a balance of risks: an audit of lipid and renal outcomes ...a balance of risks: an audit of lipid...

A balance of risks: an audit of lipid and renal outcomes in pa5ents prescribed tenofovir alafenamide Meng-San Wu, Daniela Brawley Grampian Sexual Health, NHS Grampian Aberdeen, United Kingdom Background Tenofovir alafenamide (TAF) is an alternaHve to tenofovir disoproxil fumarate (TDF) with a preferable renal safety profile. However some studies have shown that TAF can detrimentally affect lipid profile, contribuHng to a higher cardiovascular risk. The lipid and renal outcomes of paHents prescribed TAF-containing regimens in our service were audited to assess these risks in a real world seNng. Methods All paHents prescribed TAF-containing regimens between 2016 and 2018 were included in this retrospecHve audit. Data was extracted from NaHonal Sexual Health System and Trakcare for baseline demographics, lipid-lowering treatment and pre/post-TAF lipid and renal profile, which were assessed against the duraHon of TAF exposure. A raHo paired t-test was used to compare outcomes pre/post TAF whereas non-linear regression to esHmate overHme change in lipid and renal profile. Results A TAF-containing regimen was prescribed in 177 paHents; 112 with complete data were included for analysis. 82% were male with a mean age of 51 (21-84) years. Median duraHon of TAF exposure was 59 (3-131) weeks. Total cholesterol (TC), LDL-cholesterol and triglycerides increased post TAF in 67.0%, 58.0% and 59.8% of paHents respecHvely (Figure 1). Overall TC, LDL-cholesterol and triglycerides were elevated by 9.3%, 9.3% and 10.4%; for TC and LDL-cholesterol this was most significant in paHents switching from TDF (Table 1). TC to HDL-cholesterol raHo was increased in 47.3%; however the change in raHo was non-significant. StaHns were iniHated in 10.7% of paHents post TAF and 11.2% of those switching from TDF (Figure 2). CreaHnine was raised post TAF, regardless of pre-TAF anHretroviral therapy status. An5retroviral therapy Pre and post-TAF ra5o p-value Triglyceride (n=112) Naïve to TAF (n=12) TDF to TAF (n=89) Non-tenofovir to TAF (n=11) 1.104 (95%CI 1.008 - 1.210) 1.285 (95%CI 1.041 - 1.585) 1.101 (95%CI 0.9945 - 1.220) 0.9576 (95%CI 0.6252 - 1.467) 0.0333* 0.0237* 0.0635 0.8254 Total cholesterol (n=112) Naïve to TAF (n=12) TDF to TAF (n=89) Non-tenofovir to TAF (n=11) 1.093 (95%CI 1.051 - 1.137) 1.181 (95%CI 0.9996 - 1.396) 1.105 (95%CI 1.062 - 1.151) 0.9171 (95%CI 0.7946 - 1.059) <0.0001**** 0.0504 <0.0001**** 0.2085 LDL-cholesterol (n=112) Naïve to TAF (n=12) TDF to TAF (n=89) Non-tenofovir to TAF (n=11) 1.093 (95% CI 1.031 - 1.160) 1.182 (95% CI 0.9668 - 1.444) 1.113 (95%CI 1.049 - 1.180) 0.7572 (95%CI 0.4895 - 1.171) 0.0034** 0.0943 0.0005*** 0.1621 Total cholesterol to HDL- cholesterol ra5o (n=112) Naïve to TAF (n=12) TDF to TAF (n=89) Non-tenofovir to TAF (n=11) 0.9887 (95%CI 0.9537 - 1.025) 0.9923 (95%CI 0.8933 - 1.102) 1.002 (95%CI 0.9632 - 1.043) 0.8817 (95%CI 0.7603 - 1.022) 0.5317 0.8745 0.9051 0.0873 Crea5nine (n=112) Naïve to TAF (n=12) TDF to TAF (n=89) Non-tenofovir to TAF (n=11) 1.047 (95%CI 1.019 - 1.075) 1.123 (95%CI 1.038 - 1.214) 1.028 (95%CI 0.9988 - 1.058) 1.120 (95%CI 1.010 - 1.242) 0.0009*** 0.0076** 0.0600 0.0352* Conclusion TAF therapy significantly increased TC and LDL-cholesterol and doubled staHn prescribing. This is coupled with deterioraHon in renal outcomes regardless of pre- TAF anHretroviral therapy status, against common belief in the reno-protecHve role of TAF, and highlights the need to consider these factors prior to commencing TAF, parHcularly in paHents switching from TDF. Acknowledgement Mrs Vicky Bridgeford, HIV Pharmacist, data pull Table 1 Pre and post-TAF raHo in lipid and renal outcomes Figure 1 ProporHons of paHents with raised lipid profile post TAF (%) Figure 2 StaHns prescribed in TAF-treated paHents Figure 3 Post-TAF overHme changes in lipid and renal profile No statin pre- or post-TAF (n=88) Statin predates TAF (n=12) Statin postdates (naïve to TAF) (n=1) Statin postdates TAF (TDF to TAF) (n=10) Statin postdates TAF (non-tenofovir to TAF) (n=1) *LDL-cholesterol level becomes immeasurable when triglyceride level above 4.4 mmol/L

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Page 1: A balance of risks: an audit of lipid and renal outcomes ...A balance of risks: an audit of lipid and renal outcomes in paents prescribed tenofovir alafenamide Meng-San Wu, Daniela

Abalanceofrisks:anauditoflipidandrenaloutcomesinpa5entsprescribedtenofoviralafenamide

Meng-SanWu,DanielaBrawleyGrampianSexualHealth,NHSGrampian

Aberdeen,UnitedKingdom

BackgroundTenofoviralafenamide(TAF)isanalternaHvetotenofovirdisoproxilfumarate(TDF)withapreferablerenalsafetyprofile.HoweversomestudieshaveshownthatTAFcandetrimentallyaffectlipidprofile,contribuHngtoahighercardiovascularrisk.ThelipidandrenaloutcomesofpaHentsprescribedTAF-containingregimensinourservicewereauditedtoassesstheserisksinarealworldseNng.MethodsAllpaHentsprescribedTAF-containingregimensbetween2016and2018wereincludedinthisretrospecHveaudit.DatawasextractedfromNaHonalSexualHealthSystemandTrakcareforbaselinedemographics,lipid-loweringtreatmentandpre/post-TAFlipidandrenalprofile,whichwereassessedagainst theduraHonofTAFexposure.AraHopairedt-testwasusedtocompareoutcomespre/postTAFwhereasnon-linear regressiontoesHmateoverHmechangeinlipidandrenalprofile.ResultsATAF-containingregimenwasprescribedin177paHents;112withcompletedatawereincludedforanalysis.82%weremalewithameanageof51(21-84)years.MedianduraHonofTAFexposurewas59(3-131)weeks.Totalcholesterol(TC),LDL-cholesterolandtriglyceridesincreasedpostTAFin67.0%,58.0%and59.8%ofpaHentsrespecHvely(Figure1).OverallTC,LDL-cholesterolandtriglycerideswereelevatedby9.3%,9.3%and10.4%;forTCandLDL-cholesterolthiswasmostsignificantinpaHentsswitchingfromTDF(Table1).TCtoHDL-cholesterolraHowasincreasedin47.3%;howeverthechangeinraHowasnon-significant.StaHnswereiniHatedin10.7%ofpaHentspostTAFand11.2%ofthoseswitchingfromTDF(Figure2).CreaHninewasraisedpostTAF,regardlessofpre-TAFanHretroviraltherapystatus.

An5retroviraltherapy Preandpost-TAFra5o p-value Triglyceride(n=112)NaïvetoTAF(n=12)TDFtoTAF(n=89)Non-tenofovirtoTAF(n=11)

1.104(95%CI1.008-1.210)1.285(95%CI1.041-1.585)1.101(95%CI0.9945-1.220)0.9576(95%CI0.6252-1.467)

0.0333*0.0237*0.06350.8254

Totalcholesterol(n=112)NaïvetoTAF(n=12)TDFtoTAF(n=89)Non-tenofovirtoTAF(n=11)

1.093(95%CI1.051-1.137)1.181(95%CI0.9996-1.396)1.105(95%CI1.062-1.151)0.9171(95%CI0.7946-1.059)

<0.0001****0.0504<0.0001****0.2085

LDL-cholesterol(n=112)NaïvetoTAF(n=12)TDFtoTAF(n=89)Non-tenofovirtoTAF(n=11)

1.093(95%CI1.031-1.160)1.182(95%CI0.9668-1.444)1.113(95%CI1.049-1.180)0.7572(95%CI0.4895-1.171)

0.0034**0.09430.0005***0.1621

TotalcholesteroltoHDL-cholesterolra5o(n=112)NaïvetoTAF(n=12)TDFtoTAF(n=89)Non-tenofovirtoTAF(n=11)

0.9887(95%CI0.9537-1.025)0.9923(95%CI0.8933-1.102)1.002(95%CI0.9632-1.043)0.8817(95%CI0.7603-1.022)

0.53170.87450.90510.0873

Crea5nine(n=112)NaïvetoTAF(n=12)TDFtoTAF(n=89)Non-tenofovirtoTAF(n=11)

1.047(95%CI1.019-1.075)1.123(95%CI1.038-1.214)1.028(95%CI0.9988-1.058)1.120(95%CI1.010-1.242)

0.0009***0.0076**0.06000.0352*

ConclusionTAF therapy significantly increased TC and LDL-cholesterol and doubled staHnprescribing.ThisiscoupledwithdeterioraHoninrenaloutcomesregardlessofpre-TAFanHretroviraltherapystatus,againstcommonbeliefinthereno-protecHveroleofTAF,andhighlightstheneedtoconsiderthesefactorspriortocommencingTAF,parHcularlyinpaHentsswitchingfromTDF.AcknowledgementMrsVickyBridgeford,HIVPharmacist,datapull

Table1Preandpost-TAFraHoinlipidandrenaloutcomes Figure1ProporHonsofpaHentswithraisedlipidprofilepostTAF(%)

Figure2StaHnsprescribedinTAF-treatedpaHents

Figure3Post-TAFoverHmechangesinlipidandrenalprofile

No statin pre- or post-TAF (n=88)Statin predates TAF (n=12)Statin postdates (naïve to TAF) (n=1)Statin postdates TAF (TDF to TAF) (n=10)Statin postdates TAF (non-tenofovir to TAF) (n=1)

*LDL-cholesterollevelbecomesimmeasurablewhentriglyceridelevelabove4.4mmol/L

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