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Author Topic: Arguments for Isentress/Truvada vs Atripla for NHS  (Read 8039 times)

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Offline Boze

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Arguments for Isentress/Truvada vs Atripla for NHS
« on: May 14, 2010, 08:20:52 PM »
Hello everybody,

I've got a good news - the doctor said that I can start treatment, as I requested. However, the preferred initial regimen for naive patients in the UK is Atripla. I've heard so many good things here about I+T combo as compared to Atripla that I would like to start on I+T
I think the main issue I am facing is cost - I+T is probably double the price of Atripla to the NHS. However, the consultant has also mentioned a few not cost-related issues that I'd like to come back to her on:

1. Efficacy - is it as good as Atripla?
2. Keeping my options open. If I develop failure to Atripla then I could move to I+T. What if I start with I+T and fail on it - what options are available then? Can I go to Atripla?

I've got a hold of a number of studies listed below that answer the first question (as well as show how Isentress is better than Sustiva). Do you know what can be said with regard to the second? Lastly - has anyone faced this issue with NHS - where cost issues dictate getting Atripla vs I+T, and what can be done about it?

Thank you very much.

References:
1. http://www.medscape.com/viewarticle/707219 Raltegravir May Be a Well-Tolerated Alternative to Efavirenz for HIV-1 Combination Therapy
2. http://www.medscape.com/viewarticle/578786 Raltegravir Provides Durable Virologic Suppression in Treatment-Naive Patients with HIV at 96 Weeks
3. http://www.medscape.com/viewarticle/582597 Raltegravir Safe and Efficacious in Treatment-Na√Įve Patients
4. http://www.thebody.com/content/confs/icaac2009/art53695.html?ts=pf Raltegravir Exhibits More Lipid-Friendly Profile Than Efavirenz, STARTMRK Subanalysis Finds
5. http://www.natap.org/2010/CROI/croi_03.htm New Data on ISENTRESSģ (raltegravir) Presented at the Conference on Retroviruses and Opportunistic Infections (CROI)
==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

Offline Inchlingblue

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #1 on: May 15, 2010, 10:01:19 AM »
The question of developing failure has to do with your adherence. If you are adherent over 95% (especially after becoming undetectable) there is no reason to develop resistance to any combo (unless there are archived mutations, which is rare).

Isentress/Truvada has been shown to be as potent, if not more so, than Atripla (as you already state).

Some doctors cite that Isentress has a low barrier to resistance, meaning that just one mutation can render it useless; but the fact is that Sustiva also has a low barrier to resistance. The twice daily dosing of Isentress might lead to less than optimal adherence with some people since there are more chances of missing doses.

At the end of the day, cost does come into the picture and Merck priced Isentress for salvage therapy, which is what it was originally approved for. After the approval was extended to include first-time use, lowering the price would have been the right thing to do (since it's a much larger market share) but one can't always rely on Big Pharma to do the right thing.

I guess as far as the NHS if a patient has a bad reaction to Atripla they probably then go for a PI? I wonder to what extent they are prescribing Isentress at all in the UK for first line use?



« Last Edit: May 15, 2010, 10:08:31 AM by Inchlingblue »

Offline ElZorro

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #2 on: May 15, 2010, 10:06:13 AM »
InchlingBlue

I've been on Atripla for a few months and it's working great for me (100% adherence). I have a window of a few hours each day. However, from what I'm reading, the Isentress/Truvada might get rid of the focus/concentration issues I have been having. Do you know if there is as great a window for it?

Offline Inchlingblue

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #3 on: May 15, 2010, 10:10:00 AM »
InchlingBlue

I've been on Atripla for a few months and it's working great for me (100% adherence). I have a window of a few hours each day. However, from what I'm reading, the Isentress/Truvada might get rid of the focus/concentration issues I have been having. Do you know if there is as great a window for it?

I'm not sure what you mean by is there ''as great a window for it.''

Offline ElZorro

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #4 on: May 15, 2010, 10:23:03 AM »
sorry...I meant the "dosing window"... My doctor has told me I'm good with Atripla as long as I take it within +/- 4 or 5 hours every day. So, I usually take it anywhere from 9p to 1a everynight - right before bed.

I'm wondering if the same is true for Isentress/Truvada.  It sounds like a lot of people have switched to that regimen and have don't have any focus/concentration/sleep issues.

I have to say that I'm pretty nervous to switch from something that is apparently working so well, but if there was any chance that I could feel like the "old" me, I'd definitely consider it.

Offline Inchlingblue

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #5 on: May 15, 2010, 10:46:55 AM »
Yes, the window is about the same. I asked Dr. Gallant about this because I was traveling and was going to be in a new time zone with a 4 hour time difference and he said it would be fine to continue taking it at the same time I normally do but in the new time zone.

I usually take it at about 8 AM but my evening dose varies more, from about 7:30 to sometimes as late as 10 PM.

I was very exact when I first started taking it and I think it's best to initially be more exact while one still has a viral load but after reaching undetectable the timing can be a bit flexible.

Offline ElZorro

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #6 on: May 15, 2010, 10:53:05 AM »
Excellent. I am definitely going to discuss this with my doctor in July. Do you know if it leaves Atripla on the table for you in the future again if for some reason a resistence develops to Isentress/Truvada?

Offline Inchlingblue

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #7 on: May 15, 2010, 11:42:49 AM »
Excellent. I am definitely going to discuss this with my doctor in July. Do you know if it leaves Atripla on the table for you in the future again if for some reason a resistence develops to Isentress/Truvada?

Remember that resistance does not just develop for no reason. It only happens if you miss doses, which makes the level of drugs in your system too low to control the virus.

If you do miss doses and develop resistance I would imagine we are talking about Isentress resistance, which still leaves Sustiva open. But resistance can get complicated if, for example, resistance develops to the drugs in Truvada, since that is part of both combos.

Also keep in mind that it's very likely that Isentress will be approved for once daily dosing. The studies seem to be going very well. Some people are already taking it once a day and doing fine.

Offline ElZorro

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #8 on: May 15, 2010, 11:46:22 AM »
Thanks so much for the info. I am going to have the conversation with my doctor and will also ask about the state of the one dose regimen. Is Isentress/Truvada a single pill or is it two pills?

Offline Inchlingblue

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #9 on: May 15, 2010, 01:52:05 PM »
Thanks so much for the info. I am going to have the conversation with my doctor and will also ask about the state of the one dose regimen. Is Isentress/Truvada a single pill or is it two pills?

Isentress and Truvada are two separate pills. I take one Isentress and one Truvada in the morning and then in the evening I take one Isentress.

If doing once a day dosing you would take all three pills at one time.

 

Offline dist

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #10 on: May 15, 2010, 05:39:38 PM »
Isentress and Truvada are two separate pills. I take one Isentress and one Truvada in the morning and then in the evening I take one Isentress.

If doing once a day dosing you would take all three pills at one time.

So do I. Truvada and Isentress at 8.00 a.m., Isentress at 8.00 p.m.. After a few weeks, my numbers look great. :)
Everyone should wait for new research studies before taking Isentress once a day.
oct08         hiv negative
jan09         tested positive
feb09         cd4 621   vl 17000    no meds
may09        cd4 604   vl 4200     no meds
aug09         cd4 578   vl 6440     no meds
nov09         cd4 489   vl 52800   no meds
feb10          cd4 522   vl 372000  no meds
mar16, 2010 started on Isentress and Truvada
apr10           cd4 500   vl <50
may10          cd4 501   vl <50
aug10           Not Yet Available
nov10           Not Yet Available

Offline Miss Philicia

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #11 on: May 15, 2010, 05:42:47 PM »
I've actually varied my doses +/- 2 hours with no ill effect.  Most days it's fairly consistent with timing though.
"Iíve slept with enough men to know that Iím not gay"

Offline Ann

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #12 on: May 15, 2010, 09:41:57 PM »
Hello everybody,

I've got a good news - the doctor said that I can start treatment, as I requested. However, the preferred initial regimen for naive patients in the UK is Atripla.


Colour me surprised.

I'm also in the UK and it is very unusual to find a doctor here who would prescribe meds for someone such as yourself. VERY unusual. With your numbers, you simply do not need treatment.

I'm also in the UK (kinda sorta - I live on the Isle of Man but go to Liverpool for my hiv care). I've been poz since 1997 and I'm still treatment naive - because my numbers are good and I feel ok.

When I was first diagnosed, I felt similar to you - "Get this fucking virus under control! Give me meds!" Fortunately, I have one of THE BEST hiv docs in Britain - he's also an hiv pharmacologist and has published more papers on the subject than you can shake a stick (or your mother-in-law's dog) at. Long story short, he showed me the follies of my ways.

You have good numbers. You're new to all this. My advice is to wait a few more months at least before you make the decision to go on meds. Taking hiv meds takes more commitment than anything you're ever going to do or attempt in your life.

Ultimately, it's up to you and your doctor. If you want to spend NHS funds unnecessarily, I guess that's up to you. If you want to spend perhaps years on meds unnecessarily, that too is up to you. However, I implore you to become more comfortable with your status and more knowledgeable about hiv and hiv meds before you make a decision that is going to affect the REST OF YOUR LIFE.

Ann
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"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

Offline Boze

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #13 on: May 17, 2010, 01:49:18 PM »
Dear Ann,

Thank you very much for taking the time to lay out your point of view. I have thought about this in detail and researched the topic before reaching my decision. It's not something I've done in

-I am not an elite controller. My VL is 20k. All I can do is only delay the start of ARV by a few years as my CD4 will certainly drop to 500. The START trials have shown clear benefit to starting ARV at 500 vs 350.
-I am in a monogamous relationship and want to be UD for the sake of my partner. We'd also like to have children soon.
-I am of the opinion that the virus is causing inflamation (and other negative effects) even while I am asymptomatic. Most experts in the field - and by that I mean people who present at CROI - are of the opinion that if the person is 'ready' they should start at any CD4 count.  To me 'ready' is a code-word (euphemism, if you will) for those who can sustain high adherence.

Arguments to wait:
1. I will have to take a pill a day for the rest of my life - don't see the big deal. I also would like to believe that drugs WILL improve and that in 10 years the landscape of HIV treatment will look pretty different to what it is today.
I am also already taking about 27 capsules every day that are meant to slow CD4 decline + boost my immune system (I did a post in the nutrition section about it). So by starting ARV I will actually reduce my total pill consumption :)

2. I also think there is a difference between the drugs that were available in 1997 and today. There simply seem to be fewer side-effects (look at everybody who reports on the Isentress+Truvada) . Ie the argument that it is worth to wait has less credence now than when drugs were very toxic.
Of course there is also the argument that nobody has lived on these drugs for a really long time, so we are unsure of long-term side-effects. But we also don't know what damage viremia is doing. And if anything, I tend to think the virus is worse.

3. People tend to have different relationships with drugs in general. I've had girlfriends who would not take a headache pill - just because they were anti-drugs. I take a more cost-benefit approach. To me right now the benefit of starting ARV outweighs the cost.

Lastly - on the cost. while I certainly appreciate your point regarding 'wasting' NHS money on something that could be avoided, when it comes to healthcare, everybody acts in their own self interest.
==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

Offline Hellraiser

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #14 on: May 17, 2010, 01:53:32 PM »
Dude if you're taking 27 pills a day you need to slow down.  That's on the order of some sort of compulsive behavior.

Offline Boze

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #15 on: May 17, 2010, 02:51:04 PM »
It's actually 23, I reduced a little. Here is the list:


Omega-3   2
Astragalus tea   2
Green tea   2
Alpha Lipoic Acid   1
N-acetyl Cystein   1
Acetyl L-Carnitine   2
PB8 Pro-biotic   2
Bovine Colostrum   6
Curcumin   2
Selenium    1
Bitter Melon   2

Total:   23

It's actually not bad - 13 capsules AM, 9 PM. They are all pretty small, takes me one glass of water. Nothing OCD about it :)

==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

Offline Hellraiser

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #16 on: May 17, 2010, 04:00:47 PM »
It's actually 23, I reduced a little. Here is the list:


Omega-3   2
Astragalus tea   2
Green tea   2
Alpha Lipoic Acid   1
N-acetyl Cystein   1
Acetyl L-Carnitine   2
PB8 Pro-biotic   2
Bovine Colostrum   6
Curcumin   2
Selenium    1
Bitter Melon   2

Total:   23

It's actually not bad - 13 capsules AM, 9 PM. They are all pretty small, takes me one glass of water. Nothing OCD about it :)



Yeah that's not any better and I think you take 10 at night.

Offline newt

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #17 on: May 17, 2010, 05:14:02 PM »
Ahem

Tis true Atripla (efavirenz + tenofovir  + FTC) is a much cheaper combo than Isentress + 2 nukes at the moment, but....

1. Current (British HIV Assosiation) guidelines recommend efavirenz based combos for first-line therapy on the basis of effectiveness (marginally better over other combos) except in special cases. It has a long track record, and there is something to be said for the devil you (or the doctors) know.

2. But, the next draft of guidelines will most likely say all modern combos are more or less equal on effectiveness, therefore the choice will depend on other factors. One being cost, but also "patient considerations". One of these, importantly, is side effect profile. Ah yes, efavirenz has a bit of an iffy track record there for some people. Isentress is new and while initial reports are very favourable side effects wise, not enough people have taken it for long enough for the true picture to emerge (the shine always comes off, it seems, I do wish it was otherwise). Fitting the combo to your life is important. It is a fair call to say you don't want to take an efavirenz based combo because of possible side effects. It is worth sticking to your guns if this is a reason.

3. I do not read the studies as saying Isentress is better or worse than efavirenz, it's probably about the same in terms of hitting the virus.

4. Cost-wise, one or two people on odd combos will not break the bank of any NHS HIV clinic. If your doc will prescribe it and you prefer it then go for it.

5. Atripla truly is a once a day combo. This may be important Alternatives to consider if 1 x day dosing is important: an atazanavir (Reyataz) or darunavir (Prezista) based combo.

6. On the CD4 count, no study has show definitive benefit at starting at 500+ v 350+. The START trial which will test this proposition is now enrolling. However, many docs, especially at large clinics will prescribe meds regardless of CD4 count if the person is ready. I personally would wait a bit, but then again can see the benefit of starting.

7. If you don't do Atripla now, but do something else, yes (pre-existing resistance to efavirenz aside - your doc should test for this) it does leave Atripla on the table for future use.

Hope this helps

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

Offline Boze

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #18 on: May 17, 2010, 06:57:32 PM »
Thanks a lot, newt.

I guess I'm worried about the potential Atripla side-effect. It seems to affect 20-25% of the people. I guess I won't know for sure until I start. I really need to stay sharp for my job.

Inch - the doctor did mention PIs as alternative to Atripla. But I heard that PIs have worse toxicity, so not excited about those.

I guess I'll wait and see what the doctors will say.
==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

Offline newt

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #19 on: May 18, 2010, 04:48:43 PM »
The arguments for  (modern) PIs having worse toxicity than other drug classes don't really stack up these days. A lot of the PI nastiness is down to the amount of ritonavir booster they come with, and now there are PIs which use just 100mg, it's much better than the early years.

It's horses for courses. Efavirenz can raise your triglycerides v PIs can raise total cholesterol. Which is worse? Etc. A lot depends on how you react (genetically) to certain drugs. What's ok for one bod is shit for another.

If you still want to consider an NNRTI do not discount nevirapine, it's underrated. Doctors get v excited about its bad liver effects, but this is rare. Nevirapine nearly always avoids the head trip than can come with efavirenz, and, liver/rash aside, it has a good side effect profile (it's cheap too, and potentially 1 x day after a few weeks).

Good luck.

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

Offline newt

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #20 on: May 18, 2010, 04:51:02 PM »
Actually, scrub the nevirapine point, your CD4 count is too high to start on it safely - soz. - matt
"The object is to be a well patient, not a good patient"

Offline Inchlingblue

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #21 on: May 18, 2010, 04:51:17 PM »
 If you want to spend NHS funds unnecessarily, I guess that's up to you.  


That's a pretty harsh statement. There are HIV doctors as experienced and knowledgeable as yours who would recommend that a person start treatment even with good numbers (Dr. Gallant comes to mind). The question of when to start has not been definitively answered by science and we all must do our best to weigh the pros and cons when making that big decision.

To share your opinion and your story is valuable but to say that he would be using NHS funds unnecessarily if he decides to start treatment is just not right.

Offline BM

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #22 on: July 04, 2010, 08:44:29 AM »
I think the main issue I am facing is cost - I+T is probably double the price of Atripla to the NHS.

Hi Boze,
           According to the BNF website, one month of Isentress costs £647.29 and one month of Truvada costs £418.50 (total £1,065.79). The cost for one month of Atripla is £626.90.

Hope that helps,
BM
« Last Edit: July 04, 2010, 08:51:35 AM by BM »

Offline BM

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #23 on: July 04, 2010, 08:48:42 AM »
For some strange reason the NHS can claim back the VAT if you opt to have your meds delivered to your house.

Offline newt

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #24 on: July 04, 2010, 10:13:27 AM »
Tis true current UK guidelines prefer Atripla, except in certain circumstances.

However, the next set of guidelines will not prefere anything. They will instead offer scenarios to assist the prescribing decision, ine being patient need/preference eg do you drive heavy machinery? get anxious? etc Both these would mitigate against Atripla because of the CNS side effects of efavirenz.

In short, all modern combos are as effective as each other. In a big clinic the odd patient starting on a non-NNRTI combo won't break the bank. It is simple just to say "I do not consent to treatment with an efavirenz based combo for X reasons". But the upshot is, first, you might be offered a PI rather than Isentress.

If push comes to shove, tho, the docs will want to treat you, and if it means a few meetings and a bit of a wait, you will get Isentress.

I insisted on a PI, which at the time cost £3900/month more than Atripla (or the equivalent), and got it.
"The object is to be a well patient, not a good patient"

Offline Boze

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Re: Arguments for Isentress/Truvada vs Atripla for NHS
« Reply #25 on: July 04, 2010, 11:57:35 AM »
Thanks all for the information. I've actually been on Atripla for about a month now, can't complain of anything (ie side-effects that I am aware of right now). So touch wood this continues and I can stay on this "cheap" and simple regimen for a while!
==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

 


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