POZ Community Forums
Meds, Mind, Body & Benefits => Questions About Treatment & Side Effects => Topic started by: newhorizon80 on August 23, 2010, 12:06:18 am
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My doctor believes that I would be a great candidate for the Phase-III drug study for Gilead's Quad-pill and I told him that I wanted to research it before making any decisions. I think I may end up enrolling in the study from my readings so far, but was wondering if there was anyone else on it? If so, how has it been going so far?
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Which drugs are combined in this quad pill?
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It contains the new integrase inhibitor elvitegravir, the new boosting agent cobicistat, as well as tenofovir and emtricitabine (the components of Truvada).
Basically it's similar to a regimen of isentress and truvada, but for some reason the new integrase inhibitor needs a boosting agent like that with protease inhibitors and norvir.
My physician is the medical director of the largest HIV clinic in Philadelphia, and the clinic runs trial studies so he has many patients already on this and he told me during my visit last month that it's performing very well. I personally would not hesitate to go on this if I had the opportunity.
From what I've read as of Phase 2 this quad pill met the criteria for non-inferiority to Atripla, with less adverse side effects, particularly CNS ones.
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Thank you for the reply. I've been on the fence about starting treatment and my Doctor has been supportive on my decision, but I told him over the course of our visits that if I fall below 400 (my personal limit), then I'm ready. So, here we are (last CD4 was 350).
I'm leaning towards enrolling in the initial study (have to pass their requirements first)-- I just didn't want to say yes without at least knowing about it versus walking in and reading it all fresh.
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Some things to bear in mind:
The study is likely to be randomised, so you might not get the Quad pill. If it is randomised you will get a real (standard of care) and dummy set of pills or the new drug and a dummy set of pills. It could mean taking a lot of pills (well 2 actually, cos the standard of care is likely to be Atripla). Are you up for this? Are you up for possibly taking Atripla? Your doc should be able to tell you what the standard of care alternative is.
Virologically, the new Quad pill seems good so far. When Quad was compared to Atripla (efavirenz + tenofovir + FTC), over 80% of patients in each group had undetectable viral load (less than 50 copies/mL) after 24 weeks. This is a good result.
In the Phase 2 study, patients in the Quad group (48 people) became undetectable more quickly than those on Atripla (23). After 8 weeks, about 80% people were undetectable with Quad compared to about 50% with Atripla. But baseline viral load was generally modest, less than 40,000 copies. It was only over 100,000 copies in 25% of patients. If you have a high viral load (100,00+), maybe something known to work with high viral loads would be of greater benefit to you?
Quad was better tolerated in terms of not having efavirenz-related side effects (dreams, sleep disturbance etc), but there is caution on the impact of cobicistat (the new booster and Norvir alternative) on reducing estimated glomerular filtration rate (eGFR ie kidney function). This suggests that Quad may not be a good choice if you have a poor kidney function to start. Side effects from Quad are as yet unknown in full. Would you prefer something more tried and tested?
Taking antacids reduces elvitegravir (they key new drug in Quad) concentrations by about 50%. Separating antacids from Quad by 2 hours decreases elvitegravir concentrations by 10-20%. Elvitegravir concentrations are unchanged if separated by 4 hours. If you need to take antacids this is something to bear in mind (cos taking Quad and antacids together may make the antiretrovirals ineffective).
Hope this helps
- matt
References:
http://i-base.info/htb-south/999
http://i-base.info/htb/2434
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I also heard that Johnson & Johnson may be coming out with a new 3-in-1 (don't know the name at this point) pill in January, that doesn't contain Sustiva. Is this similar to the Gilead?
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I am in the quad pill study. I started almost 2 months ago (in fact, Monday 9/13 will be my 8 week checkup). You will have to take 2 pills a day: one in the morning with food which is the quad pill or a placebo and one pill in the evening on an empty stomach which is Atripla or a placebo.
I had great results at my 4 week checkup: viral load went from 110,00 to undetectable and my cd4 went from 157 to 214. I am experiencing no side effects so far. I suspect that I am taking the quad pill.
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Hi Mark, welcome to the forums. (glad we finally got you sorted!)
Those results and the lack of side-effects are remarkable. I'm not on meds yet and at the moment, my first choice would be Reyataz + Norvir + Truvada (when the time comes). When Isentress gets approved for once daily dosing, that and Truvada will be my first choice.
However, my doc (who is also an hiv pharmacologist) is very excited with the results thus far of the Quad studies and I suspect that will become my first choice when it becomes approved for treatment naive people.
So I'm looking forward to hearing updates from you about the Quad. The fact that you've been on it for two months now with no side effects is very encouraging and yes, it sounds to me also that you're likely to be on the Quad instead of the Atripla. It seems that people who start Atripla with numbers like yours experience at least some mild side effects for the first few weeks.
Keep us posted, please.
Ann
edited because I said weeks when I meant months. ::)
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I've never heard of anyone taking Atripla without getting the "Head Rush" where your head feels heated not long after taking the pill. If you're not getting this side then you're definitely not on Atripla. At least as far as I'm concerned.
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I've never heard of anyone taking Atripla without getting the "Head Rush" where your head feels heated not long after taking the pill. If you're not getting this side then you're definitely not on Atripla. At least as far as I'm concerned.
I definately got the hot-sensation head rush my second night on Atripla. It was weird and kinda unnerving, but haven't noticed anything like it since then.
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I definately got the hot-sensation head rush my second night on Atripla. It was weird and kinda unnerving, but haven't noticed anything like it since then.
Do you go to bed immediately? It takes an hour or two to hit you.
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Here's some good news about the QUAD:
http://www.bloomberg.com/news/2010-09-13/gilead-s-quad-hiv-pill-better-than-best-selling-atripla-in-48-week-study.html
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Good news, yes, but I'm a little disappointed in the size of the cohort.
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Ann, would you explain what you mean by "the size of the cohort"? Thanks.
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Sometimes a small study involving a mere hundred patients shows good results and, all of the sudden, this med becomes instantly popular (see QUAD), at the expense of the 'older' ones.
My Doc said that 30 MILLIONS of people are (or have) taking Viramune, daily, for years (it has saved millions of lives). If it were THAT bad it would show!
I thought that comment made a LOT of SENSE. A hell lot of sense...
He also cited some med that was very popular at one time until they found out , later, that is promotes cancer. This med had been removed. He gave me a name I (obviously) did not know.
Cheers
Eric
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Ann, would you explain what you mean by "the size of the cohort"? Thanks.
The size of the cohort = the size of the group of people studied. :)
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Just got my 8 week labwork results back: viral load undetectable and cd4 rose from 214 to 359! I am so pleased right now.
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Wow, that means you've actually gone 157 to 359 in the space of eight short weeks. Great news!
Still no side effects?
I hope you're on the Quad - if you are, it sounds like a great combo.
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Hey Ann,
Yes--still no major side effects. The only thing I've noticed is that I tend to burp in the morning more than I used to. This is another reason I believe I'm on the Quad--because I take that pill in the morning.
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Oh yes, definitely. I can't see them telling you to take Atripla in the morning. Good news! Thanks for keeping us updated.
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When I met with my doctor today, we discussed the Quad and the exciting possibility of it being available by possibly next year or if it becomes approved. Another once-daily option is definately good, and just one more treatment option in general (and hopefully easier) for people!
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Hi Everyone,
Just an update from my original post: I had gone in to see my DR., and I was quite surprised that the study was going in involve four pills (study: GS-US-216-0114), he mentioned the original study he was going to have me look into was no longer open (also was four pills).
It will be a randomized, double-blind comparing:
GS-9350 + atazanavir + emtricitabine/tenofovir DF: Experimental
ritonavir + atazanavir + emtricitabine/tenofovir DF: Active Comparator
After an hour+ session of reading and talking to the study coordinator, I asked for my DR to come in and I think I was just scared to finally start (the realiity of starting, etc.), I was offered Atripla, but my main concern is that if I have side effects it may affect my performance at work (given that I sometimes work afternoons and then also early mornings (4 a.m.), so if I'm taking Atripla at night, getting up at 2 a.m. my be a little hard.
My next, baseline, appointment is October 19.