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Daily oral antiretroviral use for the prevention of HIV infection in heterosexually active young adults in Botswana: re

Background. Preexposure Prophylaxis Initiative (iPrEX) study among men who have sex with menTenofovir-emtricitabine (TDF-FTC) reduced HIV transmission by 44% [95% Confidence Interval (95% CI) 15% to 63%, p=0.005]Interim data from FemPrEP study among high risk women showed no such protective eff

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Daily oral antiretroviral use for the prevention of HIV infection in heterosexually active young adults in Botswana: re

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    1. Daily oral antiretroviral use for the prevention of HIV infection in heterosexually active young adults in Botswana: results from the TDF2 study MC Thigpen, PM Kebaabetswe, DK Smith, TM Segolodi, FA Soud, K Chillag, LI Chirwa, M Kasonde, R Mutanhaurwa, FL Henderson, S Pathak, R Gvetadze, CE Rose, LA Paxton for the TDF2 Study Team 1

    2. Background Preexposure Prophylaxis Initiative (iPrEX) study among men who have sex with men Tenofovir-emtricitabine (TDF-FTC) reduced HIV transmission by 44% [95% Confidence Interval (95% CI) 15% to 63%, p=0.005] Interim data from FemPrEP study among high risk women showed no such protective effect Additional safety and efficacy data among heterosexual men and women are needed 2 Therefore in mid 2006 after a great deal of discussion among all stakeholders and meetings with a wide variety experts in HIV treatment and prevention, we made the decision to restart the trial using the two-drug combination TDF2, with the revised objective of evaluating if TDF2 taken daily is effective in preventing HIV infections among sexually active young people in Botswana. I’d now like to share with you details of this trial. Therefore in mid 2006 after a great deal of discussion among all stakeholders and meetings with a wide variety experts in HIV treatment and prevention, we made the decision to restart the trial using the two-drug combination TDF2, with the revised objective of evaluating if TDF2 taken daily is effective in preventing HIV infections among sexually active young people in Botswana. I’d now like to share with you details of this trial.

    3. TDF2 Methods Study Design: Double-blind placebo-controlled randomized clinical trial TDF-FTC vs. matching placebo = 1200 male and female Botswana citizens Followed for = 12 months Eligibility criteria: 18-39 years old HIV uninfected Sexually active within past 3 months Healthy Normal baseline laboratory tests No chronic medical conditions Not pregnant or breast feeding Willing to use hormonal contraception 3 Therefore in mid 2006 after a great deal of discussion among all stakeholders and meetings with a wide variety experts in HIV treatment and prevention, we made the decision to restart the trial using the two-drug combination TDF2, with the revised objective of evaluating if TDF2 taken daily is effective in preventing HIV infections among sexually active young people in Botswana. I’d now like to share with you details of this trial. Therefore in mid 2006 after a great deal of discussion among all stakeholders and meetings with a wide variety experts in HIV treatment and prevention, we made the decision to restart the trial using the two-drug combination TDF2, with the revised objective of evaluating if TDF2 taken daily is effective in preventing HIV infections among sexually active young people in Botswana. I’d now like to share with you details of this trial.

    4. TDF2 Methods (2) Study procedures: Tested for HIV infection every month Dual rapid fingerstick tests at screening Monthly oral transudate (Oraquick) thereafter Positives confirmed by additional testing EIA, Plasma viral load, ARV resistance testing Monitored for illness and side effects Lab testing at Month 1 & 2 then every 3 months Individualized HIV risk reduction and medication adherence counseling Assessed adherence using multiple measures Self-report, Pill counts, Drug levels 4 Therefore in mid 2006 after a great deal of discussion among all stakeholders and meetings with a wide variety experts in HIV treatment and prevention, we made the decision to restart the trial using the two-drug combination TDF2, with the revised objective of evaluating if TDF2 taken daily is effective in preventing HIV infections among sexually active young people in Botswana. I’d now like to share with you details of this trial. Therefore in mid 2006 after a great deal of discussion among all stakeholders and meetings with a wide variety experts in HIV treatment and prevention, we made the decision to restart the trial using the two-drug combination TDF2, with the revised objective of evaluating if TDF2 taken daily is effective in preventing HIV infections among sexually active young people in Botswana. I’d now like to share with you details of this trial.

    5. Preliminary Results

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    9. 9 HIV-infected in TDF-FTC group and 24 HIV-infected in placebo group Overall protective efficacy 62.6% (95% CI 21.5 to 83.4, p=0.0133) 9 Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.

    10. 4 HIV-infected in TDF-FTC group and 19 HIV-infected in placebo group Overall protective efficacy 77.9% (95% CI 41.2 to 93.6, p=0.0053) 10 Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.

    11. 11 Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.

    12. One participant with unrecognized acute wild-type HIV infection at enrollment started on TDF-FTC All mutations emerged to high levels K65R M184V Also A62V conferring cross-NRTI resistance One participant in placebo group K65R only in very low levels (<1%) 12 Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.

    13. 13 Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.

    14. 14 Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.

    15. 15 Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.Medication adherence will be supported by trained counselors Multiple methods used to measure adherence. Participants will keep a medication diary indicating for each time they take a pil the date and time of day. They will also be queried at different study visits for a self-report about their adherence. Finally, pill counts will be performed at every study visit. We will also conduct random home visits to count pills. Finally after the study is complete, we will test stored blood samples from persons who were taking TDF2 to measure drug levels.

    16. Conclusions Daily TDF-FTC effective and safe for prevention of HIV infection among heterosexual men and women overall compared to placebo Data suggests efficacy for men and women separately, but study not large enough to draw definitive conclusions by gender Overall safety and efficacy findings consistent with Partners PrEP data 16

    17. Next steps Other planned analyses include Efficacy among participants with varying levels of self-reported adherence Drug level testing for efficacy and adherence Change in bone mineral density Trends in risk behavior over time Open label provision of TDF-FTC for 12 months for all study participants CDC & partners will fully review all heterosexual trial data & develop specific guidance for use among heterosexual men and women 17

    18. Acknowledgements Botswana Study Team Sandra Johnson Thomas Sukalac Daniel Abebe Evans Buliva Neo Tamuhla Joyce Kgampi Lionah Ockhuizen Thapelo Rampebana Bonny Moapare Bakgaki Ratshaa Onkabetse Matlhaba Nkumbuludzi Ndwapi Kabo Pilane Kabo Kagiso Keodiretseng Moloi CDC and BOTUSA Staff Debra Byrd Paula Casillas Lisa Harper Brandi Collins Vasavi Thomas Sherri Pals John T. Brooks Lisa Grohskopf Peter Kilmarx Margarett Davis Kathleen Toomey Clyde Hart Kevin Malotte Craig Hendrix Eugene Jooste 18

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