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Enrollment into Open-Label Phase of TDF2 PrEP Study, Botswana, 2013

Enrollment into Open-Label Phase of TDF2 PrEP Study, Botswana, 2013. Chirwa LI 1 , Taylor AW 2 , Williams TS 2,3 , Henderson FL 2 , Kasonde M 1 , Mutanhaurwa R 1 , Matlhaba O 1 , Hageman K 2 , Casillas P 1 , Samandari T 2

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Enrollment into Open-Label Phase of TDF2 PrEP Study, Botswana, 2013

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  1. Enrollment into Open-Label Phase of TDF2 PrEP Study, Botswana, 2013 Chirwa LI1, Taylor AW2, Williams TS2,3, Henderson FL2, Kasonde M1, Mutanhaurwa R1, Matlhaba O1, Hageman K2, Casillas P1, Samandari T2 1. Centers for Disease Control and Prevention, Gaborone and Francistown, Botswana; 2. Centers for Disease Control and Prevention, Atlanta, GA; 3. ICF Macro, Atlanta, GA The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

  2. Background • TDF2 Study (2007–2009) • 1219 HIV-negative heterosexual young adults in Botswana (1563 person-years, PY) • Randomized 1:1 to TDF/FTC or placebo • 1.2 infections per 100 PY in TDF/FTC vs 3.1/100 PY in placebo group • 62% protective efficacy (Thigpen et al NEJM. 2012 Aug 2;367(5):423-34)

  3. Background • TDF2 Open-Label Extension (OLE) • Protocol: if efficacy demonstrated, provide TDF/FTC for TDF2 participants for 12 months • Further safety, effectiveness, risk and adherence data • We report: • Baseline characteristics • Preliminary visit adherence • Preliminary safety

  4. Methods • Screening occurred from Feb - May 2013 • Inclusion criteria included: • Former TDF2 participants • Provided informed consent • Normal serum creatinine/phosphorus • If female, willing to use hormonal contraceptive • Exclusion criteria included: • HIV infection • Pregnancy or breastfeeding • Other clinical condition that made the participant unsuitable for enrollment

  5. Methods • Study Procedures • Monthly follow-up visits • 30-day supply of TDF/FTC dispensed at each visit • 2 finger-stick rapid HIV tests (Ag/Ab, HIV 1/2) • If female, pregnancy testing • Adherence counseling • Quarterly visits included • HIV EIA • Safety labs • Risk reduction counseling • Retention strategies included SMS text messaging and phone calls • No reimbursement • Study Status • Last exit visits July 2014

  6. Recruitment, Screening, and Enrollment of TDF2 Open Label Extension Participants 1219 Former TDF2 participants 582(48%) able to contact and scheduled for screening 334 (57%) attended screening • Reasons for Ineligibility: • Did not consent • Had no interest/no time • Pregnant/breastfeeding • Had abnormal labs • Were HIV-positive 67 (20%) were ineligible 267 (80%) were eligible to start TDF/FTC 38 (14%) did not start TDF/FTC 229 (86%) started TDF/FTC

  7. Results *Botswana Pula converted to USD using exchange rate of 8.79.

  8. Results

  9. Results • Retention • Of the 229 participants who started TDF/FTC, 125 (54%) completed 12 months of follow-up

  10. Results

  11. Severe Adverse Events • 10 Severe Adverse Events (SAE) reported • Involving total of 8 participants

  12. Conclusions • Higher risk perception among those starting TDF/FTC compared with those not starting • Participants reporting higher baseline HIV risk were more likely to complete the study • TDF/FTC was safe and well tolerated

  13. Lessons Learned • High Interest in PrEP • 79% of those contacted scheduled screening visit to learn more • 86% of those who screened eligible began PrEP • Logistical considerations • Delay in study start • Monthly visits • Lack of reimbursement

  14. Next Steps • Motivations and risk behaviors • Drug levels and adherence • Qualitative substudy • Reasons for screening losses • Reasons for drop-out • Experience in study

  15. Ke a leboga! • TDF2 OLE Study Staff • Joseph, Tshepang • Ndungo, Josephine • Moeletsi, Febby • Keatlhotswe, Mothusi • Sebonego, Wandani • Kabelo, Tshepo • Manyiwa, Early • Mogatle, Karen • Mokanyane, Onalenna • Lekoko, Molemane • Simon, Boikhutso • Gabanthate, Rose • Lefhoko, Abigail • Majaye, Gene • Seabelo, Baganetsi • Makovore, Vongai • Molosiwa, Molefhi • TDF2 and OLE participants • Botswana MOH • Gilead Sciences, Inc. • CDC • Chuck Rose • Lisa Harper • Michael Thigpen • Lynn Paxton • Paula Casillas MINISTRY OF HEALTH REPUBLIC OF BOTSWANA

  16. Author Contact Information • Lovemore Ian Chirwa, MBBS, MPhil • hos2@cdc.gov • Tel: +267 2415222 • Allan W. Taylor, MD, MPH • ataylor2@cdc.gov • +1 404-639-6120

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