May 5, 2010
by Tim Horn
Project Inform is not the only group to struggle with the question of when to start treatment. Even the panel of experts who revised the DHHS treatment guidelines were somewhat divided—if not over their final recommendation, then certainly about how strongly they supported it. Though more than two thirds of the DHHS panelists who revised the treatment guidelines voted to change the CD4 starting point (from 350 and below to between 350 and 500), there wasn’t universal agreement on the strength of the recommendation. Fifty-five percent of the panel voted that the recommendation be “strong,” and 45 percent voted that it be “moderate.”
The rationale behind recommending treatment for those with up to 500 CD4s comes primarily from two large cohort studies. The North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) study and the ART Cohort Collaboration (ART-CC) study suggested that people who waited to start treatment until CD4s dropped below 350 faced a higher risk of premature death, from any cause, than people who start treatment at a CD4 count above 350.
Further evidence in support of early treatment—again from cohort studies—suggests that uncontrolled HIV replication might be associated with a number of illnesses not traditionally associated with AIDS. These include non-AIDS-related cancers, cardiovascular disease, liver disease, kidney disease and immune inflammation.
Simon Collins of HIV i-Base, an HIV treatment education and advocacy group in London, argues that these data need to be interpreted with a critical eye. Not only are the observed differences marginal, but the data reported thus far only come from studies with important limitations.
“The few studies involving patients starting at 350 and 500 show both options are very safe and very effective,” Collins says. “In [NA-ACCORD], 19 out of 1,000 people died in the first year of treatment if they started at 350, compared with 16 out of 1,000 people who started above 500. The absolute risk of death in both groups was very small. The difference in the absolute risk between the groups—0.3 percent—could easily have been due to confounding factors [factors unrelated to HIV] that [cohort study limitations] can’t account for.”
As for people living with HIV with CD4s above 500, the guidelines’ panelists were again split down the middle, this time as to whether to recommend treatment or not. Whereas NA-ACCORD did suggest a benefit associated with very early treatment, ART-CC did not. Even with NA-ACCORD, the guidelines’ authors themselves note important limitations, “including the small number of deaths”—which makes detailed comparisons extremely difficult—“and the potential for unmeasured confounders that might have included outcomes independent of antiretroviral therapy.”
“This brings us to why randomization is key to the quality of the evidence,” Collins says, pointing out that cohort studies lack this tried-and-true scientific device that can help neutralize confounding factors in studies. “Randomized trials generally get a balance of all factors in the two groups being compared. This includes the things we think might affect the results, but also the things we have no control over, like genetics or personal behavior.”
Pages: 1 | 2 | 3 | 4 | 5
Search: START, randomized studies, HIV treatment, antiretroviral therapy, Project Inform, Bob Huff, Mark Milano, Simon Collins, controversy
Scroll down to comment on this story.
comments 1 - 15 (of 21 total) next
G-B, USA, 2010-06-22 13:06:36
SMART is not about the best treatment for individuals, but lowering the community viral load, so transmissions decrease. It assumes poz people are transmitting it, rather then untested. It's unethical. And of course they are touting the health benefits of starting early, to convince people. After 5 years with no meds, my viral load is still at 200 and my CD4s are high. Why would I start meds that in the long run may prove to be worse for my health, after being on them for 40 years???
Frederick Wright, Tampa, 2010-05-25 11:35:00
This debate about when to start or what is a safe dose of ARV's for people is surprising that not one of the National AIDS/HIV groups from Housing Works, NMAC, AIDS ACTION , The AIDS Institute, NAPWA or State AIDS Leaders AKA employees of the States are taking a stand or position. Where is the Leadership? They are waiting I guess to inform the people they serve when it is safe to speak and act. Silents equal Death and clearly new leadership is needed within these so called AIDS Non Profits.
Tim, Pittsburgh, 2010-05-19 17:05:16
Since when is a Community Health Outcome the goal of a individual's treatment plan?
Christopher, , 2010-05-19 02:59:11
"If patients are ready and willing, go for it !!! Promote a health immune system!"--not much of an argument there; sounds more like a high school cheerleader or an advertising exec than a real doctor. This disturbs me. 20 years from now, are some of those patients going to have kidney damage who might have avoided with, potentially, ten fewer years of HAART?
Christopher, , 2010-05-19 02:57:28
(cont.) "Delayed western blot positivity,"--is that important?--"undetectable viral loads and CD4's 800-1500." Your patients will, now, never know how many med-free years they would have had, which is sad. I've had HIV for six years now and have done fine without meds; can you give me an argument why taking HAART these six years, and counting, would have improved my life?
Christopher, , 2010-05-19 02:51:41
Christopher G--I'm surprised at your statement. You write "I try to start all of my new (acute) HIV patients on HAART - all have done very, very well"--most of them would have done very, very well even without HAART; we'll never know, now, for how long--"and I haven't seen any negative outcomes."--is this meaningful? What kind of negative outcomes were you likely to find? The arguments against early treatment come from the unknown effects of decades on HAART. Get back to us in 20 years, ok?
Matt, Raleigh, NC, 2010-05-15 13:31:55
Article says nothing of VL in respect to starting treatment. I was recently diagnosed. My cd4 count is 366 and undetectable VL w/o treatment.My doc tells me my body is controlling the virus and meds are not necessary right now. With the information in the article and comments below, I am wondering if I should start treatment sooner rather than later.Docs tell me that treatment is not necessary til VL over 100,000 copies.But not excited to wait to get sick to start treatment.
Frederick Wright, Tampa, 2010-05-15 09:24:18
Tim, I am in agreement that folks should start meds when they choose in agreement with their Doctor. And Thank God for all the people before me that took these experimental drugs, some died, some live. Which makes these drug better in science and community. The problem for me is what is the right safedose, for many say take them like they are prescribed, while saying ever one is different. Does not make since if all are different for all to take the same dosage. This is not about when to start
OriginalTim, , 2010-05-14 10:32:50
I fully support starting meds as soon as possible. I took this decision as a life changing event. I was tired of waiting till I got sick to start meds. Every day waiting on my labs to come back was an extra day of unneeded stress. The meds are safe now so I started when my cd4 was well above 500 and I have not been sick a day since, not even a cold. Furthermore, the stress of waiting on my health to decline has been eliminated. I can now live my life to the fullest.
Rosetta, Buffalo, NY, 2010-05-12 12:37:46
We have been seeing for years the physical challenges from long term use of HARRT. I think this is just a way to prevention the transmission of HIV, so that's what they should say it's about!
Frederick Wright, Tampa, 2010-05-12 10:56:09
Yes, a piece of the truth would be nice and I am very happy my Faith is not in a Study or a Doctor for the confusion is in the term experts. Project Inform is an expert at data, which according to the National Physician Alliance can be mis-leading by Doctors signing off on anything that the Drug Companies want them to do. The other confusion is that Doctors are the experts in handing out pills, however the HIV person is the expert on taking pills. Craig thanks for addressing this debate.
Craig, Orlando,fla, 2010-05-11 14:14:55
Well to tell the truth. I am still undecided on the whole matter! I understand that the risk of starting early would be the potential side effects of long term meds! Now on the other hand it could be that the side effects are worse in folks whom wait till the below 300. It could be that since the virus is so rampant that the meds effect the rest. So I think instead of all this crap about who said what and when. We should wait for the results of the START study! Then make a choice with your doctor
Frederick Wright, Tampa, 2010-05-09 13:28:40
Again out of date and Tim Horn is reacting not leading. I am not suprized that this conversation is out dated compared to Europe where Titration of Drugs is a treatment option. Most people here do not know or understand Titration of Drugs and again the lack of leadership in the USA is so riddled with false information. A study that is short sided. Concerning Mr Picket comment about money, Why are the Drug Companies not coming down in price after 10 years of having a cash pig from Medicare.
Frederick Wright, Tampa, 2010-05-08 09:39:13
The sad thing about TNT is that it adresses a small part of treatment focus at pills, where nutients and life stye changes should be adressed, like if t-cells are below 500 stop using cocaine and eat well, and find a loving mentor that will help you think and act in your community. Concerning Mr Picketts concerns about money it would be less expensive to treatHIV people and notAIDS with huge hospital bills then a 50 cent drug a month that PHARMA sells to our Goverment for thousands dollars
Vanessa Anderson, San Diego, 2010-05-06 11:16:03
comments 1 - 15 (of 21 total) next
I chose to participate in the study and started my antivirals at a tcell count of 600. It has changed my life. I wasn't completely aware of how tired I was before and what a struggle everyday really was i had been doing for such a long time. My viral load is now undetectable and my tcells are at 950. I have more energy and although it can be a pain in the butt to remember to take them everyday my quality of life is back to were it was before i was infected.
[Go to top]