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Review

New option for management of HIV-1 infection in treatment-naive patients: once-daily, fixed-dose combination of rilpivirine-emtricitabine-tenofovir

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Pages 61-71 | Published online: 27 Apr 2012

References

  • CohenCJAndrade-VillanuevaJClotetBRilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trialLancet2011378978722923721763935
  • LennoxJLDejesusEBergerDSRaltegravir versus efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analysesJ Acquir Immune Defic Syndr2010551394820404738
  • MolinaJMCahnPGrinsztejnBRilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trialLancet2011378978723824621763936
  • MaggioloFAiroldiMKleinloogHDEffect of adherence to HAART on virologic outcome and on the selection of resistance-conferring mutations in NNRTI- or PI-treated patientsHIV Clin Trials20078528229217956829
  • PatersonDLSwindellsSMohrJAdherence to protease inhibitor therapy and outcomes in patients with HIV infectionAnn Intern Med20001331213010877736
  • BucherHCWolbersMPorterK2010 guidelines for antiretroviral treatment of HIV from the International AIDS Society-USA PanelJAMA2010304171897 author reply 1897–189821045094
  • MordantCSchmittBPasquierESynthesis of novel diarylpyrimidine analogues of TMC278 and their antiviral activity against HIV-1 wild-type and mutant strainsEur J Med Chem200742556757917223230
  • [No authors listed]A once-daily combination tablet (Atripla) for HIVMed Lett Drugs Ther2006481244787917001298
  • [No authors listed]European Commission approves AtriplaAIDS Patient Care STDS20082218788
  • ArribasJRPozniakALGallantJETenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-week analysisJ Acquir Immune Defic Syndr2008471747817971715
  • PozniakALGallantJEDeJesusETenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immunologic, and morphologic changes – a 96-week analysisJ Acquir Immune Defic Syndr200643553554017057609
  • [No authors listed]Atripla approval in EuropeAIDS Patient Care STDS20062012887
  • BeraEMcCauslandKNonkweloRMgudlwaBChackoSMajekeBBirth defects following exposure to efavirenz-based antiretroviral therapy during pregnancy: a study at a regional South African hospitalAIDS201024228328919864931
  • SchoutenJTKrambrinkARibaudoHJSubstitution of nevirapine because of efavirenz toxicity in AIDS clinical trials group A5095Clin Infect Dis201050578779120121419
  • [No authors listed]FDA notifications. Complera approvedAIDS Alert2011261113013122164521
  • MillerVde BethuneMPKoberAPatterns of resistance and cross-resistance to human immunodeficiency virus type 1 reverse transcriptase inhibitors in patients treated with the nonnucleoside reverse transcriptase inhibitor lovirideAntimicrob Agents Chemother19984212312331299835502
  • Complera® (package insert)Foster City, CAGilead Sciences2011
  • JanssenPALewiPJArnoldEIn search of a novel anti-HIV drug: multidisciplinary coordination in the discovery of 4-[[4-[[4-[(1E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile (R278474, rilpivirine)J Med Chem20054861901190915771434
  • LansdonEBBrendzaKMHungMCrystal structures of HIV-1 reverse transcriptase with etravirine (TMC125) and rilpivirine (TMC278): implications for drug designJ Med Chem201053104295429920438081
  • DasKClarkADJrLewiPJRoles of conformational and positional adaptability in structure-based design of TMC125-R165335 (etravirine) and related non-nucleoside reverse transcriptase inhibitors that are highly potent and effective against wild-type and drug-resistant HIV-1 variantsJ Med Chem200447102550256015115397
  • AntinoriAZaccarelliMCingolaniACross-resistance among nonnucleoside reverse transcriptase inhibitors limits recycling efavirenz after nevirapine failureAIDS Res Hum Retroviruses2002181283583812201905
  • DeeksSGBarditch-CrovoPLietmanPSSafety, pharmacokinetics, and antiretroviral activity of intravenous 9-[2-(R)-(Phosphonomethoxy) propyl]adenine, a novel anti-human immunodeficiency virus (HIV) therapy, in HIV-infected adultsAntimicrob Agents Chemother1998429238023849736567
  • SuoZJohnsonKASelective inhibition of HIV-1 reverse transcriptase by an antiviral inhibitor, (R)-9-(2-Phosphonylmethoxypropyl)adenineJ Biol Chem19982734227250272589765248
  • YingCDe ClercqENeytsJLamivudine, adefovir and tenofovir exhibit long-lasting anti-hepatitis B virus activity in cell cultureJ Viral Hepat200071798310718947
  • BrennerBTurnerDOliveiraMA V106M mutation in HIV-1 clade C viruses exposed to efavirenz confers cross-resistance to nonnucleoside reverse transcriptase inhibitorsAIDS2003171F1F512478089
  • RichmanDDAntiretroviral activity of emtricitabine, a potent nucleoside reverse transcriptase inhibitorAntivir Ther200162838811491420
  • HazenRLanierERRelative anti-HIV-1 efficacy of lamivudine and emtricitabine in vitro is dependent on cell typeJ Acquir Immune Defic Syndr200332325525812626884
  • KorbaBESchinaziRFCotePTennantBCGerinJLEffect of oral administration of emtricitabine on woodchuck hepatitis virus replication in chronically infected woodchucksAntimicrob Agents Chemother20004461757176010817750
  • GoebelFYakovlevAPozniakALShort-term antiviral activity of TMC278 – a novel NNRTI – in treatment-naive HIV-1-infected subjectsAIDS200620131721172616931936
  • MolinaJMPeytavinGPerusatSPharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial)HIV Med2004529910415012649
  • WangLHBegleyJSt ClaireRLIIIHarrisJWakefordCRousseauFSPharmacokinetic and pharmacodynamic characteristics of emtricitabine support its once daily dosing for the treatment of HIV infectionAIDS Res Hum Retroviruses200420111173118215588339
  • Van HeeswijkRHHoetelmansRKestensDThe pharmacokinetic (PK) interaction between famotidine and TMC278, a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI), in HIV-negative volunteersAbstract TUPDB01 presented at the 4th IAS Conference on HIV Pathogenesis, Treatment and PreventionJuly 22–25, 2007Sydney, Australia
  • HawkinsTVeikleyWSt ClaireRLIIIGuyerBClarkNKearneyBPIntracellular pharmacokinetics of tenofovir diphosphate, carbovir triphosphate, and lamivudine triphosphate in patients receiving triple-nucleoside regimensJ Acquir Immune Defic Syndr200539440641116010161
  • Van HeeswijkRHHoetelmansRAharchiFThe pharmacokinetic (PK) interaction between atorvastatin (AVS) and TMC278, a next-generation non-nucleoside reverse, transcriptase inhibitor (NNRTI)Presented at the 11th European AIDS ConferenceOctober 24–27, 2007Madrid, Spain
  • Edurant® (Package insert)Titusville, NJJanssen2011
  • Van HeeswijkRHHoetelmansRKestensDThe pharmacokinetic interaction between ketoconazole and TMC278, an investigational non-nucleoside reverse transcriptase inhibitor, in healthy HIV-negative subjectsAbstract TUPE0087 presented at the 16th International AIDS ConferenceAugust 13–18, 2006Toronto, Canada
  • KearneyBPYaleKShahJZhongLFlahertyJFPharmacokinetics and dosing recommendations of tenofovir disoproxil fumarate in hepatic or renal impairmentClin Pharmacokinet200645111115112417048975
  • AiroldiMZaccarelliMBisiLOne-pill once-a-day HAART: a simplification strategy that improves adherence and quality of life of HIV-infected subjectsPatient Prefer Adherence2010411512520517472
  • DejesusEYoungBMorales-RamirezJOSimplification of anti-retroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patientsJ Acquir Immune Defic Syndr200951216317419357529
  • FisherMMoyleGJShahmaneshMA randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individualsJ Acquir Immune Defic Syndr200951556256819561519
  • CrauwelsHvan HeeswijkRPGStevensTRelative bioavailability of a concept pediatric formulation of TMC278, an investigational NNRTIAbstract THPE0158 presented at the XVIIIth International AIDS ConferenceJuly 18–23, 2010Vienna, Austria
  • FatkenheuerGDuvivierCRiegerALipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trialJ Antimicrob Chemother201267368569022210755
  • RhoadsMPLaniganJSmithCJLyallEGEffect of specific ART drugs on lipid changes and the need for lipid management in children with HIVJ Acquir Immune Defic Syndr201157540441221499114
  • WilkinAPozniakALMorales-RamirezJLong-term efficacy, safety, and tolerability of rilpivirine (RPV, TMC278) in HIV Type 1-infected antiretroviral-naive patients: week 192 results from a Phase IIb randomized trialAIDS Res Hum RetrovirusesOctober 172011 [Epub ahead of print.]
  • Viread™ (package insert)Foster City, CAGilead Sciences2012
  • BlaasSSchneidewindAGluckTSalzbergerBAcute renal failure in HIV patients with liver cirrhosis receiving tenofovir: a report of two casesAIDS200620131786178716931948
  • HynesPUrbinaAMcMeekingABarisoniLRabenouRAcute renal failure after initiation of tenofovir disoproxil fumarateRen Fail20072981063106618067059
  • ZimmermannAEPizzoferratoTBedfordJMorrisAHoffmanRBradenGTenofovir-associated acute and chronic kidney disease: a case of multiple drug interactionsClin Infect Dis200642228329016355343
  • VerhelstDMongeMMeynardJLFanconi syndrome and renal failure induced by tenofovir: a first case reportAm J Kidney Dis20024061331133312460055
  • CooperRDWiebeNSmithNKeiserPNaickerSTonelliMSystematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patientsClin Infect Dis201051549650520673002
  • Irizarry-AlvaradoJMDwyerJPBrumbleLMAlvarezSMendezJCProximal tubular dysfunction associated with tenofovir and didanosine causing Fanconi syndrome and diabetes insipidus: a report of 3 casesAIDS Read200919311412119334328
  • KarrasALafaurieMFurcoATenofovir-related nephrotoxicity in human immunodeficiency virus-infected patients: three cases of renal failure, Fanconi syndrome, and nephrogenic diabetes insipidusClin Infect Dis20033681070107312684922
  • CocaSPerazellaMARapid communication: acute renal failure associated with tenofovir: evidence of drug-induced nephrotoxicityAm J Med Sci2002324634234412495304
  • GallantJEParishMAKerulyJCMooreRDChanges in renal function associated with tenofovir disoproxil fumarate treatment, compared with nucleoside reverse-transcriptase inhibitor treatmentClin Infect Dis20054081194119815791522
  • GuptaSKTenofovir-associated Fanconi syndrome: review of the FDA adverse event reporting systemAIDS Patient Care STDS20082229910318260800
  • PeyriereHReynesJRouanetIRenal tubular dysfunction associated with tenofovir therapy: report of 7 casesJ Acquir Immune Defic Syndr200435326927315076241
  • McComseyGAKitchDDaarESBone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202J Infect Dis2011203121791180121606537
  • CahnPEmtricitabine: a new nucleoside analogue for once-daily antiretroviral therapyExpert Opin Investig Drugs20041315568
  • GishRGLeungNWWrightTLDose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infectionAntimicrob Agents Chemother20024661734174012019083
  • Emtriva™ (package insert)Foster City, CAGilead Sciences2007
  • NelsonMSchiavoneMEmtricitabine (FTC) for the treatment of HIV infectionInt J Clin Pract200458550451015206508
  • KuritzkesDRDrug resistance in HIV-1Curr Opin Virol20111658258922162985
  • DasKBaumanJDClarkADJrHigh-resolution structures of HIV-1 reverse transcriptase/TMC278 complexes: strategic flexibility explains potency against resistance mutationsProc Natl Acad Sci U S A200810551466147118230722
  • HaubrichRHRiddlerSADiRienzoAGMetabolic outcomes in a randomized trial of nucleoside, nonnucleoside and protease inhibitor-sparing regimens for initial HIV treatmentAIDS20092391109111819417580
  • WittkopLGunthardHFde WolfFEffect of transmitted drug resistance on virological and immunological response to initial combination antiretroviral therapy for HIV (EuroCoord-CHAIN joint project): a European multicohort studyLancet Infect Dis201111536337121354861
  • RimskyLVingerhoetsJVan EygenVGenotypic and phenotypic characterization of HIV-1 isolates obtained from patients on rilpivirine therapy experiencing virologic failure in the phase 3 ECHO and THRIVE studies: 48-week analysisJ Acquir Immune Defic Syndr2012591394622067667
  • MillerCDCrainJTranBPatelNRilpivirine: a new addition to the anti-HIV-1 armamentariumDrugs Today (Barc)201147151521373646
  • HughesCARobinsonLTsengAMacArthurRDNew antiretroviral drugs: a review of the efficacy, safety, pharmacokinetics, and resistance profile of tipranavir, darunavir, etravirine, rilpivirine, maraviroc, and raltegravirExpert Opin Pharmacother200910152445246619678794
  • CrauwelsHVingerhoetsJRyanRWitekJAndersonDPharmacokinetic parameters of once-daily TMC278 following administration of EFV in healthy volunteersAbstract 630 presented at the 18th Conference on Retroviruses and Opportunistic InfectionsFebruary 27–March 2, 2011Boston, MA
  • MillsACohenCDejesusESwitching from efavirenz/emtricitabine/ tenofovir disoproxil fumarate (EFV/FTC/TDF) single tablet regimen (STR) to emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR in virologically suppressed, HIV-1 infected subjectsAbstract H2-794c presented at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)September 17–20, 2011Chicago, IL
  • Panel on Antiretroviral Guidelines for Adults and AdolescentsGuidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescentsDepartment of Health and Human ServicesNovember 172011 Available from: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdfAccessed March 8, 2012
  • Atripla™ (package insert)New York, NYBristol-Myers Squibb and Gilead Sciences2011