Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide Significantly Worsens the Lipid Profile in a Real-World Setting

2019 ◽  
Vol 33 (12) ◽  
pp. 500-506 ◽  
Author(s):  
Kai Juhani Kauppinen ◽  
Pia Kivelä ◽  
Jussi Sutinen
Author(s):  
I Maray Mateos ◽  
L Velasco Roces ◽  
A Rodríguez Ferreras ◽  
L Macía Rivas ◽  
C Fernández Laguna ◽  
...  

2021 ◽  
Vol 21 (4) ◽  
pp. 1593-602
Author(s):  
Bilgul Mete ◽  
Alper Gunduz ◽  
Hayat Kumbasar Karaosmanoglu ◽  
Fatma Gumuser ◽  
Sibel Bolukcu ◽  
...  

Background: Efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (E/C/F/TDF) in treatment-naïve and experienced patients with HIV infection was demonstrated in phase 3 trials. The primary objective of this study was to evaluate effectiveness and safety of E/C/F/TDF in real world settings. Methods: Retrospective, observational data collected by the Turkish ACTHIV-IST study group between May 2015 and December 2016 were analysed. Results: A total of 387 patients were prescribed E/C/F/TDF; 210 patients with available data at 6th month were eligible; 91.5% were male, and mean age was 35.2 (SD: 10.8) years; 54.0% of males identified themselves as MSM. Sixty-three percent (133) of the study population were treatment-naïve patients, and 37% (77) were treatment experienced. HIV RNA level was below 100 copies/mL in 78.9% of treatment-naïve patients and 89.9% of treatment experienced patients at month 6. Median increase in CD4 T lymphocyte count was 218 copies/mL in treatment-naïve patients and remained stable or increased in treatment experienced patients. Adverse events were observed in 15% of the patients, and the regimen was discontinued in only six patients. Conclusion: Real world data on the effectiveness and safety of E/C/F/TDF is comparable with the phase 3 trial results Adverse events are uncommon and manageable. Keywords: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; HIV; effectiveness; safety.


2018 ◽  
Vol 5 (11) ◽  
Author(s):  
Laura N Walti ◽  
Julia Steinrücken ◽  
Andri Rauch ◽  
Gilles Wandeler

Abstract Although the use of tenofovir alafenamide (TAF), a new prodrug of tenofovir, was safe and efficacious in clinical trials, real-world data from multimorbid individuals are scarce. Among 10 persons living with HIV with previous tenofovir disoproxil fumarate–induced nephrotoxicity, renal function remained stable, and proteinuria decreased in several patients after the switch to TAF.


Intervirology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Sara Jeong ◽  
Hyun Phil Shin ◽  
Ha Il Kim

<b><i>Introduction:</i></b> Chronic hepatitis B (CHB) is a major cause of chronic liver diseases and tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and entecavir (ETV) are recommended as primary treatments. This study aimed to evaluate the efficacy and safety of ETV, TDF, and TAF in a real-world clinical setting. <b><i>Methods:</i></b> In this retrospective cohort study, a total of 363 CHB patients who were treated with ETV (<i>n</i> = 163), TDF (<i>n</i> = 154), or TAF (<i>n</i> = 46) from July 2007 to September 2019 were enrolled. <b><i>Results:</i></b> Median patient age was 51 years and 66.4% of patients were male. Median duration of treatment with ETV, TDF, or TAF was 49.0 months (interquartile range, 27.0–74.0 months). In terms of safety, cholesterol was mildly increased in the ETV and TAF groups and significantly lowered in the TDF group than baseline (<i>p</i> &#x3c; 0.001). There was no significant difference in liver cirrhosis-related complications among the 3 groups at 48 weeks (<i>p</i> = 0.235). Hepatitis B e antigen seroconversion, complete virological response, and alanine aminotransferase normalization at 48 weeks as measures of treatment efficacy were not significantly different among the 3 groups (<i>p</i> = 0.142, 0.538, and 0.520, respectively). There was also no significant difference in cumulative incidence rate of hepatocellular carcinoma (HCC) between the ETV and TDF groups (<i>p</i> = 0.894). <b><i>Conclusions:</i></b> ETV, TDF, and TAF were safe antiviral agents and showed similar antiviral effect for CHB at 48 weeks. Cirrhosis-related complications and annual HCC incidence rates did not differ significantly between the ETV and TDF groups over the 48 week follow-up period.


2018 ◽  
Vol 124 (4) ◽  
pp. 479-490 ◽  
Author(s):  
Purificación Cid‐Silva ◽  
Noelia Fernández‐Bargiela ◽  
Luis Margusino‐Framiñán ◽  
Vanesa Balboa‐Barreiro ◽  
Álvaro Mena‐De‐Cea ◽  
...  

2020 ◽  
Vol 18 ◽  
Author(s):  
Jennifer Lagoutte-Renosi ◽  
Mylène Flammang ◽  
Catherine Chirouze ◽  
Geneviève BeckWirth ◽  
Fabienne Bozon ◽  
...  

Background: Tenofovir disoproxil fumarate is a prodrug of tenofovir diphosphate that exposes patients to renal toxicity over the long term. Tenofovir alafenamide, a new prodrug, now makes it possible to reduce toxicity, but at the cost of an alteration in lipid profile. There is currently no recommendation for follow-up of lipid profile when switching from tenofovir disoproxil fumarate to tenofovir alafenamide. Objective: Our study aimed to evaluate the effects on renal function and lipid profile of a switch from tenofovir disoproxil fumarate to tenofovir alafenamide, and the consequences for patient management. Methods: Demographic, clinical and biological data was recorded from a retrospective clinical cohort study in real-life, including patients who switched from tenofovir disoproxil fumarate to tenofovir alafenamide. A descriptive analysis of the study population, with comparison of biological parameters using the paired Student t test for paired data was performed. Results: From January 2016 to January 2019, a total of 103 patients were included. There was no significant difference in renal function before vs after the switch in therapy (p=0.29 for creatinine, p=0.30 for phosphoremia). We observed a change in lipid profile, with a significant increase in total cholesterol (p=0.0006), HDL cholesterol (p=0.0055) and triglycerides (p=0.0242). Four patients received lipid-lowering therapy after switching. Conclusion: In patients who switch from tenofovir disoproxil fumarate to tenofovir alafenamide, lipid profile is altered, and may require initiation of lipid-lowering therapy. It seems necessary to monitor lipid parameters after this switch, despite the absence of an official recommendation.


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