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THE PHARMA REVIEW (JAN 2010)

Drug Holidays

Rakesh Kr. Rishi

Abstract: Research is going on for developing strategy for long-term treatment of HIV disease known as “structured interruption of treatment” (STI). A treatment interruption refers to a time period when patients of HIV/AIDS stop taking their anti-HIV drugs. Some people refer to these breaks as a “drug holiday”. An STI may be defined as “a break in treatment that is agreed upon, planned and monitored together by HIV patients and their doctors”. Researchers hypothesize that this will allow the patient’s own immune system to control replication of HIV sufficiently without the continual use of anti-HIV drugs. However, STI is still theoretic and unproven treatment option. Many HIV patients and physicians have only recently learned about STI and more than a few are eager to try it. In real sense, there is actually nothing new about STI. There are many patients who do that all the time. Whether patients called them “drug holidays” or simply “taking a break from medications,” they have been doing this for some time, generally despite their doctors’ warnings that they should not.

Introduction: The enthusiasm over STI began with reports of the “Berlin patient” in 1998, who was given didanosine (ddI) and indinavir (IDV) shortly after becoming HIV-infected. This 29 year old HIV infected man decided that he would take a break from his medicines on occasion because the combination of drugs he was taking had several adverse effects. So, on several different occasions, he stopped taking all his medicines and restarted agen when got rebound viral load. After 40 days on his regimen, he decided again to stop as before. But this time, the result was different. Two years later, his viral load has still not rebounded. After a series of unscheduled, random treatment interruptions and a bout of hepatitis A virus infection, the “Berlin Patient” was maintaining an undetectable viral load and stable immunologic parameters despite not taking anti-HIV drugs. He also developed a “vigorous” HIV-specific helper-T cell and cytotoxic T-lymphocyte (CTL) response, which was increased during the 2 years he had been without anti-HIV drugs. Scientists and researchers have since labeled him the “Berlin Patient”. His continued success has sparked several clinical trials to determine whether STI can be effective strategy in the treatment of HIV patients. While some studies reported similar results, other early reports were not as encouraging. In latter reports, almost all of the patients who interrupted treatment had a rapid and significant viral rebound that approached or exceeded their baseline viral load. Still, the anecdotal reports of success seemed to support further research on STI, and this research is slowly gaining momentum.

 

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