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Author Topic: Monthly Injections  (Read 5712 times)

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Offline Delby

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  • Posts: 108
Monthly Injections
« on: September 11, 2013, 10:51:34 AM »
Not sure whether this has been posted, but GSK is developing a monthly injection which has had success with their trial patients and would carry significantly less side effects.

The story can be found here:

http://www.edgeonthenet.com/health_fitness/hiv_aids//148895/gsk_tries_to_control_hiv_with_monthly_injections

Offline Matts

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Re: Monthly Injections
« Reply #1 on: September 11, 2013, 11:56:02 AM »
So is this the future? Getting four times a year an injection of the Dolutegravir-like  GSK744 and Rilpivirine. I wonder why Edurant works as nanoinjection for 3 months and the Complera user need a high fat meal every day to make it work.
tivicay/kivexa

Offline mecch

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  • red pill? or blue pill?
Re: Monthly Injections
« Reply #2 on: September 11, 2013, 12:29:00 PM »
That will be pretty bizarre when they have to price one injection at the same price as 3 or 4 months a pill...    ;D 8) ???
All those little pills someone make the price a little less scandalous, cause it looks like a fair amount of medicine, in 3 bottles.
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline buginme2

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Re: Monthly Injections
« Reply #3 on: September 11, 2013, 12:49:35 PM »
Monthly injections are a big step not only in the convenience aspect of treatment (one injection a month/quarter versus daily pills) but currently there are no alternatives to treatment if you can't take a pill.   If you can't swallow a pill your kinda screwed right now.

Offline Jmarksto

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Re: Monthly Injections
« Reply #4 on: September 12, 2013, 11:33:14 AM »
So is this the future? Getting four times a year an injection of the Dolutegravir-like  GSK744 and Rilpivirine. I wonder why Edurant works as nanoinjection for 3 months and the Complera user need a high fat meal every day to make it work.

Matts: my understanding is that the nano-injection formulation is 100% crystallized drug which does not have to go through an absorption process through the digestive system which requires the high fat meal.  Here is the ppt presentation from IAS:

pag.ias2013.org/PAGMaterial/PPT/244_392/final.pptx‎

The question I have is that this is a two drug combo rather than the conventional three drug combo - is this two drug combo going to be sufficient?  If so, the fact that a two drug combo works seems like as much of a big deal as the fact that is a monthly injection.
03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45%  VL 25
02/25/14 CD4   792/37%  VL UD
07/09/14 CD4 1004/39%   VL UD

Offline Matts

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Re: Monthly Injections
« Reply #5 on: September 25, 2013, 04:28:24 PM »
Thx Jmarksto. I think that a dualtherapy is good enough, because GS744 is very potent and has no known resistances so far. But time will tell.

There was a press release today and I think that there will be two Rilpivirine Depot formulations in the future: - a very expensive one with GS 744 for the western world and a cheap licensed PreP version for Africa and developing countries.

"CORK, Ireland, September 25, 2013 /PRNewswire/ --

Janssen R&D Ireland (Janssen) announced today it has signed a license agreement with PATH for the early development of the human immunodeficiency virus type 1 (HIV-1) medicine rilpivirine in a long-acting injection (depot formulation) as potential pre-exposure prophylaxis (PrEP) against HIV infection.

Under the terms of the agreement, a Drug Development program of PATH, an international nonprofit organization that transforms global health through innovation, has the right to develop rilpivirine long-acting formulation as a possible new way to prevent HIV infection. PATH has the intent to conduct prophylaxis clinical trials in collaboration with partners including the HIV Prevention Trials Network. Following the completion of the clinical Phase 2 program, PATH and Janssen will evaluate entering into a late stage development agreement covering the use of rilpivirine as PrEP for uninfected individuals at high risk of acquiring HIV.

"Rilpivirine is an important treatment option for patients today and we are pleased to work with PATH to evaluate it as an injectable depot formulation that may help to reduce the spread of infection," said Wim Parys, Global Head of Research & Development, Janssen Global Health. "We believe that evaluating a long-acting formulation, which could help improve adherence in a PrEP regimen, is an important part of the Janssen commitment to the global fight against HIV and AIDS."

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It is currently commercialized by Janssen for the oral, once daily treatment of HIV-1, in combination with other antiretroviral agents (ARVs), in ARV treatment-naïve adults, and in most countries, in patients with a viral load less than or equal to 100,000 HIV-1RNA copies/mL.

This license agreement with PATH does not impact the commercialization of rilpivirine by Janssen, and does not impact the use of rilpivirine in combination treatments........."

http://www.prnewswire.com/news-releases/janssen-rd-ireland-announces-agreement-with-path-for-early-development-of-rilpivirine-in-long-acting-formulation-for-potential-prophylactic-intervention-225153442.html

http://www.path.org/

tivicay/kivexa

Offline JungleJungle

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  • Posts: 41
Re: Monthly Injections
« Reply #6 on: October 01, 2013, 05:40:17 AM »
That's the greatest news i ever read about treatment improvement!
You need coolin', baby, I'm not foolin',
I'm gonna send you back to schoolin',
Way down inside honey, you need it,
I'm gonna give you my love,
I'm gonna give you my love.

Offline Matts

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  • Posts: 205
Re: Monthly Injections
« Reply #7 on: October 21, 2013, 05:11:18 PM »
There is a new (long) paper from ViiV and GSK:
http://journals.lww.com/co-hivandaids/Fulltext/2013/11000/Long_acting_injectable_antiretrovirals_for_HIV.8.aspx

The clinical research is ongoing and what else is important:
- It will be definitively a dual-therapy
- monthly or less often injections
- no grade 3 or 4 side effects so far
- monotherapy for PreP will be possible (Nano GSK 744 OR rilpivirine)
tivicay/kivexa

Offline Jmarksto

  • Member
  • Posts: 468
Re: Monthly Injections
« Reply #8 on: October 21, 2013, 05:44:42 PM »
Matts;  Thanks for the link - very good to see this moving forward, although given that we are still in phase 1 trials it seems we are at least a few years out. 

Cheers,
JM
03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45%  VL 25
02/25/14 CD4   792/37%  VL UD
07/09/14 CD4 1004/39%   VL UD

Offline buginme2

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Re: Monthly Injections
« Reply #9 on: October 21, 2013, 06:34:32 PM »
There currently is a phase 2b study ongoing for GSK744 in combination with Rilpivirine (taken orally) to see if dual therapy is sufficient after your viral load is undetectable (after an initial three drug therapy).  So far so good.

So this brings up an elephant in the room.  Is everyone on a the drug regimen being over medicated?  Once your undetectable, is it ok to go to dual therapy?


Offline Jmarksto

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Re: Monthly Injections
« Reply #10 on: October 21, 2013, 07:22:36 PM »
So this brings up an elephant in the room.  Is everyone on a the drug regimen being over medicated?  Once your undetectable, is it ok to go to dual therapy?

I think Newt was talking about dual therapy after going UD in another thread, but I couldn't find the thread.  There has also been some discussion and research on reducing the dosages - even going to 5 days out of 7. 

It will be interesting to see where treatment goes in a few years -- until then, as long as my numbers are good I'll keep my current regimen.
03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45%  VL 25
02/25/14 CD4   792/37%  VL UD
07/09/14 CD4 1004/39%   VL UD

Offline Giancarlo

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  • Posts: 10
Re: Monthly Injections
« Reply #11 on: October 25, 2013, 09:09:28 AM »
There has also been some discussion and research on reducing the dosages - even going to 5 days out of 7.

There's been a lot of debate about this here in France in the last few years.
Dr. Jacques Leibowitch has been working on this in his ICCARE project. With his patients, after a few years of "normal" tritherapy (7 days a week), he reduced to 5 days a week, then 4 days a week if still undetectable, then 3 days a week if still undetectable, then even 2 days a week for some patients.
Hence reducing the cost of the treatment and the long-term toxicity of ARVs.
4 days a week seem to work for most patients (after a few years of 7 days a week): viral load stays undetectable (although one may argue that viral load is not the only important variable). But of course this has to be done in close cooperation with your doc, not on your own.

It was discussed a bit here: http://forums.poz.com/index.php?topic=48956.msg592220#msg592220

This is a much debated topic because Leibowitch did his stuff almost alone in his hospital, in an empirical way. It worked and he did not encounter any virological failure. But he went a lot in the media in the last months (now that he is retired) to complain about  the fact that the people who decide what can be done in terms of public health won't listen to him, and that no randomized controlled trials are being funded to prove that what he does is right, etc. So he's not acting in a very fair way: he is not playing in the science sphere anymore, but in the media sphere, which doesn't follow the same rules.

But for sure most of us are over-medicated. First of all, we all get the same dosage (for example, 1 pill of Atripla a day), whether we weigh 100 or 300 pounds...
« Last Edit: October 25, 2013, 09:21:03 AM by Giancarlo »
Nov 2011: HIV-
Jul 2012: HIV+
Aug 2012: VL 8,900 / CD4 822 (28%)
Oct 2012: VL 13,500 / CD4 887 (30%)
Jul 2013: VL 9,000 / CD4 ?
Sep 2013: VL 24,000 / CD4 625 (34%)
Oct 11th 2013: Start Atripla
Nov 7th 2013: VL 84 / CD4 665 (37%)
Dec 11th 2013: VL UD (<40) / CD4 960 (35%)

Offline Jmarksto

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  • Posts: 468
Re: Monthly Injections
« Reply #12 on: October 27, 2013, 10:09:38 AM »
... But he went a lot in the media in the last months (now that he is retired) to complain about  the fact that the people who decide what can be done in terms of public health won't listen to him, and that no randomized controlled trials are being funded to prove that what he does is right, etc. So he's not acting in a very fair way: he is not playing in the science sphere anymore, but in the media sphere, which doesn't follow the same rules.

I don't think we are going to see many trials on dose reduction - drug companies are not going to invest in research to reduce revenue.  I am not a conspiracy guy, but I do think most organizations do act out of self interest.  It should be where public money goes, if for no other reason than to be able to spread the resources more broadly in resource limited countries.

As for Dr. Leibowitch, it sounds like he is frustrated with the system and wants change.  We need to listen to people like him and we need more of them.

JM
03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45%  VL 25
02/25/14 CD4   792/37%  VL UD
07/09/14 CD4 1004/39%   VL UD

Offline YellowFever

  • Member
  • Posts: 155
Re: Monthly Injections
« Reply #13 on: February 27, 2014, 04:32:41 PM »
Apparently CROI 2014 will have a paper on this. And it is rumoured that the authors will present positive results on this experiment.

http://www.thebodypro.com/content/73937/croi-2014-preview-hot-topics-in-hiv-and-hepatitis-.html?getPage=2

Quote
Investigators from the U.S. Centers for Disease Control and Prevention (CDC) will present data that are likely to show that monthly injections with the investigational integrase inhibitor GSK744 protects macaques from repeated vaginal exposure to simian-human immunodeficiency virus (SHIV). These data, combined with previous data showing effectiveness in prevention despite repeated rectal exposure of SHIV in monkeys, suggest the opportunity to use 744 for PrEP in people.
08/2010 HIV- 08/2012 HIV+
10/2012 CD4 415(15%)
04/2013 CD4 457(15%)
10/2013 CD4 520 (20%) VL 650 (wtf?)
02/2014 CD4 410(20%) VL 390 (yay!)

Offline Dr.Strangelove

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  • Posts: 206
Re: Monthly Injections
« Reply #14 on: March 02, 2014, 09:14:11 PM »
I'm getting excited. I hope CROI will put up the talks online again like they did in previous years? (I'm not so sure since they seem to have abandoned the old website)

It seems like monthly injections might become a reality in a few years. In my opinion they'd be much better suited as PreP, since there won't be the same issues with compliance that we see now with the pills (After all, some studies had to be canceled altogether due to poor adherence of the participants).
But also for us pozzies monthly injections might have some advantages. Again, for patients with poor adherence. For patients who need to travel (for work) to countries that may give you trouble if they find your meds at the border check. And there seem to be less side effects.

What I don't understand is why apparently a dual therapy would be sufficient for the injection approach while it's not when taking meds orally. How does it make a difference to the virus how the meds get into the blood stream?

P.S.: Here is this year's CROI Program at a Glance (PDF)
« Last Edit: March 02, 2014, 09:22:02 PM by Dr.Strangelove »

Offline xinyuan

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  • Posts: 108
Re: Monthly Injections
« Reply #15 on: March 02, 2014, 10:47:15 PM »
What I don't understand is why apparently a dual therapy would be sufficient for the injection approach while it's not when taking meds orally. How does it make a difference to the virus how the meds get into the blood stream?

P.S.: Here is this year's CROI Program at a Glance (PDF)


Are you referring to needing only 2 drugs at all? In this case, they are combining a non-nuc (NNRTI) with an INSTI. Most therapies are based on nuc's (NRTI), and the current standard is to use at least 2 nucs + something else (PI/INSTI/NNRTI).

There are hints that CROI 2014 may see treatment strategies without NRTI's (one study looks at PI + INSTI). If that proves to be effective, doctors may simplify to only 2 drugs (provided neither are NRTI's).


If you're asking about differences between oral and injection, I can only guess. With oral, the drugs get metabolized in the body. It hangs around for a short time. And then gets cleared.

With GSK744, I am aware GSK was experimenting with a special nanoparticle suspension. This allows the drug to hang around in the body for months. If they can adapt that to other ART's ... oh, the possibilities ....

Somehow, getting the body to absorb that nanoparticle suspension orally may be too challenging. At least with our current technology. (Kind of like daily birth control pills vs. 3 month depo shots)

http://www.natap.org/2013/CROI/croi_38.htm
« Last Edit: March 02, 2014, 10:59:42 PM by xinyuan »

Offline Dr.Strangelove

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  • Posts: 206
Re: Monthly Injections
« Reply #16 on: March 03, 2014, 01:24:08 PM »
I was refering to Matts' post above:
There is a new (long) paper from ViiV and GSK:
http://journals.lww.com/co-hivandaids/Fulltext/2013/11000/Long_acting_injectable_antiretrovirals_for_HIV.8.aspx

The clinical research is ongoing and what else is important:
- It will be definitively a dual-therapy
- monthly or less often injections
- no grade 3 or 4 side effects so far
- monotherapy for PreP will be possible (Nano GSK 744 OR rilpivirine)

Seems like this is intended as a dual therapy (once the patient has gone undetectable  with a 'classic' three-drug regimen?). So I assume they must be confident that resistance will not occur. I just wonder why all of a sudden it should be sufficient to attack the HIV life cycle at two instead of three different points. There must be some explanation or reasoning behind it. And I wonder if that is in any way related to that way the drugs are administered (injection vs. oral), because I don't see how that would make a difference. (No matter which way you get the drugs into the blood stream, you need to keep them on a certain level at all times in order to avoid HIV from finding a loophole and develop a resistencies)

Offline buginme2

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Re: Monthly Injections
« Reply #17 on: March 03, 2014, 02:15:14 PM »
CROI this year should have some pretty significant announcements regarding integrase inhibitors (as far as them being superior to the other classes) which includes dual therapy with integrase being non inferior to a standard 3 drug combo.


Offline Matts

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  • Posts: 205
Re: Monthly Injections
« Reply #18 on: March 04, 2014, 05:28:50 PM »
More News from CROI:
"A single injection of an anti-HIV drug may someday protect people from infection with the AIDS virus for up to 3 months. That’s the implication of monkey experiments reported in the 7 March issue of Science.(...)

Ho says GSK744 has two “magical properties.” First, it’s insoluble, so at high concentrations GSK744 forms crystals when suspended in a liquid. “When this nanosuspension is injected, it essentially creates a depot effect and the drug bleeds out at a predictable rate,” Ho explains. GSK744 is also slowly metabolized. Both effects keep the blood levels of the drug steady for many weeks."
http://news.sciencemag.org/health/2014/03/long-lasting-drug-could-thwart-hiv


A study in macaques has raised hopes that preventing HIV infection in humans will soon be as easy as a shot in the arm four times a year. In a proof-of-concept study, researchers have shown that an antiviral drug injected into the muscle protects monkeys from infection for weeks afterward.
http://www.nature.com/news/long-acting-shot-prevents-infection-with-hiv-analogue-1.14819

Monthly GSK744 Long-Acting Injections Protect Macaques Against Repeated Vaginal SHIV Exposures:
http://www.croi2014.org/sites/default/files/uploads/2014CROI_TuesdayNoon_0.pdf


tivicay/kivexa

Offline Dr.Strangelove

  • Member
  • Posts: 206
Re: Monthly Injections
« Reply #19 on: March 04, 2014, 08:51:17 PM »
Oh wow, that's pretty exciting. Thanks for posting.

This would render the current pill-based PreP approach obsolete.
(And I assume it would be cheaper, too.)

Offline YellowFever

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  • Posts: 155
Re: Monthly Injections
« Reply #20 on: March 05, 2014, 07:51:51 PM »
it’s insoluble, so at high concentrations GSK744 forms crystals when suspended in a liquid. “When this nanosuspension is injected, it essentially creates a depot effect and the drug bleeds out at a predictable rate,” Ho explains

Yikes, that's actually depressing news. When I first read about the nanosuspension thingey, it seemed like a new technology to deliver drugs. It would seem as if they could take any medicine, wrap it up in nanosuspension-ey stuff and inject it into your body. Now it seems it is the very drug itself is exhibiting this behaviour which makes it unlikely that other drugs would be able to.
08/2010 HIV- 08/2012 HIV+
10/2012 CD4 415(15%)
04/2013 CD4 457(15%)
10/2013 CD4 520 (20%) VL 650 (wtf?)
02/2014 CD4 410(20%) VL 390 (yay!)


Offline dico

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  • Posts: 72
Re: Monthly Injections
« Reply #22 on: May 23, 2014, 01:11:10 AM »
I.d rather take one Eviplera pill everyday than use this injection with a needle in my stomach even if it is one a month

Offline vertigo

  • Member
  • Posts: 138
Re: Monthly Injections
« Reply #23 on: May 23, 2014, 01:45:09 AM »
Yeah, I can't see injections being preferable to daily pills for myself, unless the dosing interval is really long, like six months or something.  Nonetheless, the pharmacology is fascinating.  Thanks for the links, Matts.

Offline Jeff G

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  • How am I doing Beren ?
Re: Monthly Injections
« Reply #24 on: May 23, 2014, 07:27:48 AM »
I would happy dance the nerdiest nerd dance all over town for days if I could get an injection every few months and not have to bother with daily pills . 

Offline Jmarksto

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  • Posts: 468
Re: Monthly Injections
« Reply #25 on: May 23, 2014, 01:30:12 PM »
I would happy dance the nerdiest nerd dance all over town for days if I could get an injection every few months and not have to bother with daily pills . 

Convenience is one reason to dance, but another reason to dance may be that there are fewer side effects because there is less drug in the body (because this is dual vs. tri therapy, and direct to the blood stream vs absorbed through the digestive system).

Yikes, that's actually depressing news. When I first read about the nanosuspension thingey, it seemed like a new technology to deliver drugs. It would seem as if they could take any medicine, wrap it up in nanosuspension-ey stuff and inject it into your body. Now it seems it is the very drug itself is exhibiting this behaviour which makes it unlikely that other drugs would be able to.

I can't remember where I read it, but I recall nanosuspension drug technology being explained as molecular origami.
03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45%  VL 25
02/25/14 CD4   792/37%  VL UD
07/09/14 CD4 1004/39%   VL UD

Offline Matts

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  • Posts: 205
Re: Monthly Injections
« Reply #26 on: June 12, 2014, 10:40:31 AM »
You dont have to wait for dual therapy until Cabotegravir/Rilpivirine is approved. GSK starts a trial for Tivicay/Rilpivirine single tablet Regimen (FDC) in Q1 2015.
(also as pediatric formulation)
I think that You still have the food restrictions for Rilpivirine in this FDC, a disadvantage.

"LONDON, June 12, 2014 /PRNewswire/ -- ViiV Healthcare today announced that they have entered into an agreement with Janssen R&D Ireland Ltd (Janssen) for the development and commercialisation of a single-tablet combining dolutegravir (Tivicay®) and Janssen's non-nucleoside reverse transcriptase inhibitor rilpivirine (Edurant®[1]). This represents ViiV Healthcare's first external collaboration to develop a single-tablet regimen with another company's branded product and builds on ViiV Healthcare's strategy to expand its portfolio of dolutegravir-based regimens, which started with the approval of dolutegravir for use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs) in the US, and HIV infected adults and adolescents above 12 years of age in Europe.

As part of this agreement, the two companies will investigate the potential of combining dolutegravir and rilpivirine into a single-tablet in order to expand the treatment options available to people living with HIV. Studies included in the new development programme are expected to begin by Q1 2015 and will investigate the two drug combination regimen as an HIV maintenance therapy for patients already virally suppressed on a three drug regimen. The companies will further investigate the development of paediatric fixed-dose formulations which combine dolutegravir and rilpivirine.

"New options that advance current therapies are increasingly important as patients and clinicians consider HIV care over the long term," said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. "Through this collaboration with Janssen we aim to develop a new combination therapy that meets the needs of patients, and adds to our scientific understanding of dolutegravir."

If approved by regulatory authorities, the two drug fixed-dose combination therapy being developed by ViiV Healthcare and Janssen could offer people living with HIV an option to switch from a standard three drug therapy to a two drug nucleoside reverse transcriptase inhibitors (NRTI)-sparing combination, once a stable suppressed viral load has been achieved....."

http://www.prnewswire.co.uk/news-releases/viiv-healthcare-announces-new-collaboration-with-janssen-to-investigate-single-tablet-regimen-for-maintenance-treatment-of-hiv-1-262846701.html
tivicay/kivexa

Offline Matts

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  • Posts: 205
Re: Monthly Injections
« Reply #27 on: July 17, 2014, 05:49:51 PM »
I think that renal-, hepatic- and intestinal problems will be obsolete under quarterly, intra-muscular Cabotegravir injections. CAB doesnt use hepatic or intestinal transporters and only very weak renal transporters.

It seems to be a very easy-going drug.

http://www.natap.org/2014/Pharm/Pharm_09.htm
tivicay/kivexa

 


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