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My Thoughts on the New Guidelines.

| 3 Comments

Happy World AIDS Day just doesn't sound right does it?

Haven't blogged in a while. Why? No real reason- just a bit of ennui plus inertia. But today is our day, so here is what I am thinking today.

The new Guidelines were released this morning. I am a community member on the panel that writes the recommendations, and this update includes some important changes. Just so we are clear- I do not speak for the Guidelines panel- these are just my thoughts.  

One major change is the 'when to start' language. Specifically starting treatment with a CD4 count between 350 and 500 in now recommended. There was significant difference of opinion on how to characterize the strength of evidence for this- most saying the evidence is strong, but a significant minority seeing the evidence as more moderate. Treatment with a CD4 count above 500 is talked about- basically stating that the panel was evenly split between those basically supporting treating virtually everyone with HIV and those who feel that the evidence is just not strong enough and that treatment could be initiated, but should not be recommended.

My thinking? I have come to believe that, in most cases treatment is better than no treatment. The panel bases it's guidelines on the available evidence- which is where these questions become sticky. There simply isn't a large, prospective, randomized, controlled clinical trail answering the 'when to start' question. Lacking this gold standard means we have to look at other forms of research- non-randomized trials, retrospective analyses, cohorts and so on- to build the recommendations.

To me the data, while not straight forward, are convincing. Most of the studies done in the past 5 years or so show strong benefit of treatment, in most cases. While there is no debate that HIV drugs can cause harm, it is increasingly clear that the untreated virus wreaks much havoc, beyond CD4 counts. Looking at heart disease, liver disease, kidney disease, cognitive function, aging- whatever measure you look at, people on meds seem to do better than those not on treatment.

The other major changes are in the 'what to start' section where Kaletra was 'demoted' to alternative (while still preferred for pregnant women), and Isentress was added to the 'preferred' list. This boils down to side effects- most widely used HIV drugs work well now in terms of reducing viral load- the real differences (for the most part) are around toxicity. Simply put, Kaletra's effect on lipids (fats) and some data suggesting it might increase the risk of heart attack, dragged it down to alternative.

Adding Isentress to the 'preferred' first line group made sense to me. The STARTMRK data show it works quite well as part of initial therapy. The real question for me is more philosophical- given how well this drug works in later treatment and with no back up integrase drug in the foreseeable future, is it wise to use this drug as a first option. In my opinion- probably not. But that is just my opinion- the data support its use this way, and so I supported adding it to the list.

 

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Comments on Paul Dalton's blog entry "My Thoughts on the New Guidelines. "

Thank you for cutting it to the chase.

I am glad to see this since many assistance programs follow number guidelines to determine eligibility. Being diagnosed at a CD4 well below the then recommended threshold of 200 was the determining factor allowing me to have my Atripla paid for at a cost of $1544.00 per month at the time, now $1837.00 per month. I hope insurance, medicaid, ADAP, and medicare take heed to these recommendations. Having seen first hand the effects of thrush, cancer, tumors, kidney failure, brain lesions, neuropathy, and pneumonia, I know unequivocally what can happen once the immune system is allowed to be decimated and have been graced by the stories of those who were able to start treatment early enough to enjoy immune response recovery and good health.

I live in fort lauderdale, have for 5 years now. For the last 2 years I've been getting my treatment through Care Resource. THis July 1, due to broward county not performing a basic upload function showing that meds had been picked up on time each month the state has booted me out of my adapt program and put me at the rear of the waiting list. So finally I got a case worker through care resource (I applied several times over the 2 yrs I've been seen there). My case worker has (I believe) been trying to get me on the PAP programs, Abbott, and Gilead have been approved but Bristol Myers (reyataz) has declined (according to the case worker) so he tried under a new script from my dr for prezista. When I spoke to the doctor over a week ago he told me that my case worker was having the same problem getting this drug and was still pursueing reyataz. I called the case worker on thursday asking for an update, waited 24 hours and no call, so I called again requesting an update and that I was real stressed out (been without meds now for several weeks, he knew about my frustration), still no call, I called and let him know I found some reyataz that could get me by for a couple of month if he would just get the other drugs ready for me to pickup, no call back, I called the director and asked for her assistance, that was on friday not it's monday evening and not 1 returned call and I'm still without meds. They're ruining my health and no one should be treated like this, I'm looking for another venue to get quality care not from an organization such as "Care Resource" in Fort Lauderdale or Miami, MY RECOMMENDATION IS FOR EVERYONE TO AVOID GETTING YOUR TREATMENT FROM THEM!!! On top of this, the new drug that was approved I cannot take, it's sulfa based and I'm deadly allergic to that, it's in my file and if I had tried it without doing research on my own I may have died from their deglect and lack of attention to detail. AGAIN, DO NOT USE CARE RESOURCE AS YOUR PLACE TO GET ASSISTANCE FOR YOU HIV CONDITION, THEY DON'T CARE AND THEY MAY KILL YOU ANY WAY,

sincerely
jeff davis

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This page contains a single entry by Paul Dalton published on December 1, 2009 1:04 PM.

Wonder If I Am The Only One? was the previous entry in this blog.

On Denialism, Skepticism and Science. is the next entry in this blog.

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