May 5, 2010
by Tim Horn
HIV experts are at odds regarding an uptick in public policy and advocacy efforts to promote early HIV treatment, in light of the unknowns surrounding its potential benefits and risks. A clinical trial—the 4,000-patient START study—is now under way to explore some of the most pressing questions. But should activists and advocacy groups be waiting for answers?
In December 2009, a panel of government officials, academic researchers and HIV/AIDS activists revised the U.S. Department of Health and Human Services (DHHS) official recommendations for when to start HIV treatment. The new Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents strongly encourage treatment for all people living with HIV with CD4 counts between 350 and 500. Previously, treatment was only advised for patients with CD4 counts of 350 or lower—as remains the recommendation in most other developed nations.
A patchwork of data suggests that starting treatment earlier can benefit the health and longevity of people living with HIV, as it may better defend the immune system, lower the risk of non-AIDS diseases and further reduce the risk of death. It is this research that has sparked tremendous interest in the personal benefits of early antiretroviral (ARV) therapy.
Early treatment may also benefit the greater good of the public health. Some research suggests that undetectable viral loads in a large swath of the HIV population can potentially slow the spread of the virus. In turn, public health officials are considering whether widespread, immediate ARV therapy could be an effective HIV prevention tactic.
Few experts and activists argue that the research supporting early treatment is anything less than encouraging. Where there is less agreement, however, is whether enough sound, scientific research has been conducted to spell out the benefits and risks—the increased (or decreased) likelihood of short- and long-term side effects, adherence challenges and the development of drug resistance, for example—of early treatment and to warrant major changes to public policy. In fact, some of the most experienced and trusted sources of HIV prevention and treatment policy are struggling to make the right call.
Case in point is Project Inform’s recent switch on where it stands on the issue. On April 13, the prominent San Francisco–based HIV advocacy organization issued a policy statement containing a series of when-to-start recommendations. One in particular seemed to advise treatment at any CD4 cell count. A few weeks later—without acknowledgment or explanation in a revised policy statement—Project Inform changed its position.
In its April 13 policy statement, the organization stated, “Based upon a careful review of currently available data, Project Inform believes that all HIV-positive people who are ready to begin treatment should start before their CD4 counts fall below 500.” This exceeded the start recommendation in the DHHS guidelines, which only promoted treatment when the CD4 cell count is 500 or below, and was more along the lines of a recent San Francisco Department of Public Health (SFDPH) policy recommending immediate treatment for everyone diagnosed with HIV.
But, in a revised policy statement dated May 2010, they wrote: “Based upon a review of currently available data, Project Infom believes that all HIV-positive people who are ready to begin treatment should start if their CD4 counts fall below 500” [emphasis added]. This put the organization’s position more in line with the DHHS guidelines.
“Based on feedback and in an effort to be clearer in our positions, we made small changes [to our policy statement] and re-dated it,” said Dana Van Gorder, Project Inform’s executive director. When asked if he cared to elaborate, pointing out that some may consider the CD4 change to the policy statement to be rather significant, Van Gorder simply responded, “No.”
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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.
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