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Author Topic: Efavirenz 400mg vs 600mg - as good as, less CNS side effects  (Read 2275 times)

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Offline newt

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People may be interested in this study report:

Reduced efavirenz dose suppresses HIV as well as standard dose
http://www.aidsmap.com/page/2693397/

In brief, 400mg works as well as 600mg but has less side effects.

The study in question, ENCORE1, was a randomised, double-blind, non-inferiority trial of 600+ participants. On an intent-to-treat basis, when combined with Truvada, 400mg and 600mg were as effective as each other after 48 weeks. Side effects were significantly less in the lower dose arm, with 37% on the lower dose vs 47% on standard dose getting CNS side effects.

- matt
"The object is to be a well patient, not a good patient"

Offline OneTampa

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #1 on: July 04, 2013, 09:03:14 PM »
I have posted here on the Boards several times about taking low dose Sustiva at 400 mg. I have taken Sustiva at 400 mg since the late 1990s because I could not tolerate the 600 mg when I first started the medication.

My doctor said that he read about a small study at the time in the 1990s that said 400 mg Sustiva was just as effective as 600 mg, so I started.  I have been non detectable for over 11 years with no pronounced and intolerable side effects I often read about here on the Boards. I have also taken low dose Viracept for more than 5 years.

I also think Ann has posted about low dose Sustiva and has a different take.
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Offline mecch

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #2 on: July 04, 2013, 10:55:12 PM »
Thanks that is very cool
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline SteveS

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #3 on: July 05, 2013, 04:49:18 AM »
I would be interested in Ann's perspective. She seems quite knowledgable.

What might this mean for those of us on Atripla?

I am fine with 2 or 3 pills, as long as they can be taken at the same time each day. Might they retool the levels in Atripla? Or is another combination available to me? Sorry - I am VERY new to all of this...

Offline newt

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #4 on: July 05, 2013, 07:55:24 AM »
Efavirenz comes in 200mg capsules, so it is possible to form a 400mg dose and add this to Truvada, which contains the other two drugs present in Atripla. Obviously, for co-payers, this is not good perhaps, since it swaps 1 pill for 3....
 
I expect someone somewhere will make an all-in-one 400mg of efavirenz-based pill sooner or later.

- matt
"The object is to be a well patient, not a good patient"

Offline Ann

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #5 on: July 05, 2013, 11:08:34 AM »

I would be interested in Ann's perspective. She seems quite knowledgable.

What might this mean for those of us on Atripla?

I am fine with 2 or 3 pills, as long as they can be taken at the same time each day. Might they retool the levels in Atripla? Or is another combination available to me? Sorry - I am VERY new to all of this...


Steve, I've discussed this twice recently, so rather than type it all out again, I've quoted the relevant posts below. You can go into the thread where they were originally posted by clicking on the "Quote from: Ann [etc]" link at the top of the quote box.


And just a little Sustiva aside that you might be interested in hearing - when my partner was first put on Sustiva (and Combivir* as was usual back in the early 2000s), he had really bad nightmares every freaking night. I mean waking-up-the-whole-house-and-neighbours-too screaming nightmares.

He'd been an aide worker in South Sudan during the 90s and every night he relived every horrible thing and all the human suffering he saw there - but even more gruesome and horrifying than in real life.

Back in those days (early 2000s), Sustiva was considered the freakin' bee's knees. Instead of switching him for something else (fewer choices available then), they did something called Therapeutic Drug Monitoring (TDM) on him and discovered that he always had much, much higher concentrations of Sustiva in his blood than he should have had.

The usual dose is 600mgs. At first they dropped him down to 400mgs, but he was still having nightmares more often than not and TDM still showed too-high levels. Then they dropped him down to 200mgs (practically unheard of!) and the nightmares stopped for the most part.

He remained UD on this low dose for around nine/ten years (aside from the occasional blip), until they switched him to Intelence late last summer. (still UD) While he no longer has the nightmares, and no longer talks in his sleep, he's still having trouble getting a good night's sleep.

*They switched the Combivir out for Truvada ... around 2007, IIRC.



My partner started out on the usual 600mgs of Sustiva (back in the days before Atripla) and his Sustiva-induced side-effects were through the roof. They cut him back to 400mgs - using TDM as a guide - and eventually cut him back to 200mgs, also using TDM as a guide.

He still had side-effects, but they were more manageable. He did NOT cut down on his other two meds (AZT and lamivudine - aka Combivir) as they were NOT at too-high levels. They were just right.

During the last few years of being on Sustiva 200mgs, they switched him from Combivir to Truvada. No change in side-effects. He is now on Intelence (etravirine) and Truvada and feels much better for it.

For the record, my partner is pretty much the same size as you - slightly taller height, slightly lower weight. Having optimal drug levels in your body has much more to do with your body's metabolism, liver function and kidney function than it does your height and/or weight.



I'm happy someone has finally done a study on a reduced Sustiva dosage. However, I don't think the makers of Atripla will be very happy about it - or am I being cynical? ;)
« Last Edit: July 05, 2013, 11:17:55 AM by Ann »
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"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

Offline JMMich

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #6 on: July 05, 2013, 11:29:29 AM »
This should make the Atripla manufacturers happy, at least in theory. They can make a version #2 of the pill with the 400mg dose, then charge probably about the same amount for it but with a (presumably) larger profit margin since they don't have to put as much efavirenz into manufacturing it. And, as an added bonus, their PR flacks can tout it as "the latest cutting edge treatment for HIV" even if in reality all it is, is tweaking an already-existing product.

Then again, this is big business we're talking about...Ann is probably right, they're unlikely to be too pleased.

Offline SteveS

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #7 on: July 05, 2013, 11:49:24 AM »
Thanks - I understand more now. Thankfully, though my dreams are much more vivid, it is not bothering me much.

I do hope however that someone comes up with one pill with the lower dose. To me, the less medicine the better.

Offline Ann

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #8 on: July 05, 2013, 12:17:32 PM »

I do hope however that someone comes up with one pill with the lower dose. To me, the less medicine the better.


The less medicine the better? You'd be taking the same amount of meds whether it was one pill (Atripla) or three (two 200mgs Sustiva + one Truvada).

I really don't get the allure of taking one pill as opposed to two or three or four. They can all go down in one either way.

I take three pills at once (one Prezista, one Norvir, one Truvada) and that's recently down from four (two Prezista, one Norvir, one Truvada - Prezista went from 2x400mg to 1x800mg) and one less pill hasn't made the slightest difference. They all go down the hatch in one gulp.

In fact, I take nine pills (non-hiv meds) in the morning and they also go down in one. Swallowing a handful of pills is no different to swallowing food when you're eating.

I totally get wanting a once-a-day combo, because it can be too easy to forget to take meds twice a day, but I really, really don't get the big deal about only having to take one pill once a day as opposed to two, three or four (or nine!) once-a-day.
Condoms are a girl's best friend

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"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

Offline darryaz

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #9 on: July 05, 2013, 01:09:01 PM »
However, I don't think the makers of Atripla will be very happy about it - or am I being cynical? ;)

If they want to make lemonade from this news they will come out with a NEW product..... Atripla Lite or something like that.

Offline Ann

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #10 on: July 05, 2013, 01:37:44 PM »
If they want to make lemonade from this news they will come out with a NEW product..... Atripla Lite or something like that.

Yep, and with the new patent that will come with it. I suppose that would have them creaming their jeans jumping for joy. But in the meantime....
Condoms are a girl's best friend

Condom and Lube Info  



"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

Offline Common_ground

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #11 on: July 05, 2013, 01:48:41 PM »
How could it take 15 years finding out 400mg is enough? :o
2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

Offline MitchMiller

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #12 on: July 05, 2013, 09:55:31 PM »
Common:  I was asking why somebody wasn't running reduced dosage tests a long time ago.  I guess there is a lot of risk considering one could develop resistance.

I'm glad somebody finally has done it, especially because the Indian pharmacy I have been using just raised their price to $375 for 90 600mg Sustiva.  I can get 180 200mg tablets for $250 from them. 

400mg done deal for me.  I'm sold! 

Offline oksikoko

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #13 on: July 06, 2013, 05:02:26 AM »
If they want to make lemonade from this news they will come out with a NEW product..... Atripla Lite or something like that.

I'm just brainstorming here, but there's lots of room for growth in this area. They're really lacking in both the product line extension and brand diversification areas.

Atripla XR
Atripla (with enteric coating)
Chewable Atripla
Atripla Gummies, fortified with Vitamin C
Classic Atripla, Vanilla Atripla, Diet Atripla, Caffeine-Free Atripla

Sandra Lee doesn't do pharmaceuticals down at the Kmart, but they could probably co-brand some flatware or a rug. I suppose Atripla brand condoms and personal lubricant would be more "on demographic", but I'd kill for some Atripla pillowcases.
Code: [Select]
2013-10-03:                ☣ VL (=) undetectable ☣ CD4 (+) 1105
2013-05-23:                ☣ VL (=) undetectable ☣ CD4 (-) 945
2013-02-25:                ☣ VL (-) undetectable ☣ CD4 (+) 1123
2012-12-16: Enter Stribild
2012-11-20: HIV+           ☣ VL (→) 132,683      ☣ CD4 (→) 920
2012-04-01: HIV-
Dates in this signature file conform to ISO 8601. ;-)

Offline witch

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #14 on: September 13, 2013, 08:29:18 PM »
I suspect many, if not most, of the anti-hiv drugs are overdosed by a factor of 2 to 10. The manifacturers do not really run proper studies of the minimal effective dose.

Here is a recent example from my life. I was on Stribild for 4 months but it was causing anorgasmia and insomnia. I've read here on the forums that some guy was taking it without food and he was still undetectable. No food means probably that the absorption is reduced several times (by a factor of say 3-5 times). So I run my own experiment - I took HALF a pill Stribuild for two weeks. This didn't reduce the side effects as I was hoping, but at the end of the two weeks I got my test results and I was still undetectable.

Offline friskyguy

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #15 on: September 13, 2013, 10:24:10 PM »
Hi Witch, just be careful in your thinking....... that just cause you are UD does not means that all is fine......the virus test of a blood sample is just one of the simplest ways of checking to see if the virus is being kept in check IN YOUR BLOOD only.

I seem to recall reading that HIV can infect our bodies through cell to cell transmission in our tissues including gut and add to the reservoir size while still remaining UD in the blood/lab tests. That's why its important to take the meds every day......potentially if you cut down on the daily meds intake there may be cell to cell transmission of HIV in your tissues causing issues (maybe resistance) but this may not appear in the blood and you may still remain UD potentially giving a false sense of security.

But as we are talking about dosage reduction and not missing dosages, maybe this TDM testing makes a lot of sense. As we are all of different bodies sizes and ethnicity/chemistry make-up, drugs would react/behave a little differently in all of us.

An analogy.....small framed women can get drunk more easily on one glass of wine when compared to a big burly guy who may need a couple of bottles. Same with the alcohol breathalyser test......alcohol readings all come out different for different body types even when they drink the same volume of alcohol.

So having the TDM test done to see what level/dosage of meds ur body actually requires to reach the optimal level of safety does seem to make sense.
 
Sero converted Sept '10 / Confirmed + Dec '10
Jan '11, VL 9,500 / CD4 482 (32%)
Feb '11, VL 5,800 / CD4 680 (37%)
start Atripla
Mch '11, VL UD / CD4 700 (42%)
Jun  '11, VL UD / CD4 750 (43%)
swap to Kivexa and Efav. due to osteopenia diag. (DEXA) / kidney issues ( decline in eGFR to 77 )
start supplements - Vit D3 / Omega 3 / multivitamin / mini aspirin
Dec '11,  VL UD <20 /  CD4 670 (49%)  / CD4:CD8 = 1.4
all labs now within normal ranges
Mch '12,  VL UD / CD4 600 (51%)
Sep '12,  VL UD / CD4 810 (51%)
Mch '13   VL UD / CD4 965 (56%)
Sep '13   VL UD / CD4 (not taken)
Dec '13   VL UD / CD4 901 (35%) / CD4:CD8 = 1.1  /  eGFR > 100

Offline oksikoko

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #16 on: September 15, 2013, 02:09:40 AM »
Here is a recent example from my life. I was on Stribild for 4 months but it was causing anorgasmia and insomnia. I've read here on the forums that some guy was taking it without food and he was still undetectable. No food means probably that the absorption is reduced several times (by a factor of say 3-5 times).

Yeah, that would be me. I never eat with it, and so far so good, though who knows what's happening in this bag of meat I'm stuck in. But, um, emulate me at your own risk. I have very little to lose and take chances decent people really shouldn't.

Lee
Code: [Select]
2013-10-03:                ☣ VL (=) undetectable ☣ CD4 (+) 1105
2013-05-23:                ☣ VL (=) undetectable ☣ CD4 (-) 945
2013-02-25:                ☣ VL (-) undetectable ☣ CD4 (+) 1123
2012-12-16: Enter Stribild
2012-11-20: HIV+           ☣ VL (→) 132,683      ☣ CD4 (→) 920
2012-04-01: HIV-
Dates in this signature file conform to ISO 8601. ;-)

Offline mecch

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #17 on: September 16, 2013, 03:17:03 PM »
I suspect many, if not most, of the anti-hiv drugs are overdosed by a factor of 2 to 10. The manifacturers do not really run proper studies of the minimal effective dose.

Here is a recent example from my life. I was on Stribild for 4 months but it was causing anorgasmia and insomnia. I've read here on the forums that some guy was taking it without food and he was still undetectable. No food means probably that the absorption is reduced several times (by a factor of say 3-5 times). So I run my own experiment - I took HALF a pill Stribuild for two weeks. This didn't reduce the side effects as I was hoping, but at the end of the two weeks I got my test results and I was still undetectable.

Two week experiment, "success" based on unchanged viral load after two weeks - does not equal a success, especially since you are trying to reduce side effects, and didn't!

2 x 10 overdosing claim, is pulled out of your hat, from thin air....   Its your hunch and that's it...  Just saying...  Not terribly scientific....



“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline elf

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #18 on: September 16, 2013, 08:54:12 PM »
Here in Croatia there is no 200 mg efavirenz, only Stocrin (600 mg efavirenz) >:(
In my case, 3 mg melatonin helps (no CNS disturbances).
Let's have a Kiki!

Offline witch

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Re: Efavirenz 400mg vs 600mg - as good as, less CNS side effects
« Reply #19 on: September 20, 2013, 09:54:58 AM »
Quote
Two week experiment, "success" based on unchanged viral load after two weeks - does not equal a success, especially since you are trying to reduce side effects, and didn't!

2 x 10 overdosing claim, is pulled out of your hat, from thin air....   Its your hunch and that's it...  Just saying...  Not terribly scientific....

Not terribly scientific but way more scientific than manufacturers without published studies of the correct doses. I've see this happening with other drugs - in 10 years it turns out the necessary dose is 1/10 of what they started with ... All these requirements for Complera and Stribild to take them with food were not studied properly, just some isolated "observations" and generalities that absorbtion is higher with food.

 


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