Estimated glomerular filtration rate slopes on tenofovir alafenamide

Abstract

Objectives The aim of the study was to analyse and compare estimated glomerular filtration rate (eGFR) slopes during exposure to tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) in individuals who initiated TAF, regardless of prior regimen, before October 2016. Methods An observational cohort study was conducted at 11 clinics in the UK and Ireland. Mixed effects models with random intercept and time terms fitted were used to generate and compare eGFR slopes while participants were exposed to TDF and TAF, with adjustment for age, eGFR at TDF/TAF initiation, gender, ethnicity, and time‐updated CD4 cell count and HIV RNA measurements. Results Data were available for 357 subjects (median age 50 years; 80% male; 82% white/other ethnicity; 51% men who have sex with men; median nadir CD4 count 216 cells/µL). The median duration of exposure to TAF was 2.0 (interquartile range 1.6, 2.3) years. At TAF initiation, the median CD4 count was 557 cells/µL, the median eGFR was 80 mL/min/1.73 m2, and 86% had suppressed HIV infection. The mean adjusted eGFR slope during TDF and TAF exposure was −2.08 [95% confidence interval (CI) −2.24, −1.92] and 1.18 (95% CI 0.20, 1.52) mL/min/1.73 m2/year, respectively (P < 0.001). Individuals who experienced rapid eGFR decline (> 3 or 5 mL/min/1.73 m2/year) while receiving TDF experienced significant eGFR recovery while on TAF (P < 0.001). Conclusions Significant improvement in eGFR slope was observed in patients who switched from TDF‐ to TAF‐containing antiretroviral regimens. These data provide further support for the renal safety of TAF, and for switching those who experience progressive worsening of renal function from TDF to TAF.

Efficacy and safety of tenofovir alafenamide fumarate in nucleoside analogue treatment-naïve patients with chronic hepatitis B

“…Considering HBV DNA response rate was HBV-DNA <10 IU/ml in the study by Ibrahim et al (15), this was likely due to the different sensitivities of the tests used for HBV DNA detection between the two studies. In addition, the proportion of HBeAg-positive patients in the study by Ibrahim et al (15) was 75.4%, differed from the present study's follow-up cases, which could have resulted in differences in the HBV DNA level at baseline and differences in the complete virological response rate after 24 weeks of TAF treatment. In the present study, the seroconversion rate of HBeAg at 48 weeks was consistent with that in Study 110 (10%) (8).…”

“…In the present study, in which patients with HBeAg-positive CHB accounted for 73.8% of the cases, the HBV DNA response rate (HBV-DNA <20 IU/ml) at 24 weeks of TAF treatment was 39.34%, which was higher compared with the value of 36.4% obtained in the study by Ibrahim et al (15). Considering HBV DNA response rate was HBV-DNA <10 IU/ml in the study by Ibrahim et al (15), this was likely due to the different sensitivities of the tests used for HBV DNA detection between the two studies.…”

The characteristics of HIV-positive patients with mild/asymptomatic and moderate/severe course of COVID-19 disease – a report from Central and Eastern Europe

“…This study did not analyze other cART components. We did not see the same associations in our study, however due to a small sample we were unable to disentangle the effects of different forms of tenofovir (17). Certainly there is a risk of bias per indication reflecting that ‘healthier patients” would stay on more toxic regimen containing tenofovir disoproxil, while patients with comorbidities would be switched or prescribed tenofovir alafenamide.…”

Bone mineral density, kidney function and participant‐reported outcome measures in women who switch from tenofovir disoproxil emtricitabine and a nonnucleoside reverse transcriptase inhibitor to abacavir, lamivudine and dolutegravir

“…High systemic tenofovir exposure may affect BMD via renal tubular dysfunction and increased bone turnover [35,36], although measures of renal tubular dysfunction and bone turnover do not explain the association between TDF and low BMD, suggesting that direct or other indirect effects of tenofovir on bone may be more important [29,37,38]. Exposure to TDF is also a modifiable risk factor for chronic kidney disease, eGFR decline and proteinuria [39,40], and discontinuation of TDF may reverse these manifestations of renal injury and preserve kidney function [12,41].…”