POZ Community Forums
Main Forums => Living With HIV => Topic started by: phildinftlaudy on February 16, 2013, 02:32:58 pm
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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.
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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.
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Miss P, I don't think you'll need to take Truvada since Dolutegravir contains Epzicom ... so it'll be once daily ;D
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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 companies’ fixed-dose combination pill containing the experimental integrase inhibitor S/GSK1349572 (S/GSK-572) [aka Dolutegravir] and Epzicom (lamivudine plus abacavir).
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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 (http://www.aidsmeds.com/archive/dolutegravir_2422.shtml)
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I don't see that here (http://www.aidsmeds.com/archive/dolutegravir_2422.shtml)
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. :)
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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.
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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
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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:)
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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.
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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.
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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 (http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm) 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.
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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.
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This drug does not contain epzicom.
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572-Trii, the companies’ 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
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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 (http://www.bfarm.de/DE/Arzneimittel/1_vorDerZul/compUse/compUse-node.html#doc1015148bodyText3)