POZ Community Forums
Meds, Mind, Body & Benefits => Questions About Treatment & Side Effects => Topic started by: tommy246 on September 05, 2009, 05:28:58 am
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What are your opinions on this drug .What i have read its even better than atripla in that it performs the same but has even less side effects. Two more questions 1.are there no lipid side effects with this drug i think i read that somewhere but not sure and 2. When did this drug first come into use in the usa as its not available here in spain yet ,here the first line is atripla
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I've read a lot about it recently. It is not generally used as a single drug. Like all the others it needs to be used in a combination with, for example, Truvada. Think of it as replacing the sustiva part of Atripla. So, while insentress may not have lipo side effects, the drugs you need to combine it with do, but only for a small percentage of people. Inssentress does not have the nervous system effects of sustiva which are a problem for some people.
Also, insentress has only been in trials and in use for a few years. In July it was approved as a first line treatment with Truvada. While it seems to have fewer side effets, there is no long term data so you can't be sure. So risks I have read about include loss of muscle mass and some cancers but the actual fact is no one knows or will know for some time.
That said, it is apparently a very effective drug. Others like it are in development. It seems that it will become a major choice.
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I think it's brilliant, the most side effect free drug I've ever been on. I don't think it will be long at all before it's licensed everywhere for first line therapy. It just has a low barrier to resistance, but then so does Efavirenz in Atripla. The biggest negative I guess is we don't know enough about longer term effects as Ruralguy rightly says.
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I agree with Marka.
One other thing is that insentress is currently is a 2x a day drug. Perhaps soon it will be formulated into a 1x a day dose and perhaps into a complete 1x a day pill like atripla. It is clearly more easily tolerated than atripla/sustiva. I wish I could have a 1x a day morning regime without any PIs and their boosters.
My doc reminded me that the single biggest issue with all the drugs is compliance. And a million studies prove compliance goes down with the number of doses per day and the number of pills involved.
Whiel it has just been approved here for 1st line use, I think most docs see it as something to keep in reserve for use when/if you become resisitent to the standard drugs.
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...So, while insentress may not have lipo side effects, the drugs you need to combine it with do, but only for a small percentage of people...there is no long term data so you can't be sure. So risks I have read about include loss of muscle mass and some cancers but the actual fact is no one knows or will know for some time.
That said, it is apparently a very effective drug. Others like it are in development. It seems that it will become a major choice.
I've taken Insentress + Truvada for 20 months. I recommend this as "first-line" OR "salvage" (a friend was in the "salvage" study group; he's thriving), as it works for most types of patients.
Since it took 2.5 years on my previous regimen to develop Lipo (suddenly---not slowly---as many report), I will see. To date: zero Lipo side effects from my combo. VL is undetectable; CD4s increase above 50%.
I think MDs need to answer why they're prescribing anything other than Insentress (unavailable is a pretty good reason).
Since drug development is profit-driven, not sure a competitor in this "class" (Integrase) will ever be released.
8) -megasept
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There is a new Integrase inhibitor in clinical trials, as reported by Tim Horn:
http://www.poz.com/articles/hiv_gsk1349572_integrase_761_16953.shtml
What makes this new inhibitor exciting, is that it might work after resistance arises to Isentress.
v
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veritas:
a single daily dose would be nice, but "NO :o BOOSTING AGENT" would be much better medically.
I promise to become a better reader. ;)
8) -megasept
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mega,
The HIV landscape is changing so rapidly we all have trouble keeping up. That's why forums such as these are so beneficial ----- exchange of information.
v
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There is a new Integrase inhibitor in clinical trials, as reported by Tim Horn:
http://www.poz.com/articles/hiv_gsk1349572_integrase_761_16953.shtml
What makes this new inhibitor exciting, is that it might work after resistance arises to Isentress.
v
Veritas my specialist told me that with these excellent new drugs like issentress and atripla you dont develope resistance if as with most people they keep you non detectable,do you agree.
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tommy246,
The most important aspect concerning resistance is to not skip any doses. Resistance is a lot more likely to appear with non-adherence.
v
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I have been on Isentress since July. I switched to it because of hyperlipidemia that could not be controlled by diet. Statins have shown they don't like me.
Isentress is a breeze to take and within a few weeks, my lipids had fallen to near normal levels.
No, we don't know what long-term effects will pop up. But, when I started Crix in 96 we didn't know what to expect down the road either. Its a roll of the dice, so to speak.
All I can say is for right now, Isentress is a godsend.
HUGS,
Mark
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Since it took 2.5 years on my previous regimen to develop Lipo (suddenly---not slowly---as many report), I will see. To date: zero Lipo side effects from my combo. VL is undetectable; CD4s increase above 50%.
what was your previous regimen?
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Aztecan thats good news about your lipids issentress seems to be the real deal ,can you have lipid issues with atripla ?
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There is another drug that can replace Sustiva in Atripla. Intelence - etravirine. I got mine in Switzerland so dont know if its available in the European Union. It got rid of the central nervous system weirdness I had with Sustiva. 2x a day. with 1 truvada.
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meech your meds are working really well sounds like a good combo.
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Yep they work well. Most modern combos do! I just saw my ID 10 minute ago. Viral load below 20, undetectable in the most modern tests. Thank you science.
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tommy246,
The most important aspect concerning resistance is to not skip any doses. Resistance is a lot more likely to appear with non-adherence.
v
V: gotta agree. "resistance" was once thought to be such a huge issue. i can't think of a single adherent POZ who's ever told me they suffered from it. We used to discuss "saving" protease meds for later; the "inevitable" just never arrived. i'm fine with that.
8) -megasept
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"resistance" was once thought to be such a huge issue. i can't think of a single adherent POZ who's ever told me they suffered from it.
Really? I know 100% adherence (or close to it) would dramatically reduce the possibility of resistance but still thought it happened randomly to some people even without any archived resistances.
Have been taking B-12's for 3 weeks to get ready for meds (to test myself) and last night for the first time I missed one. Kind of mad at myself even though it is only a damn vitamin pill >:(
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As someone who adhered for 16 years of taking HIV meds, I find that comment ill-informed and inconsiderate, especially coming from someone that has been diagnosed for 18 years megasept. There are lots and lots of us exposed to resistance issues due to mono/dual therapy before HAART that adhered day in and day out only to find ourselves with multiple resistance issues that then took a further decade to rectify. Exactly how much personal exposure do you have to other LTS'ers when you make such a comment? As if we don't feel stigmatized within the larger Poz community as it is. Thanks.
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As someone who adhered for 16 years of taking HIV meds, I find that comment ill-informed and inconsiderate, especially coming from someone that has been diagnosed for 18 years megasept. There are lots and lots of us exposed to resistance issues due to mono/dual therapy before HAART that adhered day in and day out only to find ourselves with multiple resistance issues that then took a further decade to rectify. Exactly how much personal exposure do you have to other LTS'ers when you make such a comment? As if we don't feel stigmatized within the larger Poz community as it is. Thanks.
For what it's worth, when I read his statement I did not think he was referring to pre-1997, when many developed resistance, despite adherence, due to mono/dual therapy, IOW, before the advent of PIs and 3-drug cocktails.
It should go without saying that adherence to sub-par regimens is not to be compared to adherence to a potent 3-drug cocktail, two very different things.
PS: There's a nice pic of Mark (aztecan) on the poz.com homepage, tied to the article "Breathe Easy" (Tab #1)
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As someone who adhered for 16 years of taking HIV meds, I find that comment ill-informed and inconsiderate, especially coming from someone that has been diagnosed for 18 years megasept. There are lots and lots of us exposed to resistance issues due to mono/dual therapy before HAART that adhered day in and day out only to find ourselves with multiple resistance issues that then took a further decade to rectify. Exactly how much personal exposure do you have to other LTS'ers when you make such a comment? As if we don't feel stigmatized within the larger Poz community as it is. Thanks.
l'll check with you first, next time i want to (mistakenly or not) agree with someone's posted theory/comment based on my own irrelevant (empirical) experience. We're all a bunch of haters. jeeeeez.
8) -megasept
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Just a newbie here, but....
If you read comments by Dr Gallant, and the doctors from the Body website, they say if you are adherhent, resistance should not take place and one can stay on the same regimen for decades.
I'm sure they were talking about adherence to current HAART protocols.
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I have just read some lessons on starting treatment on this website and was surprised to read that it says that issentress should never be used for people starting treatment yet a few on here have been prescribed it.
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I have just read some lessons on starting treatment on this website and was surprised to read that it says that issentress should never be used for people starting treatment yet a few on here have been prescribed it.
I just took a look at the Isentress page and they need to update the information, I'm very surprised it hasn't been done by now.
Even before it was officially approved by the FDA for treatment-naive patients, doctors were already prescribing it for such use "off-label," but at this point it's officially approved and that info. should be updated.
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Even though it may be approved I have spoken with a few docs who do not prescribe Issentriss to treatment-naive patients. Whether or not it is because it doesn't have the history of some of the other meds, or they want to keep it for use as a second line treatment I do not know.....I just know they do not recommend it as an initial treatment. I am going to ask more detailed questions when the time comes...not on meds yet as I am still trying to establish my baseline numbers.
Mega and bufguy.,..thank you for the info.
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It was approved in early July (the 9th?) for treatment naive patients but docs still think of it as a backup. And as to side effects that is only a few years of data. Still, everyone on it says it is very easy to take, usually 2x a day combined with truvada. One person said to me he was on an off-label insentress only regime, 1x a day at lunchtime. That would be cool.
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When my doctor and I talked about switching to Isentress/Truvada, it would still have been off label use because I was not switching because of resistance and it wasn't approved for anything but salvage.
As for not having much long-term information on it, I agree. There isn't any.
But, I knew that continuing on a PI based regimen, which I had been on for 13 years, wasn't going to work either, because I would probably fall victim to a coronary or a stroke caused by hyperlipidemia.
My lipids fell almost immediately after switching to Isentress/Truvada from Lexiva/Combivir.
What will happen in 10 or 15 years? I don't know.
I hope to be around to let you know.
HUGS,
Mark
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One person said to me he was on an off-label insentress only regime, 1x a day at lunchtime. That would be cool.
...really? As in only Isentress? Interesting....
What will happen in 10 or 15 years? I don't know. I hope to be around to let you know.
Let's catch up in 2024 and you can let me know :) :) :)
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One person said to me he was on an off-label insentress only regime, 1x a day at lunchtime. That would be cool.
Isentress is very potent but it has a low barrier to resistance. It does not work as monotherapy, this was shown to be the case with the SWITCHMRK study. It would be unethical for a doctor to prescribe Isentress monotherapy. Are you absolutely sure he is only on Isentress and no other HIV drugs?
There was a small non-randomized study that looked at Isentress/Reyataz, which would be duo therapy, and it actually worked for some people. It's too soon to actually try it but if it were to work it would be great since it's only two drugs and they are both good ones with not-so-bad toxicity. It's tricky, though, because both Isentress and Reyataz need only one mutation and they are useless.
No HIV drug so far works as monotherapy except maybe some PIs such as Kaletra and Prezista, both boosted with Norvir. PIs as a rule (there are exceptions) have higher barriers to resistance than other classes.
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I just took a look at the Isentress page and they need to update the information, I'm very surprised it hasn't been done by now.
l," but at this point it's officially approved and that info. should be updated.
Our Isentress page (http://www.aidsmeds.com/archive/Isentress_1639.shtml) was updated on July 15.
First section, first bullet:
Isentress is an integrase inhibitor manufactured by Merck & Company. It was approved by the U.S. Food and Drug Administration (FDA) in October 2007. Isentress is approved both for treatment-experienced patients who have HIV strains that are resistant to multiple antiretroviral (ARV) drugs and for people with drug-sensitive HIV strains, such as those starting antiretroviral therapy for the first time.
Second section, third bullet:
Isentress is also approved for people who have not yet taken ARV therapy.
The dosing requirements are the same for both treatment-experienced and treatment-naive individuals.
As for the information in our "When to Start, What to Start With" lesson, Isentress is not included in the "What to Start With" table because the U.S. Department of Health and Human Services -- the source we use -- has not yet ruled on the use of Isentress in treatment-naive indviduals. Once new guidelines come down, we'll update immediately.
Tim Horn
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Thanks, Tim.
When I checked the other day I could have sworn it was not on there but I could be mistaken (and probably am!). I know aidsmeds is meticulous about such things.
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More good news about Raltegravir:
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0006877
v
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confidentIwillbeOK, Mark:
where should we meet in 2024?
BTW: not a provocative AMG question, and please, well above present sea level, OK?
8) -megasept
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Some really great news about Issentress Veritas. Thanks.
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confidentIwillbeOK, Mark:
where should we meet in 2024?
Oh let's see.....Costa Rica was awesome. One of my favorite vacations.
The summer Olympics will be in 2024 and the location will be announced in 2017.....let's check in then. ;)
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Not sure if this has been posted. I looked through the previous posts and saw something from Inchlingblue announcing that it would be approved. UK news from today advise that it be marketed in Europe.
Raltegravir approved for first-line use in European Union
http://aidsmap.com/en/news/0C311F64-DA97-4BFC-BF66-2391B9709A15.asp
The new integrase inhibitor raltegravir (Isentress) has been granted marketing approval for use as a first-line HIV treatment in the European Union, manufacturer Merck Sharp & Dohme (MSD) announced today.
Raltegravir is one of the new class of antiretroviral drugs that blocks HIV from integrating its genetic material into human cells. It is already approved for use in treatment-experienced adults in Europe.
The drug was approved for first-line treatment in combination with other antiretroviral drugs after data from the STARTMRK phase III study showed that patients treated with raltegravir were just as likely to achieve and maintain a viral load below 50 copies/ml after 48 weeks when compared to patients treated with efavirenz.
Further 96-week results from the STARTMRK study were presented this week at the Interscience Conference on Antimicrobial Agents and Chemotherapy, and show that raltegravir continued to maintain parity with efavirenz at 96 weeks, but was better tolerated.
Patients who received raltegravir were less likely to report central nervous system problems such as dizziness and abnormal dreams, and had significantly smaller increases in total and LDL cholesterol levels (although there was no significant difference between the drugs after 96 weeks in the ratio of total cholesterol to HDL cholesterol, which is considered to be one of the key measures of cardiovascular risk).
Reference
Lennox J et al. Raltegravir demonstrates durable efficacy through 96 weeks: results from STARTMRK, a phase III study of raltegravir-based vs efavirenz-based therapy in treatment-naïve HIV+ patients. Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, abstract H924b, 2009.
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Hi live by the moon your numbers are incredible for such a short time on atripla whats your secret and how old are you.
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Hi live by the moon your numbers are incredible for such a short time on atripla whats your secret and how old are you.
Tommy, I really carnt say. It may be the fact that I started the meds almost immediately after infection (the high number --above one million-- was due to the fact that I was dealing with my initial acute infection). It may be the fact that I have dealt with this issue in the "best" way possible (with some lows and highs), avoiding stress, drinking less, and trying to be as healthy as I can be. It may simply be that Atripla is one powerful little jellybean. It is probably a combination of all. Oh, and since you asked, I am 32.
It is simply great that nowadays we have more ammunition to fight this virus. Isentress is one that many people have [nearly] only good things to say about. Science is quite a wonderful thing for which I am grateful every single day.
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It may simply be that Atripla is one powerful little jellybean.
:D
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It was approved in early July (the 9th?) for treatment naive patients but docs still think of it as a backup. And as to side effects that is only a few years of data. Still, everyone on it says it is very easy to take, usually 2x a day combined with truvada. One person said to me he was on an off-label insentress only regime, 1x a day at lunchtime. That would be cool.
Hey there- I need to correct the above quote. He is taking a 1x/day insentress/truvada combo at lunchtime and has no side effects at all. I'm on day of atripla now and I have to say the hangover effect is a drag. If insentress/truvada was a 1/day combo with no side effects, gee, why wouldn't one go for it. I guess the main negative remains less long term data than the meds in atripla. Kudos to science!
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...He is taking a 1x/day insentress/truvada combo at lunchtime and has no side effects at all...
hey! no one should take this combo with the expectation of no side effects, but rather fewer or lesser side effects, most, if not all, of which subside over weeks/months. I had side effects yesterday, for a few hours, and this is my 21st month on the combo. My guess? it's the Truvada.
8) -megasept
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It's looking promising for Isentress to be approved for once-daily dosing. I personally would not try it until it's officially approved.
ICAAC: Once-Daily Isentress as Good as Twice-Daily?
LINK:
http://www.poz.com/articles/hiv_isentress_raltegravir_761_17251.shtml
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It's looking promising for Isentress to be approved for once-daily dosing. I personally would not try it until it's officially approved.
Good news. I'm holding out for once-daily dosing. One thing that give me pause for thought about the study linked to above is that the participants were already stable on another combo - and therefore, I presume, already undetectable. I'm waiting for a once-daily dosing study on treatment naive individuals.
Ann
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Good news. I'm holding out for once-daily dosing. One thing that give me pause for thought about the study linked to above is that the participants were already stable on another combo - and therefore, I presume, already undetectable. I'm waiting for a once-daily dosing study on treatment naive individuals.
Ann
Merck is currently doing such a study. I heard that the results might be released at next year's CROI (February 2010). One of the forum members is in the study (maybe more than that but one that I know of). Based on all the early data/rumors and the study linked above, etc., it looks like it will be fine as once a day.
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Thanks, Inch. I thought there was an on-going study, but wasn't sure if it involved treatment naive individuals or not.
Ann
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It's looking promising for Isentress to be approved for once-daily dosing. I personally would not try it until it's officially approved.
ICAAC: Once-Daily Isentress as Good as Twice-Daily?
LINK:
http://www.poz.com/articles/hiv_isentress_raltegravir_761_17251.shtml
That sounds great to me. Nothing against you treatment naive folks, of course, its just that I've already been down the primrose path - more than once!
HUGS,
Mark
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Has anyone had an increase in Creatinine levels when taking Isentress. Mine shot up from 1.1 to 1.6. in one month. I just started taking it in July. August test showed this increase. Will this even out or should I be concerned?
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Has anyone had an increase in Creatinine levels when taking Isentress. Mine shot up from 1.1 to 1.6. in one month. I just started taking it in July. August test showed this increase. Will this even out or should I be concerned?
Are you taking it with Truvada? This would more likely be a side effect of Truvada and it should be monitored and if necessary, a switch made.
I'm on Isentress/Truvada and am trying to minimize this problem by drinking lots of water which is supposed to help flush toxins from the kidneys and also staying away from NSAIDs which can exacerbate the problem.
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Are you taking it with Truvada? This would more likely be a side effect of Truvada and it should be monitored and if necessary, a switch made.
I'm on Isentress/Truvada and am trying to minimize this problem by drinking lots of water which is supposed to help flush toxins from the kidneys and also staying away from NSAIDs which can exacerbate the problem.
Hey Redbear,
I agree, this sounds like the Viread (Tenofovir) component of Truvada.
This is from the drug section here:
Some patients treated with Viread have had kidney problems. Viread can be problematic for HIV-positive people who have a history of kidney problems (renal impairment). If you have a history of kidney problems, your doctor will need to order a simple laboratory test to calculate your "creatinine clearance," which is a measure of your kidney function. Depending on the results of this test, you may not be able to take Viread, or you may need to take it less frequently. It is always important to be careful if using Viread in combination with drugs that cause kidney problems or other drugs that are removed from the body by the kidneys.
You may read more here:
http://www.aidsmeds.com/archive/Viread_1587.shtml
As Itchingblue said, keep up your intake of fluids, i.e., water, juices, tea, etc. Just as in the old Crixivan days, the more you pee, the better for you.
What did your doctor say about the increase in creatinine?
HUGS,
Mark