Start memorizing this acronym: LOTTI. It could change your life if you are on one of the AIDS drug cocktails, also known as HAART (highly active anti-retroviral therapy). LOTTI stands for the LOng Term Treatment Interruption study, which recently reported that those of us who have had success with “treatment interruption” might not be all that unusual.
Although some results from the LOTTI study were first reported back in November, 2008, the complete report wasn’t published in the journal AIDS until April and didn’t hit my radar screen until this month, when it was finally published on Medscape. In an industry that often falls over itself rushing to trumpet breaking news to the media, this sluggishness to report good news (for people on HAART, if not the pharmaceutical industry) is certainly suspect.
Good news: drug vacations DO work!
The randomized, controlled, prospective LOTTI study concludes that those patients who took vacations from their HAART drugs fared as well clinically as those who took their drug cocktail continuously. “The two strategies may be considered clinically equivalent,” stated the study’s authors. Even more importantly (though not emphasized in the report): more than a fourth of those who quit their cocktail of drugs never had to restart them, even though the mean length of time in the study was more than four years!
What is so exciting about this scientifically controlled study is that it offers hope to those who are currently taking anti-retroviral (ARV) drugs, but are concerned about long term effects, or are already experiencing illness because of toxicity. Based on the study’s results, there are not only no good reasons for HAART patients to stay on the drugs continuously and indefinitely, there are several advantages to stopping them:
- Reduced toxicity – Not surprising, the LOTTI trial found that those patients randomized to the continuous HAART arm of the study experienced more cardiological problems due to the effects of drug toxicity. These problems are well known, and modern clinical practice is to attempt to “manage” them with… yep, more pharmaceutical products. Other known effects of continuous use of HAART include disfiguring body effects called lypodystrophy, liver disease, bone problems, aberrant blood levels such as lipids, enzymes and hormones, and more.
- Drug “resistance” – The boogeyman most frequently used to discourage patients from considering drug interruptions–was also higher in the continuous HAART cohort. Of those in the STI arm who developed resistance, all but one did so after viral suppression was achieved, and while on HAART. In other words, being off the drugs did not cause resistance, but being on them did! This contradicts the “common wisdom” pronounced by most HIV practitioners.
- CD4 counts – While about the same number of patients from each arm reached one of the primary end points (death or disease), those in the continuous arm had a mean CD4 count of 891, compared to 557 in the STI arm. So much for the protective power of higher CD4 counts.
- Cost effectiveness – Daily treatment cost for patients on STI was less than half that of the continuous HAART group. Cost alone should not be the determining factor in treatment, but there never seems to be enough money to fuel the AIDS machine, so this is an important finding.
Are Italians SMART(er)?
The largest study of STI, the SMART study, was sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and was terminated early, supposedly because early results showed virologic failure and deaths for those on STI’s. The design (and execution) of SMART has been challenged and the study may serve better as an indication of the tremendous influence of pharmaceutical interests on the U.S. health research industry than on STI itself.
Current treatment guidelines are based on lifelong adherence to what might best be described as chemotherapy. LOTTI’s Italian researchers felt compelled to take on the SMART study as well, though they are far more diplomatic about it than I need to be, attributing the difference in results to their choice of higher CD4 counts to trigger treatment interruption and resumption.
Let’s talk about t-cells (CD4)
The issue of using CD4 markers to guide treatment is a problematic one, though it’s not likely to be replaced by researchers anytime soon. Based on personal experience, I would urge anyone considering a treatment interruption to be prepared to allow sufficient time for laboratory markers to stabilize. Some of us who have quit HAART have reported a sudden rise in the so-called “viral load”, as well as a dip in CD4 counts that reverses over time (probably months, not days or weeks).
It can be very unnerving to watch this drop, especially when we’ve been conditioned to believe they are infallible indicators of health. They are not. CD4 counts are notorious for their fluctuations and no decision should be made based on a single test result. It is not clear what the VL test is actually measuring, nor what the significance of CD4 count is in terms of general health. Any sudden changes in these numbers after quitting HAART may as easily be a marker of reaction to clearing toxicity from the ARV drugs as any indication of decline in immunity.
After an initial bounce from quitting HAART, my counts have remained reasonably steady for the six years I’ve been off of the cocktails. Secondly, it is important to keep CD4 counts in perspective. The “threshold” for illness is a moving target that lacks consensus from medical experts. It was considered to be 200 in the early years, then raised to 350, and now some are suggesting 500. There is no evidence that having a CD4 count of, say, 300 is, in and of itself, inherently dangerous. My CD4 count hasn’t been above 700 for six years. A typical range for me seems to be 250-500, and I’ve never had any AIDS-defining OIs, or other serious illnesses related to immune deficiency, but what is “normal” for these markers may vary considerably for different individuals.
I admit I would be more concerned if my CD4 count was single digit, or perhaps even double digit for any length of time. On the other hand, the evidence for a strategy of striving to maintain a CD4 count of 700+ by subscribing to a lifetime of experimental drugs simply isn’t very well-founded, and is contraindicated, given the dangerous effects of those drugs. Read my story surviving “aids” without drugs to learn more about my personal experience with quitting HAART.
Answers beget more questions
There are questions raised, but not answered by LOTTI. What about those people who have a “positive” test result, but who have not yet begun HAART? When I was diagnosed in 1998, the buzz phrase for HIV treatment was “hit it hard, hit it early”, in other words, take the drugs as soon as you know you’re poz. That strategy was quickly debunked when otherwise healthy patients got incredibly sick from the drugs. I know, I was one of the biggest advocates for drug treatment at the time.
Recently, the AIDS/pharma media machine is once again churning out press releases and announcements pushing for “early intervention”, which is just a repeat of that earlier failed strategy. I think the results from LOTTI can also be interpreted as supporting a choice to refrain from initiating HAART unless a combination of symptoms and very distressing laboratory markers suggest otherwise.
Why aren’t AIDS groups shouting LOTTI from the rooftops?
So, what is left of the rationale to support early intervention with continuous, lifelong HAART treatment? Why aren’t AIDS service organizations and advocacy groups promoting the information in the LOTTI study and calling for more research on ways to minimize HAART-related deaths and suffering? Why aren’t doctors talking to their patients about this option? You won’t hear or read a lot about the LOTTI study on those AIDS sites sponsored by pharmaceutical companies, like thebody, aidsmeds or poz.com, even though these same sites ran dozens of articles, commentary and opinion pieces about the less-promising SMART study.
That organizations supposedly run by and advocating for the well-being of HIV-positive people are withholding their enthusiasm and support for this study, while trumpeting the fear-based, trumped up charges about SMART is disgusting and disgraceful. It is behavior like this that makes dissidents like me suspicious that their dependence on pharmaceutical funding for their salaries and international travel to conventions must be clouding their thinking.
Just to be clear…
Does this mean I’m supporting HAART STIs? Not exactly. I stand by my personal position that well-informed patients should avoid such toxic therapy based solely on polyreactive tests, such as the “HIV test”, or based on questionable laboratory markers such as CD4 counts and “viral load”. That means not starting HAART in the first place, with possible extremely rare exceptions.
However, I know many people who are already on HAART and who believe they will do themselves harm, or perhaps die if they even consider quitting their HAART drugs, or take a vacation from them. I offer this scientific study as supportive evidence that they can consider taking a break from their drugs and see how they fare. It would be a mistake for anyone to think or suggest that I advocate refusing drugs as a means to good health. That is far too simplistic. It is my experience and my suggestion to others that regaining good health requires a multi-factoral approach that involves recognition of our mind/body/spirit connections; attention to diet, lifestyle, and environment; and proactive strategies that emphasize genuine health, rather than just medical/pharmaceutical intervention.