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Author Topic: The Quad Pill to enter phase ll  (Read 5894 times)

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Offline esper

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  • Posts: 57
Re: The Quad Pill to enter phase ll
« Reply #1 on: January 06, 2010, 08:44:30 PM »
Looks like the mid-term phase II results are in and positive for this.....

Phase II Clinical Trial of Gilead's Investigational Integrase-Based, Once-Daily, Fixed-Dose "Quad" Regimen Meets 24-Week Primary Objective - 24-Week Data from a Second Phase II Study Supports GS 9350 as an Effective Boosting Agent
http://www.cnbc.com/id/34724299/site/14081545

« Last Edit: January 06, 2010, 10:19:26 PM by esper »
tested positive June 26, 2009
06/26/2009-CD4 428: VL 56,200: 34.1%
09/28/2009-CD4 388: VL 105,000: 31.9%
11/16/2009-CD4 330: VL 242,000: 23.4%
12/11/09 started stocrin (sustiva) & truvada
02/02/2010-CD4 588: VL 204: 31.6%
04/27/2010-CD4 620; VL 154; 38.5%
08/25/2010-CD4 504; VL undet; 39.2%
11/16/2010-CD4 499: VL undet: 44.6%
03/01/2011-CD4 534: VL undet: 33.2%
06/01/2011-CD4 709: VL undet: 45.6%
12/11/2011-CD4 537: VL undet: 41.5%
06/10/2012-CD4 597: VL undet: 42.8%

Offline veritas

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Re: The Quad Pill to enter phase ll
« Reply #2 on: January 07, 2010, 05:00:40 AM »

esper,

Thanks for that post. Looks like Norvir could be a bad memory pretty soon, not to mention another single pill regimen.

v

Offline bmancanfly

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  • Medicare For All !
Re: The Quad Pill to enter phase ll
« Reply #3 on: January 07, 2010, 10:35:34 AM »
One less co-pay.  That would be nice.
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline sensual1973

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  • Posts: 196
Re: The Quad Pill to enter phase ll
« Reply #4 on: January 07, 2010, 03:36:58 PM »
funny to see all the quick achievements happen with HAART and NOT when it comes to alternative therapies,make you go hmmm !!!
God grant me the serenity to accept the things i can not change.

Online leatherman

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Re: The Quad Pill to enter phase ll
« Reply #5 on: January 07, 2010, 04:05:11 PM »
Looks like Norvir could be a bad memory pretty soon,
let's hope not ;), as my reyetaz/norvir/viread/videx combo has been working fine for yrs against my mutated wild strain of HIV.

Sure changing to a single pill could be nice; but I've run out of meds before, because of resistance issues (hence the wild mutant HIV), and had to wait until something new came along. I'm a little loathe to give up working meds to start something new, risking resistance again, and perhaps ending up with no med available to fight this infection. That sort of thinking (by a doc trying to politely simplify my regimen) ended up with me in the hospital once and was nearly was the death of me.

Right now the only med change I'm waiting for is the upcoming Norvir tablet that won't have the nastiness of the current gelcap.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline Miss Philicia

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Re: The Quad Pill to enter phase ll
« Reply #6 on: January 07, 2010, 04:27:32 PM »
let's hope not ;), as my reyetaz/norvir/viread/videx combo has been working fine for yrs against my mutated wild strain of HIV.

Sure changing to a single pill could be nice; but I've run out of meds before, because of resistance issues (hence the wild mutant HIV), and had to wait until something new came along. I'm a little loathe to give up working meds to start something new, risking resistance again, and perhaps ending up with no med available to fight this infection. That sort of thinking (by a doc trying to politely simplify my regimen) ended up with me in the hospital once and was nearly was the death of me.

Right now the only med change I'm waiting for is the upcoming Norvir tablet that won't have the nastiness of the current gelcap.

You should be able to swap out just the Norvir for GS-9350 as AFAIK it won't just be used in the quad pill, but will marketed as well as a stand alone booster assuming completed trials show that can be done, and last I read that was the case.

If (older line) PI's are the culprit with visceral abdomen fat then this will be a good thing (assuming new line PI's like Prezista aren't also contributing of course).  I won't hesitate to make the change.  I don't ascribe to the "if it ain't broke don't fix it" meme, within reason of course.
"Iíve slept with enough men to know that Iím not gay"

Offline freaky_dream

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  • mmm
Re: The Quad Pill to enter phase ll
« Reply #7 on: January 07, 2010, 05:01:49 PM »
Yeah norvir's days are numbered. It was created as a PI however it is no longer used for that purpose. It's prescribed for it's blood booster characteristics, however because it is a PI norvir still has the same side effects such diarrhea and possible lypodystrophy even with it's lowered dosage. The trial for stand alone gs9350 is going on concurrently though it did start a little later then the quad trial. The doctor in LA handling the trial invited me to participate in the standalone 9350 trial but i declined because as a double blinded trial I didn't want the chance that I may be given norvir. What Gilead did with gs9350 was basically excise the PI portion of norvir and kept the blood boosting capability in.

Offline xman

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Re: The Quad Pill to enter phase ll
« Reply #8 on: January 07, 2010, 05:37:01 PM »
I sincerely don't see the advantages of this new ARV drug. Even for resistant patients it has no warranty to be effective. Additionally what is the safety profile? Any lipo issues? Long term toxicities are not known. We have Isentress and Atripla. Do we really need this one?
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline sensual1973

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Re: The Quad Pill to enter phase ll
« Reply #9 on: January 07, 2010, 05:56:38 PM »
xman
dont know if u r on meds or not,there are many people out there having resistance issues and would be happy with the news,maybe in 2010 you should be abit optimistic too i think.
God grant me the serenity to accept the things i can not change.

Offline freaky_dream

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  • mmm
Re: The Quad Pill to enter phase ll
« Reply #10 on: January 07, 2010, 06:27:01 PM »
I sincerely don't see the advantages of this new ARV drug. Even for resistant patients it has no warranty to be effective.

Wow just wow... Your pessimism knows no bounds xman. The major concern in Atripla is the psychological effects of sustiva which a lot of people cannot tolerate. Elvitegravir replaces sustiva in Quad and it has no known psychological side effects and being an integrase inhibitor does not have a lipo profile such as PI's which are believed to be the main culprit in lipo/lipid problems as stated by miss phillicia.

Quote
Additionally what is the safety profile? Any lipo issues? Long term toxicities are not known.

No kidding Sherlock hence the reason quad is in a clinical trial(it's second i might add) which is going to go on for almost a year longer. After that it goes into a third and final trial lasting approximately another 2 years. So yeah in total at the end quad will have undergone 5 or 6 years of trials.

A recap of it's first clinical trial:
http://www.hivandhepatitis.com/2009icr/croi/docs/021009_a.html

Offline xman

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Re: The Quad Pill to enter phase ll
« Reply #11 on: January 07, 2010, 06:28:18 PM »
I understand but I really don't see the need for drugs that needs boosting or enhancers like this when we have drugs of new classes which don't need a booster. It's really only to push the industry. We are warming up the same old soup. Let's invest in those which are easy to take, cheap and with a long half life.
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline Miss Philicia

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Re: The Quad Pill to enter phase ll
« Reply #12 on: January 07, 2010, 06:38:33 PM »
Wow just wow... Your pessimism knows no bounds xman.

Not to mention an inability to read other posts that just explained it for him.
"Iíve slept with enough men to know that Iím not gay"

Offline MitchMiller

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Re: The Quad Pill to enter phase ll
« Reply #13 on: January 10, 2010, 04:51:32 PM »
Well.. the patent for Sustiva is ending 2013, based on other posts I've read.  That could affect how insurance companies reimburse.  For example, Atripla is just Truvada + Sustiva.  Insurance companies could refuse to reimburse for Atripla if generic Sustiva + Truvada is cheaper.  Seems perfectly reasonable to me.  So Gilead may want another "single pill" therapy that in their arsenal.
Also, Gilead wants a pill that contains only their drugs.  They don't have to split the profits like they do with Atripla. 
This quad pill makes a lot of sense to me given that Gilead is a private company in business to turn a profit.

Offline John2038

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Re: The Quad Pill to enter phase ll
« Reply #14 on: April 13, 2010, 11:33:17 AM »
Gilead Sciences

Gilead Initiates Phase III Clinical Program Evaluating Single-Tablet, Once-Daily "Quad" Regimen for HIV

Gilead Sciences has begun a new phase III clinical study of a new combination therapy for sufferers of HIV.

The pharmaceutical company has dosed the trial's first patient with its new daily Quad treatment, which combines elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate in a single fixed-dose tablet.

Over the course of the 96-week trial, the treatment's efficacy will be monitored and compared to the alternative Atripla regimen, with around 700 patients set to be involved in total.

Dr Norbert Bischofberger, executive vice-president of research and development and chief scientific officer at Gilead Sciences, expressed confidence in the drug based on positive findings from a phase II study.

In this earlier trial, it was found that the treatment was able to achieve high rates of virological suppression.

Dr Bischofberger said: "We look forward to further defining the clinical profile of the Quad in a larger number of patients in the phase III trials."


Source

Offline xman

  • Member
  • Posts: 289
Re: The Quad Pill to enter phase ll
« Reply #15 on: April 14, 2010, 01:42:12 PM »
Not considering resistance issues can someone summarize the real advantages of this drug compared with the top brands actually on the market?
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline georgep77

  • Member
  • Posts: 148
Re: The Quad Pill to enter phase ll
« Reply #16 on: April 14, 2010, 02:22:34 PM »
Not considering resistance issues can someone summarize the real advantages of this drug compared with the top brands actually on the market?
xman, When it comes to HIV, you always have to consider resistance, is a big issue
so the quad pill is good news for everybody.

                          :D
Come on Sangamo,  Geovax,  Bionor immuno, ...Make us happy !!!
+ 2008

Offline Hellraiser

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  • Posts: 4,143
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Re: The Quad Pill to enter phase ll
« Reply #17 on: April 14, 2010, 05:45:34 PM »
Not considering resistance issues can someone summarize the real advantages of this drug compared with the top brands actually on the market?

It's a once a day alternative to Atripla.  This could potentially lower the cost of Atripla before it's patent runs out in 2018 by giving it some market competition.  In addition For those of who had resistances to the component drugs in atripla or developed them, it's again a once a day alternative.  That's enough for me.  I can handle a once daily and I could probably handle a twice daily regimen, but that's twice as many chances to miss a dose which frankly is the thing that really still stresses me out, running out of treatment options because of my forgetfulness.

Offline geobee

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  • Posts: 288
Re: The Quad Pill to enter phase ll
« Reply #18 on: April 15, 2010, 01:22:08 AM »
Hey Hellraiser,

I was freaked out too about missing doses until I got my trusty Ironman, cheapie Timex.  Beeps at the start and end of my two hour window -- haven't missed a dose since I got it.

or you could stop raising hell and start going to be on time.  :)

George

Offline Hellraiser

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  • Semi-misanthropic
Re: The Quad Pill to enter phase ll
« Reply #19 on: April 15, 2010, 09:01:46 AM »
I can't wear a watch, I would be stoned to death for believing the universe isn't geocentric here in Mississippi.

 


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