Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial
AIDS patient care and STDs
HIV; clinical trial; long-acting injectable ART; oral lead-in; providers; survey
Cabotegravir and rilpivirine long-acting (LA) antiretroviral therapy (ART) demonstrated similar safety and efficacy in maintaining viral suppression among participants switching from daily oral to LA ART in the Extension Phase of the FLAIR trial. The Phase IIIb SOLAR study comparing efficacy and safety of daily oral versus LA ART every 2 months allowed participants and health care providers (HCPs) to choose an oral lead-in (OLI) before LA initiation or proceed by immediately starting with injections (SWI). We conducted an online survey among SOLAR HCPs ( = 110) in 13 countries to assess reasons for choosing OLI versus SWI. Logistic regression was used to identify factors influencing this decision. Thirty-two percent of HCPs reported a future preference to use OLI, whereas 54% reported a future preference for SWI. HCPs had greater odds of reporting future intentions for SWI if they were from Continental Europe versus North America [adjusted odds ratio (aOR): 3.83, < 0.05], from sites with a greater number of participants who initiated LA ART without OLI (aOR: 1.56, < 0.01), and those who reported comfort with the medication safety profile (aOR: 6.39, < 0.01). HCPs who participated in LA ART trials before SOLAR had decreased odds of reporting a preference for SWI compared to those with no prior LA ART trial experience (aOR: 0.11; < 0.01). Results indicated higher intentions to SWI over OLI among HCPs initiating participants on LA ART. A major factor associated with SWI was provider comfort with safety data, reinforcing the role of continued training regarding an SWI approach.
Karver, Tahilin Sanchez; Pascual-Bernaldez, Miguel; Berni, Alessandro; Hnoosh, Ahmed; Castagna, Antonella; Messiaen, Peter; Puerto, Maria Jose; Bloch, Mark; Adachi, Eisuke; Sinclair, Gary; Felizarta, Franco; Angel, Jonathan B.; Sutton, Kenneth; Sutherland-Phillips, Denise; D'Amico, Ronald; and Kerrigan, Deanna, "Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial" (2023). GW Authored Works. Paper 2319.
Prevention and Community Health