LOTTI stands for the LOng Term Treatment Interruption study, which recently reported that “Scheduled Treatment Interruptions” (STI) for toxic AIDS drug cocktails do work.
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, 2009 and was finally published on Medscape this month. 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.
The randomized, controlled, prospective LOTTI study concluded 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, 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 people 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 surprisingly, 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.
LOTTI results challenge SMART study
The largest study of the STI treatment strategy to date, 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.
One question raised by LOTTI is: if so many people do well once they stop taking the toxic drugs, why should otherwise healthy people start taking them in the first place?
(Note: this report is a summary of a longer discussion of the LOTTI results on my blog here.)