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Table 7. Antiretroviral Components or Regimens Not Recommended as Initial Therapy

ARV drugs or components Reasons for NOT recommending as initial therapy
(in alphabetical order)

ABC/3TC/ZDV (coformulated) as triple-NRTI • Inferior virologic efficacy
combination regimen (BI)
ABC + 3TC + ZDV + TDF as quadruple-NRTI • Inferior virologic efficacy
combination regimen (BI)

DRV (unboosted) • Use without RTV has not been studied
DLV (BIII) • Inferior virologic efficacy
• Inconvenient (three times daily) dosing
ddI + 3TC (or FTC) (BIII) • Inferior virologic efficacy
• Least clinical trial experience in ART-naive patients
ddI + TDF (BII) • High rate of early virologic failure
• Rapid selection of resistance mutations
• Potential for immunologic nonresponse/CD4 T-cell decline
• Increased ddI drug exposure and toxicities
T20 (BIII) • No clinical trial experience in ART-naive patients
• Requires twice-daily subcutaneous injections

ETR (BIII) • Insufficient data in ART-naive patients
FPV (unboosted) (BIII) • Less potent than RTV-boosted FPV
• Virologic failure with unboosted FPV-based regimen may select mutations
that confer resistance to DRV
IDV (unboosted) (BIII) • Inconvenient dosing (three times daily with meal restrictions)
• Fluid requirement

IDV (RTV-boosted) (BIII) • High incidence of nephrolithiasis
NFV (BI) • Inferior virologic efficacy
• High incidence of diarrhea
RTV as sole PI (BIII) • High pill burden
• GI intolerance

SQV (unboosted) (BI) • Inferior virologic efficacy
d4T + 3TC (BI) • Significant toxicities including lipoatrophy; peripheral neuropathy; and
hyperlactatemia, including symptomatic and life-threatening lactic acidosis,
hepatic steatosis, and pancreatitis

TPV (RTV-boosted) (BI) • Inferior virologic efficacy

Key to Abbreviations: 3TC = lamivudine, ABC = abacavir, ART = antiretroviral therapy, ARV = antiretroviral, d4T = stavudine, ddI = didanosine,
DLV = delavirdine, DRV = darunavir, ETR = etravirine, FPV = fosamprenavir, FTC = emtricitabine, GI = gastrointestinal, IDV = indinavir,
NFV = nelfinavir, NRTI = nucleoside reverse transcriptase inhibitor, PI = protease inhibitor, RTV = ritonavir, SQV = saquinavir,
T20 = enfuvirtide, TDF = tenofovir, TPV = tipranavir, ZDV = zidovudine

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents F-20

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