Real-Life Therapeutic Concentration Monitoring of Long-Acting Cabotegravir and Rilpivirine: Preliminary Results of an Ongoing Prospective Observational Study in Switzerland.

SHCS#879 is an ongoing Switzerland-wide multicenter observational study conducted within the Swiss HIV Cohort Study (SHCS) for the prospective follow-up of people living with HIV (PLWH) receiving long-acting injectable cabotegravir-rilpivirine (LAI-CAB/RPV). All adults under LAI-CAB/RPV and part of SHCS are enrolled in the project. The study addresses an integrated strategy of treatment monitoring outside the stringent frame of controlled clinical trials, based on relevant patient characteristics, clinical factors, potential drug-drug interactions, and measurement of circulating blood concentrations. So far, 91 blood samples from 46 PLWH have been collected. Most individuals are less than 50 years old, with relatively few comorbidities and comedications. The observed concentrations are globally in accordance with the available values reported in the randomized clinical trials. Yet, low RPV concentrations not exceeding twice the reported protein-adjusted 90% inhibitory concentration have been observed. Data available at present confirm a considerable between-patient variability overall. Based on the growing amount of PK data accumulated during this ongoing study, population pharmacokinetic analysis will characterize individual concentration-time profiles of LAI-CAB/RPV along with their variability in a real-life setting and their association with treatment response and tolerability, thus bringing key data for therapeutic monitoring and precision dosage adjustment of this novel long-acting therapy.

Déclaration de conflit d'intérêts

D.B. received honoraria for advisory board from the companies Gilead, MSD, Pfizer, and ViiV. H.F.G. has received unrestricted research grants from Gilead Sciences; fees for data and safety monitoring board membership from Merck; consulting/advisory board membership fees from Gilead Sciences, Merck, Johnson and Johnson, Novartis, and ViiV Healthcare; and grants from the Swiss National Science Foundation, the Yvonne Vontobel Foundation and from National Institutes of Health. B.S. reports support to his institution for advisory boards and travel grants from Gilead Sciences and ViiV. The institution of H.F. received educational grants from ViiV, MSD, AbbVie, Gilead, and Sandoz paid to the institution. M.S. reports advisory board paid to his institution by Gilead, MSD, and ViiV and grant to participate at conferences paid to his institution by Gilead. A.C. received a research grant from MSD, and educational grants from Gilead, MSD, and ViiV. C.M. has received speaker honoraria from ViiV and MSD unrelated to this work. The other authors declare no conflict of interest.