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

التفاصيل البيبلوغرافية
العنوان: 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
المؤلفون: Roman Iakoubov, Jochen G. Schneider, Christoph D. Spinner, Ulrike Bauer, Johanna Bobardt, Eva Wolf, Sebastian Schulz, Alexander von Werder, Roland M. Schmid, Alexander Zink
المصدر: Antiviral therapy. 23(7)
سنة النشر: 2018
مصطلحات موضوعية: 0301 basic medicine, Drug, Adult, Blood Glucose, Male, Anti-HIV Agents, media_common.quotation_subject, Type 2 diabetes, Pharmacology, Emtricitabine, 03 medical and health sciences, 0302 clinical medicine, Insulin resistance, Medicine, Humans, Pharmacology (medical), Prospective Studies, Risk factor, Tenofovir, media_common, business.industry, Elvitegravir, Cobicistat, Adenine, Body Weight, Rilpivirine, Glucose clamp technique, medicine.disease, Healthy Volunteers, Drug Combinations, 030104 developmental biology, Infectious Diseases, 030220 oncology & carcinogenesis, Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Glucose Clamp Technique, Insulin Resistance, business, medicine.drug
الوصف: 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 emtricit-abine/tenofovir alafenamide (F/TAF), elvitegravir/cobi-cistat/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 (MBW [mg glucose/(minxkg)]). 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 anti-retroviral combinations resulted in a significant change in IR after 14 days compared with baseline values, as measured by MBW (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.
تدمد: 2040-2058
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c7018646ea6a82b6c8cd0e25a9823fe6
https://pubmed.ncbi.nlm.nih.gov/30281025
Rights: CLOSED
رقم الانضمام: edsair.doi.dedup.....c7018646ea6a82b6c8cd0e25a9823fe6
قاعدة البيانات: OpenAIRE