Publication
CD4-guided scheduled treatment interruptions compared with continuous therapy for patients infected with HIV-1: results of the Staccato randomised trial
Journal Paper/Review - Aug 5, 2006
Ananworanich Jintanat, Leduc Dominic, Satchell Claudette, Yerly Sabine, Perrin Luc, Hill Andrew, Perneger Thomas, Phanuphak Praphan, Furrer Hansjakob, Cooper David, Ruxrungtham Kiat, Hirschel Bernard, Staccato Study Group, Bernasconi Enos, Vernazza Pietro, Nüesch Reto, Gayet-Ageron Angèle, Le Braz Michelle, Prasithsirikul Wisit, Chetchotisakd Ploenchan, Kiertiburanakul Sasisopin, Munsakul Warangkana, Raksakulkarn Phitsanu, Tansuphasawasdikul Somboon, Sirivichayakul Sunee, Cavassini Matthias, Karrer Urs, Genné Daniel, Swiss HIV Cohort Study
Units
PubMed
Doi
Citation
Type
Journal
Publication Date
Issn Electronic
Pages
Brief description/objective
BACKGROUND: Stopping antiretroviral therapy in patients with HIV-1 infection can reduce costs and side-effects, but carries the risk of increased immune suppression and emergence of resistance. METHODS: 430 patients with CD4-positive T-lymphocyte (CD4) counts greater than 350 cells per muL, and viral load less than 50 copies per mL were randomised to continued therapy (n=146) or scheduled treatment interruptions (n=284). Median time on randomised treatment was 21.9 months (range 16.4-25.3). Primary endpoints were proportion of patients with viral load less than 50 copies per mL at the end of the trial, and amount of drugs used. Analysis was intention-to-treat. This study is registered at ClinicalTrials.gov with the identifier NCT00113126. FINDINGS: Drug savings in the scheduled treatment interruption group, compared with continuous treatment, amounted to 61.5%. 257 of 284 (90.5%) patients in the scheduled treatment interruption group reached a viral load less than 50 copies per mL, compared with 134 of 146 (91.8%) in the continued treatment group (difference 1.3%, 95% CI-4.3 to 6.9, p=0.90). No AIDS-defining events occurred. Diarrhoea and neuropathy were more frequent with continuous treatment; candidiasis was more frequent with scheduled treatment interruption. Ten patients (2.3%) had resistance mutations, with no significant differences between groups. INTERPRETATION: Drug savings with scheduled treatment interruption were substantial, and no evidence of increased treatment resistance emerged. Treatment-related adverse events were more frequent with continuous treatment, but low CD4 counts and minor manifestations of HIV infection were more frequent with scheduled treatment interruption.