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Author Topic: New HIV Drug - GSK Wins Priority  (Read 3125 times)

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Offline phildinftlaudy

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  • sweet Ann what you think babe...
New HIV Drug - GSK Wins Priority
« on: February 16, 2013, 02:32:58 PM »
http://news.yahoo.com/gsk-wins-priority-status-hiv-drug-u-140116042--finance.html and

http://www.reuters.com/article/2013/02/15/glaxosmithkline-hiv-idUSL5N0BFBTO20130215

U.S. regulators gave priority review status to an experimental GlaxoSmithKline drug for HIV/AIDS, which industry analysts view as a possible multibillion-dollar-a-year seller.
 
The U.S. Food and Drug Administration awards certain drugs priority status when they have the potential to offer significant improvement over existing treatments.
 
The agency is due to give its verdict on whether to approve dolutegravir by August 17, Britain's biggest drugmaker said on Friday.
 
The once-daily drug, which belongs to a novel class known as integrase inhibitors that block the virus causing AIDS from entering cells, is owned by ViiV Healthcare, a joint venture focused on HIV in which GSK is the largest shareholder.
 
The new medicine has already performed strongly in clinical trials, prompting GSK to raise its bet on the product last October by redrawing a deal with Japan's Shionogi.
September 13, 2008 - diagnosed +
Labs:
Date    CD4    %   VL     Date  CD4  %   VL
10/08  636    35  510   9/09 473  38 2900  12/4/09 Atripla
12/09  540    30    60   
12/10  740    41  <48   
8/11    667    36  <20  
03/12  1,041  42  <20
05/12  1,241  47  <20
08/12   780    37  <20
11/12   549    35  <20
02/12  1,102  42  <20
11/12   549    35  <20

Online Miss Philicia

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Re: New HIV Drug - GSK Wins Priority
« Reply #1 on: February 16, 2013, 03:55:33 PM »
Yeah, they actually first filed for FDA approval in December IIRC. My doctor plans to switch me to this once it is approved. I think then I'll just take it with truvada, so for the first time in my life I'll be down to only two HIV pills.

It would be nice not to have to take so many diarrhea pills though so we'll see what effect this will have with that.
"Iíve slept with enough men to know that Iím not gay"

Offline ad2san

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Re: New HIV Drug - GSK Wins Priority
« Reply #2 on: February 16, 2013, 04:19:41 PM »
Miss P, I don't think you'll need to take Truvada since Dolutegravir contains Epzicom ... so it'll be once daily  ;D
Feb   2009 CD4 358 VL 2000 16%
May  2009 CD4 305 VL 3069  14% <---- Started TVD+ATZ/r
Jul  2009 CD4 512 VL <50   18%
Jul 2010 CD4 418 VL <50 24%                     
Switched to Kivexa (Epzicom) + Norvir + Reyataz (due to sleep problem)
Aug 2010 CD4 606 VL <50 25%
Jul 2011 CD4 494 UD 23%
Switched to Kivexa (Epzicom) + Viramune XR (due to kidney problems)
January 2012 CD4 564 UD 31%
October 2012 CD4 684 UD 29%
January 2013 CD4 594 UD 26%
Switched to Kivexa (Epzicom) + Isentress due to BIG increase GammaGT
Feb 2013 CD4 699 UD 28%
May 2013 CD4 385 UD 28%
July 2013 CD4 CD4 636 UD 25%
Oct 2013 CD4 588 UD 39%
Aug 2014 CD4 639 UD 25%

Offline leatherman

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Re: New HIV Drug - GSK Wins Priority
« Reply #3 on: February 16, 2013, 04:20:09 PM »
Dolutegravir may eventually come out in a single dose regimen
http://www.aidsmeds.com/articles/ViiV_integrase_572_Trii_1667_19850.shtml
        
February 3, 2011
Clinical Trial of Triple-Drug Combination Pill 572-Trii Begins
ViiV Healthcare and Shionogi & Co. announced Thursday, February 3, that the first patient has been enrolled into a study exploring the safety and efficacy of 572-Trii, the companiesí fixed-dose combination pill containing the experimental integrase inhibitor S/GSK1349572 (S/GSK-572) [aka Dolutegravir] and Epzicom (lamivudine plus abacavir).
leatherman (aka mIkIE)


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

Online Miss Philicia

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Re: New HIV Drug - GSK Wins Priority
« Reply #4 on: February 16, 2013, 04:34:59 PM »
Miss P, I don't think you'll need to take Truvada since Dolutegravir contains Epzicom ... so it'll be once daily  ;D

I don't see that here
"Iíve slept with enough men to know that Iím not gay"

Offline Ann

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    • Num is sum qui mentiar tibi?
Re: New HIV Drug - GSK Wins Priority
« Reply #5 on: February 16, 2013, 04:52:42 PM »
I don't see that here

Nope - it's not there. Adsan got mixed up with the trial-combo-med 572-Trii that combines Dolutegravir and Epzicom.

I think they should name it the Triad. :)

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 buginme2

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Re: New HIV Drug - GSK Wins Priority
« Reply #6 on: February 16, 2013, 04:56:21 PM »
My memory is going but even with the "priority" review it seems like this approval is scheduled to take quite awhile.

Did the Stribild approval take this long?  From what I remember it seemed that it took about 6 months from the time they submitted the application to approval.  Even with Dolutegravir's "priority" review it is going to be at least 8 months.  AND Stribild had 2 new medications.

Regardles, Dolutegravir will become the new standard.  So far nothing beats its efficacy and resistance profile.  From here on out any new medication is going to have to match or exceed Dolutegravir.  That's going to be hard sell.  This may be one of the last HIV medications for awhile.

Offline ad2san

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Re: New HIV Drug - GSK Wins Priority
« Reply #7 on: February 16, 2013, 05:09:32 PM »
Nope - it's not there. Adsan got mixed up with the trial-combo-med 572-Trii that combines Dolutegravir and Epzicom.

I think they should name it the Triad. :)

Right Ann I am mixed up  8)  I am looking forward to the triad soooo hard  ;D
Feb   2009 CD4 358 VL 2000 16%
May  2009 CD4 305 VL 3069  14% <---- Started TVD+ATZ/r
Jul  2009 CD4 512 VL <50   18%
Jul 2010 CD4 418 VL <50 24%                     
Switched to Kivexa (Epzicom) + Norvir + Reyataz (due to sleep problem)
Aug 2010 CD4 606 VL <50 25%
Jul 2011 CD4 494 UD 23%
Switched to Kivexa (Epzicom) + Viramune XR (due to kidney problems)
January 2012 CD4 564 UD 31%
October 2012 CD4 684 UD 29%
January 2013 CD4 594 UD 26%
Switched to Kivexa (Epzicom) + Isentress due to BIG increase GammaGT
Feb 2013 CD4 699 UD 28%
May 2013 CD4 385 UD 28%
July 2013 CD4 CD4 636 UD 25%
Oct 2013 CD4 588 UD 39%
Aug 2014 CD4 639 UD 25%

Offline Matts

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Re: New HIV Drug - GSK Wins Priority
« Reply #8 on: February 16, 2013, 05:48:05 PM »
seems like a wonder drug:) dosage of only 50mg and it beats the other drugs by far regarding resistance and effectivity. I wonder if ViiV Healthcare will combine it with its own MVC. Then I finally had a one-pill combo:)
tivicay/kivexa

Online OneTampa

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Re: New HIV Drug - GSK Wins Priority
« Reply #9 on: February 16, 2013, 07:14:08 PM »
Appears to be good news.

I take generic Epivir and low doses of Viracept and Sustiva which have been effective at holding the virus in check with undectable readings for me the last 10 years or so. Curious if I would be able to switch to this new drug.

Also wondering what the patient costs will be.
« Last Edit: February 16, 2013, 07:16:20 PM by OneTampa »
"He is my oldest child. The shy and retiring one over there with the Haitian headdress serving pescaŪto frito."

Offline positivelynerd

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  • Life isn't a struggle, it's a wiggle.
Re: New HIV Drug - GSK Wins Priority
« Reply #10 on: February 16, 2013, 07:21:02 PM »
I'm in a phase II clinical trial pitting GSK1265744 (GSK's other integrase inhibitor) against Sustiva + Epzicom/Truvada.  I got placed in the control arm (lame) but my charge nurse was telling me they created a nano-suspension of the drug that has an almost month long half-life.  Not sure how the pharmokinetics of this 572 stack up but this looks to be an exciting new potential for treatment.  Once-a-month injections?  I know they would have to have similar success with other classes of medication in this nano-suspension fluid to make it a truly effect once a month treatment.  Anyone heard anything about this?

http://www.hivandhepatitis.com/hiv-aids/hiv-aids-topics/hiv-treatment/3722-aids-2012-long-acting-integrase-inhibitor-sgsk1265744-may-allow-monthly-dosing

And as a comment on the original article,  I thought fusion inhibitors kept HIV from entering the cell and integrase inhibitors kept it from assimilating viral DNA into cellular DNA.  I suppose it is a little bit of a technicality.
5/25/12 Seroconversion
9/25/12 Diagnosed
10/12/12: VL- 799k, CD4 285
10/25/12 VL- 599k, CD4 274 
Started Sustiva + Epzicom
11/8/12: VL- 1790, CD4 412, 24%,
11/20/12: VL- 1470, CD4 350, 28%
12/19/12: VL- 584, CD4 293, 24%
1/16/13: VL- 411, CD4 404, 27%
2/13/13: VL- 314, CD4 523, 20%
3/13/13: VL- 171, CD4 404, 26%
4/10/13: VL- 96, CD4 397, 27%
5/8/13: VL- UD, CD4 422, 26%
6/5/13: VL- UD, CD4 462, 31%
7/24/13: VL- UD, CD4 559, 33%

"The most beautiful thing we can experience is the mysterious. It is the source of all true art and all science. He to whom this emotion is a stranger, who can no longer pause to wonder and stand rapt in awe, is as good as dead: his eyes are closed." -A. Einstein

Offline oksikoko

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  • Writing the congressman again
Re: New HIV Drug - GSK Wins Priority
« Reply #11 on: February 16, 2013, 09:50:38 PM »
Did the Stribild approval take this long?  From what I remember it seemed that it took about 6 months from the time they submitted the application to approval.  Even with Dolutegravir's "priority" review it is going to be at least 8 months.  AND Stribild had 2 new medications.

Yes, Stribild took six months and still does have two new medications. They're not approved outside of this combination yet.
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm

Does anyone know why Stribild is the only one with cobicistat or something like cobicistat?

Thank you.
Code: [Select]
2014-??-??: off treatment  ☣ VL (?)              ☣ CD4 (?)
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. ;-)

If no one complains, nothing will ever change.

Offline randym431

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Re: New HIV Drug - GSK Wins Priority
« Reply #12 on: February 17, 2013, 08:53:00 PM »
Im a little Leary of anything Epzicom or its ingredients. I took Epzicom for years and while my T-count did recover quite well, it hovered about 500-600 mark (from originally 85 upon diag). After 5-6 years my T count seemed to stay around the upper 500 mark as a trend. Sometimes jumping up into the 800's but always dropping back down into the 500's with later labs. Only after switching to Atripla, because my doc felt studies with Epzicom and heart disease was a concern, did I find labs under Atripla had sent my T count into the upper 900's and remained steady in that range. Everyone has their own experiences, but Epzicom for me seemed to limit my immune recovery, where as Atripla has proven much better with immune recovery. So I would have to see real hard evidence that anything new but still containing Epzicom or its ingredients actually produced outstanding results over just sticking with Atripla.

Offline buginme2

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Re: New HIV Drug - GSK Wins Priority
« Reply #13 on: February 17, 2013, 09:42:09 PM »
This drug does not contain epzicom.


Offline leatherman

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Re: New HIV Drug - GSK Wins Priority
« Reply #14 on: February 17, 2013, 10:34:10 PM »
572-Trii, the companiesí fixed-dose combination pill containing the experimental integrase inhibitor S/GSK1349572 (S/GSK-572) [aka Dolutegravir] and Epzicom (lamivudine plus abacavir).
Epzicom is only in the triple med combo 572-Trii, which also includes Dolutegravir <-- the med that is the topic of this thread
leatherman (aka mIkIE)


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

Offline Matts

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Re: New HIV Drug - GSK Wins Priority
« Reply #15 on: March 23, 2013, 05:22:50 PM »
If somebody should live in Germany and be IntegraseInhibitor resistant- You can get Dolutegravir yet. There is a "Emergency Drug Program" of the government to make unapproved important drugs available.

You can contact:
Frau Ewa Lopacinska
Parexel International
Kartaeuserstr. 47
79102 Freiburg
T.:+49 761 2828 0934
F.: +49 761 2828 081
Email:
Ewa.Lopacinska@PAREXEL.com

http://www.bfarm.de/DE/Arzneimittel/1_vorDerZul/compUse/compUse-node.html#doc1015148bodyText3
tivicay/kivexa

 


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