Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment

Pozniak, Anton; Arribas, José Ramón; Gathe, Joseph; Gupta, Samir K.; Post, Frank A.; Beling, Antje; Avihingsanon, Anchalee; Crofoot, Gordon; Benson, Paul M.; Lichtenstein, Kenneth A.; Ramgopal, Moti; Chetchotisakd, Ploenchan; Custodio, Joseph M.; Abram, Michael E.; Wei, Xuelian; Cheng, Andrew; McCallister, Scott; SenGupta, Devi; Fordyce, Marshall W.

doi:10.1097/qai.0000000000000908

Cited by 168 publications

(171 citation statements)

References 21 publications

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“…A significant difference was noted in decrease of eGFR in both studies: À0.6 ml/min vs. À5. These co-infected data also demonstrate stabilisation in renal parameters (GFR, creatinine) but improvement in proteinuria, albuminuria and tubular proteinuria, (p \0.001) as well as increases in hip and spine bone mineral densitometry from baseline to week 48 (mean percent change +1.47 and +2.29, respectively, p \0.05) 91 ; with similar findings to 96 weeks. 92 Whether these findings translate into improved long-term clinical outcomes in CHB patients remains to be defined, but an optimised safety profile of long-term NA therapy might be preferred, particularly in an ageing CHB population, with accruing co-morbidities.…”

Section: Monitoring Of Patients Treated With Etv Tdf or Taf Recommensupporting

confidence: 65%

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,032

3,081

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Section: Monitoring Of Patients Treated With Etv Tdf or Taf Recommensupporting

confidence: 65%

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,032

3,081

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“…In contrast to the analyses at week 48 and 96 [20,21], only the later update of 144 weeks data claimed superiority in the effectiveness of a specific TAF based fix combination co-formulated with elvitegravir/cobicistat/emtricitabine. But the inferior virological results at week 144 in the TDF arm were exclusively driven by missing values in the intention to treat Food and Drug Administration (FDA)-snapshot analysis, although the number of confirmed viral failures was slightly higher in the TAF group [22].…”

Section: Introductionmentioning

confidence: 81%

“…TAF became recently available as a component of cART and has shown similar efficacy but superior renal and bone safety compared with TDF in clinical studies [19][20][21]. In contrast to the analyses at week 48 and 96 [20,21], only the later update of 144 weeks data claimed superiority in the effectiveness of a specific TAF based fix combination co-formulated with elvitegravir/cobicistat/emtricitabine.…”

Section: Introductionmentioning

confidence: 94%

“…As described, our model assumes a superiority of TAF/FTC in terms of renal and bone safety but comparable effectiveness between TDF/FTC and TAF/FTC [19][20][21]. As this kind of TDF-associated clinically relevant AEs are usually not severe and, moreover, occur only rarely [29], they result in relatively low costs for the expense of the Gx-TD treatment group.…”

Section: Discussionmentioning

confidence: 99%

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Budget Impact Analysis Highlighting the Cost-Saving Potential of Generic Tenofovir Disoproxil Based Antiretroviral Therapy in Comparison with Tenofovir Alafenamide Based Treatment Regimens in the German Healthcare System

Stoll¹,

Balkin²,

Goldbach³

et al. 2017

J AIDS Clin Res

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Objective: The fixed dose combination (FDC) of tenofovir disoproxil (TD) fumarate/emtricitabine (FTC) has been the most widely used backbone treatment for HIV until recently. In 2016, tenofovir alafenamide (TAF)/FTC became available as FDC, which promises superior renal and bone safety. However, in November 2016, the German Federal Joint Committee concluded that there is no additional benefit to the use of TAF versus TD fumarate. The decision of choosing TD or TAF in FDC with FTC is of economic impact as cost-saving generics (Gx-TD/FTC) became available in Germany in August 2017. Methods:A budget impact analysis (BIA) was conducted to estimate the impact of Gx-TD/FTC on the German healthcare system for 5-years. The BIA compared a theoretical setting with and without introduction of Gx-TD/FTC; calculating the respective costs for antiretroviral treatment, monitoring, and adverse event management.Results: Based on the model assumptions, low and high values of year-wise savings with Gx-TD/FTC throughout 5 years were estimated. The scenario of Gx-TD/FTC use growing to 35% by year 5, deemed the most realistic scenario(switch from TDF/FTC to Gx-TD/FTC only), would result in a saving of €22.6 million in first year and a maximum saving of €31.8 million by second year. In a maximum patient share scenario (80%) for Gx-TD/FTC which includes switch from branded TD fumarate/FTC and TAF/FTC, savings increased from €22.6 million annually to a maximum of €62.1 million. Conclusion:The estimated savings are based on a conservative approach and will be higher with increasing generic price rebates. Additionally, this analysis makes cautious assumptions in favor of patient safety and care pathways. This analysis highlights the potential for substantial and sustainable cost savings by the use of Gx-TD/FTC for the German healthcare system which is most pronounced when patients from branded TD fumarate/FTC and TAF/ FTC are switched to this generic treatment.

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“…A destra, immagine T2-pesata 1 anno dopo lo switch da TDF a TAF. moderata (eGFR 30-69 mL/min) (18,19). I dati illustrati in letteratura e questa esperienza suggeriscono che, qualora si rendesse necessaria una terapia basata su TFV in pazienti con infezione da HIV e/o da HBV e ridotta funzionalità renale, TAF può essere utilizzato con ragionevole sicurezza.…”

Section: Discussioneunclassified

Sindrome di Fanconi Tenofovir-correlata in paziente con coinfezione HIV/HBV: un problema di gestione clinica

Tebini¹,

Zeroli²,

Pizzi³

et al. 2017

JHA

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RiassuntoLa sindrome di Fanconi è un raro evento avverso di tenofovir disoproxil fumarato (TDF). L'osteonecrosi è una condizione multifattoriale descritta nei pazienti HIV-positivi, il cui meccanismo eziologico è dibattuto. Riportiamo il primo caso di un paziente coinfetto HIV-1/HBV trattato con successo con elvitegravir/cobicistat/emtricitabina/tenofovir alafenamide dopo una sindrome di Fanconi TDF-correlata, con miglioramento della funzionalità renale e completa regressione di una precoce osteonecrosi della testa del femore, con un follow-up di 1 anno. Abstract Introduzione L'utilizzo di tenofovir (TVF) è tutt'oggi fondamentale nella terapia antiretrovirale; nei pazienti coinfetti HIV/ HBV costituisce molto spesso una scelta obbligata (1). Tenofovir Alafenamide (TAF) è un nuovo profarmaco di TFV che, rispetto a tenofovir-disoproxil-fumarato (TDF) consente di ottenere adeguate concentrazioni intracellulari del metabolita attivo tenofovir-difosfato (TFV-DP) a fronte di concentrazioni plasmatiche significativamente ridotte (2-3). Anche a livello epatico, TAF consente il raggiungimento di concentrazioni più elevate di TFV-DP, con una emivita superiore alle 24 ore (4). Tenofovir alafenamide ha un minore impatto sulla funzionalità renale e sul metabolismo osseo rispetto a TDF, grazie alle minori concentrazioni plasmatiche di TFV, come ampiamente dimostrato da studi clinici relativi alla co-formulazione di TAF 10 mg con elvitegravir 150 mg, cobicistat 150 mg, emtricitabina 200 mg (E/C/F/TAF) (5-6). L'esposizione prolungata ad alti livelli plasmatici di TFV è associata a disfunzione tubulare e circa lo 0,3% dei pazienti in terapia con TDF può sviluppare una sindrome di Fanconi (7), una condizioni rara caratterizzata da una disfunzione del tubulo renale prossimale che altera il trasporto di aminoacidi, glucosio, fosfato, acido urico, sodio, potassio, bicarbonato e proteine (8). L'utilizzo di TDF è notoriamente correlato anche a riduzione della densità minerale ossea nell'anca e nella colonna, tramite un aumentato turnover osseo, correlato anche alla perdita di fosfati dovuta alla tossicità tubulare (9-12). Descriviamo di seguito il caso di un paziente coinfetto HIV-1/HBV in esiti di sindrome di Fanconi TDF-correlata e affetto da un'iniziale osteonecrosi della testa del femore sinistro, trattato con E/C/F/TAF con miglioramento della funzionalità renale e completa regressione dell'osteonecrosi femorale, con un anno di follow-up. Case report

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Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 168 publications

References 21 publications

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Budget Impact Analysis Highlighting the Cost-Saving Potential of Generic Tenofovir Disoproxil Based Antiretroviral Therapy in Comparison with Tenofovir Alafenamide Based Treatment Regimens in the German Healthcare System

Sindrome di Fanconi Tenofovir-correlata in paziente con coinfezione HIV/HBV: un problema di gestione clinica

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