May 5, 2010
by Tim Horn
The potential benefits of early treatment, as spelled out by the data reported thus far, are encouraging to say the least. But the only way to know these benefits are what they seem to be is to conduct a scientific study. In fact, a massive study exploring the potential health benefits and risks of early HIV therapy is currently under way. It’s called the Strategic Timing of Antiretroviral Treatment (START) study, and it’s being conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).
The START trial is ambitious in its goal, yet simple in its basic design. Taking place at roughly 90 sites in nearly 30 countries, it seeks to randomize more than 4,000 antiretroviral-naive HIV-positive individuals with CD4s above 500 cells to either begin treatment immediately or defer treatment until their CD4s are less than 350 cells.
Some researchers associated with START are concerned that the revised DHHS guidelines will lead to conclusions among people living with HIV and their care providers that deferring treatment until the CD4 cell count hits 350 is too great of a safety gamble. “We are concerned that some may interpret the new [U.S.] recommendations as implying that the deferral group of this trial is no longer ethical,” Andrew Phillips, PhD, a statistician for the START trial, and his colleagues write in the February 20 issue of The Lancet. The authors add: “Such an interpretation would endanger the future of the trial in the USA.”
In an effort to challenge such interpretations, members of START’s Community Advisory Board (CAB) issued a sign-on letter highlighting the controversy surrounding the DHHS recommendations, allaying safety concerns and reiterating the need for sound, scientific data to determine, once and for all, when treatment should be started.
“We wanted to see whether there was still strong community support for getting proper evidence before changing policy so dramatically,” says Collins, a lead author of the letter. “We also wanted to emphasize that it is still a very safe study, whether someone is randomized to the immediate or deferred treatment groups.”
Collins and his fellow START CAB members—roughly 260 signatures have been added to the letter including more than 150 organizations—express a number of grievances with the revised DHHS guidelines and, indeed, the promotion of treatment at any CD4 cell count.
According to the sign-on letter, the new U.S. recommendation “is based on poor evidence and therefore might not be in the best interest of patients.”
Collins comments that the sign-on letter has actually shown how widely the study is supported. “Getting a study like START has been an activist priority for at least 10 years, and luckily, it is now being run when treatment is at its safest. Many activists continue to believe in the importance of this study, probably many more than those who think we already know enough without the data it will provide.”
Researchers are also on board with the study. “Researchers in the U.S. still see the study as safe and important,” Collins adds. “Many of the experts on the guidelines panel are also on the steering committee for START.”
START is proceeding in two phases. The pilot phase will ultimately enroll at least 900 participants, followed by a definitive phase, which will expand enrollment to an estimated 4,000 participants.
In addition to the primary study objective—to determine whether or not those who start therapy immediately are less likely to develop a serious AIDS illness, a serious non-AIDS illness or death from any cause—some patients enrolled in the trial will be followed closely to answer more specific questions about early treatment, including its effects on neurological, arterial, pulmonary and bone diseases.
“START is a randomized study, which isn’t just a technical detail,” Collins stresses. “It means the results will be solid and is the gold-standard for research. Otherwise, we have nothing other than guesses—and those guesses, even by experts, have been wrong too often in the past.”
START isn’t just about evaluating the potential benefits of treatment for practically everyone living with HIV, but also about its potential risks. “Cohort studies show the potential benefits of earlier treatment, but they haven’t been able to look at the risks of drug resistance or side effects,” Collins points out. “If we are asking people to start treatment when they feel well, we need to be able to know the risks too. The risks may turn out to be low, but we don’t know. Even aspirin does more harm than good if you give it to everyone, and this could easily be the case for HIV drugs.”
Collins also points out that, for people in the United States, the study provides free treatment. “This may in fact guarantee access to newer drugs and earlier treatment than they would have access to otherwise.”
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]