Antiretroviral Agents in HIV-1 Infected Adults and Adolescents

Publication Date: December 6, 2023

Selecting a Treatment Regimen

Selecting a Treatment Regimen

Initiating Antiretroviral Therapy

Antiretroviral therapy (ART) is recommended for all HIV-infected individuals, regardless of CD4 count, to reduce the morbidity and mortality associated with HIV infection.
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ART is also recommended for HIV-infected individuals to prevent transmission of HIV. (, )
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When initiating ART, it is important to educate patients regarding the benefits and considerations of ART, and to address strategies to optimize adherence.
  • On a case-by-case basis, ART may be deferred because of clinical and/or psychosocial factors, but therapy should be initiated as soon as possible.
(, )
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What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient

An antiretroviral (ARV) regimen for a treatment-naive patient generally consists of two nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third active ARV drug from one of three drug classes: an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a protease inhibitor (PI) with a pharmacokinetic (PK) enhancer (booster) (cobicistat or ritonavir).
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A pregnancy test should be performed for those of childbearing potential prior to the initiation of antiretroviral therapy. (A, III)
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Table 1a. Recommended Initial Regimens for Most People with HIV

Recommended regimens are those with demonstrated durable virologic efficacy, favorable tolerability and toxicity profiles, and ease of use.

INSTI + 2-NRTIs:
BIC/TAF/FTCa (A, I)
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DTG/ABC/3TCa (A, I)
— if HLA-B*5701 negative
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DTGb + tenofovir/FTCa (A, I)
(for both TAF/FTC and TDF/FTC)
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RALc + tenofovir/bFTCa (B, I)
(for TDF/FTC)
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RALc + tenofovir/bFTCa
(for TAF/FTC)
a3TC may be substituted for FTC, or vice versa, if a non–fixed-dose NRTI combination is desired.
bTAF and TDF are two forms of tenofovir approved by the FDA. TAF has fewer bone and kidney toxicities than TDF, while TDF is associated with lower lipid levels. Safety, cost, and access are among the factors to consider when choosing between these drugs.
cRAL can be given as 400 mg bid or 1200 mg (two 600-mg tablets) once daily.
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a3TC may be substituted for FTC, or vice versa, if a non–fixed-dose NRTI combination is desired.
bTAF and TDF are two forms of tenofovir approved by the FDA. TAF has fewer bone and kidney toxicities than TDF, while TDF is associated with lower lipid levels. Safety, cost, and access are among the factors to consider when choosing between these drugs.
cRAL can be given as 400 mg bid or 1200 mg (two 600-mg tablets) once daily.

Table 1b. Recommended Initial Regimens in Certain Clinical Situations

These regimens are effective and tolerable, but have some disadvantages when compared with the regimens listed in Table 1a, or have less supporting data from randomized clinical trials. However, in certain clinical situations, one of these regimens may be preferred.
Note: For individuals of childbearing potential, see Table 6b in the full text Guidelines before prescribing one of these regimens.
INSTI + 2 NRTIs:
EVGb/c/tenofovir/FTC (B, I)
(for both TAF/FTC and TDF/FTC)
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RALc + ABC/3TCa (C, II)
(if HLA-B*5701 negative and HIV RNA <100,000 copies/mL)
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Boosted PI + 2-NRTIs: (In general, boosted DRV is preferred over boosted ATV)
(DRV/c or DRVb/r) + tenofovir/FTCa (A, I)
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(ATV/c or ATVb/r) + tenofovir/FTCa (B, I)
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(DRV/c or DRV/r) + ABC/3TCa (B, II)
(— if HLA-B*5701 negative)
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NNRTI + 2 NRTIs:
DOR/TDFb/3TC (B, I)
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DOR plus TAFb/FTC (B, III)
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EFVb+ tenofovir/FTCa (B, I)
(for EFV 600 mg/TDF/FTC or EFV 600 mg/TDF/3TC)
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EFVb+ tenofovir/FTCa (B, II)
(for EFV 600 mg + TAF/FTC)
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RPVb/tenofovir/FTCa (B, I)
(if HIV RNA <100,000 copies/mL and CD43 cell count >200 cells/mm)
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Regimens to consider when ABC, TAF and TDF cannot be used or are not optimal:
DTG plus 3TC (B, I)
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DRV/r + RAL (bid) (C, I)
(if HIV RNA <100,000 copies/mL and CD43 >200 cells/mm)
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DRV/r once daily + 3TCa (bid) (C, I)
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Note: The following are available as coformulated drugs: ABC/3TC, ATV/c, BIC/TAF/FTC, DOR/TDF/3TC, DRV/c, DRV/c/TAF/FTC, DTG/ABC/3TC, EFV 600 mg/TDF/3TC, EFV/TDF/FTC, EVG/c/TAF/FTC, EVG/c/TDF/FTC, RPV/TAF/FTC, RPV/TDF/FTC, TAF/FTC, TDF/3TC, and TDF/FTC.
a3TC may be substituted for FTC, or vice versa. ABC/3TC, TDF/3TC, TDF/FTC, and TAF/FTC are available as coformulated, two-NRTItablets, and they are also available as part of various STRs. Cost, access, and availability of STR formulations are among the factors toconsider when choosing between 3TC and FTC.
bTAF and TDF are two forms of tenofovir approved by the FDA. TAF has fewer bone and kidney toxicities than TDF, while TDF is associated with lower lipid levels. Safety, cost, and access are among the factors to consider when choosing between these drugs.
cRAL can be given as 400 mg bid or 1200 mg (two 600-mg tablets) once daily.

HIV-Infected Adolescents and Young Adults

Adolescents living with HIV largely belong to two distinct groups—those who acquired HIV in infancy and are heavily ART-experienced, and those who acquired HIV more recently during their teens.
ART is recommended for all HIV-infected individuals to reduce morbidity and mortality. (A, I)
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Thus, ART is also recommended for ART -naive adolescents. However, before initiation of therapy, adolescents’ readiness and ability to adhere to therapy within their psychosocial context need to be carefully considered as part of therapeutic decision making. ( A , III )
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Once ART is initiated, appropriate support is essential to reduce potential barriers to adherence and maximize the success in achieving sustained viral suppression. (A, II)
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The adolescent sexual maturity rating can be helpful to guide regimen selection for initiation of or changes in ART as recommended by either the Adult and Adolescent ART Guidelines or the Pediatric ART Guidelines. The Adult/Adolescent Guidelines are more appropriate for postpubertal adolescents (i.e., sexual maturity rating IV or V). (A, III)
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Pediatric and adolescent care providers should prepare adolescents for the transition into adult care settings. Adult providers should be sensitive to the challenges associated with such transitions, consulting and collaborating with care providers for adolescents with HIV to ensure adolescents’ successful transition and continued engagement in care. (A, III)
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Table 2. Advantages and Disadvantages of Antiretroviral Components Recommended as Initial ART

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ARV Class ARV Agent(s) Advantages Disadvantages
Dual-NRTI ABC/3TC
  • Coformulated with DTG
  • Generic formulations are available for ABC/3TC, ABC, and 3TC.
  • May cause life-threatening hypersensitivity reaction (HSR) in patients positive for the HLA-B*5701 allele. As a result, HLA-B*5701 testing required before use.
  • In the ACTG 5202 study, patients with baseline HIV RNA ≥100,000 copies/mL showed inferior virologic responses when ABC/3TC was given with EFV or ATV/r as opposed to TDF/FTC. This difference was not seen when ABC/3TC was used in combination with DTG.
  • ABC use has been associated with CV disease and cardiac events in some, but not all, observational studies.
TAF/FTC
  • Coformulated with BIC, DRV/c, EVG/c or RPV
  • Active against HBV; a recommended dual-NRTI option for patients with HIV/HBV coinfection
  • Smaller decline in renal function, less proteinuria, and smaller reductions in BMD than after initiation of TDF/FTC
  • Approved for patients with eGFR ≥30 mL/min
  • TDF is associated with lower lipid levels than TAF, perhaps because TDF results in higher plasma levels of tenofovir, which lowers lipids.
TDF/3TC
  • Coformulated with DOR and EFV
  • Available as the following generic formulations:
  • TDF
  • 3TC
  • TDF/3TC
  • EFV/TDF/3TC
  • Long-term clinical experience
  • Active against HBV
  • Renal toxicity, including proximal tubulopathy and acute or chronic renal insufficiency, especially when combined with pharmacologic boosters.
  • Osteomalacia has been reported as a consequence of proximal tubulopathy.
  • Decreased BMD has been associated with use of TDF, especially when combined with pharmacologic boosters.
TDF/FTC
  • Coformulated with EFV, EVG/c, and RPV as single-tablet regimens (STRs)
  • Active against HBV; a recommended dual-NRTI for patients with HIV/HBV coinfection
  • Better virologic responses than with ABC/3TC in patients with baseline viral load ≥100,000 copies/mL when combined with ATV/r or EFV
  • Associated with lower lipid levels than ABC or TAF
  • Renal toxicity, including proximal tubulopathy and acute or chronic renal insufficiency, especially when combined with pharmacologic boosters.
  • Osteomalacia has been reported as a consequence of proximal tubulopathy.
  • Decreased BMD has been associated with use of TDF, especially when combined with pharmacologic boosters.
INSTI BIC
  • Coformulated with TAF/FTC
  • In trials in ART-naive participants, BIC resistance was not detected
  • No food requirement
  • Compared to other INSTIs, BIC has the shortest postmarketing experience.
  • Oral absorption of BIC can be reduced by simultaneous administration with drugs or supplements containingpolyvalent cations (e.g., Al-, Ca-, or Mg-containing antacids or supplements, or multivitamin tablets with minerals).
  • Inhibits tubular secretion of creatinine without affecting glomerular function.
  • CYP3A4 and UGT1A1 substrate (but not a CYP3A4 inducer or inhibitor); potential for drug interactions.
DTG
  • Higher barrier to resistance than EVG or RAL
  • Coformulated with ABC and 3TC
  • No food requirement
  • No CYP3A4 interactions
  • Favorable lipid profile
  • Preliminary data suggests that DTG use before pregnancy and through conception may be associated with an increased risk of NTDs in the infant.
  • Oral absorption can be reduced by simultaneous administration with products containing polyvalent cations (e.g., Al-, Ca-, or Mg-containing antacids or supplements, or multivitamin tablets with minerals).
  • Inhibits renal tubular secretion of Cr and can increase serum Cr without affecting glomerular function.
  • UGT substrate; potential for drug interactions
  • Depression and suicidal ideation (rare; usually in patients with preexisting psychiatric conditions).
EVG/c
  • Coformulated with TDF/FTC or TAF/FTC
  • Compared with ATV/r, causes smaller increases in total and LDL cholesterol
  • EVG/c/TDF/FTC is recommended only for patients with baseline CrCl ≥70 mL/min. This regimen should be discontinued if CrCl decreases to <50 mL/min.
  • cobi is a potent CYP3A4 inhibitor, which can result in significant interactions with CYP3A substrates.
  • Oral absorption of EVG can be reduced by simultaneous administration with products containing polyvalent cations (eg, Al-, Ca-, or Mg-containing antacids or supplements, or multivitamin tablets with minerals).
  • cobi inhibits active tubular secretion of Cr and can increase serum Cr without affecting renal glomerular function.
  • Has a lower barrier to resistance than boosted PI-, BIC- or DTG-based regimens.
  • Food requirement.
  • Depression and suicidal ideation (rare; usually in patients with preexisting psychiatric conditions).
RAL
  • Compared to other INSTIs, has longest post-marketing experience
  • No food requirement
  • No CYP3A4 interactions
  • Favorable lipid profile
  • Lower genetic barrier to resistance than boosted PI-, BIC- or DTG-based regimens
  • Increases in creatine kinase, myopathy, and rhabdomyolysis have been reported.
  • Rare cases of severe HSRs (including SJS and TEN) have been reported.
  • Higher pill burden than other INSTI-based regimens.
  • No fixed-dose combination formulation.
  • Oral absorption can be reduced by simultaneous administration with products containing polyvalent cations (eg, Al-, Ca-, or Mg-containing antacids or supplements, or multivitamin tablets with minerals).
  • UGT substrate; potential for drug interactions.
  • Depression and suicidal ideation (rare; usually in patients with preexisting psychiatric conditions).
NNRTIs DOR
  • Coformulated with TDF/3TC
  • Compared to EFV, CNS side effects are less frequent
  • No food requirement
  • Favorable lipid profile
  • Shorter-term clinical experience than with EFV and RPV.
  • Potential for CYP450 drug interactions.
  • Treatment-emergent DOR resistance mutations may confer resistance to certain NNRTIs.
EFV
  • EFV 600 mg is coformulated with TDF/FTC and TDF/3TC
  • EFV 400 mg is coformulated with TDF/3TC
  • EFV-based regimens (except for EFV plus ABC/3TC) have well-documented efficacy in patients with high HIV RNA.
  • Short- and long-term neuropsychiatric (CNS) side effects, including depression and, in some studies, suicidality and catatonia. Screening for depression and suicidality is recommended in people with HIV who are taking a regimen that includes EFV.
  • Teratogenic in non-human primates.
  • Dyslipidemia.
  • Rash.
  • QTc interval prolongation; consider an alternative to EFV in patients taking medications with known risk of causing TdP, or in those at higher risk of TdP.
  • Transmitted resistance more common than with PIs and INSTIs.
  • Greater risk of resistance at the time of treatment failure than with PIs.
  • Potential for CYP450 drug interactions.
  • Should be taken on an empty stomach (food increases drug absorption and CNS toxicities).
RPV
  • Coformulated with TDF/FTC and TAF/FTC.
  • RPV/TDF/FTC and RPV/TAF/FTC have smaller pill size than other coformulated ARV drugs.
  • Compared with EFV:
    • Fewer CNS adverse effects
    • Fewer lipid effects
    • Fewer rashes
  • NOT recommended in patients with pre-ART HIV RNA >100,000 copies/mL or CD43 count <200 cells/mm because of higher rate of virologic failure in these patients.
  • Depression and suicidality
  • QTc interval prolongation; consider an alternative to RPV in patients taking medications with known risk of causing TdP, or in those at higher risk of TdP.
  • Rash.
  • Transmitted resistance more common than with PIs and INSTIs.
  • More NNRTI-, TDF-, and 3TC-associated mutations at virological failure than with regimen containing EFV and two NRTIs.
  • Potential for CYP450 drug interactions.
  • Food requirement (>390 kcal).
  • Requires acid for adequate absorption.
    • Contraindicated with PPIs
    • Use with H2 antagonists or antacids with caution
PIs ATV/c or ATV/r
  • Higher genetic barrier to resistance than NNRTIs, EVG, and RAL.
  • PI resistance at the time of treatment failure uncommon with PK-enhanced PIs.
  • ATV/c and ATV/r have similar virologic activity and toxicity profiles.
  • Observational cohort studies have found an association between some PIs (DRV, LPV/r, FPV, IDV) and an increased risk of CV events. this risk has not been seen with ATV. Further study is needed. See text for discussion.
  • Individual ATV and RTV components available as generics
  • Commonly causes indirect hyperbilirubinemia, which may manifest as scleral icterus or jaundice.
  • Food requirement.
  • Absorption depends on food and low gastric pH.
  • Nephrolithiasis, cholelithiasis, nephrotoxicity.
  • GI adverse effects.
  • CYP3A4 inhibitors and substrates: potential for drug interactions.
ATV/c (specific considerations)
  • Coformulated tablet
  • cobi inhibits active tubular secretion of Cr and can increase serum Cr without affecting renal glomerular function.
  • Coadministration with TDF is NOT recommended in patients with CrCl <70 mL/min.
  • Less long-term clinical experience than for ATV/r.
  • cobi (like RTV) is a potent CYP3A4 inhibitor, which can result in significant interactions with CYP3A substrates.
DRV/c or DRV/r
  • Higher genetic barrier to resistance than NNRTIs, EVG, and RAL
  • PI resistance at the time of treatment failure uncommon with PK-enhanced PIs
  • Skin rash.
  • Food requirement.
  • GI adverse effects.
  • CYP3A4 inhibitors and substrates: potential for drug interactions.
  • Increased CV risk in one observational cohort study.
DRV/c (specific considerations)
  • Coformulated as DRV/c and DRV/c/TAF/FTC
  • cobi inhibits active tubular secretion of Cr and can increase serum Cr without affecting renal glomerular function.
  • Coadministration with TDF is NOT recommended in patients with CrCl <70 mL/min.
  • cobi (like RTV) is a potent CYP3A4 inhibitor, which can result in significant interactions with CYP3A substrates.
LPV/r
  • Only RTV-coformulated PI
  • No food requirement
  • Requires RTV 200 mg per day.
  • Possible higher risk of MI associated with cumulative use of LPV/r.
  • PR and QT interval prolongation have been reported. Use with caution in patients at risk of cardiac conduction abnormalities or in patients receiving other drugs with similar effects.
  • Possible nephrotoxicity
  • CYP3A4 inhibitors and substrates: potential for drug interactions

Co-Receptor Tropism Assays

A co-receptor tropism assay should be performed whenever the use of a CCR5 co-receptor antagonist is being considered. (A, I)
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Co-receptor tropism testing is also recommended for patients with HIV who exhibit virologic failure on a CCR5 antagonist. (B, III)
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A phenotypic tropism assay is preferred to determine HIV-1 co-receptor usage. (A, I)
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A genotypic tropism assay should be considered as an alternative test to predict HIV-1 co-receptor usage. (B, II)
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A proviral DNA tropism assay can be utilized for patients with undetectable HIV-1 RNA when a CCR5 antagonist is considered for use in a new regimen (e.g., as part of a regimen switch or simplification). (B, II)
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HLA-B*5701 Screening

The Panel recommends screening for HLA-B*5701 before starting patients on an abacavir (ABC)-containing regimen to reduce the risk of HSR. (A, I)
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HLA-B*5701-positive patients should NOT be prescribed ABC. (A, I)
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The positive status should be recorded as an ABC allergy in the patient’s medical record. (A, II)
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When HLA-B*5701 screening is not readily available, it remains reasonable to initiate ABC with appropriate clinical counseling and monitoring for any signs of HSR. (C, III)
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Table 3. Cockcroft-Gault Equation for Creatinine Clearance

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Male:

(140 – age in years) × (weight in kg) ÷ (72 × serum creatinine)

Female:

(140 – age in years) × (weight in kg) × (0.85) ÷ (72 × serum creatinine)

Table 4. Child-Pugh Score

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Component

Points Scored

1

2

3

Encephalopathya

None

Grade 1–2

Grade 3–4

Ascites

None

Mild or controlled by diuretics

Moderate or refractory despite diuretics

Albumin

>3.5 g/dL

2.8–3.5 g/dL

<2.8 g/dL

Total bilirubin

OR

<2 mg/dL (<34 μmol/L)

2–3 mg/dL (34–50 μmol/L)

>3 mg/dL (>50 μmol/L)

Modified total bilirubinb

<4 mg/dL

4–7 mg/dL

>7 mg/dL

Prothrombin time (seconds prolonged) or

<4

4–6

>6

International normalized ratio (INR)

<1.7

1.7–2.3

>2.3

a Encephalopathy Grades:
Grade 1: Mild confusion, anxiety, restlessness, fine tremor, slowed coordination
Grade 2: Drowsiness, disorientation, asterixis
Grade 3: Somnolent but rousable, marked confusion, incomprehensible speech, incontinence, hyperventilation
Grade 4: Coma, decerebrate posturing, flaccidity

b Modified total bilirubin used for patients who have Gilbert’s syndrome or who are taking indinavir or atazanavir

Child-Pugh Classification

Total Child-Pugh Score

Class A

5–6 points

Class B

7–9 points

Class C

>9 points

Table 5. Laboratory Testing Schedule for HIV-Infected Patients Before and After Initiation of ARTa

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Laboratory Test Timepoint/Frequency of Testing
Entry into Care ART Initiationb or Modification 2–8 Weeks After ART Initiation or Modification Every 3–6 Months Every 6 Months Every 12 Months Treatment Failure Clinically Indicated If ART Initiation is Delayedc
HIV Serology ✔︎
If HIV diagnosis has not been confirmed
CD4 Count ✔︎ ✔︎ ✔︎
During first 2 years of ART or if viremia develops while patient on ART or CD4 count <300 cells/mm3		 ✔︎
After 2 years on ART with consistently suppressed viral load:
CD4 Count 300–500 cells/mm3:
  • Every 12 mos
CD4 Count >500 cells/mm3:
CD4 monitoring is optional		 ✔︎ ✔︎ ✔︎
Every 3–6 months
HIV Viral Load ✔︎ ✔︎ ✔︎d ✔︎e ✔︎e ✔︎ ✔︎ Repeat testing is optional
Resistance Testing ✔︎ ✔︎f ✔︎ ✔︎ ✔︎f
HLA-B*5701 Testing ✔︎
If considering ABC
Tropism Testing ✔︎
If considering a CCR5 antagonist		 ✔︎
If considering a CCR5 antagonist or for failure of CCR5 antagonist-based regimen		 ✔︎
Hepatitis B Serologyg,h,i
(HBsAb, HBsAg, HBcAb total)		 ✔︎ ✔︎
May repeat if patient non-immune and not chronically infected with HBVh		 ✔︎
May repeat if patient non-immune and not chronically infected with HBVh		 ✔︎
Including prior to starting HCV DAA
Hepatitis C Screening
(HCV antibody or, if indicated, HCV RNA)j		 ✔︎ ✔︎
Repeat HCV screening for at-risk patientsk		 ✔︎
Basic Chemistryl,m ✔︎ ✔︎ ✔︎ ✔︎ ✔︎ ✔︎
Every 6–12 mos
ALT, AST, Total bilirubin ✔︎ ✔︎ ✔︎ ✔︎ ✔︎ ✔︎
Every 6–12 mos
CBC with Differential ✔︎ ✔︎ ✔︎
If on ZDV		 ✔︎
If on ZDV or if CD4 testing is done		 ✔︎ ✔︎ ✔︎
Every 3–6 mos
Fasting Lipid Profilen ✔︎ ✔︎ ✔︎
If abnormal at last measurement		 ✔︎
If normal at last measurement		 ✔︎ ✔︎
If normal at baseline, annually
Fasting Glucose or Hemoglobin A1C ✔︎ ✔︎ ✔︎
If abnormal at last measurement		 ✔︎
If normal at last measurement		 ✔︎ ✔︎
If normal at baseline, annually
Urinalysism,o ✔︎ ✔︎ ✔︎
If on TAF or or TDFl		 ✔︎ ✔︎
Pregnancy Test ✔︎ ✔︎
In women with child-bearing potential		 ✔︎
This table pertains to laboratory tests done to select an aARV regimen and monitor for treatment responses or ART toxicities. Please refer to the HIV Primary Care guidelines for guidance on other laboratory tests generally recommended for primary health care maintenance of HIV patients.
If bART initiation occurs soon after HIV diagnosis and entry into care, repeat baseline laboratory testing is not necessary.
cART is indicated for all HIV-infected individuals and should be started as soon as possible. However, if ART initiation is delayed, patients should be retained in care, with periodic monitoring as noted above.
d If HIV RNA is detectable at 2–8 weeks, repeat every 4–8 weeks until viral load is suppressed to <200 copies/mL, and thereafter, every 3–6 months.
In patients on eART, viral load typically is measured every 3–4 months. However, for adherent patients with consistently suppressed viral load and stable immunologic status for more than 2 years, monitoring can be extended to 6-month intervals.
-naive patients who do not immediately begin fART, repeat testing before initiation of ART is optional if resistance testing was performed at entry into care. In virologically suppressed patients who are switching therapy because of toxicity or for convenience, viral amplification will not be possible. Therefore, resistance testing should not be performed. Results from prior resistance testing can be helpful in constructing a new regimen.
If patient has gHBV infection (as determined by a positive HBsAg or HBV DNA test), TDF or TAF plus either FTC or 3TC should be used as part of the ARV regimen to treat both HBV and HIV infections.
If hHBsAg, HBsAb and HBcAb are negative, hepatitis B vaccine series should be administered. Refer to HIV Primary Care and Opportunistic Infections guidelines for more detailed recommendations.
Most patients with isolated iHBcAb have resolved HBV infection with loss of HBsAb. Consider performing an HBV viral load for confirmation. If the HBV viral load is positive, the patient may be acutely infected (and will usually display other signs of acute hepatitis) or chronically infected. If negative, the patient should be vaccinated. Refer to HIV Primary Care and the Adult and Adolescent Opportunistic Infections Guidelines for more detailed recommendations.
jHCV antibody may not be adequate for screening in the setting of recent HCV infection (acquisition within past 6 months), or advanced immunodeficiency (CD43 count <100 cells/mm). HCV RNA screening is indicated in persons who have been successfully treated for HCV or who spontaneously cleared prior infection. HCV antibody-negative patients with elevated ALT may need HCV RNA testing.
Injection drug users, persons with a history of incarceration, men with HIV who have unprotected sex with men, and persons with percutaneous/parenteral exposure to blood in unregulated settings are at risk of kHCV infection.
Serum lNa, K3, HCO, Cl, BUN, creatinine, glucose (preferably fasting), and creatinine-based eGFR. Serum phosphorus should be monitored in patients with chronic kidney disease who are on TAF- or TDF-containing regimens.
m Consult the Guidelines for the Management of Chronic Kidney Disease in HIV-Infected Patients: Recommendations of the HIV Medicine Association of the Infectious Diseases Society of America for recommendations on managing patients with renal disease. More frequent monitoring may be indicated for patients with evidence of kidney disease (e.g., proteinuria, decreased glomerular function) or increased risk of renal insufficiency (e.g., patients with diabetes, hypertension).
n Consult the National Lipid Association’s recommendations for management of patients with dyslipidemia.
o Urine glucose and protein should be assessed before initiating TAF- or TDF-containing regimens, and monitored during treatment with these regimens.

Table 6. Dosing of Antiretroviral Agents

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ARVs
Generic Name
(Abbreviation)
Trade Name		 Usual Daily Dosea Dosing in Renal Insufficiencyb Dosing in Hepatic Impairment
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Abacavir
(ABC)
Ziagen®		 300 mg PO bid No dosage adjustment necessary Child-Pugh Class A:
  • 200 mg PO bid
    (use oral solution)
Child-Pugh Class B/C:
  • Contraindicated
Didanosine EC
(ddI)
Videx® EC		 Body weight ≥60 kg:
  • 400 mg PO once daily
Body weight <60 kg:
  • 250 mg PO once daily
 Dose (Once Daily) No dosage adjustment necessary
CrCl
(mL/min)		 ≥60 kg <60 kg
30–59 200 mg 125 mg
10–29 125 mg 125 mg
<10, HDc, CAPD 125 mg 75 mg oral solution
Didanosine Oral Solution
(ddI)
Videx®		 Body weight ≥60 kg:
  • 200 mg PO bid, OR
  • 400 mg PO once daily
Body weight <60 kg:
  • 250 mg PO once daily, OR
  • 125 mg PO bid
 Dose (Once Daily) No dosage adjustment necessary
CrCl
(mL/min)		 ≥60 kg <60 kg
30–59 200 mg 150 mg
10–29 150 mg 100 mg
<10, HDc, CAPD 100 mg 75 mg
Emtricitabine
(FTC)
Emtriva®		 200 mg oral capsule once daily OR 240 mg (24 mL) oral solution once daily CrCl
(mL/min)		 Capsule Dose Solution Dose No dosage recommendation
30–49 200 mg q48h 120 mg q24h
15–29 200 mg q72h 80 mg q24h
<15 or on HDc 200 mg q96h 60 mg q24h
Lamivudine
(3TC)
Epivir®		 300 mg PO once daily OR 150 mg PO bid CrCl
(mL/min)		 Dose No dosage adjustment necessary
30–49 150 mg q24h
15–29 1 × 150 mg, then 100 mg q24h
5–14 1 × 150 mg, then 50 mg q24h
<5 or on HDc 1 × 50 mg, then 25 mg q24h
Stavudine
(d4T)
Zerit®		 Body weight ≥60 kg:
  • 40 mg PO bid
Body weight <60 kg:
  • 30 mg PO bid
 Dose No dosage recommendation
CrCl
(mL/min)		 ≥60 kg <60 kg
26–50 20 mg q12h 15 mg q12h
10–25 or on HDc 20 mg q24h 15 mg q24h
Tenofovir Disoproxil Fumarate
(TDF)
Viread®		 300 mg PO once daily CrCl
(mL/min)		 Dose No dosage adjustment necessary
30–49 300 mg q48h
10–29 300 mg twice weekly (every 72-96 hours)
<10 and not on HD No rec.
On HDc 300 mg q7d
Tenofovir Disoproxil Fumarate/Lamivudine
(TDF/3TC)
Cimduo		 1 tablet PO once daily CrCl
(mL/min)		 Dose No dose recommendation
<50 or on HD NOT recommended
Zidovudine
(ZDV)
Retrovir®		 300 mg PO bid CrCl
(mL/min)		 Dose No dosage recommendation
<15 or on HDc 100 mg tid or 300 mg once daily
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Doravirine
(DOR)
Pifeltro		 1 tablet PO once daily No dose adjustment required in mild, moderate, or severe renal impairment.
Has not been studied in ESRD or HD.		 Child-Pugh Class A or B:
  • No dose adjustment
Child-Pugh Class C:
  • Not studied
Efavirenz
(EFV)
Sustiva®		 600 mg PO once daily, at or before bedtime No dosage adjustment necessary Child-Pugh Class A:
  • No dose adjustment
Child-Pugh Class B/C:
  • NOT recommended
Etravirine
(ETR)
Intelence®		 200 mg PO bid No dosage adjustment necessary Child-Pugh Class A/B:
  • No dose adjustment
Child-Pugh Class C:
  • No dosage rec.
Nevirapine
(NVP)
Viramune®
Viramune® XR
  • 200 mg PO bid, or
  • 400 mg PO once daily (using Viramune XR formulation)
 No dose adjustment for patients with renal impairment.
Patients on HD should receive an additional dose of 200 mg following each dialysis treatment.		 Child-Pugh Class A:
  • No dosage adjustment
Child-Pugh Class B/C:
  • Contraindicated
Rilpivirine
(RPV)
Edurant®		 25 mg PO once daily No dosage adjustment necessary Child-Pugh Class A/B:
  • No dose adjustment
Child-Pugh Class C:
  • No dosage rec.
Atazanavir
(ATV)
Reyataz®		 400 mg PO once daily
OR
ATV 300 mg + RTV 100 mg PO once daily		 No dosage adjustment for patients with renal dysfunction who do not require HD
ARV-Naive Patients on HD:
  • ATV 300 mg + RTV 100 mg once daily
ARV-Experienced Patients on HD:
  • ATV or ATV/r NOT recommended
 Child-Pugh Class B:
  • 300 mg once daily
Child-Pugh Class C:
  • NOT recommendedRTV boosting is NOT recommendedin patients with hepatic impairment (Child-Pugh Class B or C).
Atazanavir/cobi
(ATV/c)
Evotaz®		 1 tablet PO once daily If Used with TDF:
  • NOT recommended for use in patients with CrCl <70 mL/min
 NOT recommendedin patients with hepatic impairment
Darunavir
(DRV)
Prezista®		 ARV-Naive Patients and ARV-Experienced Patients with No DRV Resistance Mutations:
  • DRV 800 mg + RTV 100 mg PO once daily
ARV-Experienced Patients with ≥1 DRV Resistance Mutation:
  • DRV 600 mg + RTV 100 mg PO bid
 No dosage adjustment necessary Mild-to-Moderate Hepatic Impairment:
  • No dosage adjustment
Severe Hepatic Impairment:
  • NOT recommended
Fosamprenavir
(FPV)
Lexiva®
  • 1400 mg PO bid, or
  • FPV 1400 mg + RTV 100–200 mg PO once daily, or
  • FPV 700 mg + RTV 100 mg PO bid
 No dosage adjustment necessary PI-Naive Patients Only
Child-Pugh Score 5–9:
  • 700 mg bid
Child-Pugh Score 10–15:
  • 350 mg bid
PI-Naive or PI-Experienced Patients
Child-Pugh Score 5–6:
  • 700 mg bid + RTV 100 mg once daily
Child-Pugh Score 7–9:450 mg bid + RTV 100 mg) once daily
Child-Pugh Score 10–15:
  • 300 mg bid + RTV 100 mg once daily
Indinavir
(IDV)
Crixivan®		 800 mg PO q8h No dosage adjustment necessary Mild-to-Moderate Hepatic Insufficiency Because of Cirrhosis:
  • 600 mg q8h
Lopinavir/
Ritonavir
(LPV/r)
Kaletra®
  • LPV 400 mg + RTV 100 mg PO bid, or
  • LPV 800 mg + RTV 200 mg PO once daily
 Avoid once-daily dosing in patients on HD No dosage recommendation; use with caution in patients with hepatic impairment.
Nelfinavir
(NFV)
Viracept®		 1250 mg PO bid No dosage adjustment necessary Mild Hepatic Impairment:
  • No dosage adjustment
Moderate-to-Severe Hepatic Impairment:
  • Do NOT use
Ritonavir
(RTV)
Norvir®		 As a PI-Boosting Agent:
  • 100–400 mg per day
 No dosage adjustment necessary Refer to recommendations for the primary PI.
Saquinavir
(SQV)
Invirase®		 SQV 1000 mg + RTV 100 mg PO bid No dosage adjustment necessary Mild-to-Moderate Hepatic Impairment:
  • Use with caution
Severe Hepatic Impairment:
  • Contraindicated
Tipranavir
(TPV)
Aptivus®		 TPV 500 mg + RTV 200 mg PO bid No dosage adjustment necessary Child-Pugh Class A:
  • Use with caution
Child-Pugh Class B/C:
  • Contraindicated
Darunavir/
cobi
(DRV/c)
Prezcobix®		 1 tablet PO once daily
(recommended only for patients without DRV-associated resistance mutations)		 If Used with TDF:
NOT recommended for use in patients with CrCl <70 mL/min		 Child-Pugh Class A/B:
  • No dosage adjustment
Child-Pugh Class C:
  • NOT recommended
Integrase Strand Inhibitors (INSTIs)
Dolutegravir
(DTG)
Tivicay®		 50 mg once daily
OR
50 mg bid		 No dosage adjustment necessary Child-Pugh Class A/B:
  • No dosage adjustment
Child-Pugh Class C:
  • NOT recommended
Raltegravir
(RAL)
Isentress® HD
  • 400 mg bid
    (using Isentress formulation), or
  • 1200 mg once daily (use Isentress HD formulation only)
  • Do NOT substitute Isentress tablets for Isentress HD dosage.
 No dosage adjustment necessary Mild-to-Moderate Hepatic Insufficiency:
  • No dosage adjustment necessary
Severe Hepatic Insufficiency:
  • No recommendation
Fusion Inhibitor
Enfuvirtide
(T20)
Fuzeon®		 90 mg subcutaneous bid No dosage adjustment necessary No dosage adjustment necessary
Trade Name
Contents		 Usual Daily Dosea Dosing in Renal Insufficiencyb Dosing in Hepatic Impairment
CCR5 Antagonist
Maraviroc
(MVC)
Selzentry®		 The recommended dose differs based on concomitant medications and potential for drug-drug interactions. CrCl <30 mL/min or on HD:
Without Potent CYP3A Inhibitors or Inducers:
  • 300 mg bid; reduce to 150 mg bid if postural hypotension occurs.
With Potent CYP3A Inducers and Inhibitors:
  • NOT recommended
 No dosage recommendations.
Concentrations will likely be increased in patients with hepatic impairment.
CD4 Post-Attachment Inhibitor
Ibalizumab
(IBA)
Trogarzo®
  • Loading dose of 2000 mg IV, followed by a maintenance dose of 800 mg IV every 2 weeks
 No dosage adjustment necessary No recommendation
Fixed-dose Combinations
Atripla ®
FTC 200 mg
EFV 600 mg
TDF 300 mg		 1 tablet once daily on an empty stomach, preferably at bedtime NOT recommended if CrCl <50 mL/min. Instead use the individual drugs of the fixed-dose combination and adjust TDF and FTC doses according to CrCl level. Child-Pugh Class A:
  • No dosage adjustment
Child-Pugh Class B/C:
  • NOT recommended
Biktarvy ®
BIC 50 mg
FTC 200 mg
TAF 25 mg		 1 tablet once daily NOT recommended if CrCl <30 mL/min Child-Pugh Class C:
  • NOT recommended
Cimduo
TDF 300 mg
3TC 300 mg		 1 tablet once daily NOT recommended if CrCl <50 mL/min or on HD No dose recommendation
Combivir ®
3TC 150 mg
ZDV 300 mg		 1 tablet bid CrCl <50 mL/min
NOT recommended
  • Monitor for hematologic toxicity
Complera ®
FTC 200 mg
RPV 25 mg
TDF 300 mg		 1 tablet once daily with a meal NOT recommended if CrCl <50 mL/min. Instead use the individual drugs of the fixed-dose combination and adjust TDF and FTC doses according to CrCl level. Child-Pugh Class A/B:
  • No dosage adjustment
Child-Pugh Class C:
  • No dosage recommendation
Delstrigo ®
DOR 100 mg
TDF 300 mg
3TC 300 mg		 1 tablet once daily NOT recommended if CrCl <50 mL/min. Child-Pugh Class A or B:
  • No dose adjustment
Child-Pugh Class C:
  • Not studied
Descovy ®
FTC 200 mg
TAF 25 mg		 1 tablet once daily NOT recommended if CrCl <30 mL/min or on HD Child-Pugh Class A/B:
  • No dosage adjustment
Child-Pugh Class C:
  • No dosage recommendation
Dovato
DTG 50 mg
3TC 300 mg		 1 tablet once daily NOT recommended if CrCl <50 mL/min Child-Pugh Class C:
  • 200 NOT recommended
Epzicom ®
ABC 600 mg
3TC 300 mg		 1 tablet once daily NOT recommended if CrCl <50 mL/min Child-Pugh Class A:
  • 200 mg PO bid
    (use oral solution)
Child-Pugh Class B/C:
  • Contraindicated
Genvoya ®
FTC 200 mg
EVG 150 mg
cobi 150 mg
TAF 10 mg		 1 tablet once daily with food NOT recommended if CrCl <30 mL/min or ≤15 mL/min who are not receiving chronic HD.
In patients on chronic HD: One tablet once daily. On dialysis days, administer after dialysis.		 Mild-to-Moderate Hepatic Insufficiency:
  • No dosage adjustment necessary
Severe Hepatic Insufficiency:
  • NOT recommended
Juluca
RPV 25 mg
DTG 50 mg		 1 tablet once daily with food No dose adjustment necessary.
In patients with CrCl <30 mL/min, monitor closely for adverse effects.		 Child-Pugh Class A/B:
  • No dosage adjustment
Child-Pugh Class C:
  • No dosage recommendation
Odefsey ®
FTC 200 mg
RPV 25 mg
TAF 25 mg		 1 tablet once daily with food NOT recommended if CrCl <30 mL/min Child-Pugh Class A/B:
  • No dosage adjustment
Child-Pugh Class C:
  • No dosage recommendation
Stribild ®
FTC 200 mg
EVG 150 mg
cobi 150 mg
TDF 300 mg		 1 tablet once daily EVG/c/TDF/FTCshould NOT be initiated in patients with CrCl <70 mL/min.
Discontinue EVG/c/TDF/FTC if CrCl declines to <50 mL/min while patient is on therapy.		 Mild-to-Moderate Hepatic Insufficiency:
  • No dosage adjustment necessary
Severe Hepatic Insufficiency:
  • NOT recommended
Symfi
EFV 600 mg
TDF 300 mg
3TC 300 mg		 1 tablet once daily on an empty stomach, preferably at bedtime NOT recommended if CrCl <50 mL/min or if patient is on HD. Instead, use the individual drugs and adjust TDF and 3TC doses according to CrCl level. NOT recommended for patients with moderate or severe hepatic impairment. Use caution in patients with mild hepatic impairment.
Symfi Lo
EFV 400 mg
TDF 300 mg
3TC 300 mg		 1 tablet once daily on an empty stomach, preferably at bedtime NOT recommended if CrCl <50 mL/min or if patient is on HD. Instead, use the individual drugs and adjust TDF and 3TC doses according to CrCl level. NOT recommended for patients with moderate or severe hepatic impairment. Use caution in patients with mild hepatic impairment.
Symtuza
DRV 800 mg
c 150 mg
TAF 10 mg
FTC 200 mg		 1 tablet once daily Not recommended if CrCl <30 mL/min. Not recommended for patients with severe hepatic impairment.
Temixys
TDF 300 mg
3TC 300 mg		 1 tablet once daily NOT recommended if CrCl <50 mL/min or on HD No dose recommendation
Triumeq
DTG 50 mg
ABC 600 mg
3TC 300 mg		 1 tablet once daily NOT recommended if CrCl <50 mL/min.
Instead, use the individual drugs and adjust 3TC dose according to CrCl.		 Child-Pugh Class A:
  • Patients with mild hepatic impairment require a dose reduction of ABC. Use the individual drugs instead of the fixed-dose combination in these patients.
Child-Pugh Class B/C:
  • Contraindicated, due to the ABC component
Trizivir ®
3TC 150 mg
ABC 300 mg
ZDV 300 mg		 1 tablet bid NOT recommended if CrCl <50 mL/min. Child-Pugh Class A:
  • May required adjustment of abacavir dose
Child-Pugh Class B/C:
  • Contraindicated
Truvada ®
FTC 200 mg
TDF 300 mg		 1 tablet once daily CrCl
(mL/min)		 Dose No dosage recommendation
30–49 1 tablet q48h
<30 or on HD NOT rec.
a Refer to full guideline for additional dosing information.
b Including with chronic ambulatory peritoneal dialysis and hemodialysis.
On dialysis days, take dose after cHD session.

Table 7. Antiretroviral Regimen Considerations as Initial Therapy based on Specific Clinical Scenarios

Having trouble viewing table?

Patient or Regimen Characteristics Clinical Scenario Consideration(s) Rationale/Comments
Pre-ART Characteristics CD4 count
<200 cells/mm3		 Do NOT use the following regimens:
  • RPV-based regimens
  • DRV/r plus RAL
 A higher rate of virologic failure has been observed in those with low pretreatment CD4 cell count.
HIV RNA >100,000 copies/mL Do NOT use the following regimens:
  • RPV-based regimens
  • ABC/3TC with EFV or ATV/r
  • DRV/r plus RAL
 Higher rates of virologic failure have been observed in those with high pretreatment HIV RNA.
HLA-B*5701 positive or result unknown Do NOT use ABC-containing regimens. Abacavir hypersensitivity, a potentially fatal reaction, is highly associated with positivity for the HLA-B*5701 allele.
ARV must be started before HIV drug resistance results are available (e.g., in a person with acute HIV or when a rapid initiation of ART is warranted). Avoid NNRTI-based regimens.
Avoid ABC.
Recommended ART Regimens:
  • DRV/r or DRVa/r + tenofovir/FTC; or
  • DTGa + tenofovir/FTC
  • Transmitted mutations conferring NNRTI resistance are more likely than mutations associated with PI or INSTI resistance.
  • HLA-B*5701 results may not be available rapidly.
  • Transmitted resistance to DRV and DTG is rare, and these drugs have high barriers to resistance.
  • Refer to Table 6b for further guidance before initiating DTG in persons of childbearing potential.
ART-Specific Characteristics A one-pill, once-daily regimen is desired STR Options as Initial ART Include:
  • BIC/TAF/3TC
  • DOR/TDF/3TC
  • DRV/c/TAF/FTC
  • DTG/ABC/3TC
  • EFV/TDF/FTC
  • EVG/c/TAF/FTC
  • EVG/c/TDF/FTC
  • RPV/TAF/FTC
  • RPV/TDF/FTC
  • Do NOT use RPV-based regimens if HIV RNA >100,000 copies/mL and CD43 count <200/mm.
  • Do NOT use DTG/ABC/3TC if HLA-B*5701 positive
  • Refer to Table 6b for further guidance before initiating an INSTI in persons of childbearing potential.
  • See Appendix B, Table 8 for ARV dose recommendations in the setting of renal impairment.
Food effects Regimens that can be taken without regard to food:
  • BIC-, DOR-, RAL- or DTG-based regimens
 Oral bioavailability of these regimens is not significantly affected by food.
Refer to Table 6b for further guidance before initiating an INSTI in persons of childbearing potential.
Regimens that should be taken with food:
  • ATV/r- or ATV/c-based regimens
  • DRV/r- or DRV/c-based regimens
  • EVG/c/TDF/FTCa
  • EVG/c/TAF/FTCa
  • RPV-based regimens
 Food improves absorption of these listed regimens. RPV-containing regimens should be taken with at least 390 calories of food.
Regimens that should be taken on an empty stomach:
  • EFV-based regimens
 Food increases EFV absorption and may increase CNS side effects.
Presence of Other Conditions Chronic kidney disease (defined as CrCl <60 mL/min)
  • Avoid TDF unless the patient has ESRD. Use ABC or TAF.
  • ABC may be used if HLA-B*5701 negative. If HIV RNA >100,000 copies/mL, do NOT use ABC/3TC + (EFV or ATV/r).
  • TAF may be used if CrCl >30 mL/min.
  • Consider avoiding ATV.
ART Options When ABC, TAF or TDF Cannot be Used:
  • DTG plus 3TC
  • DRV/r plus 3TC
  • DRV/r plus RAL (if CD43 cell count >200 cells/mm and HIV RNA <100,000 copies/mL)
  • TDF has been associated with proximal renal tubulopathy. Higher rates of renal dysfunction reported in patients using TDF in conjunction with RTV-containing regimens.
  • An adjusted dose of TDF can be used in patients with ESRD or in those who are on hemodialysis. Refer to Appendix B, Table 8 for specific dosing recommendations.
  • TAF has less impact on renal function and lower rates of proteinuria than TDF.
  • ATV has been associated with chronic kidney disease in some observational studies.
  • ABC has not been associated with renal dysfunction.
  • Refer to Table 6b for further guidance before initiating an INSTI in persons of childbearing potential.
Liver disease with cirrhosis Some ARVs are contraindicated or may require dosage modification in patients with Child-Pugh class B or C disease.
  • Refer to Table 6 for specific dosing recommendations.
  • Patients with cirrhosis should be carefully evaluated by an expert in advanced liver disease.
Osteoporosis
  • Avoid TDF.
  • Use ABC or TAF.
  • ABC may be used if HLA-B*5701 negative.
  • If HIV RNA >100,000 copies/mL, do NOT use ABC/3TC + (EFV or ATV/r).
  • TDF is associated with decreases in bone mineral density along with renal tubulopathy, urine phosphate wasting and resultant osteomalacia.
  • TAF and ABC are associated with smaller declines in bone mineral density than TDF.
Psychiatric illnesses
  • Consider avoiding EFV- and RPV-based regimens.
  • Patients on INSTI-based regimens with pre-existing psychiatric conditions should be closely monitored.
  • Some ARVs are contraindicated and some psychiatric medications need dose adjustments when coadministered with certain ARVs.
  • EFV and RPV can exacerbate psychiatric symptoms and may be associated with suicidality.
  • INSTIs have been associated with adverse neuropsychiatric effects in some retrospective cohort studies and case series.
  • See the drug-drug interaction tables (Tables 19a, 19b, and 19d) for dosing recommendations when drugs used for psychiatric illnesses are used with certain ARVs.
HIV-associated dementia (HAD)
  • Avoid EFV-based regimens if possible.
  • Favor DRV- or DTG-based regimens.
  • EFV-related neuropsychiatric effects may confound assessment of ART’s beneficial effects on improvement of HAD-related symptoms.
  • There is a theoretical CNS penetration advantage of DTG- or DRV-based regimens.
Narcotic replacement therapy required
  • If patient is receiving methadone, consider avoiding EFV-based regimens.
  • If EFV is used, an increase in methadone dose may be necessary.
 EFV reduces methadone concentrations and may lead to withdrawal symptoms.
High cardiac risk
  • DTG-, RAL- or RPV-based regimens may be advantageous in this setting.
  • Consider avoiding ABC- and LPV/r-based regimens.
  • If a boosted PI is the desired option, an ATV-based regimen may have advantages over a DRV-based regimen.
  • An increased CV risk has been observed in some studies.
  • Observational cohort studies reported an association between some PIs (DRV, IDV, FPV, and LPV/r) and an increased risk of CV events, while this has not been seen with ATV. Further study is needed.
Cardiac QTc interval prolongation Consider avoiding EFV- or RPV-based regimens if taking other medications with known risk of TdP, or in patients at higher risk of TdP. High EFV or RPV concentrations may cause QT prolongation.
Hyperlipidemia The following ARV drugs have been associated with dyslipidemia:
  • PI/r or PI/c
  • EFV
  • EVG/c
  • DTG, RAL and RPV have fewer lipid effects.
  • TDF has been associated with lower lipid levels than ABC or TAF.
Patients with history of poor adherence to ARV or inconsistent engagement in care Consider boosted PI- or DTG-based regimens. These regimens have a high genetic barrier to resistance.
Pregnancy Refer to the Perinatal Guidelines at http://aidsinfo.nih.gov/guidelines
Presence of Coinfections HBV infection
  • Use TDF or TAF, with FTC or 3TC, whenever possible.
If TDF and TAF are Contraindicated:
  • For treatment of HBV, use FTC or 3TC with entecavir and a suppressive ART regimen (see HBV/HIV Coinfection at http://aidsinfo.nih.gov/guidelines).
 TDF, TAF, FTC, and 3TC are active against both HIV and HBV. 3TC- or FTC-associated HBV mutations can emerge rapidly when these drugs are used without another drug active against HBV.
HCV treatment required
  • Refer to recommendations for HCV/HIV Coinfection at http://aidsinfo.nih.gov/guidelines with special attention to potential interactions between ARV drugs and HCV drugs.
Treating TB disease with rifamycins TAF is NOT recommended with any rifamycin-containing regimen.
If Rifampin is Used:
  • EFV can be used without dosage adjustment.
  • If RAL is used, increase RAL dose to 800 mg bid.
  • Use DTG at 50 mg bid dose only in patients without selected INSTI mutations (refer to product label).
If using a PI-based regimen, rifabutin should be used in place of rifampin in the TB regimen.
  • Rifamycins may significantly reduce TAF exposure.
  • Rifampin is a strong inducer of CYP3A4 and UGT1A1 enzymes, causing significant decrease in concentrations of PIs, INSTIs, and RPV.
  • Rifampin has a less significant effect on EFV concentration than on other NNRTIs, PIs, and INSTIs.
  • Rifabutin is a less potent inducer and is a good option for patients receiving non-EFV-based regimens.
Refer to http://aidsinfo.nih.gov/guidelines for dosing recommendations for rifamycins used with different ARV agents.
aTAF and TDF are two approved forms of tenofovir. TAF has less bone and kidney toxicities than TDF, whereas TDF is associated with lower lipid levels. Safety, cost, and access are among the factors to consider when choosing between these drugs.

This quick-reference version of the DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents is not intended to replace the full text guideline available at https://clinicalinfo.hiv.gov/en/guidelines