, Piscitelli S. The effect of calcium and iron supplements on the pharmacokinetics of Dolutegravir in healthy subjects. 15th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. May 19-21, 2014. Washington, DC. Abstract P_13.  "

http://natap.org/2014/Pharm/Pharm_01.htm

tivicay/kivexa

 


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