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Medication Vacations

A Poz Point of View on Structured Treatment Interruptions

Summer 2000

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

From the ever-evolving world of HIV vocabulary comes a new phrase that has been given much press recently: Structured Treatment Interruption (STI). Although it sounds more like a military maneuver, STI simply means taking a brief vacation from your HIV pill regimen.


Adherence Nazis

After years of having the Adherence Nazis pound their message into my head -- spending many nights in my bed riddled with guilt and "missed med" anxiety -- and just when I think I have finally come to grips with the fact that I'm going to be on these friggin' meds forever. . . . Ah Ha! . . . They change the story. Ironic as it is, many things we thought we knew six months ago about HIV/AIDS may not be the same today. Not that I'm complaining; actually I find it very inspiring that new information continues to surface. It's the proverbial "carrot on a string" for many of us. For pozzies like me who have been slugging along for many years on HAART, the idea of being able to take a break from medications is not only a dream come true, but probably the most motivating news to come out in recent times. We all know that taking HIV medications is not a walk in the park. Many of us suffer from severe physical side effects from these life-prolonging cocktails; besides, the idea of being chained to a pillbox for the rest of your life can wreak havoc on one's emotional well being. There are many different rationalizations for taking an STI, and we will attempt to explore some of them here.


I'm Not Gonna Take the Damn Pills Today

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Many of us have already experimented with our own form of STI long before it became fashionable. Either due to the extreme side effects of certain medications (been there), sloppy adherence (done that), or maybe it was just the "I'm not gonna take the damn pills today!" attitude (felt that). The possibility of suspending treatment for a brief or extended period of time (with our physicians blessing) from what was once termed as something we must do for the rest of our lives, is not only intriguing but also very exciting.

Many researchers and clinicians have taken notice of STI's recently as a possible treatment strategy, and as a way of dealing with the many complications that arise from long-term exposure to HAART. Taking a short respite from medications cannot only help relieve some of the stress placed on our body, (Lord knows our livers need a break) but also can be used as a research tool to study our body's own immune response to HIV. Our immune system in and of itself is a powerful weapon. During early stages of HIV infection, it puts up a valiant fight against the virus, hence the glorious "asymptomatic" phase.


'Vive la Resistance'!

Many of us go on for years with fairly normal CD4 counts and little or no signs or symptoms of illness. Researchers have found that many of our immune system's key defenses to HIV are depleted during this phase, and that our immune system loses its ability to recognize HIV as a threat. Especially if someone is on HAART therapy for a long period of time and their viral load is suppressed to undetectable, the immune system may actually forget that HIV is there. After all, it can't fight something that it doesn't see. It is thought that by stopping therapy periodically for a set amount of time, the immune system is given a chance to see the virus again, and hopefully stimulate it to respond; possibly restoring some of the natural immunity to HIV through a form of auto-vaccination.


The Berlin Patient

One of the key things that has spirited all this recent research into treatment interruption was a very interesting phenomenon seen in a mysterious German guy dubbed "The Berlin Patient." Several years ago HIV/AIDS researcher Dr. Franco Lori encountered a peculiar situation occurring with one of his patients enrolled in a clinical trial for newly infected individuals. The patient had entered the study (which consisted of using a triple drug cocktail containing Crixivan, Videx, and Hydroxyurea) just a couple of months after an unsafe sexual experience that resulted in a positive HIV test. His viral load quickly became undetectable on therapy. Due to various reasons unrelated to the trial, the patient had several unscheduled interruptions in treatment. The first time he went off meds for a short period of time his viral load came right back with a vengeance. Again medication was restarted, and it brought the viral load back down to undetectable. The second time, several months later, he developed Hepatitis A and was taken off meds due to elevated liver enzymes. This time however, the viral load remained undetectable after stopping treatment. Even though he was offered to begin HAART again, he decided not to, and has continued for a long period of time with his own immune system apparently controlling the virus.


Disappointing Results

Although this was extremely exciting at the time, and has since sparked a lot of renewed interest in looking at other ways of boosting our own immune defenses against the virus; we must remember that this was a very unique situation with many different variables. As yet, no one else has had the same success with an STI as this individual (in other words he was very lucky). We must keep in mind that he has not been cured, and detectable virus can still be found in other parts of his body. As more and more actual data comes out of clinical trials looking at the use of STI's, the results have been a little disappointing. What researchers thought was going to happen, with our own immune system mounting a strong second response to the virus, has been slow in coming or has failed to materialize at all. However, there have been some successes noted in recent trials regarding the return of viral load after an STI. In several of the trials, after the second and third STI, viral load in many of the participants came back to a lower level each time. This could mean that each time an STI is done it is triggering some sort of immune response to control HIV. Could this possibly prove to mean a longer and longer break between treatments? Although it was great news for the Berlin guy, and possibly for others who find out about their HIV status early and have access to clinical trials. For the rest of us reality is not so rosy, and all we are left with is questions.


Questions

What about someone who has a lot of treatment experience and maybe a small viral load to begin with, will they have the same type of response? What about people taking an STI with very low t-cells? What happens when IL2 is used in conjunction with an STI?

While we wait for more research to be done, and our many questions to be answered on this issue, let's discuss in practical terms why an STI may (or may not) be beneficial to an average pozzie like you and me. First it must be understood that an STI is not the same thing as when you missed your meds for 2 or 3 days last month because you forgot. A few days or even a week of missing your medication does not constitute an STI; and (as has been well documented) is very dangerous and can actually promote resistance. Hence the word "Structured."


Keep Your Doc Informed

If you are going to try an STI, it is important that you have your physician's prior knowledge (and hopefully their consent) so that he/she can monitor your viral load and CD4 counts. Also if you stop your meds, you must stop them all at once; do not taper off. The length of time for an STI like those typically used in the clinical trials discussed earlier usually range anywhere from 2 to 6 weeks in duration, with 30 days being the average time span. Choosing to take a break in your antiretroviral treatment for other reasons outside of a clinical trial may be much different depending on the circumstances. An interruption in treatment for someone with very low CD4's could be very dangerous and obviously would put that person at risk of developing an opportunistic infection. However, if someone were experiencing an adverse event such as liver inflammation or other serious toxicity, their CD4 count would have little or no bearing. Generally, persons with higher T-cells might have more time to play with. The following are some of the reasons to take a Structured Treatment Interruption.


Rationales

You have developed resistance to all available medications.

It is thought that by discontinuing treatment for an extended period of time there may be a reemergence of Wild Type virus. Wild Type virus being a form of HIV that is sensitive to the medications. As is the way of HIV, the virus develops resistance to the medication fairly quickly through mutation. Quite often in the presence of HAART, the original Wild Type virus that you were infected with (assuming that you were infected by someone who wasn't resistant to their medications) goes into hiding, and the resistant form that has developed while you've been on medication becomes the prevalent strain. Taking someone off of a combination that they are resistant to for a long enough period of time might allow the wild type strain to proliferate again. The hope is that it may be possible to recycle medications that you have used in the past now that the wild type strain is the prevalent one again.

To allow your body to recover from drug related side effects and toxicity.

Wonderful as these cocktails are in prolonging people's lives, they are not without drawbacks. Long term side effects such as neuropathy, lipodystrophy, lactic acidosis, and mitochondrial toxicity are showing up in a large percentage of the population as people continue on therapy for longer and longer periods of time. As more data becomes available on the long term toxicities associated with the use of these medications, it becomes a dilemma as to what to do for people who are experiencing problems. It is not known at this time whether stopping medications can reverse conditions such as lipodystrophy or neuropathy. Strategies such as Pulse Therapy (e.g.; a month on, a month off) are currently being looked at as a way to help avoid some of these negative side effects from occurring in the first place. It is important to keep yourself as healthy as possible while on treatment, and it is critical that you and your doctor monitor things such as cholesterol, triglycerides, liver enzymes, red blood cells, bone density, etc. If you are experiencing side effects, you need to report them to your physician or treatment advocate right away so that steps can be taken to hopefully alleviate or eliminate the problem.

You were started on treatment too soon.

When to start treatment is still a hot topic of debate, and is actually a whole other can of worms to discuss in the next newsletter. But, for those who tested positive during the eradication era as we are finding out now, many may have been started on treatment prematurely. The Federal guidelines that most physicians have followed in the past few years regarding the care and treatment of individuals with HIV generally states that treatment is optional for someone with CD4's over 500, and V.L. less than 10,000. (How many of you out there were started on treatment with high CD4's of say, 700?) Currently, many physicians have moved to initiating treatment when CD4's fall below 350, as long as V.L. is below 30,000. Delaying treatment for as long as possible without putting the patient at risk is now being advocated in many circles. As it stands right now, taking HIV medications is a commitment that requires many changes in someone's lifestyle. By delaying treatment a person may have the time they need to emotionally adjust to this disease, and better adhere to therapy when it becomes necessary.

You just need a break (They gotta give ya this one).

Let's say that you've been on meds for quite a while. You're doing great, the model patient. You hardly miss a dose or an appointment. You haven't had a normal bowel movement in over 3 years... but hey, no problem. That hump on the back of your neck?... no sweat, you're dealing with it. You are SUPER POZ WOMAN!... But damn it, you need a rest. Nobody ever said that living with HIV was gonna be a party, and every time you open that little pillbox it's a constant reminder that you are sick. You just wanna feel normal again, even if it's just for a couple of weeks. Who cares if you lose a few T-cells? What good is a high t-cell count, if you have to spend your life in search of a potty? Come on Docs... Give us a break.

Note: It is the writer's desire to educate the readers about the options available to them, and Women Alive encourages women to make informed decisions about their treatment. Please keep in mind that this is still very controversial in the medical field, and as with many things related to HIV and treatment, there is still much that is not known. HIV disease is different in everyone. What may be beneficial medically for one person may be very detrimental to another. It is critical that you consult your physician before making any changes in your treatment regimen. Some of the risks associated with taking an STI include:

  • Possible sharp decline in CD4 count (potentially placing the person at risk for an OI)
  • Marked increase in viral load (which may cause fatigue and illness)
  • Resistance may develop (causing the medications to be less effective -- or not at all)
  • Viral load and CD4 changes may not return to the levels that they were before the interruption (which could lead to an overall declined health status).


A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.
 
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