Lower Urine Tenofovir Concentrations Among Individuals Taking Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate: Implications for Point-of-Care Testing

Johnson, Kent C.; Niu, Xin; Glidden, David V.; Castillo‐Mancilla, José; Yager, Jenna; MaWhinney, Samantha; Morrow, Mary; Okochi, Hideaki; Cressey, Tim R.; Drain, Paul K.; Gandhi, Monica; Anderson, Peter L.; Spinelli, Matthew A

doi:10.1093/ofid/ofab200

Cited by 10 publications

(9 citation statements)

References 12 publications

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“…to indicate TDF or TAF adherence in other studies and was a less invasive method for assessing exposure in infants. 32,33 We found very low concentrations of TFV in infant urine with a median steadystate concentration of 5 ng/ml. We compared our findings to steadystate adult urine TFV concentrations reported in adults taking TDF and TAF, which were 12,504 and 1480 ng/mL, respectively.…”

Section: Discussionmentioning

confidence: 79%

“…To indirectly quantify infant drug exposure, we measured urine TFV concentrations. Measuring urine concentrations has been used to indicate TDF or TAF adherence in other studies and was a less invasive method for assessing exposure in infants 32,33 . We found very low concentrations of TFV in infant urine with a median steady‐state concentration of 5 ng/ml.…”

Section: Discussionmentioning

confidence: 99%

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Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection

Kayes

Crane

Symonds

et al. 2022

Aliment Pharmacol Ther

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Summary Background Antenatal antiviral therapy (AVT) is effective in preventing mother‐to‐child transmission (MTCT) in chronic hepatitis B (CHB); tenofovir disoproxil fumarate (TDF) is the preferred agent. Tenofovir alafenamide (TAF) is a prodrug of tenofovir (TFV) similar to TDF, with improved bone and renal safety. There are no data on TAF breast milk pharmacokinetics and exposure to breastfeeding infants in CHB. Aim To assess the pharmacokinetics of TAF/TFV in breastfeeding women with CHB on TAF monotherapy. Methods Pregnant women with CHB requiring AVT commenced TAF 25 mg daily at third trimester or postpartum. Sample collection occurred while breastfeeding and taking TAF for minimum 4 weeks. Maternal blood, breast milk and infant urine samples were collected. Drug concentrations were measured by LCMS/MS analyses using validated methods. Non‐compartmental analyses were performed to quantify the pharmacokinetic parameters. Results Eight women provided samples. In breast milk and plasma, median TAF half‐life was 0.81 and 0.94 h, respectively, and Cmax 1.69 and 120.5 ng/ml, respectively. Median maternal breast milk to plasma (M/P) ratio of TAF was 0.029; for and TFV it was 2.809. The relative infant dose of TAF was 0.005% of maternal dose, well below safety threshold of 5–10%. TFV was detectable in three out of seven infant urine samples with median steady‐state concentration of 5 ng/ml being 300–2500 times less than reported adult steady‐state urine concentrations in those taking TAF and TDF, respectively. Conclusions In this first pharmacokinetic study of TAF monotherapy in breastfeeding women with CHB, concentrations of TAF and TFV were low in breast milk with negligible infant exposure, supporting the use of TAF to prevent MTCT.

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Section: Discussionmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection

Kayes

Crane

Symonds

et al. 2022

Aliment Pharmacol Ther

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“…Previous studies showed that therapeutic dose of TAF has a better renal safety profile compared with TDF, due to the fact that the level of TFV in the plasma is lower, hence lessens the exposure of proximal tubular epithelial cells to TFV [ 12 – 14 ]. However, TFV from TAF is still renally excreted and may cause tubular injury [ 15 – 17 ]. A pharmacokinetic study of a single-dose TAF administered to severe renal impairment participants with eGFR 15–29 mL/min/1.73m 2 resulted in higher TAF and TFV plasma levels compared to the matched normal healthy controls with eGFR ≥ 90 mL/min/1.73m 2 [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Tenofovir alafenamide nephrotoxicity: a case report and literature review

et al. 2021

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Background Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has become the preferred drug for the treatment of HIV-1 and chronic hepatitis B infection in clinical practice. Results from clinical trials showed that it had better renal and bone mineral outcomes compared to tenofovir disoproxil fumarate (TDF). However, as we have seen with TDF, side effects from the new medication can be more prevalent and recognized after extensive use in real world situations. Sporadic cases of acute kidney injury in patients using TAF have started to emerge. Case presentation We report a case of 49-year-old Thai, HIV treatment-experienced female with hypertension presented with worsening renal function after switching her antiretroviral regimen from TDF, emtricitabine (FTC), and lopinavir/ritonavir (LPV/r) to TAF, FTC and dolutegravir (DTG) for 3 months. Kidney biopsy showed distinctive picture of tenofovir nephrotoxicity with acute tubular injury and mitochondrial injury. The possible causes of acute kidney injury and nephrotoxicity from TAF for this patient were discussed. We have extensively reviewed all published case reports of TAF-associated nephrotoxicity and summarized the essential information in this article. Conclusion Although TAF has less nephrotoxicity compared with TDF; renal function should always be monitored after the initiation of both drugs. Future large cohort studies are required to identify the risk factors of TAF-associated nephrotoxicity and to design an effective preventive strategy.

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“…For example, a recently tested LFA for tenofovir TDM in clinical specimens has the ULOQ of as high as 100 mg/L. 147 , 148 …”

Section: Carbapenem Dosingmentioning

confidence: 99%

Can precision antibiotic prescribing help prevent the spread of carbapenem-resistant organisms in the hospital setting?

Vasikasin

Rawson

Holmes

et al. 2023

JAC-Antimicrobial Resistance

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The emergence of carbapenem-resistant organisms (CROs) is a significant global threat. Reduction of carbapenem consumption can decrease CROs. In the global endemic era of ESBL-producing bacteria, carbapenems are considered the treatment of choice, leading to challenge in limiting carbapenem use. This review describes the role of precision prescribing for prevention of CROs. This involves improving antibiotic selection, dosing and shortening duration. The effect of different antibiotics, dosing and duration on CRO development are explored. Available options for precision prescribing, gaps in the scientific evidence, and areas for future research are also presented.

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Lower Urine Tenofovir Concentrations Among Individuals Taking Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate: Implications for Point-of-Care Testing

Cited by 10 publications

References 12 publications

Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection

Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection

Tenofovir alafenamide nephrotoxicity: a case report and literature review

Can precision antibiotic prescribing help prevent the spread of carbapenem-resistant organisms in the hospital setting?

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