Page 76 - HIV/AIDS Guidelines

efficacydataforbothmotherandnewborn.FormoredetailedinformationregardingARVdrugchoicesand
relatedissuesinpregnancy,seetheperinatalguidelines. 39

Nucleoside Reverse Transcriptase Inhibitors and Hepatitis B Virus. Threeofthecurrentlyapproved
NRTIs—FTC,3TC,andTDF—haveactivityagainstHBV.MostHIV/HBV-coinfectedpatientsshoulduse
coformulatedTDF/FTC(orTDF+3TC)astheirNRTIbackbonetoprovideadditionalactivityagainstHBV
andtoavoidselectionofHBVmutationthatconfersresistanceto3TC/FTC.Importantly,patientswhohave
HIV/HBVcoinfectionmaybeatriskofacuteexacerbationofhepatitisafterinitiationorupon
discontinuationofTDF,3TC,orFTC. 106-108 Thus,thesepatientsshouldbemonitoredcloselyforclinicalor
chemicalhepatitisifthesedrugsareinitiatedordiscontinued.(SeeHIV/HepatitisBCoinfection and
InitiatingAntiretroviralTherapy.)

All-Nucleoside Reverse Transcriptase Inhibitor Regimens
Triple-NRTIregimensstudiedinseveralclinicaltrialshaveshownsuboptimalvirologicactivity. 22-23,109-112

Abacavir/Lamivudine/Zidovudine (coformulated). ABC/3TC/ZDVistheonlytriple-NRTIcombination
forwhichrandomized,controlledtrialsareavailable.ABC/3TC/ZDVdemonstratedcomparableARV
activitytoIDV-based 104-105 andNFV-basedregimens 112 butwasinferiorvirologicallytoanEFV-based
22
regimen. Thiscombinationisgenerally not recommended (BI) andshouldbeusedonlywhenapreferred,
analternative,oranacceptableNNRTI-,PI-,orINSTI-basedregimenislessdesirablebecauseofconcerns
abouttoxicities,druginteractions,orregimencomplexity.

Zidovudine/Lamivudine + Tenofovir. TheDARTstudydemonstratedthatthecombinationofZDV/3TC+
TDFhasantiviralactivity. 113 However,becausecomparativedatawithstandardregimensarenotavailable,
thiscombinationcannot be recommended inroutineclinicalpractice(BIII).
Zidovudine/Lamivudine + Abacavir + Tenofovir. Aquadruple-NRTIregimenofZDV/3TC+ABC+TDF
firstshowedcomparablevirologicresponsestoanEFV-basedregimeninasmallpilotstudy. 114 Alargerstudy
randomized322subjectstoreceiveTDF/FTCcombinedwithEFV,ATV/RTV,oraquadruple-NRTIregimen
withZDVandABC.Althoughthethresholdofnoninferiorityfortheprotocol-definedvirologicresponsewas
satisfiedbythequadruple-NRTIregimen,theproportionofpatientsreachingHIVRNA<50copies/mLwas
lowerwiththequadruple-NRTIregimenandtherateofserioustoxicitywastwiceashighasthatobserved
withtheEFV-basedregimen. 115 Thus,thisregimencannot be recommended (BI).

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents F-15

Downloaded from http://aidsinfo.nih.gov/guidelines on 12/8/2012 EST.