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Www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Comparison of Adherence among Partners’ PrEP Participants on Placebo before and after Release.

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Presentation on theme: "Www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Comparison of Adherence among Partners’ PrEP Participants on Placebo before and after Release."— Presentation transcript:

1 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Comparison of Adherence among Partners’ PrEP Participants on Placebo before and after Release of Trial Results – Kisumu, Kenya B. Wamuti, J. Odoyo, B. Rono, C. Cohen, E. Bukusi Kenya Medical Research Institute University of Washington University of California, San Franscisco

2 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Adherence crucial for success of any clinical drug trial and/or treatment Effective HIV treatment and prevention requires good compliance to medication Reduction of HIV acquisition by the HIV negative individual: PrEP PrEP studies with high adherence show greater efficacy in reduction of transmission Adherence has been the key issue with PrEP INTRODUCTION

3 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Partners’ PrEP Kisumu site INTRODUCTION

4 Kuala Lumpur, Malaysia, 30 June - 3 July arms: Tenofovir, Tenofovir/Emtricitabine (Truvada) and placebo Kisumu participants: 630 HIV sero-discordant couples HIV –ve partner: Randomized to PrEP HIV +ve partner: Not eligible for HAART at enrolment INTRODUCTION

5 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Definition: Compliance to once-a-day dose of PrEP Assessed by pill count Blood drug levels not available Strategies to improve adherence 1.Monthly adherence counseling: By nurse counselor, clinician, pharmacist and social worker 2.Pill reminders ADHERENCE

6 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 July 2011: Release of the preliminary results by the Data Safety Monitoring Board (DSMB) Reduction of HIV transmission 63% (Tenofovir), 75% (Truvada) Recommended re-assignment of placebo participants to active arms BACKGROUND

7 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 BACKGROUND Tenofovir arm Truvada arm Placebo arm 2011: Re-assignment as per DSMB recommendation Tenofovir/Truvada Study start Study close-out

8 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 To compare adherence to the study medication before and after release of the preliminary results of the clinical trial among PrEP participants on placebo OBJECTIVE

9 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Compared adherence at month 1, 6 and 12 before and after re-randomization Reviewed by pill counts Blood drug levels not yet available METHODS

10 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Challenges to adherence: “If I am not sick, aren’t these drugs just accumulating in my system?” Source: METHODS

11 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Adherence counseling METHODS

12 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Pill reminders METHODS

13 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Placebo participant numbers 45 clients not reassigned RESULTS TIME PERIODNo. of participantsPercentage At start of the study (2008)210100% At placebo stop (July 2011) % At re-enrolment (Sep 2011) %

14 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Reasons for not being reassigned *Jailed, abnormal renal function, abnormal liver function RESULTS Reasons for IneligibilityNumber Declined participation25 Pregnant4 Not located8 Sero-converted1 Other reasons*10

15 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Adherence levels RESULTS Visit MonthAdherence Before Re- randomization Adherence After Re- randomization P-Value 196% %97% % 0.822

16 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 High adherence reported before and after re- randomization Likely resulted from intensive, ongoing adherence counselling Possibly also from focus on sero-discordant couples Adherence results from this study are encouraging DISCUSSION

17 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Develop intensive, cost-effective counselling curricula that result in excellent adherence PrEP demonstration projects - way forward RECOMMENDATION

18 Kuala Lumpur, Malaysia, 30 June - 3 July 2013 ACKNOWLEDGEMENTS 1.Partners‘ PrEP Kisumu study participants, site staff 2.Kenya Medical Research Institute – Research Care and Training Program 3.University of Washington, USA 4.University of California San Franscisco, USA 5.Gilead (study drug) 6.Bill and Melinda Gates Foundation (study funder)


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