Adherence-enhancing intervention in PrEP in low-resource settings

Transcription

1 Adherence-enhancing intervention in PrEP in low-resource settings Collaboration project: Bill and Melinda Gates Foundation project team Terrence F. Blaschke, Papa Salif Sow Kenya project team, LVCT Health Michael Kiragu Senegal project team, RARS Souleymane Mboup, Daouda Gueye, WestRock Healthcare Eric Tousset, Rodrigo Paiva

2 2 Background

3 3 HIV profile

4 4 HIV incidence

5 Use of Antiretroviral therapy (ART) and incidence ART/TasP The use of antiretroviral drugs to maximally suppress the HIV virus and stop the progression of HIV disease in HIV positive individuals. All children, adolescents and adults, including all pregnant and breastfeeding women living with HIV, regardless of CD4 cell count. PrEP The use of antiretroviral drugs to prevent infection with the human immunodeficiency virus (HIV) among HIV negative individuals. All populations with an incidence of HIV above 3 per 100 person-years. 5 Consolidated Guidelines on The use of Antiretroviral Drugs for treating and Prevention of HIV Infection, WHO 2016

6 Use of Antiretroviral therapy (ART) and incidence PEP Persons not receiving PrEP who seek care within 72 hours after an isolated sexual or injection-related HIV exposure should be evaluated for the potential need for non occupational PEP. 6 PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES CDC

7 Recommendation for PrEP Twelve trials on the effectiveness of oral PrEP have been conducted among serodiscordant couples, heterosexual men, women, men who have sex with men, people who inject drugs and transgender women Where adherence has been high, significant levels of efficacy have been achieved, showing the value of this intervention as part of combination prevention approaches. 7 Consolidated Guidelines on The use of Antiretroviral Drugs for treating and Prevention of HIV Infection, WHO 2016

8 Adherence as a driver heterogeneity 8 Vrijens et al; Methods for measuring, enhancing, and accounting for medication adherence in clinical trials, Clin Pharmacol Ther Jun

9 9 Guidelines

10 PrEP a as part of an holistic approach Across all trials, PrEP was provided in the context of a package of HIV prevention interventions: regular HIV testing and counselling provision of condoms screening and treatment for sexually transmitted infections (STIs) adherence counselling contraception for women methadone maintenance therapy for people who inject opioids. 10 Consolidated Guidelines on The use of Antiretroviral Drugs for treating and Prevention of HIV Infection, WHO 2016

11 PrEP Follow-up CDC Guidelines At least every 3 months to: Repeat HIV testing and assess for signs or symptoms of acute infection to document that patients are still HIV negative (see Figure) Repeat pregnancy testing for women who may become pregnant Provide a prescription or refill authorization of daily TDF/FTC for no more than 90 days (until the next HIV test) Assess side effects, adherence, and HIV acquisition risk behaviours Provide support for medication adherence and riskreduction behaviours Respond to new questions and provide any new information about PrEP use 11 PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES CDC

12 PrEP Follow-up CDC Guidelines At least every 6 months to: Monitor renal function Conduct STI testing recommended for sexually active adolescents and adults (i.e., syphilis, gonorrhea, chlamydia) At least every 12 months to: Evaluate the need to continue PrEP as a component of HIV prevention 12 PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES CDC

13 Key Components of Medication Adherence Counselling Establish trust and bidirectional communication Provide simple explanations and education Medication dosage and schedule Management of common side effects Relationship of adherence to the efficacy of PrEP Signs and symptoms of acute HIV infection and recommended actions 13 PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES CDC

14 Key Components of Medication Adherence Counselling Support adherence Tailor daily dose to patient s daily routine Identify reminders and devices to minimize forgetting doses Identify and address barriers to adherence Monitor medication adherence in a nonjudgmental manner Normalize occasional missed doses, while ensuring patient understands importance of daily dosing for optimal protection Reinforce success Identify factors interfering with adherence and plan with patient to address them Assess side effects and plan how to manage them 14 PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES CDC

15 Ideal starting point to discuss adherence Work with objective data Realization that there is an adherence issue Understand the time relation with non adherence Follow up the evolution of the dynamic adherence behavior 15

16 Medication Event Monitoring System as a tool to support adherence interventions 16

17 Population Senegal Site Subjects Diamnidio 34 Mbao 44 Pikine 49 Rufisque 39 Total 166 Kenya Site Subjects CBD 251 Homabay 223 Kisumu 286 Korogcho 162 SOKONIP 46 SWOP 335 Total

18 How is it being used 18

19 MEMS as a tool for adherence data driven intervention 19

20 20 Tool for how to start the conversation

21 21 Tool for how to follow up the conversation

22 22 Example of the support document

23 Daily Percentage of Adherers (%) Where are we now? Adherence over time All active subjects 61% of the subjects take their daily medication as prescribed All CBD Homabay SWOP Kisumu Pikine Mbao Rufisque Diamniadio N NA with large disparities between countries and centers ranging from 46% to 78% Days since start of monitoring 23

24 Daily Percentage of Adherers (%) Where are we now? Impact of first intervention 64.7 % 77.9 % Model estimate Average 13% increase (p<0.001) in daily percentage of adherers after intervention All CBD Homabay SWOP Kisumu Pikine Mbao Rufisque Diamniadio N NA Days Since Intervention Subjects with post intervention adherence data (N=258)

25 Thank you Bill and Melinda Gates Foundation project team Terrence F. Blaschke, Papa Salif Sow Kenya project team, LVCT Health Michael Kiragu Senegal project team, RARS Souleymane Mboup, Daouda Gueye, WestRock Healthcare Eric Tousset, Rodrigo Paiva 25