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Author Topic: Kaletra Monotherapy?  (Read 2475 times)

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Offline JamieD

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Kaletra Monotherapy?
« on: July 29, 2007, 06:55:08 PM »
I had talked to my doctors (they are two doctor's together in a practice) about Kaletra monotherapy as an option for me once my viral load was suppressed to undetectable. Both of them absolutely flipped out on me at the mere idea of a monotherapy. They both went on a rant and rave about how they were experts in the field and yadda yadda yadda. But I frequently look at clinical trials and I have seen many trials testing Kaletra monotherapy, some of them are even Phase III. When I review the Phase II data for Kaletra monotherapy it seems to be effective at up to 48 weeks and those who develop resistance tend to be people with low blood levels of the drugs, which the study conductors suggest as poor adhearance. Wouldn't it atleast be worth a look at if it means that you can take 1 drug for 48 weeks instead of 3? That's 2 less co-pays, and 2 less drugs to cause side effects. Even if the effect will onlt last for 48 weeks, that's still something worth trying.

Here is a Phase III study for Kaletra Monotherapy, but it's for people with HIV and HCV co-infection.

http://clinicaltrials.gov/ct/show/NCT00508222?order=1

BTW- My doctors both say that if I come in with suffienct scientific evidence for ANY type of "alternative" treatment then they will have no problem prescribing it to me. I was thinking of Reyataz monotherapy, since there have been a few trials of that as well but they seem to be more focused on Kaletra rather then Reyataz. I would think that Reyataz would be preferred over Kaletra due to less problems with lipodystrophy and increased blood lipids.

Offline Matty the Damned

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Re: Kaletra Monotherapy?
« Reply #1 on: July 29, 2007, 07:13:47 PM »
Jamie,

I've heard some stuff about Kaletra monotherapy but as you point out it's for people with HCV/HIV co-infection. I've never heard of Reyataz monotherapy. If you're concerned about co-pays and side effects maybe Atripla would be a better answer, but it can be problematic in people with mental health issues.

The trial you talk about has only just started has a very low enrollment. My advice to you would be the same as your doctor. Monotherapy is really not a good idea and I can't see a responsible medico approving of such a regimen. Remember too that there is a real risk of cross resistance here as well. You can become resistant to a whole class of drugs.

MtD

Offline blondbeauty

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Re: Kaletra Monotherapy?
« Reply #2 on: July 29, 2007, 08:28:36 PM »
There is a trial going on in Spain called OK (Only kaletra). The following link includes all the hospitals in which it is being done.
I am sorry but it is in Spanish.
http://www.ibanezyplaza.com/Prensa/NotaResult.asp?offset=0&Id=246&Contacto=11
And this is the hospital leading the trial:
http://www.capiosanidad.es/fjd/
The only member in these forums approved by WINBA: World International Nail and Beauty Association.
Epstein Barr +; CMV +; Toxoplasmosis +; HIV-1 +.
Counts when starting treatment:
V.L.:80.200 copies. CD4: 25%=503
Started Sustiva-Truvada 14/August/2006
Last V.L.count (Oct 2013): Undetectable
Last CD4 count (OCT 2013): 52%= 933

Offline JamieD

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  • Posts: 259
Re: Kaletra Monotherapy?
« Reply #3 on: July 29, 2007, 09:40:40 PM »
MTD-

I wasn't really talking about it for me, I was just putting the idea out there since its being researched. Notice I didn't put it in "Questions about Treatment and Side Effects", but rather in "Research News".
The co-pay, is nothing to do with me. I have no problem paying for my medication so long as my doctor isn't changing it every week or two. I get 3 months of ANY medication for $35 through my mail order plan. But not everyone is as lucky as I am. When I buy medication at the pharmacy I pay a HUGE amount of money, well over a $1000 for 3 months worth of medication (which I had to do once). But anywho, that's besides the point. Current HAART is very expensive for most people, even with health insurance. Current HAART also poses a lot of problems for people who take it for a long period of time. These problems are likely to continue for a long time so any attempt that the scientific community is making to reduce the cost, and toxicity is a good thing in my eyes.

Not all of the studies going on are in people with HIV and HCV, just the majority of them. I'll post more about Reyataz monotherapy.

And no, I can not take Atripla because of the Sustiva. That was the first drug I asked my doctor about and he/she both said absolutely not due to my severe mental health problems.


Offline JamieD

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  • Posts: 259
Re: Kaletra Monotherapy?
« Reply #5 on: July 29, 2007, 09:46:59 PM »
BlondeBeauty-
No tenía ninguna idea que usted habló español, aunque conjeturo debo haber conjeturado que eso cuando usted dijo usted era de España. :P ¿Adónde usted va generalmente a buscar para artículos como esto en español, porque no puedo encontrar cualquier cosa en inglés refiriéndole?

Offline Matty the Damned

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Re: Kaletra Monotherapy?
« Reply #6 on: July 29, 2007, 09:49:25 PM »
Sorry Jamie,

When I was reading about how you'd discussed it with your doctors and their reaction to the issue, I presumed you were asking for yourself. Now I see you were just canvassing some of the potential benefits of monotherapy (side effects, copay costs etc) as a broad issue in light of the new trial(s) currently underway.

As for the issue of monotherapy in general, it will be interesting to see the outcomes of those trials. I rather fancy that some of the newer classes of drugs might be more suitable candidates for this sort of therapy. It certainly would be a step forward. Combination therapy can be tedious and cumbersome, not to mention expensive.

As for sustiva, I feel your pain babe. Sustiva (or stocrin as well call it here in Australia) caused me no end of grief. Ghastly behavioural issues. It's a shame because it's a potent and effective virus slayer.

MtD

Offline JamieD

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  • Posts: 259
Re: Kaletra Monotherapy?
« Reply #7 on: July 29, 2007, 09:54:32 PM »
http://www.aidsmap.com/en/news/72FC6990-2991-4008-A3D6-F7FEFD7131B8.asp

This is on Reyataz Monotherapy. 90% of patients maintained a supressed viral load, and those whose viral load did rebound did not show resistance mutations. 2 out of the 3 of those who rebounded, showed very little to no plasma levels of atazanavir, which suggests they weren't being compliant.

Offline JamieD

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  • Posts: 259
Re: Kaletra Monotherapy?
« Reply #8 on: July 29, 2007, 09:57:27 PM »
MtD-

Well, I mean, I have talked to them about the possibility of one day switching to something else, but I haven't even been on the drugs long enough to see if they are working or not. My current regimen has absolutely no noticeable side effects, so I am happy with it right now. I've been focusing my research on TNF-alpha blockers to talk to my doctors about as a possible treatment oneday, but information is sparse and the clinical trials that are going on for people with HIV and TNF-alpha blockers are all for people who are resistant to more then 1 medication in each class.... which I am not.

Offline Matty the Damned

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Re: Kaletra Monotherapy?
« Reply #9 on: July 29, 2007, 10:01:01 PM »
Interesting stuff.

It's important to note that the report you link to is almost 18 months old and that such results would probably have to be reproduced independently of that original study to be more widely accepted. Not only that they're talking about using monotherapy in people who have had "sustained virological suppression" as a result of combination therapy over a lengthy period of time.

Well, I mean, I have talked to them about the possibility of one day switching to something else, but I haven't even been on the drugs long enough to see if they are working or not. My current regimen has absolutely no noticeable side effects, so I am happy with it right now. I've been focusing my research on TNF-alpha blockers to talk to my doctors about as a possible treatment oneday, but information is sparse and the clinical trials that are going on for people with HIV and TNF-alpha blockers are all for people who are resistant to more then 1 medication in each class.... which I am not.


It's good to see that you're keeping abreast of these things. And you're right, if you're happy with your current regimen there's no real pressing need to change anything.

Cheers for the thought provoking info!

Best regards,

MtD

Offline JamieD

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Re: Kaletra Monotherapy?
« Reply #10 on: July 29, 2007, 10:11:16 PM »
MtD-
There are more trials then just that one, but they are all small. Less then 200 people. Like I said, Kaletra seems to be the focus of monotherapy, but Reyataz is being studied as well. I am not quite sure why, maybe because Kaletra is one drug and Reyataz would still need to be boosted with Norvir (even though Kaletra contains Norvir, too). The studies with Kaletra do not all start out with patients who have undetectable viral load, some of them start out that way from the beginning and they see pretty good results from those too. The most encouraging thing though is that even when a patient experiences failure they don't usually develop resistance, so at that point they can be switched back to triple therapy.

Offline penguin

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Re: Kaletra Monotherapy?
« Reply #11 on: July 30, 2007, 07:25:31 AM »
Jamie, some more stuff for you to read...from ibase

march 06 study,university of nebraska - 5/36 people experienced viral rebound on atz/r monotherapy

Reyataz monotherapy - 1/30 people didnt maintain viral suppression, CNS penetration potential issue too

Lopinavir monotherapy - less potent than triple therapy with higher risk of resistance

Resistance implications of kaletra monotherapy

And most recent..(june/july 07) - Higher risk of resistance using lpv/r monotherapy

In these (fairly short & small) studies, clearly many people do well on the monotherapy - but the overall results still aren't as good as triple drug studies. Plus, we really don't have enough data to assess long term durability/things like cns penetration etc…
Kaletra on its own, I think it can be worth discussing for a small number patients, maybe more so as a short term measure? - but key considerations would include if they already have (sustained) undetectable VL beforehand, baseline resistance issues, and are likely to have 100%adherence
Reyataz, even boosted, somehow i doubt this is ever gonna be demonstrated as strong enough to be a lasting/safe bet for monotherapy option..

Kate
« Last Edit: July 30, 2007, 07:27:27 AM by penguin »

Offline blondbeauty

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  • Posts: 1,784
Re: Kaletra Monotherapy?
« Reply #12 on: August 01, 2007, 05:17:51 PM »
This is a good Spanish website. I enclose the link to one of its articles: filling materials for lipoatrophy
http://gtt-vih.org/actualizate/lo_mas_positivo/lmp37/por_la_cara_reparacion_facial?#
The only member in these forums approved by WINBA: World International Nail and Beauty Association.
Epstein Barr +; CMV +; Toxoplasmosis +; HIV-1 +.
Counts when starting treatment:
V.L.:80.200 copies. CD4: 25%=503
Started Sustiva-Truvada 14/August/2006
Last V.L.count (Oct 2013): Undetectable
Last CD4 count (OCT 2013): 52%= 933

 


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