Effects of antiretroviral combination therapies F/TAF, E/C/F/TAF and R/F/TAF on insulin resistance in healthy volunteers: the TAF-IR Study.

Autor: Spinner CD; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany., Schulz S; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany., Bauer U; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany., Schneider J; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany., Bobardt J; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany., Von Werder A; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany., Schmid RM; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany., Zink A; Department I of Dermatology and Allergology, University Hospital Klinikum rechts der Isar, Munich, Germany., Wolf E; MUC Research, Munich, Germany., Iakoubov R; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany.
Jazyk: angličtina
Zdroj: Antiviral therapy [Antivir Ther] 2018; Vol. 23 (7), pp. 629-632. Date of Electronic Publication: 2018 Oct 03.
DOI: 10.3851/IMP3271
Abstrakt: Background: Increased insulin resistance (IR), associated with specific antiretroviral drugs or drug classes, is an established risk factor for type 2 diabetes in HIV patients, ultimately increasing morbidity and mortality. To date, data on the risk of IR in tenofovir alafenamide (TAF)-based protocols are unavailable.
Methods: This prospective randomized, open-label study evaluated the effects of IR on 30 healthy volunteers receiving fixed-dose combinations (FDCs) of emtricitabine/tenofovir alafenamide (F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or rilpivirine/emtricitabine/tenofovir alafenamide (R/F/TAF). IR was measured before and after 14-day treatments using the hyperinsulinemic-euglycaemic clamp technique (HEGC). Changes in IR in each group were evaluated using the mean glucose disposal rate, normalized with body weight (M BW [mg glucose/(min×kg)]).
Results: A total of 30 subjects underwent randomization: one subject in the F/TAF arm withdrew consent after randomization and one in the R/F/TAF arm had to be excluded because of technical failure during HEGC, resulting in 28 subjects in the per-protocol population (F/TAF, n=9 subjects; E/C/F/TAF, n=10 subjects; R/F/TAF n=9 subjects). No significant differences were detected on the baseline characteristics. IR did not differ among the groups before treatment. None of the studied antiretroviral combinations resulted in a significant change in IR after 14 days compared with baseline values, as measured by M BW (F/TAF, 11.42 ±3.04 mean [±sd] versus 11.43 ±3.23, P=0.49; E/C/F/TAF, 10.04 ±2.49 versus 10.95 ±4.26, P=0.30; R/F/TAF, 11.03 ±1.96 versus 13.01 ±4.11, P=0.13).
Conclusions: Short-term treatment for F/TAF, E/C/F/TAF or R/F/TAF did not increase IR in healthy male volunteers.
Databáze: MEDLINE