The AIDS Beacon™

Panel members debated the pros and cons of starting early Highly Active Antiretroviral Therapy (HAART) in a discussion last week at the International AIDS Conference in Vienna, Austria.

Previous guidelines advised patients to begin HAART after the onset of AIDS symptoms or when their CD4 (white blood cell) count dropped below 200 cells per microliter.

In 2009, however, the World Health Organization released new guidelines recommending that treatment start when CD4 counts drop to 350 cells per microliter. Proponents argued that this number better protects patients from long-term immune system damage.

Some doctors feel there might be benefits to initiating HAART even earlier, perhaps as soon as HIV is diagnosed. Others worry that this will maximize exposure to antiretroviral drug toxicity and side effects and argue treatment should be delayed until necessary for health reasons.

In the panel discussion, doctors and activists, including a speaker with HIV, debated the benefits and drawbacks to starting HAART early.

Arguments For Starting Early HAART: HIV Causes “Irreversible Damage”

The first speaker on the panel was Dr. Steven Deeks, professor of medicine at the University of California in San Francisco, who argued for starting HAART as soon as possible.

When diagnosed, he said, patients have two options. “Option one is to do nothing; but that is an active decision in which you are going to allow a virus, which is known to be pathogenic and cause some irreversible damage, to replicate at will. That could, perhaps, affect your long-term outcome and your quality of life.”

“Option two,” he said, “is to go on therapy immediately, and that also is associated with harm. Each of these drugs has toxicity; and so the question is, how do you manage it? How do you balance it?”

Dr. Deeks stated that in his opinion, it is much easier to predict and manage the consequences of drug toxicity than the results of viral progression due to a lack of treatment.

“I think most of the toxicity with the current generation of drugs can be managed,” Dr. Deeks said. “On the other hand, I think that the harm of ongoing virus replication, in terms of the irreversible damage it does to the immune system…on [the heart], [brain], bone and so forth, is far greater than any potential harm from the drugs.”

He added that since most patients will be taking antiretrovirals for several decades, a few extra years of treatment are not likely to have much additional effect on toxicity.

“At the end of the day, they are going to spend most of their life on therapy. Do we actually have less long-term toxicity by preserving those three or four years?”

However, Dr. Deeks conceded that the push to start HAART at CD4 counts higher than 350 cells per microliter was presently based on opinion, not research.

“There are lots of data that can inform what to do, but none of it is definitive. At the end of the day, you, as the patient, need to decide which of the two options you want to pursue. Both are associated with potential harm,” Dr. Deeks said.

AIDS Activist: Clinical Trials Are Needed On Benefits And Risks Of Early HAART

Another speaker in the session was Mark Harrington, executive director of Treatment Action Group, a non-profit organization focusing on AIDS research and policy. Harrington, who is HIV positive, was less convinced of the wisdom of starting treatment early.

Harrington delayed treatment for more than 10 years after his diagnosis. By that time, HAART had been developed and he was able to avoid some of the earlier, more toxic drug regimens.

He emphasized the need for clinical trial data before making any decisions on earlier HAART treatment. “There is a human right to informed consent based on the best available information,” he argued.

“There is a mandate on us to do the research to provide rigorous, controlled clinical trial evidence so that people with HIV…can make a truly informed decision and not one that is just based on even the most expert informed opinion,” he added.

Harrington also suggested that the first priority should be making sure everyone who meets the current guidelines is receiving antiretroviral therapy. He noted that, even in the United States, there are many patients well below the 350 CD4 cell count threshold that are unable to get access to HAART.

“In the U.S., we have huge disparities in our health systems. People with HIV are often from groups suffering from other socioeconomic problems…and are not in a position to get good health care in many parts of the country,” he said.

“We have Band-Aid solutions like the AIDS drug assistance programs in some states, but there is a waiting list of over 2,000 people with AIDS/HIV that need therapy right now,” he added.

Harrington also pointed out the need for more research into better, less toxic antiretrovirals that can be taken less often, and he stressed the need for research toward a cure for HIV.

“We need to accelerate research on curative therapy, both for people at early infection and later infection,” he said.

In the end, he argued, “People [should] get treatment based on what is best for them.”

U.S. Global AIDS Coordinator Emphasizes Personal Health Decisions Over Policy

The final speaker on the panel was Dr. Eric Goosby, the U.S. Global AIDS Coordinator, who emphasized the need to separate government policy decisions from personal health choices.

“There needs to be a real distinction between what a provider who is in front of a patient should be thinking about…versus a more public health thought process,” he said.

“The provider/patient interaction must retain the assumption that the physician or nurse practitioner or health officer in front of that patient is always, and every time, making decisions that they believe are in the best interest of the patient,” he added.

As a result, a patient’s personal treatment decisions should not necessarily be governed by official guidelines and policies, which are also affected by financial and social factors.

Dr. Goosby did not definitively state a position on early HAART treatment, but agreed with Harrington that more clinical trials are necessary.

“The science clearly shows that we should be trying to put patients on [HAART at CD4 counts of] 350. The science above that is less clear,” he said.

On the other hand, he stated, “The issue of unchecked viral replication with the persistent fueling of inflammation and acceleration of [blood vessel] damage, [heart disease] acceleration, etc., are all a real concern.”

START Trial Studies Benefits Of Starting HAART At CD4 Counts Of 500

A clinical trial testing the effects of starting HAART when a person’s CD4 count drops below 500 cells per microliter is currently underway.

The study – named Strategic Timing of Antiretroviral Treatment (START) – is carried out jointly by the University of Minnesota, the National Institutes of Health, various European HIV institutes, and several pharmaceutical companies.

The study is currently recruiting participants.

For more information on the panel discussion, please see the AIDS 2010 webpage on the Kaiser Family Foundation website. For more details on the START study, please visit the United States Clinical Trials registry.