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Author Topic: New single combo (Sustiva/Truvada)  (Read 5981 times)

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Offline Cliff

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New single combo (Sustiva/Truvada)
« on: July 10, 2006, 03:46:43 PM »
I'm considering going back on meds soon and I'm seriously considering trying the new single pill (once-a-day).  Are there any studies already available on comparing the new formulation to the old (or other combos)?  Is it a gamble to try it out before any significant studies can be done, or is it pretty safe to assume it will work as well as the old, separate pills?

Thanks

Offline lydgate

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Re: New single combo (Sustiva/Truvada)
« Reply #1 on: July 11, 2006, 12:03:25 AM »
No reason to think the single-pill will work any differently than the separate formulations. Same chemicals, same doses, just more convenient is all. After all, Truvada itself was two separate drugs first, later combined for convenience.

Another example: AZT came out first, then 3TC. Combivir (AZT/3TC) is the same potency as the separate drugs. Ditto for Trizivir (AZT/3TC/ABC) and the three separate drugs.

Jay
Her finely-touched spirit had still its fine issues, though they were not widely visible. Her full nature, like that river of which Cyrus broke the strength, spent itself in channels which had no great name on the earth. But the effect of her being on those around her was incalculably diffusive: for the growing good of the world is partly dependent on unhistoric acts; and that things are not so ill with you and me as they might have been, is half owing to the number who lived faithfully a hidden life, and rest in unvisited tombs.

George Eliot, Middlemarch, final paragraph

Offline newt

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Re: New single combo (Sustiva/Truvada)
« Reply #2 on: July 11, 2006, 03:47:43 AM »
Hey Cliff, see Fixed-dose formulation of efavirenz/tenofovir/FTC bioequivalent to separate dosing (report from the 7th International Workshop on Clinical Pharmacology of HIV Therapy, 20-22 April 2006, Lisbon witten up by Simon Collins for i-Base).  This is an early study that shows promising results for what has been a difficult co-formulation exercise.

- matt
"The object is to be a well patient, not a good patient"

Offline lydgate

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Re: New single combo (Sustiva/Truvada)
« Reply #3 on: July 11, 2006, 03:55:55 AM »
Interesting. Were the same problems encountered with Combivir and Trizivir. Or with the new single pill Combivir + Viramune formulation? Jay
Her finely-touched spirit had still its fine issues, though they were not widely visible. Her full nature, like that river of which Cyrus broke the strength, spent itself in channels which had no great name on the earth. But the effect of her being on those around her was incalculably diffusive: for the growing good of the world is partly dependent on unhistoric acts; and that things are not so ill with you and me as they might have been, is half owing to the number who lived faithfully a hidden life, and rest in unvisited tombs.

George Eliot, Middlemarch, final paragraph

Offline RAB

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Re: New single combo (Sustiva/Truvada)
« Reply #4 on: July 11, 2006, 08:21:09 AM »
Cliff

Glad to see you're checking out options.  If ease of dosing is a concern this sounds like a possibility.

(What was your 1st regimen?)

RAB

Offline Cliff

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Re: New single combo (Sustiva/Truvada)
« Reply #5 on: July 11, 2006, 05:46:40 PM »
I was on Reyataz/Norvir & Truvada.  But I think the one-pill will be better suited for me, because of traveling.

Offline lydgate

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Re: New single combo (Sustiva/Truvada)
« Reply #6 on: July 11, 2006, 06:23:29 PM »
So you're switching drug classes, from PI to NNRTI. Don't know much about that. Does your doctor agree? Jay
Her finely-touched spirit had still its fine issues, though they were not widely visible. Her full nature, like that river of which Cyrus broke the strength, spent itself in channels which had no great name on the earth. But the effect of her being on those around her was incalculably diffusive: for the growing good of the world is partly dependent on unhistoric acts; and that things are not so ill with you and me as they might have been, is half owing to the number who lived faithfully a hidden life, and rest in unvisited tombs.

George Eliot, Middlemarch, final paragraph

Offline cubbybear

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Re: New single combo (Sustiva/Truvada)
« Reply #7 on: July 12, 2006, 02:00:52 AM »
When is this once a day single pill regimen supposed to become available, any ideas?  Im on Truvada/Sustiva and wouldnt mind changing to one pill a day when I can just for convenience sake, though Truvada was only made available in Australia since around february, so I'm guessing it might take a while to reach our shores down here anyway.
There's a bear in there!
Positive since 2000
Diagnosed 17/9/2005 CD4 35 VL 293,000
Meds 23/9/2005 Sustiva/Truvada
Currently CD4 232 VL Undetectable

Offline Cliff

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Re: New single combo (Sustiva/Truvada)
« Reply #8 on: July 12, 2006, 09:16:39 AM »
So you're switching drug classes, from PI to NNRTI. Don't know much about that. Does your doctor agree? Jay
I haven't spoken with him (my US doctor) about it yet.  Most likely I would need to get it through the US, since it probably won't be available in the UK for a period of time after it has been approved in the US.  But I don't think he would mind.  The plan was for me to go back on my old PI regimen, but as long as there aren't any resistance issues, I don't think there will be any issues in moving to a NNRTI.

Offline Cliff

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Re: New single combo (Sustiva/Truvada)
« Reply #9 on: July 12, 2006, 04:00:28 PM »
The drug was approved by the FDA and will be available in 7 days.  There's no timing for submitting applications outside of the US, because of negotiations needed to get Merck onboard first, (I guess Sustiva must be co-owned by Merck outside the US).

Offline DingoBoi

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Re: New single combo (Sustiva/Truvada)
« Reply #10 on: July 12, 2006, 04:59:59 PM »
First one-a-day AIDS pill approved
Combo treatment from Bristol-Myers, Gilead gets OK from Food and Drug Administration.
By Aaron Smith, CNNMoney.com staff writer
July 12 2006: 3:37 PM EDT


NEW YORK (CNNMoney.com) -- The Food and Drug Administration Wednesday approved the first once-daily pill for fighting AIDS, according to the the drug's makers, Bristol-Myers Squibb and Gilead Sciences.

Atripla, which treats HIV, the virus that causes AIDS, is a combination of Bristol-Myers' (down $0.41 to $25.07, Charts) Sustiva and Gilead's (down $0.16 to $61.60, Charts) Truvada, two other drugs that fight the virus. Truvada itself is a combination of two other drugs.

"You're getting the first and only medication to contain a complete triple-drug once-daily cocktail contained in a single tablet," Bristol-Myers spokesman Eric Miller said in a phone interview.

The development of Atripla is important because it simplifies treatment for AIDS patients, who have had to take complex drug "cocktails" that included many pills a day. Miller said that 10 years ago, HIV patients took as many as 25 pills a day, staggered at different times throughout the day.

Though Atripla is the first HIV drug that can be taken alone as a single-pill regimen, it also can be combined with other drugs, depending on the needs of the patient, said Miller.

The consolidation of various compounds into one drug, Atripla, has been a decade in the making.

"The availability of Atripla marks the culmination of 10 years of efforts to simplify dosing while helping to achieve and maintain effective viral suppression for adults infected with HIV-1," Dr. John Bartlett, an HIV expert with Johns Hopkins University, said in a statement.

There are more than 38 million people living with AIDS worldwide, with two-thirds of them in sub-Saharan Africa, according to the United Nations. The agency estimates there are about 4 million new infections and nearly 3 million deaths every year.

The market for AIDS drugs worldwide is at least $4 billion, but it's capped by the fact that drugmakers give much of the product to poor Africans for free. GlaxoSmithKline (down $1.05 to $55.41, Charts) is the industry leader with eight HIV drugs on the market, including Combivir, a combination of two drugs.

Andrew McDonald, analyst for ThinkEquity Partners, said in a note that the development of Atripla should help boost Gilead stock to about $76 a share, from about $61 now, over the next 12 months.

"This landmark event, which comes 25 years into the AIDS epidemic, represents a significant growth opportunity for Gilead as the company further entrenches itself as the leader in the treatment for HIV," he wrote.


Offline newt

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Re: New single combo (Sustiva/Truvada)
« Reply #11 on: July 12, 2006, 05:20:34 PM »
"You're getting the first and only medication to contain a complete triple-drug once-daily cocktail contained in a single tablet,"

Obviously forgot about Triomune then

However, good news, I look forward to consistent clinical outcomes from the single pill

- matt
"The object is to be a well patient, not a good patient"

Offline Robert

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Re: New single combo (Sustiva/Truvada)
« Reply #12 on: July 12, 2006, 09:43:34 PM »
Quote
...I'm seriously considering trying the new single pill (once-a-day).  Are there any studies already available on comparing the new formulation to the old....
  CLIFF.  July 10

Quote
First one-a-day AIDS pill approved
Combo treatment from Bristol-Myers, Gilead gets OK from Food and Drug Administration.
  DINGOBOY.  July 12.

Cliff. your presceint.  Nothing you say or do surprises me anymore.

robt
« Last Edit: July 12, 2006, 09:46:13 PM by Robert »
..........

Offline Tim Horn

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Re: New single combo (Sustiva/Truvada)
« Reply #13 on: July 12, 2006, 10:18:43 PM »
Here's the AIDSmeds.com news story posted earlier today:

http://www.aidsmeds.com/news/am20060712.html

And here's the Atripla "lesson" on AIDSmeds.com:

http://www.aidsmeds.com/drugs/atripla.htm

Tim Horn

Offline Joel90069

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  • "Another turning point a fork stuck in the road."
Re: New single combo (Sustiva/Truvada)
« Reply #14 on: July 13, 2006, 01:16:34 AM »
And don't forget to buy stock in Gilead Sciences tomorrow morning!

Offline cubbybear

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Re: New single combo (Sustiva/Truvada)
« Reply #15 on: July 13, 2006, 01:59:12 AM »
I wonder how long this will take to get approved in Australia.  One less prescription to get sorted the better, I've already told my Doc I'd like to change to Atripla when it's available.
There's a bear in there!
Positive since 2000
Diagnosed 17/9/2005 CD4 35 VL 293,000
Meds 23/9/2005 Sustiva/Truvada
Currently CD4 232 VL Undetectable

Offline DingoBoi

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Re: New single combo (Sustiva/Truvada)
« Reply #16 on: July 13, 2006, 02:03:06 AM »
glad to see you are all so proactive in getting this new lesson out.   I suppose you've been expecting it a bit so it shouldn't have come as much a surprise.  

The only negative comment I have.. and did you really not expect me to present one?... well... it's minor..

but WTF is up with this poz logo?

It's just damn fucking ugly and looks amatuerish like a 12 year old did it.

I just cringe when i look at it.

I do applaud you all for your email notifications about this from poz and aidsmeds... it's great to get the info out there to people who may not be so 'in-tune' to the news.

But aaaack.. that logo hurts my eyes.   I would seriously suggest replacing it with the standard poz logo or some derivation of that, but this one is just nasty.  It just doesn't look professional.

And since that is my only complaint... i hope you are happy. :P  Ya'll done good on this rollout i think.  


Offline Cliff

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Re: New single combo (Sustiva/Truvada)
« Reply #17 on: July 13, 2006, 05:07:52 AM »
I wonder how long this will take to get approved in Australia.  One less prescription to get sorted the better, I've already told my Doc I'd like to change to Atripla when it's available.
I wouldn't hold your breath.  There's always a delay in getting the new meds to Europe/Australia (6 months to a year), but in this situation it sounds like they need to get Merck on board (which really means agree to give Merck it's piece of the pie) before they will even submit it the governmental authorities for approval.  Let's hope their negotiations come to a speedy conclusion. 

Though it does beg the question as to why are they just now starting negotiations.  They knew this would be an issue when they first decided to combine these drugs.  The skeptic in means thinks that they have been negotiating with Merck since Day One but they have been unable to reach an agreement.

- Cliff

Offline cubbybear

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Re: New single combo (Sustiva/Truvada)
« Reply #18 on: July 13, 2006, 07:22:57 AM »
Yeah you're right Cliff, I won't be holding my breathe waiting, considering Truvada was only released her in February this year
There's a bear in there!
Positive since 2000
Diagnosed 17/9/2005 CD4 35 VL 293,000
Meds 23/9/2005 Sustiva/Truvada
Currently CD4 232 VL Undetectable

Offline Matty the Damned

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Re: New single combo (Sustiva/Truvada)
« Reply #19 on: July 13, 2006, 08:49:23 AM »
The way in which pharmaceuticals are made available in Australia differs considerably from that in the US. We have a government authority here called the Therapeutic Goods Administration (TGA) which functions in a similar way to the American Food and Drug Administration.

Crucially, however, we have a national method of making drugs affordable called the Pharmaceutical Benefits Scheme (PBS). Essentially almost all prescription drugs are listed by the PBS and subsidised by the Commonwealth Government. Australian citizens and permanent residents are entitled to these subsisdised drugs. The PBS pays the vast bulk of the cost and small co-payment per script is footed by the consumer. The actual co-payment varies. Most Australians pay the general rate, around $30 per script and concession holders (pensioners, the unemployed etc) pay about $5. After 52 scripts in one year, you pay nothing.

The private insurers are not players in this process.

The PBS determines the actual price that the government will pay the companies for their drugs. Medications that do not receive PBS listing are pretty much unavailable to the public. Doctors simply cannot prescribe non PBS listed drugs because their patients cannot afford them.

The delay that Tripla faces in Australia will be based on it recieving PBS listing. Given that there are clinically equivalent alternatives available (ie the constituent components of Tripla are already PBS listed) I would think that a compelling case for the inclusion of this product would have to made to the expert committee that approves PBS listed medications.

This system, despite the apparent overbearance of red tape to the detriment of consumers, has worked very well in Australia. Pharamceutical companies and their eye for profit margins are not the foremost consideration in what is subsidised by the Commonwealth.

MtD

Offline cubbybear

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Re: New single combo (Sustiva/Truvada)
« Reply #20 on: July 14, 2006, 08:16:38 PM »
Yeah I had another talk with my specialist on Atripla and he said it will be lucky to see our market here in Australia before 2008 the way things are going, and negotiations needed with pharma companies.  Damn!
There's a bear in there!
Positive since 2000
Diagnosed 17/9/2005 CD4 35 VL 293,000
Meds 23/9/2005 Sustiva/Truvada
Currently CD4 232 VL Undetectable

Offline fearless

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Re: New single combo (Sustiva/Truvada)
« Reply #21 on: July 17, 2006, 11:26:24 PM »
Spot on Matty and Matt,

For the reasons Matty espoused, we have only just had Truvada approved in Feb this year and are still waiting for Kaletra tablets to be approved. Atripla may be some time off yet Matt.

I'm curious though, the speel from the drug companies are saying that this is a great breakthrough as a one pill a day regimen will lead to better adherence than the 'complex drug cocktails' involving many pills a day. They then use the situation from 10 years ago to accentuate the benefit of one pill a day. I just don't find my twice a day regimen all that complicated.
I also assume that for most people who will take Atripla it will only be a reduction of one pill a day - if they already take Sustiva and Truvada once a day.

Is the introduction of Atripla really going to increase adherence, or is it more of a marketing exercise? (eg HIV is a breeze: 'Just one pill a day keeps AIDS at bay'!
From my own perspective, I think I'd probably be more likely to skip my dose if it was just one pill a day - it would seem almost insignificant. Whereas with my current regimen, the whole eating a meal, getting the right pills out of the fridge etc makes the whole process significant and such a part of my routine that I'm not likely to forget my pills. Just my thoughts.

Little Steve
Be forgiving, be grateful, be optimistic

Offline newt

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Re: New single combo (Sustiva/Truvada)
« Reply #22 on: July 18, 2006, 04:02:05 AM »
Good point Steve, it's not that much of a great advance in some respects.  It will be better for some people to have just 1 pill, but is 2 pills really that more convenient than one? Indeed, as some people here know personally, Viread on an empty stomach can = jet engine bottom, so one pill will = no way to split the dose n avoid this.
"The object is to be a well patient, not a good patient"

Offline Cliff

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Re: New single combo (Sustiva/Truvada)
« Reply #23 on: July 19, 2006, 09:03:58 PM »
A small baby step in terms of adherence assistance/reduction in pill count.  A giant leap in terms of collaboration among drug companies to improve treatment.  To me, the collaboration IS the great advance here, and a successful Atripla would encourage more.

One can't also discount the financial benefit to patients, (speaking of US private insurance here), who generally pay a copay for each pill.  A $15 copay would have meant that a couple of years ago, (prior to Atripla and Truvada), a patient's out-of-pocket expense for this combo would have been $45 a month or $540 a year.  Atripla would reduce it to $15 a month or $180 a yaer, for a savings of $30 a month and $360 for the year.

Offline jordan

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Re: New single combo (Sustiva/Truvada)
« Reply #24 on: July 19, 2006, 09:09:43 PM »
One can't also discount the financial benefit to patients,


The two major advantages are:



  • Convenience
  • Cost



Agreed.  In June my copay went from $15 dollars  per prescription to 20% or a to a range of $18 - $36 per script.  Ergo, my Sustiva and Truvada for one month supply was $30 dollars and now costs $72.

Switching to Atripla, I will save $36 dollars per month.



« Last Edit: July 19, 2006, 09:19:25 PM by jordan »
If you think your lonely now, wait until tonight.

Offline Duude

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Re: New single combo (Sustiva/Truvada)
« Reply #25 on: July 19, 2006, 09:12:39 PM »
Hi Cliff,
     Very good point on the co-pay scenario.
duude

 


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