Economic modeling of the combined effects of HIV-disease, cholesterol and lipoatrophy based on ACTG 5142 trial data.docVIP

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Economic modeling of the combined effects of HIV-disease, cholesterol and lipoatrophy based on ACTG 5142 trial data.doc

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Economic modeling of the combined effects of HIV-disease, cholesterol and lipoatrophy based on ACTG 5142 trial data

Simpsonetal.CostEffectivenessandResourceAllocation2011,9:5 /content/9/1/5 RESEARCH OpenAccess Economicmodelingofthecombinedeffectsof HIV-disease,cholesterolandlipoatrophybasedon ACTG5142trialdata KitNSimpson1*,BirgittaDietz3,RobertWBaran2,KevinWGarren2,SharonARiddler4,MenakaBhor2and RichardHHaubrich5 Abstract Background:ThisstudyexaminesthecostandconsequencesofinitiatinganARVregimenincludingLopinavir/ ritonavir(LPV/r)orEfavirenz(EFV),usingdatafromarecentclinicaltrialinapreviouslypublishedmodelofHIV- disease. Methods:WepopulatedtheMarkovmodelofHIV-diseasewithdatafromACTG5142studytoestimatethe economicoutcomesofstartingARVtherapywithaPI-containingregimenascomparedtoanNNRTI-containing regimen,giventheirvirologicandimmunologicefficacyandeffectsoncholesterolandlipoatrophy.CNStoxicities andGItolerabilitywerenotincludedinthemodelbecauseoftheirtransientnatureorlowcostremedies,and thereforelackofeconomicimpact.CD4+T-cellcountsandtheHIV-1RNA(viralload)valuesfromthestudywere usedtoassignaspecifichealthstate(HS)toeachpatientforeachquarteryear.Theresultingfrequenciesusedas “raw”datadirectlyintothemodelobviatetherelianceonstatisticaltests,andallowthemodeltoreflectactual patientbehaviorintheclinicaltrial.AnHSjustbelowthelastobservedHSwasusedtoreplaceamissingvalue. Results:Themodeledestimates(undiscounted)fortheLPV/r-basedregimenresultedin1.41quality-adjustedlife months(QALMs)gainedoveralifetimecomparedtotheEFV-basedregimen.TheLPV/r-basedregimenincurred $7,458(1.8%)greatercostoveralifetimeduetodifferencesindrugcostsandsurvival.Theincrementalcost effectivenessratiousingthediscountedcostandQALYswas$88,829/QALY.Mostofthehighercostsaccruebefore the7thyearoftreatmentandwereoffsetbysubsequentsavings.Theestimatesarehighlysensitivetotheeffect oflipoatrophyonHealth-relatedQualityofLife(HRQOL),butnottotheeffectofcholesterollevels. Conclusions:ThecosteffectivenessofARVregimensmaybestronglyaffectedbyenduringAEs,suchas lipoatrophy.ItisimportanttoconsiderspecificAEeffectsfromalldrugsinaregimen