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One Pill a Day?
#188628 - 04/29/06 12:21 PM
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The Advocate.com
April 28, 2006
One-pill HIV regimen submitted for FDA review
Gilead Sciences and Bristol-Myers Squibb on Thursday submitted for review to the Food and Drug Administration their once-daily anti-HIV pill that contains a full three-drug regimen. The tablet contains a full day’s dosing of Gilead’s drugs Viread and Emtriva—already packaged in a combination pill called Truvada—and BMS’s Sustiva. If approved by the FDA, it would be the first one-pill, once-daily complete HIV treatment available in the United States.
Gilead and BMS announced in December 2004 that they planned to collaborate on a venture to combine Gilead’s Truvada with Bristol-Myers Squibb’s Sustiva into a single pill that would be taken just once daily. The first two attempts to combine the medications were unsuccessful, as the resulting combination pill did not have the same bioequivalence of the drugs dosed separately. But the companies announced in January 2006 that using bilayering technology to incorporate the drugs into a single formulation was successful, and studies showed the combination pill had the same bioequivalence as the individual medications.
The U.S. Department of Health and Human Services lists the combination of Truvada and Sustiva as one of the preferred nonnucleoside reverse transcriptase inhibitor–based regimens for treating newly diagnosed HIV patients.
A decision by the FDA could come before the end of the year.
“The partnership between Bristol-Myers Squibb and Gilead was founded on the companies’ shared commitment to addressing the needs of people living with HIV,” said John C. Martin, Gilead president and CEO, in a statement. “Significant progress in science and medicine has been achieved since the advent of the first combination regimens 10 years ago, but more work is needed, and we view this partnership to create the first-ever once-daily single tablet regimen for HIV as an important step toward further simplifying dosing of HIV therapy for physicians and patients.” (The Advocate)
Associated Press material © Associated Press. All rights reserved. No material may be published, broadcast, rewritten, or redistributed.
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AIDS2HIV
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yep its on the horizon....i wonder how much it will cost tho. Dr. House had a good episode last night when he addressed the pharmacutical companies, on the issue of of a successful medicine they make millions off of, then just before the patent runs out they alter it slightly, give it a new name and make twice what they did before...LOL.
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i figure this pill if i slice it up into six peieces I will be on the same meds anyways... Different wrapping paper.. different price.. But maybe it will be in the shape of Bam Bam or Barnie?
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ny10001
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Yep. It's coming...good news for those of us already taking Sustiva and Truvada.
Since there is no change in the formulation of the drugs, approval of this pill should be pretty easy. They just had to demonstrate bioequivalence...meaning that the new pill produced the same levels in the blood stream as is the case when taking Sustiva and Truvada separately.
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Well jeezz.. I feel left out in the cold!! I know they will be dropping Kaletra down to 4 pills instead of six... WHOOPIE F... DO... I dont care how many pills I take, I am just a sloth...
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I just spoke with my ID on the 21st & he told me that it will have a different name & he will need to change the prescription. He said that everything else will be exactly the same as what I'm taking now, just in 1 pill. YIPPIE!! I don't care if it still costs me $80 a month... I'm excited about the 1 pill thing!!!
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The question is, will that one pill fit in your new Louis V bag?? And more importantly, will it look good?
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