Efficacy, safety and pharmacokinetic of once-daily boosted saquinavir (1500100 mg) together with 2 nucleos(t)ide reverse transcriptase inhibitors in real life a multicentre prospective study.docVIP

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Efficacy, safety and pharmacokinetic of once-daily boosted saquinavir (1500100 mg) together with 2 nucleos(t)ide reverse transcriptase inhibitors in real life a multicentre prospective study.doc

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Efficacy, safety and pharmacokinetic of once-daily boosted saquinavir (1500100 mg) together with 2 nucleos(t)ide reverse transcriptase inhibitors in real life a multicentre prospective study

López-Cortésetal.AIDSResearchandTherapy2010,7:5 /content/7/1/5 RESEARCH OpenAccess Efficacy,safetyandpharmacokineticofonce-daily boostedsaquinavir(1500/100mg)togetherwith 2nucleos(t)idereversetranscriptaseinhibitorsin reallife:amulticentreprospectivestudy LuisFLópez-Cortés1*,PompeyoViciana1,RosaRuiz-Valderas1,JuanPasquau2,JosefaRuiz3,FernandoLozano4, DoloresMerino5,AntonioVergara6,AlbertoTerrón7,LuisGonzález8,AntonioRivero9,AgustinMu?oz-Sanz10 Abstract Background:Ritonavir-boostedsaquinavir(SQVr)isnowadaysregardedasanalternativeantiretroviraldrug probablyduetoseveraldrawbacks,suchasitshighpillburden,twicedailydosingandtherequirementof200mg ritonavirwhengivenatthecurrentstandard1000/100mgbiddosing.Severalonce-dailySQVrdosingschemes havebeenstudiedwiththe200mgSQVoldformulations,tryingtoovercomesomeofthesedisadvantages.SQV 500mgstrengthtabletsbecameavailableattheendof2005,thusfacilitatingaonce-dailyregimenwithfewer pills,althoughthereisverylimitedexperiencewiththisformulationyet. Methods:Prospective,multicentrestudyinwhichefficacy,safetyandpharmacokineticsofaregimenofonce-daily SQVr1500/100mgplus2NRTIswereevaluatedunderroutineclinicalcareconditionsineitherantiretroviral-na?ve patientsorinthosewithnoprevioushistoryofantiretroviraltreatmentsand/orgenotypicresistancetests suggestingSQVresistance.PlasmaSQVtroughlevelsweremeasuredbyHPLV-UV. Results:Fivehundredandfourteencaucasianpatientswereincluded(47.2%coinfectedwithhepatitisCand/orBvirus; 7.8%withcirrhosis).Efficacyat52weeks(plasmaRNA-HIV50copies/ml)was67.7%(CI95:63.6-71.7%)byintention-to- treat,and92.2%(CI95:89.8-94.6%)byon-treatmentanalysis.Thereasonsforfailurewere:dropoutorlosstofollow-up (18.4%),virologicalfailure(7.8%),adverseevents(3.1%),andotherreasons(4.6%).Thehighrateofdropoutmaybe explainedbyanenrollementandfollow-upunderroutineclinicalcarecondition,andapopulationwithasignificant numberofdrugusers.ThemedianSQVCmin(n=49)was295ng/ml(range,53-2172).Theonlyvariableassociated withvirologicalfailureinthemultivariat