Comparing TDF-FTC vs Placebo as HIV PrEP for Transgender Women in iPrEx Trial Substudy

Subgroup analysis from the iPrEx trial and open-label extension assessed the efficacy, drug concentrations, and adherence of TDF-FTC PrEP for transgender women assigned male at birth. Results indicate varying drug detection consistency and non-condom receptive anal intercourse among participants.

• HIV PrEP
• Transgender Women
• iPrEx Trial
• Drug Concentrations
• Adherence

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1. TDF-FTC versus Placebo as HIV PrEP for Transgender Women iPrEx Trial Substudy

2. TDF-FTC versus Placebo as HIV PrEP for Transgender Women iPrEx Substudy: Study Design Background: Subgroup analysis of the iPrEX randomized controlled trial (RCT) and open-label extension (OLE), designed to assess efficacy, tolerability, drug concentrations, and adherence with TDF-FTC PrEP for transgender women Participants from the RCT (all assigned male sex at birth) - Total number = 339 - 296 who identified as trans - 29 who identified as women - 14 who identified as men but reported taking feminizing hormone therapy Outcomes: HIV seroconversions Drug concentrations overall and at the time of seroconversion Participants in OLE (all assigned male sex at birth) - 192 transgender women enrolled - 151 (79%) chose to take PrEP for at least part of the study Source: Deutsch MB, et al. Lancet HIV. 2015;2:e512-9.

3. TDF-FTC versus Placebo as HIV PrEP for Transgender Women (TGW) iPrEx Substudy: Baseline Demographics in the RCT TGW (n = 339) 26.2 126 (37%) 169 (50%) 42 (13%) 14 (4%) 82 (24%) 50 (15%) 193 (57%) 49 (14%) 290 (86%) 302 (89%) 37 (11%) MSM (n = 2,160) 27.3 397 (19%) 1,209 (57%) 527 (25%) 198 (9%) 803 (37%) 476 (22%) 683 (32%) 965 (45%) 1,195 (55%) 2,020 (94%) 140 (7%) Variable Value Mean age Education Years Les than High school High school College 1 1-5 5-10 >10 No Yes No Yes Partners (baseline) Condomless RAI Cocaine or meth use Abbreviations: RAI = receptive anal intercourse Source: Deutsch MB, et al. Lancet HIV. 2015;2:e512-9.

4. TDF-FTC versus Placebo as HIV PrEP for Transgender Women (TGW) iPrEx Substudy: Baseline Demographics in the RCT (continued) TGW (n = 339) MSM (n = 2,160) Variable Value STI (past 6 months) No 212 (63%) 1,635 (76%) Yes 127 (38%) 525 (24%) Circumcised No 323 (96%) 1,835 (85%) Yes 13 (4%) 320 (15%) Living situation With partner 27 (8%) 154 (7%) Alone 77 (23%) 306 (14%) With family/friends 230 (68%) 1,663 (77%) Other 5 (2%) 37 (2%) Transactional sex No 122 (36%) 1,250 (63%) Yes 217 (64%) 810 (38%) Source: Deutsch MB, et al. Lancet HIV. 2015;2(12):e512-9.

5. TDF-FTC versus Placebo as HIV PrEP for Transgender Women (TGW) iPrEx Substudy: Results from the RCT Proportion of participants by consistency of drug detection (never, some, always), gender, and non-condom receptive anal intercourse (ncRAI), regardless of hormone use 100 Percent of participants No Condomless Receptive Anal Intercourse Condomless Receptive Anal Intercourse 80 60 (%) 40 20 0 Never 83 Some 95 Always 84 Never 11 Some 23 Always 6 n = MSM TGW Source: Deutsch MB, et al. Lancet HIV. 2015;2:e512-9.

6. TDF-FTC versus Placebo as HIV PrEP for Transgender Women (TGW) iPrEx Substudy: Results (Drug Concentrations & HIV Incidence in the OLE) Drug level by dried blood spot Off PrEP Person years of follow up 447 53 HIV acquisition (Rate) per 100 person years follow up 2.68 1.90 Gender HIV acquisitions (number) MSM TGW 12 1 Below limit of quantification MSM 326 17 5.21 TGW MSM TGW MSM TGW MSM TGW MSM TGW 58 324 76 156 24 288 28 176 5 1 8 1 1 0 0 0 0 0 1.72 2.47 1.31 0.64 0.00 0.00 0.00 0.00 0.00 <2 pills/week 2-3 pills/week 4-6 pills/week Daily Source: Deutsch MB, et al. Lancet HIV. 2015;2:e512-9.

7. TDF-FTC versus Placebo as HIV PrEP for Transgender Women (TGW) iPrEx Substudy: Interpretation Interpretation: There were no HIV infections among TGW having drug concentrations commensurate with use of 4 or more FTC/TDF tablets per week. TGW receiving PrEP had low drug concentrations, especially at times of potential HIV exposure, leading to no PrEP effectiveness among this subgroup. Source: Deutsch MB, et al. Lancet HIV. 2015;2:e512-9.