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Do I still need to take my meds with my condition? (TREATMENT INTERRUPTIONS, 2010) (DRUG HOLIDAYS, 2010)
Apr 16, 2010

In May of 2003 I was determined to have full blown AIDS. I was infected just 4-5 months prior to that. My Infectious disease specialists determined I had a very powerful super strain of the virus that took over my immune system very rapidly. Due to how he wrote up my medical report, Social Security Disability determined me to be terminal and fast tracked my benefits. Then I had 159,000 viral load and about 100 T cell count. I had thrush, wasting syndrome, and flu like symptoms for weeks. I couldn't hold down food and my throat was on fire. They put me on a very aggressive HARRT treatment. Within a year I was undetectable and my T cell count got to around 600. Now, about 7 years later I'm still undetectable on the <40 ppm test. The odd thing is my T cell count is over 1400! The doctors are amazed at me. The best they can determine is my body fought off the HIV infection in a very rare way. By mistake I forgot to take my main HIV drug for three months before realizing my error. I stayed undetectable and my t cell actually climbed during that time. I'm back on my Nevirapine 200mg, and Turvada (the one I missed). I've never shown resistance to treatments. Here is my question. Would it be safe for a patient like me, to take a drug holiday, stop treatments, and get tested say every 3 or 4 months? How else could I know if I don't need the meds anymore? My VA clinic handles over 1,000 HIV patients, and they said they have never seen anyone with numbers as good as mine for decades. I do have side effects affecting my other blood work and weight gain.

Response from Dr. Frascino

Hi,

First a few comments and then answer your question:

1. We do not use the term "full blown AIDS," because there is no such thing as "partially blown AIDS." AIDS is AIDS.

2. How was it determined in 2003 that you were infected just four to five months previously? Your low CD4 counts would suggest you had been infected for a number of years.

3. Your dramatic response to "very aggressive HAART" with plummeting HIV plasma viral load and skyrocketing CD4 counts is not uncommon! Most likely this response, both immunological (CD4 count) and virological (viral load), was directly due to the potent combination antiretroviral therapy, not your body's own immune response. Remember, your body's immune system was not handling your HIV infection very well at all prior to beginning HAART!

4. You forgot to take your Truvada for a full three months???? Dude, what's up with that? Sure, maybe you could forget a dose or two, but three months' worth??? I've seen Alzheimer's patients with better memories than that! Luckily your suboptimal therapy -- single-drug nevirapine -- was apparently able to hold down HIV viral replication during your lapse in adherence. This is extremely lucky, because nevirapine has a low threshold for the development of resistance. So just consider this one of those very, very lucky situations.

Finally, on to your question. Would it be safe and/or advisable for you to discontinue your combination antiretroviral therapy, since you are doing so well now (CD4 count of 1,400 and undetectable viral load)? The answer is a resounding no! A number of very well-designed clinical trials have been done to address this very question, and they all come up with the exact same answer. Drug holidays, particularly for folks who had low CD4 count nadirs, are a very bad and dangerous idea! (See below.)

Dr. Bob

Treatment Interruptions January 20, 2010

What Are Treatment Interruptions?

Researchers have studied interruptions of antiretroviral therapy for various reasons. These treatment interruptions are usually called structured or strategic treatment interruptions (STIs), or structured intermittent therapy (SIT). During most treatment breaks, the viral load climbs very quickly and CD4 cell counts drop. Some people get the same symptoms as if they were newly infected with HIV. Fact Sheet 103 has more information on acute HIV infection.

When people start medications again after taking a break, they might experience more side effects, like when they first started taking antiretroviral drugs (ARVs). They might also have difficulty with adherence (see Fact Sheet 405), taking all of their doses correctly.

There were several reasons why treatment interruptions were studied:

It was thought that people who started treatment as soon as they got infected might eradicate the virus. The hope was that in these rare cases, patients could stop taking medications. Unfortunately, this approach now does not seem to work. There are several reasons. First, most people aren't aware that they have just been infected with HIV. Once HIV infection has continued for a few months, it's too late for this approach. Also, researchers cannot predict which patients might be able to stop their therapy. But most important, newer research shows that the immune response in these patients does not continue to protect them against HIV disease.

Some people started therapy even though they didn't meet treatment guidelines. The target CD4 cell count when treatment should be started keeps changing. In the past few years, this target level has been rising. See Fact Sheet 404 for more information on treatment guidelines for HIV. Some people started treatment with higher CD4 counts than the then-current guidelines. In some cases, their providers recommended that they stop taking medications. They checked their CD4 cell counts and their viral loads regularly. Most providers put these patients back on therapy when they met the current guidelines.

Maybe using "intermittent therapy" could reduce side effects and costs. Providers have studied "cycling" people on and off ART. Their goal was to give patients more time off of therapy, and reduce side effects, while still controlling HIV. Two major clinical studies of this type of treatment interruption were recently stopped. There were more cases of AIDS disease progression and death among people who stopped treatment. Two types of "cycling" were studied. The first type put patients on a fixed schedule. They would start and stop therapy for a certain number of days or weeks. The second type of cycling used CD4 counts and/or viral loads to decide when to end a treatment break and start medications again. Neither of these approaches seems to work.

Treatment was stopped to deal with drug side effects. Some patients get very serious side effects. In some cases they can switch medications. However, if they have already used most antiretroviral drugs (ARVs), they might need to take a break from treatment to recover from the side effects before getting back on treatment. Some doctors stopped treatment while waiting for a new drug to be approved. This was used by providers when there wasn't any treatment regimen that could control their patient's virus. Maybe HIV had developed resistance to all of the available drugs. Fact Sheet 126 has more information on resistance. During a treatment interruption, the "wild type" virus becomes more common. At first, researchers thought this was a good thing, because the wild type virus can be controlled by medications. However, the wild type virus does not replace all existing resistant strains. Resistance can come back quickly when drugs are re-started. Most patients do better if they keep taking medications, even if HIV is not totally controlled. A study in 2008 showed that patients who continued a "failing" regimen developed fewer AIDS-related medical problems than those who stopped their medications.

Do not stop your ART without careful discussion with your health care provider. Viral load and CD4 cell levels should be carefully monitored. Do not stop taking medications to prevent or treat opportunistic infections (see Fact Sheet 500).

What Are the Risks?

The biggest risk of an STI is that you will develop an AIDS-related infection. Also, the viral load will probably climb and the CD4 count will drop. These risks are greatest for people who have a low CD4 count. If you have only 50 CD4 cells, losing another 10 might have serious consequences. Stopping medications to prevent opportunistic infections can allow them to develop. A research study on STIs showed that people who stopped treatment had a much higher chance of developing an opportunistic infection. Stopping and re-starting medications could make it easier for the virus to develop resistance to medications. This has happened to some patients in STI studies.

People ending a treatment interruption might have a hard time re-starting medications. This can be due to side effects, or due to psychological difficulties in getting back on treatment.

The Bottom Line

HIV patients stop ART for various reasons. If we can learn how to use treatment interruptions safely, patients might be able to take periods of time off of ARVs. However, we will have to learn how to avoid HIV disease progression, and minimize drug resistance and transmission of HIV. So far, large research studies have not shown any benefits to discontinuing therapy.



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