Background:
HPTN 083 demonstrated superiority of long-acting injectable cabotegravir (CAB-LA) compared to daily oral tenofovir disoproxil fumarate-emtricitabine (TDF/FTC) for HIV pre-exposure prophylaxis (PrEP) in cisgender men and transgender women (TGW) who have sex with men. At a planned interim review, an independent data safety and monitoring board recommended the study be unblinded. The protocol was then amended to continue as an open-label extension (OLE) in which participants without contraindication were offered the choice of open-label CAB-LA or to complete study participation with daily oral TDF/FTC. United States (US) participants completed transition to the OLE before other regions, and therefore this analysis is limited to US participants.
Methods:
US participant characteristics, including gender, race, ethnicity, age, education, and original randomized regimen were compared between participants choosing TDF/FTC or CAB-LA using chi-squared tests. We also described participants’ reported reasons for choice of regimen.
Results:
Regimen choice data were available for 803 participants, of whom 770 (95.9%) chose CAB-LA and 33 (4.1%) chose TDF/FTC. Of these 803, 65 (8.1%) were TGW, 418 (52.1%) were Black or mixed race including Black, 140 (17.4%) were Hispanic/Latinx, 613 (76.3%) had completed college or higher level of education, 229 (29.8%) were less than 25 years of age, and 415 (51.7%) were originally randomized to CAB-LA. Among those initially randomized to CAB-LA, 13 (3.1%) chose TDF/FTC and 402 (96.9%) chose CAB-LA, and among those initially randomized to TDF/FTC (n=388), 20 (5.2%) chose TDF/FTC and 368 (94.8%) chose CAB-LA; choice differences by original randomized study arm were not statistically significant, nor were there any significant differences in product choice by other subgroups. Reasons and proportions of participants choosing CAB-LA or TDF/FTC are listed in the Table.
Conclusions:
Nearly all HPTN 083 US participants chose CAB-LA over daily oral TDF/FTC upon transition to the OLE phase of the study; no specific subgroup drove this choice disparity. General preference for either pills or injections largely dictated participants’ choice of regimen. A limitation of this analysis is that individuals preferring an oral PrEP regimen may not have chosen to enroll in HPTN 083. Data from the non-US participants in HPTN 083 will provide important insights into regional/cultural differences in product preference.
Reported reasons for choosing an HIV PrEP regimen at the time of HPTN 083 open label extension entry, US participants only (n=803)