CROI 2020 Abstract eBook

Abstract eBook

Poster Abstracts

<30 years were prescribed PrEP compared to men aged >30 years (35.2% and 43.1%) (p<0.05). Conclusion: The THRIVE demonstration project expanded access to PrEP services for MSM and TGW of color, however challenges exist in prescribing PrEP to younger MSM of color. Increased use of interventions that support PrEP uptake among MSM and TGW of color are needed to improve the PrEP care continuum for these populations. Further investigation is needed to understand reasons that MSM of color were prescribed PrEP after referral and linkage to PrEP less frequently than white MSM.

1020 DISCOVER: NO EFFECT OF HORMONES ON F/TAF OR F/TDF PK, EFFICACY & SAFETY IN TRANSWOMEN Michelle S. Cespedes 1 , Sophia R. Majeed 2 , Maria Prins 3 , Ivanka Krznaric 4 , Anita Mathias 2 , Deqing Xiao 2 , Pamela Wong 2 , Jason Hindman 2 , Christoph Carter 2 , Diana Brainard 2 , Moupali Das 2 , Elske Hoornenborg 5 , Peter Ruane 6 , John Phoenix 7 , Jason Halperin 8 1 Icahn School of Medicine at Mount Sinai, New York, NY, USA, 2 Gilead Sciences, Inc, Foster City, CA, USA, 3 University of Amsterdam, Amsterdam, Netherlands, 4 Center for Infectious Diseases, Berlin, Germany, 5 Public Health Service Amsterdam, Amsterdam, Netherlands, 6 Peter J Ruane MD Inc, Los Angeles, CA, USA, 7 Huntridge Family Clinic, Las Vegas, NV, USA, 8 CrescentCare, New Orleans, LA, USA Background: Emtricitabine (F), tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) do not have relevant drug interactions with low-dose hormones used for contraception. The current analysis explored PK as well as efficacy and safety of transwomen receiving either F/TAF or F/TDF in the DISCOVER trial, the majority of whomwere taking high-dose, gender-affirming, hormonal therapy. Methods: Overall, 74 transwomen at risk of HIV were randomized 1:1 to receive blinded F/TAF or F/TDF once daily in DISCOVER. Efficacy and safety results are summarized. TFV-DP and FTC-TP PBMC trough levels (C tau ; defined as 20 to 28 hours postdose) were evaluated at steady-state (W4) and compared between transwomen taking high-dose hormones concomitantly with F/TAF (N=17) and a randomly pre-selected, representative group of MSM randomized to F/TAF not using high-dose hormones (N=161) using geometric least squares mean (GLSM) ratios and 90% confidence intervals (CIs). Comparisons were made using a lack of PK alteration boundary of 50 to 200% to identify potentially clinically relevant differences. Levels of TFV-DP and FTC-TP with F/TDF in transwomen on high-dose hormones (N=10) were compared descriptively to levels in MSM randomized to F/TDF (N=155) due to a smaller sample size. Results: No transwomen acquired HIV. Transwomen had similar numerical improvements in dipstick proteinuria and markers of tubular proteinuria as MSM. No transwomen developed clinically significant proteinuria (UPCR>200 mg/g). There were no differences between F/TAF and F/TDF in change from baseline in weight or eGFR in transwomen. GLSM ratios and 90% CIs for comparisons of PBMC TFV-DP and FTC-TP levels with F/TAF between transwomen taking high-dose hormones and MSMwere within the 50 to 200% boundary, indicating no clinically significant interaction. In transwomen taking F/TDF and high-dose hormones, TFV-DP and FTC-TP levels were comparable to MSM, suggesting no interaction (Table). Conclusion: The absence of infections suggests that both F/TAF and F/TDF were effective for HIV prevention in transwomen. Both F/TAF and F/TDF were safe and well-tolerated in transwomen and MSM. No clinically meaningful differences in PBMC TFV-DP and FTC-TP levels with F/TAF or F/TDF were observed between transwomen taking high-dose hormone therapy and MSM, suggesting that both F/TAF and F/TDF are effective and safe options for PrEP in transwomen on gender-affirming, high-dose hormone therapy.

1019 PrEP INDICATION AND CARE CONTINUUM AMONG TRANSGENDER WOMEN IN THE UNITED STATES Jowanna Malone 1 , Sari Reisner 2 , Andrea L.Wirtz 1 , for the American Cohort to Study HIV Acquisition Among Transgender Women (LITE) Study Group 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 2 Harvard T.H. Chan School of Public Health, Boston, MA, USA Background: U.S. transgender women (TGW) have a disproportionate burden of HIV, with an estimated prevalence of 28%. Pre-exposure prophylaxis (PrEP) is effective in preventing HIV acquisition among adherent users. However, the PrEP care continuum among TGW as well as factors associated with high risk for HIV and subsequent PrEP indication (e.g. condomless anal sex, high sex partner number, having an STI, etc.) are not well understood. Methods: The LITE study is a multi-site cohort enrolling TGW across six cities in the southern and eastern U.S. Upon screening, participants underwent HIV/ STI testing and completed a socio-behavioral survey in which they reported experiences with PrEP. We identified factors associated with PrEP indication using prevalence ratios from a multivariate Poisson regression with robust variance. We also calculated descriptive statistics to depict the PrEP care continuum. Results: As of April 2019, there were 751 participants not living with HIV at baseline. Among this group, 293 (39%) met PrEP indication based on the following: had a laboratory confirmed STI, recent partner who was known to be living with HIV, reported recent sex work, and/or recent condomless anal sex. Participants who were Non-Hispanic Black [ref: Non-Hispanic White, PR: 1.98, p=<0.0001] or had self-perceived low risk of HIV [ref: no risk, PR: 2.09, p=0.012], medium risk of HIV [ref: no risk, PR: 3.33, p<0.001], or high risk of HIV [ref: no risk, PR: 3.81, p<0.0001,] were more likely to be indicated for PrEP. Having some college education or above was associated with being less likely to be PrEP indicated [ref: high school education or less, PR: 0.79, p=0.04]. Ultimately, among those indicated for PrEP, 42 (14%) were currently using and adherent to PrEP (Figure 1). Eighty-four percent of those indicated were aware of PrEP, 76% of those aware of PrEP had health insurance, 63% of those insured were taking PrEP, and 68% of PrEP users reported 100% adherence within the prior 7 days of the survey (14% among all who were indicated for PrEP). Conclusion: Over a third of TGW not living with HIV at baseline were indicated for PrEP. Although most PrEP users were adherent, overall uptake and adherence among those PrEP indicated were low. Improving uptake and adherence among TGWwarrants further investigation, particularly with respect to development of culturally appropriate strategies to increase uptake and adherence among Black TGW for whom PrEP indication is higher.

Poster Abstracts

CROI 2020 383