Changes in alanine aminotransferase levels after switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) in HIV‐positive people without viral hepatitis in the Swiss HIV Cohort Study

Kovari, Helen; Surial, Bernard; Tarr, Philip E.; Cavassini, Matthias; Calmy, Alexandra; Schmid, Patrick; Bernasconi, Enos; Rauch, Andri; Wandeler, Gilles; Ledergerber, Bruno

doi:10.1111/hiv.13106

Cited by 2 publications

(3 citation statements)

References 14 publications

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“…Five hundred and thirty-nine PLWH were enrolled in the BIC cohort, with a median observation time of [16][17][18][19][20][21]. Mean age was 48 years (SD 12.1).…”

Section: Resultsmentioning

confidence: 99%

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Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir

Squillace,

Ricci,

Maggi

et al. 2023

PLoS ONE

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Introduction Integrase strand transfer inhibitors (INSTI) are one of the most prescribed drug classes for the treatment of HIV infection worldwide. Emtricitabine/Tenofovir Alafenamide/ Bictegravir (FTC/TAF/BIC) has been evaluated in randomized clinical trials; few studies have verified tolerability and safety in clinical practice. Our aim was to investigate the metabolic and hepatic safety in a real-life setting of FTC/TAF/BIC. Materials and methods Consecutive people living with HIV infection (PLWH) enrolled in the SCOLTA project, switching to or initiating their first antiretroviral treatment with FTC/TAF/BIC were included. PLWH with HBV co-infection were excluded. Metabolic and hepatic variables were collected at T0 and T1, were defined as baseline and 6-month follow-up respectively, and their modifications were analysed using the paired t-test and the analysis of variance. Results Five hundred and thirty-nine PLWH with at least one follow-up visit were included in the analysis. Mean age was 48 years (±12.1), 74% were male, 16.1% were naïve to antiretrovirals (ART). At T1, ART-experienced PLWH showed a significant reduction of total cholesterol (TC) and triglycerides, and a slight increase in blood glucose (BG) and ALT. On the contrary, in ART-naïve PLWH blood lipids significantly increased, although with an unaffected TC/high density lipoprotein (HDL)-c ratio, while alanine aminotransferase (ALT) decreased significantly, mainly in those with altered baseline level. The treatment interruptions were 45 (8.4%) over the whole observation period, 13 (2.4%) due to AEs. The most frequent AEs were related to the central nervous system (6 events of depression, insomnia, headache, agitation) and 3 PLWH discontinued the regimen because of grade 1–2 weight gain. Conclusions In ART-experienced PLWH switching to FTC/TAF/BIC a significant improvement of lipid profile occurred but with significant BG and ALT variation without clinical relevance. In ART-naïve PLWH, blood lipids increased even though lipid profile did not worsen, and a trend towards normalization of liver enzymes was suggested. FTC/TAF/BIC is well tolerated in the real life setting.

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“…Five hundred and thirty-nine PLWH were enrolled in the BIC cohort, with a median observation time of [16][17][18][19][20][21]. Mean age was 48 years (SD 12.1).…”

Section: Resultsmentioning

confidence: 99%

“…We demonstrated a minimal but statistically significant increase in BG and ALT levels. The trajectories of ALT during treatment with FTC/TAF and INSTI were previously analysed [ 18 , 19 ], consistently showing a trend towards the reduction of ALT, after switching from FTC/tenofovir disoproxil fumarate (FTC/TDF) to FTC/TAF.…”

Section: Discussionmentioning

confidence: 99%

Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir

Squillace,

Ricci,

Maggi

et al. 2023

PLoS ONE

View full text Add to dashboard Cite

show abstract

“…We adjusted our multivariable model for sex to control for biological differences in ALT levels between males and females, and for ART experience at tenofovir start to control for potential immune reconstitution-induced hepatic flares. Treatment with TDF and TAF were included as separate time-updated covariates with an interaction term between them to take into account treatment interruptions and the potential additional beneficial impact of TAF on ALT values ( 17 ). In addition, we included all baseline variables with a p -value < 0.1 in univariable analyses of risk factors for ALT elevation after 2 and 5 years of tenofovir treatment in a preliminary model but excluded those with a p -value > 0.1 in a backward stepwise fashion from the final model.…”

Section: Methodsmentioning

confidence: 99%