Publication: Failures of 1 week on, 1 week off antiretroviral therapies in a randomized trial
2
Issued Date
2003-10-17
Resource Type
ISSN
02699370
Other identifier(s)
2-s2.0-10744229013
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
AIDS. Vol.17, No.15 (2003)
Suggested Citation
Jintanat Ananworanich, Reto Nuesch, Michelle Le Braz, Ploechan Chetchotisakd, Asda Vibhagool, Saijai Wicharuk, Kiat Ruxrungtham, Hansjakob Furrer, David Cooper, Bernard Hirschel Failures of 1 week on, 1 week off antiretroviral therapies in a randomized trial. AIDS. Vol.17, No.15 (2003). doi:10.1097/00002030-200310170-00001 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/20875
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Failures of 1 week on, 1 week off antiretroviral therapies in a randomized trial
Abstract
Background: Scheduled treatment interruptions are being evaluated in an effort to decrease costs and side effects of highly active antiretroviral therapy (HAART). A schedule of 1 week on and 1 week off therapy offers the promise of 50% less drug exposure with continuously undetectable HIV RNA concentration. Methods: In the Staccato study 600 patients on successful HAART were to be randomized to either continued therapy, CD4-guided therapy, or one week on, one week off therapy. A scheduled preliminary analysis evaluated effectiveness in the 1-week-on-1-week-off arm. Results: Of 36 evaluable patients, 19 (53%) had two successive HIV RNA concentrations > 500 copies/ml at the end of the week off therapy, and were classified as virological failure. Most of those who failed took didanosine, stavudine, saquinavir, and ritonavir (11 patients). In these patients, there was no evidence of mutations suggestive of drug resistance, and plasma saquinavir levels were within the expected range. Two of three patients failing on triple nucleotides had drug resistance mutations, but nonetheless responded to reintroduction of triple nucleotide therapy. One of two patients taking nevirapine, and one of eight taking efavirenz, also failed. Both had resistance mutations at the time of failure, but not at baseline. Conclusions: The 1-week-on-1-week-off schedule, as tested in the Staccato study, showed an unacceptably high failure rate and was therefore terminated. © 2003 Lippincott Williams & Wilkins.