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3rd International AIDS Society Conference on HIV Pathogenesis and TreatmentRio de Janeiro - July 24 - 27, 2005 |
THE FOTO STUDY 48 WEEK RESULTS: VIRAL SUPPRESSION CAN BE MAINTAINED WHEN ANTIRETROVIRALS ARE TAKEN FIVE CONSECUTIVE DAYS ON, AND TWO DAYS OFF EACH WEEK
IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePe12.4C10
Cohen C.1, Colson A.1, Morris A.1, Alberts L.2, Sheble-Hall A.1, Hussey S.1, Schulte M.3
1CRI New England, Boston, United States of America, 2CRI Provincetown, Provincetown, United States of America, 3CRI Springfield, Springfield, United States of America
INTRODUCTION: We evaluated viral load (VL), CD4s, and QOL when changing from daily antiretroviral therapy (ART) to a weekly schedule of 5-days-on treatment and 2-days-off treatment (5/2). This schedule was chosen to enhance adherence by mimicking the work week and to minimize risk of VL rebound by keeping interruptions brief.
METHODS: N=30 HIV+ adults with VL<50 and CD4s >200 on stable ART for >3 months. At enrollment, subjects changed from daily ART to 5/2. Subjects with VL rebound (>500 × 2) resumed daily ART. Change in CD4 and lipids was analyzed using repeated measure ANOVA.
RESULTS:
| Group | Week 24 | Week 48 |
| EFV | 10/10; 100% (70 – 100%) | 8/8; 100% (63 – 100%) |
| NVP | 9/10; 90% (71 – 100%) | 8/9; 89% (68 – 100%) |
| All NNRTIs | 19/20; 95% (85 – 100%) | 16/17; 94% (83 – 100%) |
| PI | 7/9; 78% (51 – 100%) | 7/9; 78% (51 – 100%) |
Three on NNRTIs and one on PIs were LTFU before wk 48. Two on PIs had confirmed VL rebound, one on NVP had unconfirmed rebound; all resuppressed on daily ART. Mean LDL Chol fell from 116 at baseline to 103 at week 48(p=0.016); this was driven by changes in the PI arm. There were no significant changes to HDL or TG. No significant changes were seen to CD4 counts. Twenty of 23 completing week 24 completed a Likert scale: 0 was strong preference for daily Rx, 10 was strong preference for 5/2. The mean score was 9.8.
CONCLUSIONS: In this pilot, ART 5 consecutive days per week maintains virologic suppression for at least 48 weeks in 100% on EFV/NRTI regimens; lower rates were seen with PIs. The 5/2 schedule is strongly preferred by subjects, and reduces ART costs by 28%. If results are confirmed, these results have enormous implications especially for developing nations.
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050724
Clinical | WePe12.4C10 | Calvin Cohen
Treatment Interruption
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