Information Bulletin #16 - August 2002
Three reports were especially interesting. Researchers at The Johns Hopkins University in Baltimore, Maryland studied 75 people with an average of 677 CD4 cells and an average viral load of 263 who were taking a treatment regimen (HAART). The point of the study was to have people stop taking treatment, and see how long it took until their CD4 count dropped down to around 200. After 30 weeks, twenty-three people (31%) went back on treatment. After sixty-nine weeks, there were still fifty-two people (69%) who had not restarted treatment.
When looking at the difference between the two groups, the researchers found that people who had higher CD4 counts when they first started on HAART were able to stay off treatment longer. People with higher CD4 counts lost 115 CD4 cells a year, meaning that they could possibly take a four-year treatment break until they needed to restart treatment. The people who had lower CD4 counts when they started HIV treatment in the first place had to restart treatment earlier because they had an average decline of 314 CD4 cells per year. This study is good news for people who started treatment with high CD4 counts. An STI may be a useful treatment strategy for them. It was estimated that the other people in the study with lower CD4 cells could safely stay off treatment for about 8 months, a lengthy drug holiday.
Pulse Therapy is another approach being studied. People take their HIV meds for one week, then stop taking them for one week, then start taking them again the next week. It has been shown that the virus doesn't have enough time to bounce back in 7 days during studies of this type of STI. Mark Dybul from the National Institute of Health looked at a small group of people whose viral load was undetectable, taking either of two combinations: d4T, 3TC, indinavir/ritonavir, or ddI, 3TC, efavirenz. After one year of pulse therapy, none lost control of their virus. At the same time, there was improvement in their blood lipids (fat) levels.
There is also a strategy called Stop and Switch. There were some surprising results presented from a French study call GigaHAART. The researchers worked with a group of people with high viral loads that their treatments were unable to control. In the study, one group of people started on an eight (8) drug regimen of Zerit, Videx, Ziagen, Epivir, a non-nucleoside reverse transcriptase inhibitor (NNRTI) and three (3) protease inhibitors. The other group stopped treatment altogether for eight weeks, after which they started taking the GigaHAART. The researchers found that 50% of the people who stopped before switching were able to get a one log drop in viral load, compared with only 24% participants who switched without stopping. These results conflicted with an earlier Spanish study that found no difference between the two groups. It is not clear what the reason is behind the different findings.
These approaches are based on recent scientific findings that lend support to the concept of STIs, but still leave a large number of questions unanswered. Are they safe? Will they lose the gains someone has already made against the virus? Will HIV seek out other compartments or cells in the body? Is the drug resistant virus really gone, or is it just lying low in hostile territory?
Unfortunately, drug toxicities and long term side effects begin to increase the longer the drugs are taken. They can damage body organs, disrupt metabolism and cause strange and unpleasant body shape changes, and increase fat in the blood to dangerous levels. The main cause of AIDS related deaths in the US today is liver failure, which is attributed not only to co-infection with hepatitis viruses, smoking, obesity, and alcohol use, but also the side effects of anti-HIV meds. The side effects and potentially serious conditions that can occur from the use of HIV meds - including diabetes, metabolic disorders, heart disease, etc. - is driving the research to limit exposure to anti-HIV drugs only for as long as they are needed.
Not having to take any medications on an everyday basis is what many people really want. But no scientific research supports taking HIV meds whenever you feel like it as an effective treatment strategy, and the new drugs are just not here yet. Researchers are trying their best to determine if there is an orderly, safe, and effective way to give treatment and side effect weary people a break. The fact that many people with HIV struggle to come up with the cash to cover what the doctor ordered is a factor that may leave them no other option but to interrupt continuous therapy.
On top of all these factors, taking medications every day on a scheduled basis can lead to burn out. One study at the conference reported that people with HIV prefer to take simpler drug combination of fewer pills, preferably once or twice a day. They would also like not to experience any side effects from any of the treatments they take. People with HIV would like less toxic and more convenient treatments that control HIV. New formulations of drugs, some taken as one pill once a day, may help ease some of the burden, but not necessarily the side effects.
Again, these are promising but preliminary results. There are even more studies of STIs taking place that give participants drugs such as interleukin-2 or a vaccine while they are off drug, but there are no clear answers at this point. Much remain unknown about the long-term outcome of these approaches to HAART. If you are having problems with staying on HAART, these results do seem to provide you with some encouraging options. However, don't try it on your own. Talk to your doctor about it. It may allow you to recover your strength and determination to start taking the same or other medications with fewer problems.
Some drugs and drug combinations are the wrong choices for an STI. If you feel that you can't discuss your treatment options frankly with your doctor and need some coaching or a referral, contact The Network Case Management Program at (800) 734-7104.
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