Page 62 - HIV/AIDS Guidelines

What to Start: Initial Combination Regimens for the Antiretroviral-
Naive Patient (Last updated March 27, 2012; last reviewed March 27, 2012)

Panel’s Recommendations
• The Panel recommends the following as preferred regimens for antiretroviral (ARV)-naive patients:

• efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC) (AI)
• ritonavir-boosted atazanavir + tenofovir/emtricitabine (ATV/r + TDF/FTC) (AI)
• ritonavir-boosted darunavir + tenofovir/emtricitabine (DRV/r + TDF/FTC) (AI)
• raltegravir + tenofovir/emtricitabine (RAL + TDF/FTC) (AI)
• A list of Panel-recommended alternative and acceptable regimens can be found in Table 5a and Table 5b.

• Selection of a regimen should be individualized on the basis of virologic efficacy, toxicity, pill burden, dosing frequency,
drug-drug interaction potential, resistance testing results, and comorbid conditions.
• Based on individual patient characteristics and needs, in some instances, an alternative regimen may actually be a
preferred regimen for a patient.

Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = data from randomized controlled trials; II = data from well-designed nonrandomized trials or observational
cohort studies with long-term clinical outcomes; III = expert opinion

Morethan20approvedantiretroviral(ARV)drugsin6mechanisticclassesareavailabletodesign
combinationregimens.These6classesincludethenucleoside/nucleotidereversetranscriptaseinhibitors
(NRTIs),non-nucleosidereversetranscriptaseinhibitors(NNRTIs),proteaseinhibitors(PIs),fusion
inhibitors(FIs),CCR5antagonists,andintegrasestrandtransferinhibitors(INSTIs).

ThePanelprovidesrecommendationsforpreferred,alternative,andacceptableregimens;regimensthatmay
beacceptablebutmoredefinitivedataareneeded;andregimensthatmaybeacceptablebutshouldbeused
withcaution(Tables5aand5b).Potentialadvantagesanddisadvantagesofthecomponentsrecommendedas
initialtherapyforARV-naivepatientsarelistedinTable6 toguideprescribersinchoosingtheregimenbest
suitedforanindividualpatient.Table7 providesalistofagentsorcomponentsnotrecommendedforinitial
treatment.

Considerations When Selecting A First Antiretroviral Regimen for Antiretroviral

Therapy-Naive Patients
Data Used for Making Recommendations

ThePanel’srecommendationsareprimarilybasedonclinicaltrialdatapublishedinpeer-reviewedjournals
anddatapreparedbymanufacturersforFoodandDrugAdministration(FDA)review.Inselectedcases,the
Panelconsidersdatapresentedinabstractformatatmajorscientificmeetings.Thefirstcriterionforselection
ofevidenceonwhichtobaserecommendationsispublishedinformationfromarandomized,prospective
clinicaltrialwithanadequatesamplesizethatdemonstratesdurableviralsuppressionandimmunologic
enhancement(asevidencedbyincreaseinCD4count).Fewofthesetrialsincludeclinicalendpoints,suchas
developmentofAIDS-definingillnessordeath.Thus,assessmentofregimenefficacyandpotencyis
primarilybasedonsurrogatemarkerendpoints(HIVRNAandCD4responses).ThePanelrevieweddata
fromrandomizedclinicaltrialstoarriveatpreferred,alternative,oracceptableratingsnotedinTables5aand
5b.“Preferredregimens”arethoseregimensstudiedinrandomizedcontrolledtrialsandshowntohave

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

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