Interlukin-2 to Stimulate CD4

[wiser]

I have been on meds for 3 years and from the start achieved and maintained undetectable viral loads. However there has been no significant increase in T Cells. They hover between 200 and 230 and the trend in my last 3 labs was to decrease. My doc wants me to consider Interlukin-2 treatment - 5 injections - with the goal of boosting CD4 Cells. I am 62yrs old and though healthy his concern is that with the low T Cell Count I am at higher risk for the ordinary diseases of aging (cancers I guess). The problem is that FDA has not approved IL-2 as an HIV treatment and insurance may not cover the treatment. Injections will run about $900 each, for a total f $5,000 for the treatment.

I assume from what I have read that I would continue with the Atripla I am taking to keep VL in the blood undetectable.

Doc is wondering if T Cell production is being hampered by active virus in my bone marrow or lymph nodes. I guess the blood tests only says there is no detectable in virus in the blood, but the virus can be active elsewhere impeding T Cell growth.

We are waiting until my next blood work in Jan to move toward a decision. Anyone have any experience or reactions or links for further research on any of this.

Thanks.

[mecch]

1)  If you visit this site and download the text (PDF), then search IL-2, there is some basics on the treatment.  http://hivmedicine.com/    For instance, Table 3.1

2) One year old article on the treatment:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2189557
Human T Cell Reconstitution in DiGeorge Syndrome and HIV-1 Infection

Good luck and best wishes

[wiser]

Thanks for the articles. I can see why there the jury is still out in terms of FDA. I am reading that while CD4's rise, this may be only of cosmetic benefit (nice to have higher numbers), but since the cells are not produced from the Thymus they are not associated with improved ability to fight opportunistic infections.

However, my doctor's caveat is that in my case it is the age factor to consider, and these increased cells might have a positive effect in deterring age related diseases if not the OIs that go along with the definition of AIDS.

In the end there seems no harm ... it will be about the cost.

[mecch]

I only have second hand info from a friend who took IL-2 and found it very uncomfortable, so I'm not sure about your "no harm" estimation.  Anyway, check with your doc for the latest info about how well the treatment is supported. And again, all best wishes for your treatment success.

[libvet]

I took IL-2 for about a year (8 week cycle of subcutaneous injections twice a day for 5 days) because it seemed like a good idea because my t-cells were hovering under 200 for the first couple of years on treatment (my nadir which was at diagnosis was 22 t-cells).

First of all.  It did work.  It seemed like the kick my immune system needed.  My t-cells went up to about 400 and even after stopping they continued to rise (currently 500-600 after on 8 years on meds).

In a nutshell, it is....unpleasant.  Not unbearably so, but hardly the ease I've had with antivirals.   Day 1 is not so bad, practically normal in fact.  By the end of Day 2, I felt a fatigued, but again, no so bad.  Day 3 I would feel run down and achy (mind you I usually started the course on Wednesday so I could not worry about taking time off from work).

By day four, it was bed rest for the most part taking aspirin, tylenol, and advil to keep the fever down and deal with the muscle aches.   There was also intermittent nausea.  (my advice is to have some soup or something easy and ready to eat on hand).

Day 5 was usually a worse version of day 4.  I will admit there were times I wimped out and skipped my last shot (of course insurance was covering it, so it didn't feel as wasteful).  It feels pretty much like a really bad case of the flu (fever, chills, muscle aches, extreme fatigue, nausea).

I usually used my personal time at work to take the Monday after the course off to rest.  By Tuesday, I felt pretty decent again.

I had injection site reactions (recommend a cold compress after the injection to help). But for a week or so, I had lumps at the injection site that were slightly uncomfortable, but not painful.

The upshot is that it did work and it was only really bad for 2 days every 8 weeks.  Would I do it again if I was in the same place I was then?  Absolutely. 

I hope that helps.

[wiser]

Thanks libvet. That was the kind of feedback I am looking for. I am leaning toward giving it a shot (no pun intended). . So it is 2 injections a day for 5 days then 8 weeks off. That would be about 6 cycles of 5 days each if you did this for a year. If I am doing the math correctly at $900 an injection that would run about $54,000 for a year. Insurance is the problem for me. If they will not cover it, then the cost is just prohibitive. But it is good to hear the results. Too bad because one hospitilzation for pneumonia which would be covered would cost double this.

I guess FDA approval needs more clinical trials to document the efficacy.

[jjmcm]

I took IL-2 every eight weeks for a year and found it did not help my CD4's.  It is MUCH more difficult than you realize, particularly day 4 and 5.  I ran a fever on both of those days confined to bed shaking for hours.  It was very challenging to eat more than soup and to get my oral HIV meds down.

The injection site reactions (knots) were not painful for more than a week, but some of them stayed in place for months.  My HIV doctor is one of the best and well known in the state of Texas.  He has always done many trials, including IL-2 years ago.  For the most part it did not work well enough for the majority of people in the long run.  Some people do have good results. 

Think about it - if it worked well- the studies would have continued and we would all be using it.

Most insurance does not pay for it.  Even the Bioscript pharmacy which fills lots of HIV meds here in Houston did not have any other patient on it at the time.  They had to order it for me and it took several days to get.

The cost at the time was not $900 per injection - it was about $900 for the entire vial which was enough at a low dose for the entire treatment.  I also think that your age is a factor.  I certainly would change my HIV meds before trying IL-2 again. 

Ask your doctor the results of his other patients that have used IL-2 before you make a decision.

[wiser]

Thanks jjcm. The financial information is very helpful as high cost would automatically rule this treatment option out. I see you went through 8 trials over the course of a year. That is 8 weeks down with the side effects. That seems a high cost for a benefit that at best might be "cosmetic" at best . higher T cells but not necessarily any correlation with improved general health of the immune system.

As I read the research and the blogs, I am feeling I am better off taking my chances with my low Tcells. It just may be that my immune system is shot and that I just have to take my chances dealing with the high risk for OIs.

This is not a simple disease easily controlled in its later stages. Perhaps I got hit hard and late in life or my own body is more susceptible to the virus than others. There are long term survivors, assymptomatic folks, and those who are short term survivors for whatever reason their body reacts to the whole process.

[edfu]

It seems to take a bit longer for us older guys to raise our CD4s.  At age 59 I started HAART (Sustiva + Trizivir in an ACTG study) when my CD4 was 29 and VL 16,000.  After four years and the end of the study, I was never able to raise my CD4 above the low to mid 200s (no OIs, luckily), although VL went undetectable almost immediately.  (In my case I was fighting the age factor in addition to a very low CD4 baseline and 20 years of HIV infection--I'm a nonprogressor who finally progressed).   

When the study ended, I changed my HAART to Sustiva + Epzicom (which is basically Trizivir minus the AZT), and within three months my CD4 went from 214 to 510, around which it's stayed for the last three years.  So it took me four years.   I feel your frustration.  However, I see on another of your posts that you have a terrific CD4%.  Mine is only 21%, and I feel frustrated about that. 

I would advise a little more patience.   Best of luck.

[wiser]

Thanks edfu. I have just finished 4 years on meds this month. I went from  89 CD4 to 220 CD4 after just one month on meds. The problem is that CD4s have stopped at that 200-220 level for the 4 year period after that first month jump. I went from Kaletra/Viread/Combivir to Sustiva/Truvada (now Atripla) within the first year. I am ok with the 220 zone as my general health over this time has been very good, there are no toxicities showing up, and the Atripla has been easy to take and tolerate. Had my doc not suggested the IL-2 treatment I would have been ok with the current status of things.

[wiser]

Just to give some closure to this IL-2 discussion. At my Feb 2009 visit to the doctor he informed me that at the last HIV Conference in Canada just a day before my appointment the research on IL-2 was in. It does not work to improve overall health or slow down the progression to OIs. The reasoning is that even though the IL-2 does raise CD4 counts, it may be having some negative side effect on some other aspect of the immune system so there is overall no net gain in terms of survival rates. I was ready to try this non FDA approved treatment at that session, but the data made it a no brainer that this the treatment as has been tried is not effective. Perhaps different doses and/or combinations with other treatments in the future may have promise, but for now the book is closed on the efficacy of this treatment. Thanks to all who gave me advice on this over the past 6 months.