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| |  HIV Suppression Maintained Despite 2-Day Breaks in Drug Therapy: Presented at IAS By Ed Susman CAPE TOWN, South Africa -- July 21, 2009 -- No rebound of HIV occurred during 48 weeks among patients testing whether a 5-day-on, 2-day-off (FOTO) regimen is safe and effective, researchers reported here at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. Previous trials that involved so-called drug holidays have generally been unsuccessful, and patients experienced more clinical events or produced detectable levels of HIV. "I don't consider this a structured treatment interruption study," said Cal Cohen, MD, Community Research Initiative, and Harvard Medical School, Boston, Massachusetts, in a poster presentation on July 20. "I prefer to look at this as another way of taking medication, in this case using the pharmacokinetic properties to structure treatment." The study suggests that the long half-life of efavirenz, tenofovir, and emtricitabine, gives patients the opportunity to take brief drug holidays without creating virologic rebound. "We have 60 patients on this study and all of them have maintained suppression of HIV for a year -- some of them for as long as 18 months," said Dr. Cohen. "Half the patients are on the 5-day-on, 2-day-off regimen; the other 30 are taking their regimen daily. All the patients had suppressed HIV, with viral loads undetectable using the 50 copies/mL at the time they began the study." He said the number of patients in the study was sufficient to show that FOTO was noninferior to daily treatment. "I think we have shown this," Dr. Cohen said. Because the treatment uses fewer drugs, he said the participants who are on the FOTO regimen use 28% less medication than the patients taking the drugs on a daily basis. However, "I would not recommend this treatment for an initial therapy," he said. "You have to get the virus suppressed first and then make sure your patients are compliant in staying on the drugs and maintaining that suppression. Then you can consider the FOTO regimen." "This study only has 60 patients," noted Pedro Cahn, MD, Fundacion Huesped, Buenos Aries, Argentina. "We really cannot recommend this type of trial unless we can be certain that it would apply to a larger group of patients." Dr. Cahn suggested that the FOTO study benefits from use of the "right drugs among the right patients" and that replication of the trial might be difficult. He is seeking to collaborate with other institution in a major clinical trial to test his hypothesis. [Presentation title: The FOTO Study: The 48 Week Extension to Assess Durability of the Strategy of Taking Efavirenz, Tenofovir and Emtricitabine Five Days On, Two Days Off (FOTO) Each Week in Virologically Suppressed Patients. Abstract MOPEB063]
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