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Published byDaniella White Modified over 9 years ago
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Modified Directly Observed Therapy for First Virologic Failure: ACTG A5234 PI Dr A Chisada Presenter: Dr W Samaneka MBChB, MSc UZ-UCSF ARD 17 April 2015
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Sustained and consistent adherence is a key factor for durable ART success 2nd line therapy is typically more complex and expensive than 1 st line Conventional DOT is logistically challenging Enhanced partner support may benefit patients with prior treatment failure. Background
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Main Objective To test whether a partner-based modified DOT (mDOT) intervention would result in higher rates of virologic suppression compared with standard of care after first-line treatment failure
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Methods Study duration: Apr 2009 – Sep 2011 Confirmed virologic failure on 1st line Identifiable mDOT partner (family, friend, etc.) 1:1 allocation to mDOT and standard of care 2nd line: lopinavir/r (400 mg/100 mg) BID + TDF/FTC (300 mg/200 mg) qD Brazil, Botswana, Haiti, Peru, SA, Uganda, Zambia, Zimbabwe
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End Points Primary efficacy endpoint Confirmed Virologic Failure HIV RNA>400 cpm by week 48 Secondary endpoints Confirmed virologic failure HIV RNA>400 cpm by week 24 Adherence measured using electronic monitors[MEMS] summarized quarterly as % of doses taken
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mDOT Intervention Design Single training session of mDOT partner (1.5 hrs) Drug regimen Adherence &handling missed doses Side effects Examples of +ve and –ve social support Documentation of observed doses How and when to contact site for help Provision of airtime (buddie) Duration of active phase: 24 weeks (total follow up 52 wks)
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Participant Flow Diagram
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RESULTS Baseline Characteristics CharacteristicmDOTSOC n =129N=128 Median age (IQR)38 y (34,44)37 y (33, 45) Female sex62 (48%)65 (51%) Black race101 (78%)103 (80%) Hispanic ethnicity27 (21%)25 (20%) Prior rx duration153 wks144 wks (IQR)(82, 230)(89, 245) Entry CD4 (median)164 c/mm3201 c/mm3 (IQR)(91, 250)(97, 292) Nadir CD4 (median)122 c/mm3109 c/mm3 (IQR)(37, 187)(45, 202) HIV RNA (median)4.2 log cpm (IQR)(3.8, 4.9)
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Endpoints by Study Arm Fishers Exact Points for VF,Wicoxon Rank Sum test for Adherence Endpoints mDOTSOCP-value Endpointn =129N = 128 VF wk 4834 (26%)23 (18%)0.13 VF wk 2424 (19%)17 (13%)0.31 Adherence Q195%96%0.38 Adherence Q291%94%0.30 Adherence Q390%93%0.17 Adherence Q490%93%0.36
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Virologic suppression ≤ 400 At all time points after week 12 undetectable VL was higher in SOC, however not significant Week 48, 75% (CI 67-83) in mDOT and 82% in SOC (CI 74-89) had VL ≤ 400, (p=0.37) No sig diff between groups at week 24; p=0.18
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Virologic Suppression (HIV-RNA ≤ 400 cpm)over time
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Conclusion mDOT had no significant impact on virologic failure High rate of suppression in both arms mDOT had no significant impact on adherence High rate of adherence in both arms Other interventions still need to be tested in this setting
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Although mDOT intervention not successful findings are encouraging > high rates of virologic success on second line therapy in RLS
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Acknowledgements Sponsors – NIAID - Abbott Laboratories - Gilead Sciences Study participants + partners CAB CRS Leader- Prof JG Hakim ACTG site staff UZ-UCSF
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