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Author Topic: can i have a drug holiday .... please!  (Read 5171 times)

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Offline Donna

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can i have a drug holiday .... please!
« on: August 26, 2011, 08:35:14 AM »
Hi, i need some urgent help. I was diagnosed in 1997, started meds in 2007; Combivir (zidovudine + lamivudine) and efavirenz. I've been doing really well on it - undetectable for four years, with a CD4 climbing from 185 to 1130 on last week's result. But, my viral load has started climbing again. I don't know why - I'm meticulous about taking the meds; forgot max of 2 pills this year and only sometimes don't quite manage the 12 hourly interval. So i'm feeling a bit freaked out!

My dilemma and request for help is this. I have a hectic work schedule for the next 6 months and cannot take time off adjusting to side effects of a new regimen. Does anyone have any advise on drug holidays? Can i take 6 months off given i have a CD4 of over 1100? I've seen in some literature that  drug holiday is sometimes recommended during regimen changes but no one says for how long.

Help!

Please email me if i'm not online and you can help - donnah@icon.co.za. Ja, I'm South African.
Thanks, Donna

Offline Ann

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Re: drug resistance
« Reply #1 on: August 26, 2011, 08:58:48 AM »
Hi Donna,

I moved your thread from the Long Term Survivors forum to the Treatment forum for two reasons. One being that as you were diagnosed after 1996, you do not qualify, under this forum's definition, as an LTS. The other reason is that you will get more responses in this forum, as many members cannot post in LTS (because they were diagnosed after 1996).

You've told us what your CD4 levels are like, but what are your VL numbers? It could be that you've just had a blip.

Ann
Condoms are a girl's best friend

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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 Donna

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can i have a drug holiday .... please!
« Reply #2 on: August 26, 2011, 11:24:40 AM »
Hi, hoping no one reading this has already read my other post under drug resistence. I'm feeling pretty desperate.

My viral load is rising after 4 years undetectable and now face prospect of new regimen (Truvada and kaletra) and i terrified of the side effects. Last time was a nightmare for nearly four months.

I've got a frantic work schedule in the next 6 months and want to consider a drug holiday in this time before starting new meds. Does anyone have any experience or thoughts on this?

Really look forward to hearing from you

Donna

Offline Ann

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Re: can i have a drug holiday .... please!
« Reply #3 on: August 26, 2011, 11:31:03 AM »
Donna,

I've merged your two threads on the same subject - you're asking the same question in both and it will be easier for everyone if all your replies are in the same thread.

As I asked you earlier, what are your last few VL results? There is a chance that you have just had a VL blip, which would mean you would not have to change meds or take a "drug holiday".

If you want to stop taking meds purely because of your upcoming heavy work-load, then that would depend on several factors, such as what your numbers were like before you started meds. There's a lot to consider and you have not given us much information to go on.

Ann
Condoms are a girl's best friend

Condom and Lube Info  



"...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 Donna

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Re: can i have a drug holiday .... please!
« Reply #4 on: August 26, 2011, 12:06:56 PM »
Thanks Ann.

I actually forgot to ask what the viral load is - not a good state of mind! I'll do so tomorrow. However, it was undetectable four months ago. I've had new bloods taken but the results will only be available on Tuesday.

What can cause a blip (i presume a blip is a sudden unexpected increase in VL)?

I've had a look at the SMART and STACCATO studies on drug holidays but there's no mention in the articles of whether taking a holiday after resistance has started makes any difference to the outcomes.

What other information would enable people to help me, Ann, other than the VL?

Donna

Offline Ann

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Re: can i have a drug holiday .... please!
« Reply #5 on: August 26, 2011, 12:36:36 PM »
Donna, as you were undetectable four months ago, it probably is a blip. I don't think anyone knows what causes them, but they usually happen sooner or later to someone who is on meds. It sounds like it's far too soon for you to be worrying about changing your combo.

I don't think there's much more we can tell you until you find out what your VL result was. Let us know when you find out tomorrow, and try to not worry about it so much in the mean time.

Hang in there!
Condoms are a girl's best friend

Condom and Lube Info  



"...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 newt

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Re: can i have a drug holiday .... please!
« Reply #6 on: August 26, 2011, 12:43:18 PM »
Hello Donna

Blips just happen 1) because the test has a margin of error and sometimes are done wrong 2) temporary, transient popping of HIV. More than 2 rising viral load tests is a trend, a one-off odd result is a blip until further tests suggest otherwise.

Truvada and Kaletra is usually less harsh side effects wise than your current combo, easy to take even in many cases. The main problem at the start maybe a bit of the poops << Imodium works here ... and/or some wind at the beginning, but with the new tablet formulated Kaletra this is less of an issue. It can also potentially be taken once a day.

When you stop meds your CD4 tends to fall to its pre-treatment level << no-one can say how fast, and your viral load rise << generally in a few weeks to a high enough level to damaging your immune system. Also, it is possible that stopping meds, by virtue of changing how much work your immune system is doing, can contribute to a higher risk of serious non-HIV health problems. << how would that fit with your work schedule if it happened?

I'd take a rain check on the resistance idea for a minute, you don't know you have resistance, if you have been taking your meds day in day out it's very unlikely. Wait and see what the next test says.

Greetings to the land of the Mother City

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

Offline legolas613

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Re: can i have a drug holiday .... please!
« Reply #7 on: September 10, 2011, 12:35:36 AM »
Donna and any other users who are having problems with their regimens,

DO NOT be fooled into thinking that somehow after starting ARV treatments that you are a slave to them and your doctors advice. YOU are in control of your life and decisions concerning your health, HIV has not changed that. If you need a break from ARV treatments and your CD4s are at a healthy enough level (which is different for everyone), stand up and share your feelings with your doctor. You are paying them for their ADVICE, not to make the decisions for you. Let your doctor know that if you desire to leave ARV treatments for a period it is to improve your quality of life. He has to respect that. Just make sure you keep your CD4's and VL monitored at least while your off meds. The only thing the doctor can do w/o caring what you think is removing you from / propose changing meds due to AE's and such.

I'm not advocating quiting (aka "vacations") ARV regimens, that is a personal choice. I just wanted to highlight the fact that it is a choice available to all because I get a feeling that too many of us who have started ARV regimens feel obliged to keep on taking them without even pausing to consider the choice to stop is ours to make. Losing the ideal that ALL decisions pertaining to ones health and course of treatment, (regardless of ailment) if one is chosen at all, is their own to make (so long as one isn't clinically insane of coarse, lol).

I'm having fatigue/malaise issues ever since I've been on my regimen. I just told my doctor I want to change up my regimen up to see if my CD4's will return to where they were pre-treatment (525+) and see if the fatigue/malaise will resolve. I told him if I continue to feel my quality of life is compromised I will be discontinuing ARVs and will opt for medical surveillance until I DECIDE it's time to re-start an ARV regimen again. I told him if given the choice I choose quality of life over quantity. He was a little disappointed but very understanding and supportive of my feelings I shared.

I don't have a death wish, I just don't see the point of obsessing about living as long as I can if that requires me to take ARVs that make those years miserable. I would rather have a solid 5-15 years of life feeling good, all day long. Of coarse living with active replicating HIV can have it's AE's, those generally don't hit hard though until the CD4 count approaches the AIDS definition but this is different for different people as well. The avg drop in CD4 count to those not on treatment is only 25 a year. The average amount of time from infection to AIDS w/o recieving ARVs AT ALL is a whopping 10 years. No one knows for sure which is more detrimental because there are many points of view and theories; pumping your body full of kidney, heart, liver, pancreatic and brain toxins EVERY DAY for the rest of our lives or letting a virus multiply unimpeded, damaging your immune system til ARVs are restarted. I'm starting to think it might be easier to try to repair the immune system from time to time realizing that too might have limited or short term success. Many have found the happy medium of a daily, permanent ARV regimen without feeling nasty doing so. That is what I still hope to find for myself as well but I'm keeping an open mind and so should we all.

Hope this helps,

Best wishes ~ Gary
« Last Edit: September 10, 2011, 02:11:35 AM by legolas613 »
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline jkinatl2

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Re: can i have a drug holiday .... please!
« Reply #8 on: September 10, 2011, 01:37:38 AM »
Quote
I told him if given the choice I choose quality of life over quantity.

I hear this a great deal. I have not seen a lot of long - term evidence for it.  People seem to think with HIV life's totally cool until the day you get sick and then quickly pass away.

Maybe if it was 1977, and Ricardo Montalbán was giving it to Michelle Lee over a weekend. The truth, and many long term survivors (including myself) can attest to this, is that what you will face is a slow decline over years.

To the OP, I still don't understand why you want to stop meds after what seems to be a blip in your viral load. Are the side effects unbearable? Is it a scheduling thing?

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

Welcome Thread

Offline legolas613

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Re: can i have a drug holiday .... please!
« Reply #9 on: September 10, 2011, 01:53:08 AM »
I never once discussed stopping meds permenently or letting a CD4 drop below or too close to the AIDS level. I'm talking about taking a holiday and maybe an extended one at that, under the care of ones HIV specialist and the labwork performed regularly. And as many long- timers can attest, CD4 counts can be very resilient. There are so many examples of folks here who had CD4s of less than 25 or 50 who are alive today 20+ years later with very high CD4 counts.  
« Last Edit: September 10, 2011, 02:06:33 AM by legolas613 »
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline jkinatl2

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Re: can i have a drug holiday .... please!
« Reply #10 on: September 10, 2011, 02:30:44 AM »
Sorry that was your takeaway, legolas.

As a LTR I have many interesting stories about what happens when your CD4 count is 12. I rebounded, of course.

Ask me about my hospitalizations and shunts and bone marrow biopsies! They really do show the quality of life, versus quantity.

"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

-Kimberly Page-Shafer, PhD, MPH

Welcome Thread

Offline legolas613

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Re: can i have a drug holiday .... please!
« Reply #11 on: September 10, 2011, 03:58:56 AM »
Hmmmm.......no ones talking about intentionally letting CD4s drop to the extremely low levels your talking about so you are misreading my comments. By quality of life I'm merely saying day to day life with active HIV assymptomatic infection is far more tolerable than taking a regimen that makes one feel like crap every day. If someone is lucky enough to have an ARV regimen that doesn't affect them negatively, thats the best way to go. That's not to say that there aren't risks associated with having an uncontrolled HIV infection or possible SEs either. What ARVs did for you when you were a 12, the same rebound success can happen to someone who has a CD4 that drops to a 250 as an example before they start or restart ARVs. The terrible things your talking about that happened to you, happened to you because of your low CD4 count deep within the AIDS range, what your describing does not encompass the assymtomatic part of HIV infection. I'm not talking about allowing such a CD4 drop to occur if you had read my post. Realizing the unpredictable is always possible with ones health and increased OI or AIDS DI risks with lower CD4s even if they're above 200, that's the gamble. The payoff is less time to receive ARV body damage and possible SEs.


    
« Last Edit: September 10, 2011, 04:09:03 AM by legolas613 »
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline wolfter

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Re: can i have a drug holiday .... please!
« Reply #12 on: September 11, 2011, 06:29:12 AM »
Curious, how long of a drug vacation can a person take before resistence issues arise?  Quality of life might be worse if forced on a different combo!
Complacency is the enemy.  ;)  Challenge yourself daily for maximum  return on investment.

Online mecch

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Re: can i have a drug holiday .... please!
« Reply #13 on: September 11, 2011, 06:53:46 AM »
Donna has not been back in this thread and thus hasn't verified if she has simply had a blip, or not.
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline legolas613

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Re: can i have a drug holiday .... please!
« Reply #14 on: September 11, 2011, 07:58:46 AM »
Wolfter: you bring up a valid point, anytime a regimen is changed there is always a chance it could be worse than the previous one as far as side effects go.

To answer your resistance question, resistance gained by ones own HIV strain usually (but not always) requires an active viral load higher than detectable levels. The higher the VL when exposed to any HIV drug, the greater the chance of some resistance developing to it.
Resistance is most likely to occur when (a) stopping a regimen -- meaning taking in the last dose with the meds having variable half lives potentially leaving only one drug in the bloodstream for a period of time, (b) starting or re-starting a regimen when the VL is detectable with an increased but diminishing chance of resistance as the VL lowers and until it reaches UD again, (c) losing UD VL status while taking a regimen either through non- adherance or SE/metabolic issues.
Resistance is unlikely to occur if (a) your VL is UD as you take your regimen or (b) when you are away from ARV treatment since gaining resistance requires the VL to be exposed to a drug in order to mutate.
It is possible to also gain resistance at any point (on or off treatment) of ones HIV infection by aquiring it from a different HIV strain from another person that has developed resistance(s).

Hope this helps,
Cheers ~ Gary
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline wolfter

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Re: can i have a drug holiday .... please!
« Reply #15 on: September 11, 2011, 08:18:32 AM »
That's exactly my point, taking a "vacation" is in effect, stoping your regiment...hence likely resistence.
Complacency is the enemy.  ;)  Challenge yourself daily for maximum  return on investment.

Offline legolas613

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Re: can i have a drug holiday .... please!
« Reply #16 on: September 11, 2011, 12:07:59 PM »
I see your point, however if the VL is UD when you stop meds, chances are very remote but certainly not unheard of. One is not likely to gain resistance when the VL is UD because the virus needs to come in contact with the meds. That is not as likely to happen when the VL level is so low it is UD.

Resistance is an issue to take seriously, however my take on it is that it is not as easy to aquire resistance to most ARVs as the medical community portrays. They want everyone on meds to be scared into thinking that if they miss one dose, resistance will undoubtably set in. My god, look how many posts come in all the time from HIV regimen takers making a forum post that they just missed a dose and are afraid they will get resistance because of it. When in fact someone who has a UD VL has a low chance of developing resistance because of the fact their VL count is UD. It takes approx 2 days after the meds in ones bloodstream disipate for the VL to begin to reach detectable levels again. I still take my meds on schedule, however having this knowledge if I were to miss one dose periodically, I know it's not the end of the world and should be most likely recoverable but realize it should never become habitual behaviour to miss doses. Back to back days missed or missing doses of ARVs that have very short half lives are both definately more concerning and riskier to the potential development of resistance issues.
« Last Edit: September 11, 2011, 12:20:09 PM by legolas613 »
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Online mecch

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  • red pill? or blue pill?
Re: can i have a drug holiday .... please!
« Reply #17 on: September 11, 2011, 12:52:39 PM »
Is resistance an issue if the stop of HAART is done correctly as directed by the doctor?

Donna has other information to divulge to us and/or to discover herself before any of this is an issue.

“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline legolas613

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Re: can i have a drug holiday .... please!
« Reply #18 on: September 11, 2011, 01:15:44 PM »
if the stop of HAART is done correctly

Well said, if HAART is stopped properly there is a smaller chance of resistance developing, especially under the direction of ones doctor. 
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline wolfter

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Re: can i have a drug holiday .... please!
« Reply #19 on: September 11, 2011, 02:15:03 PM »
I didn't have questions about resistence.  I was making a point.  I hope the OP takes time to to persue the SMART study and other similar information.  STI (structured treatment interuptions) are not recommended! 

I'm not referencing skipping a dose here and there, but rather an extended absence of HIV drugs.  Even with monitoring, resistence is likely to occur else we could all simply stop taking our drugs once we become UD.  I'm surprised that more people are not commenting on this risky proposal.
Complacency is the enemy.  ;)  Challenge yourself daily for maximum  return on investment.

Offline legolas613

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Re: can i have a drug holiday .... please!
« Reply #20 on: September 11, 2011, 03:11:17 PM »
There are different points of view coming from various studies. I found this article in my phone app but couldn't get any Internet address to link it to so I copy and paste it all for those interested:

Short Early ART Course Delays Fall in CD4 Cell Count in HIV

Emma Hitt, PhD

July 25, 2011 (Rome, Italy) — A 48-week short course of antiretroviral therapy (ART) initiated within 6 months of HIV seroconversion significantly delays the time until CD4 levels fall below 350 cells/mm3, as well as the need for long-term ART, compared with standard therapy, which is no treatment until the CD4 cell count drops below 350 cells/mm3, according to new findings from the Short Pulse Anti Retroviral Therapy at HIV Seroconversion (SPARTAC) trial.

Sarah J. Fidler, MBBS, MRCP, PhD, from Imperial College London, United Kingdom, and colleagues presented the findings here at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, during a late-breaking session.

"SPARTAC is the largest ever randomized controlled trial in primary HIV infection, enrolling men and women in both developed and developing world settings," Dr. Fidler told Medscape Medical News.

According to Dr. Fidler, HIV-induced immunological destruction begins early and, despite later ART, is never completely reversed. "Observational studies have shown encouraging data to suggest potential immunological benefit for early ART," she added.

The SPARTAC trial was designed to evaluate whether ART initiated as near to HIV transmission as possible may protect against HIV-induced immune damage.

A total of 366 patients diagnosed with primary HIV infection were randomly assigned within 6 months of seroconversion to receive ART for 48 weeks, ART for 12 weeks, or no therapy (ie, standard of care). Participants were followed for an average of 4.2 years.

Only half of the 48-week ART group reached the primary endpoint (CD4 level < 350 cells/mm3 and long-term ART initiation) compared with 61% in both the 12-week ART group and the no-therapy group.

Participants receiving 48-week ART had long-term therapy delayed for a median of 65 weeks (range, 17 - 114 weeks) longer than those receiving no therapy, indicating an average hazard ratio of 0.63 (95% confidence interval, 0.45 - 0.90; P = .01); 48-week ART also conferred a higher average CD4 count of 138 cells over 4.5 years. In contrast, the delay with ART for 12 weeks was not significantly different from that observed with no therapy.

The researchers also found a trend for greater delay to primary endpoints the sooner ART was initiated after estimated seroconversion (P = .09).

ART given for 48 weeks reduced HIV RNA by 0.44 log10 copies/mL 36 weeks after interrupting therapy compared with no therapy. There was no significant difference among the 3 groups in terms of AIDS, deaths, or serious adverse events, and virological failure on long-term ART was similar across groups.

"In contrast to the SMART study, there was no rebound in [interleukin] 6 and a drop in d-dimer compared with baseline levels 4 weeks after stopping ART," Dr. Fidler said during her talk. She added that "interruption of ART in primary HIV infection showed no evidence of harm, development of drug resistance, or CD4 recovery after starting long-term ART."

"It is reassuring to see that there is no apparent harm in starting and stopping early ART, as this regimen might allow us to treat initial acute sickness and then give patients a drug-free break for a year or 2," said independent commentator Myron S. Cohen, MD, the J. Herbert Bate Distinguished Professor of Medicine, Microbiology and Immunology, and Public Health at the University of North Carolina at Chapel Hill. Dr. Cohen is also associate vice chancellor of Global Health and the director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill and serves as chief of the Division of Infectious Diseases.

"It's clear that ART alone in early HIV does not change the course of the disease, and adjunctive intervention is needed," he told Medscape Medical News. "However, we do see less HIV rebound and some sparing of immune function," he added.

The study was not commercially supported. Abbott Laboratories Limited supplied the study drug. Dr. Fidler and Dr. Cohen have disclosed no relevant financial relationships.

6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention: Abstract WELBX06. Presented July 20, 2011.

Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Online mecch

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Re: can i have a drug holiday .... please!
« Reply #21 on: September 11, 2011, 04:57:32 PM »
I'm not referencing skipping a dose here and there, but rather an extended absence of HIV drugs.  Even with monitoring, resistence is likely to occur else we could all simply stop taking our drugs once we become UD.  I'm surprised that more people are not commenting on this risky proposal.

Wolfter, you seem to misunderstand what "resistance" means. It does not mean having a viral load. It means a virus is no longer inhibited by a present drug.  If we stop HAART correctly, there is no drug resistance.  But viral loads return.
“From each, according to his ability; to each, according to his need” 1875 K Marx

Offline newt

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Re: can i have a drug holiday .... please!
« Reply #22 on: September 11, 2011, 07:01:59 PM »
Thanks mecch, useful clarification, resistance can't develop when you's off drugs

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

Offline spacebarsux

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Re: can i have a drug holiday .... please!
« Reply #23 on: September 12, 2011, 12:50:26 AM »
If we stop HAART correctly, there is no drug resistance.  But viral loads return.

Thanks mecch, useful clarification, resistance can't develop when you's off drugs

- matt


So if someone is on Atripla and has an UD viral load for a few years and then decides to take a treatment break, can that person go back on Atripla at a later point and expect 'no drug resistance at all resulting from such a break' and that the VL will go back to undetectable levels and remain suppressed as effectively as before- on the same combo ? Will the virus, that rebounds post-interruption, be just as sensitive to the same drug as it was the first time around ?

I thought such interruptions increased the likelihood of developing drug resistance even though it may not directly cause this. Isn't this why treatment interruptions are generally not recommended?  
« Last Edit: September 12, 2011, 03:27:47 AM by spacebarsux »
Infected-  2005 or early 2006; Diagnosed- Jan 28th, 2011; Feb '11- CD4 754 @34%, VL- 39K; July '11- CD4 907@26%,  VL-81K; Feb '12- CD4 713 @31%, VL- 41K, Nov '12- CD4- 827@31%

Offline newt

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Re: can i have a drug holiday .... please!
« Reply #24 on: September 12, 2011, 06:01:14 AM »
Quote
So if someone is on Atripla and has an UD viral load for a few years and then decides to take a treatment break, can that person go back on Atripla at a later point and expect 'no drug resistance at all resulting from such a break' and that the VL will go back to undetectable levels and remain suppressed as effectively as before- on the same combo ?

Yes, this is the likely outcome provided Atripla (specifically efavirenz) is stopped in the recommended way.

Because efavirenz can take 2-3 weeks to leave the body completely, a short course of alternative meds is usually prescribed. Usually this means Truvada or a boosted PI + Truvada. This is to avoid the virus having a chance to evolve into an efavirenz-resistant type of HIV (which can happen quickly with less than enough efavirenz in your body for a week or two).

Unless the person acquires a new drug-resistant batch of HIV, new resistance will not develop on a treatment break.

Full viral suppression can be expected on restarting drugs, but note a lesson from the SMART study, for people taking a break of more than 6 months, CD4 count did not always recover to its previous highest on treatment level.

Treatment breaks are not generally recommended because of the clinical and immunological downsides, not because of concerns about resistance.

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

Offline buginme2

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Re: can i have a drug holiday .... please!
« Reply #25 on: September 12, 2011, 06:15:35 AM »



Treatment breaks are not generally recommended because of the clinical and immunological downsides, not because of concerns about resistance.

- matt


What specifically do you mean when you say "clinical and immunological downside?"

Is that like, increased risk of OI? Cancer? Low CD4? Worse?

How bad of a downside are we talking?

Offline newt

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Re: can i have a drug holiday .... please!
« Reply #26 on: September 12, 2011, 12:26:15 PM »
The SMART study was the big study on treatment interruptions. This compared two groups, people on continuous treatment and people on episodic treatment (ie with breaks in it) guided by CD4 count.

It found:

For people on episodic treatment, 18 months after a doc recommended resuming meds full time CD4 cell counts were typical around 150 less than at the beginning of the study.

The risk of OIs, serious health issues or death was higher in people on episodic treatment, about 2 times that of people on continuous treatment.
 
People on episodic treatment may still have had a greater risk of OIs/death even after being back on ARVs full time (somewhere between the same risk and 2 x the risk of people on continuous treatment). The extra risk was attributed to some people not restarting full-time treatment when recommended and slow recovery of CD4 cell counts for for many who did.

My comments:

The study contained people who didn't follow their doc's recommendations to go back on meds and got ill. So whether the risk of OIs etc really remains higher after restarting treatment is hard to tease out.

In this study, a typical person's lowest ever CD4 count was around 250. At the start of the trial the typical person's CD4 count was around 650. Some way in the typical CD4 count for people on treatment with breaks was still good at 450 but 1/3rd had gone below 350 (no change in the people on continuous treatment).

Long term you can't conclude 150 less on your CD4 count is important to life and health if your CD4 count has never been especially low (the study didn't provide long enough follow up). But if it has been low, do you want to bet it ain't?

Markers of inflammation in people on episodic treatment (bad for your heart, bad for your wrinkles etc) were considerably up. This isn't surprising, this is what happens in untreated HIV. But this info comes from an analysis of non-AIDS related deaths.

Whether this picture is true for people who have only ever had high (500+) CD4 counts is a moot point. Safety wise there's gonna be a world of difference between taking a break when your lowest ever CD4 was 900 and one when your lowest ever count was 250 as far as AIDS related illness goes.

Clearly, people on treatment with high CD4 counts do take breaks, maybe quite long ones, specifically the few who do 6 months-1 year treatment soon after getting HIV then stop. But this is a special case, not really comparable to on/off treatment for people who have been quite ill and had low CD4 counts.

SMART was conceived to test the idea that episodic treatment was safe and would mean less side effects, but what it seemed to show is that HIV is worse than the meds if you give the virus a holiday. Treatment does more than protect your CD4 count and therefore stave off OIs. Unchecked HIV increases factors that contribute to eg heart attack, kidney disease etc.

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

Offline spacebarsux

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Re: can i have a drug holiday .... please!
« Reply #27 on: September 12, 2011, 01:00:40 PM »
Matt, thanks for your post. Some of the points you raise also highlight why (IMO) someone with CD4s consitently above 500 should be mentally prepared before making a lifetime-commitment to therapy.
Infected-  2005 or early 2006; Diagnosed- Jan 28th, 2011; Feb '11- CD4 754 @34%, VL- 39K; July '11- CD4 907@26%,  VL-81K; Feb '12- CD4 713 @31%, VL- 41K, Nov '12- CD4- 827@31%

Offline Assurbanipal

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Re: can i have a drug holiday .... please!
« Reply #28 on: September 12, 2011, 01:31:45 PM »
Matt, thanks for your post. Some of the points you raise also highlight why (IMO) someone with CD4s consitently above 500 should be mentally prepared before making a lifetime-commitment to therapy.

I don't see how that follows.

1) We don't know, but I find it highly suspect that it will be a lifetime commitment -- thinking of it in terms of a potentially renewable 10 year commitment seems more consistent with the current state of the science and far more manageable on an individual level.

2) The SMART study was not restricted to people with CD4's over 500 without treatment, pretty much the contrary.

3) Most importantly, the SMART study did not address whether it was better to stop and start than to not start -- the results address a different question of whether those whose tcell counts had recovered on therapy could safely take a drug holiday and start up again when tcell counts declined again. It could be the case that starting with a high tcell count and then stopping is better for your health than waiting until you start up for good.   

4) Is there an implied theory in your post that people can only tolerate taking HAART so long before the process or the side effects get too difficult?   Many people find HAART to be relatively easy to take, particularly those starting with high tcell counts. And those who start and stop may still have better health than those who do not start.  We don't know.

A
5/06 VL 1M+, CD4 22, 5% , pneumonia, thrush -- O2 support 2 months, 6/06 +Kaletra/Truvada
9/06 VL 3959 CD4 297 13.5% 12/06 VL <400 CD4 350 15.2% +Pravachol
2007 VL<400, 70, 50 CD4 408-729 16.0% -19.7%
2008 VL UD CD4 468 - 538 16.7% - 24.6% Osteoporosis 11/08 doubled Pravachol, +Calcium/D
02/09 VL 100 CD4 616 23.7% 03/09 VL 130 5/09 VL 100 CD4 540 28.4% +Actonel (osteoporosis) 7/09 VL 130
8/09  new regimen Isentress/Epzicom 9/09 VL UD CD4 621 32.7% 11/09 VL UD CD4 607 26.4% swap Isentress for Prezista/Norvir 12/09 (liver and muscle issues) VL 50
2010 VL UD CD4 573-680 26.1% - 30.9% 12/10 VL 20
2011 VL UD-20 CD4 568-673 24.7%-30.6%
2012 VL UD swap Prezista/Norvir for Reyataz drop statin CD4 768-828 26.7%-30.7%

Offline spacebarsux

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Re: can i have a drug holiday .... please!
« Reply #29 on: September 12, 2011, 01:46:00 PM »
My implication was only this:

Until it is conclusively demonstrated (from the START study results which are awaited) that there is a ‘net benefit or not’ of commencing ARVs for people with > 350 CD4s, for people with CD4s consistently above 500 (which is normal range) it isn’t really an ‘end of the world type scenario’ if they take some time getting used to the idea of popping pills.

I think getting mentally prepared is crucial for asymptomatic people with > 500 CD4s since it is directly linked to proper adherence and consequently the person is less likely to discontinue meds midway (unscheduled treatment break). I was told as much by by doctor.

This is just my personal view and I really don’t see it as illogical or self-destructive. In fact all guidelines support it.
« Last Edit: September 12, 2011, 01:59:43 PM by spacebarsux »
Infected-  2005 or early 2006; Diagnosed- Jan 28th, 2011; Feb '11- CD4 754 @34%, VL- 39K; July '11- CD4 907@26%,  VL-81K; Feb '12- CD4 713 @31%, VL- 41K, Nov '12- CD4- 827@31%

 


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