Appendix B: Drug Characteristics Tables

Actualizado Reviewed

To view a table, please click on the corresponding link:

Appendix B, Table 1. Coformulated and Copackaged Antiretroviral Regimens

Updated: September 12, 2024
Reviewed: September 12, 2024

The following table includes dose recommendations for U.S. Food and Drug Administration (FDA)–approved coformulated and copackaged antiretroviral regimens for adults with HIV. Not all products are FDA approved for adolescents with HIV. For information regarding the use of these medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines. Please see the class-specific drug characteristics tables (Appendix B, Tables 3, 4, 5, and 6) for details about the individual drugs included in these products, including information on elimination and metabolic pathways, serum and intracellular half-lives, and adverse effects. The products in this table are listed by drug class and arranged in alphabetical order by trade name within each class.

Trade Name
(Abbreviation)		ARV Drugs Included in the RegimenDosing Recommendationa
INSTI Plus Two NRTIs
Biktarvy
(BIC/TAF/FTC)		Bictegravir 50 mg/tenofovir alafenamide 25 mg/emtricitabine 200 mgOne tablet PO once daily
Genvoya
(EVG/c/TAF/FTC)		Elvitegravir 150 mg/cobicistat 150 mg/tenofovir alafenamide 10 mg/‌emtricitabine 200 mgOne tablet PO once daily with food
Stribild
(EVG/c/TDF/FTC)		Elvitegravir 150 mg/cobicistat 150 mg/‌tenofovir disoproxil fumarate 300 mg/‌emtricitabine 200 mgOne tablet PO once daily with food
Triumeq
(DTG/ABC/3TC)		Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mgOne tablet PO once daily
INSTI Plus One NRTI
Dovato
(DTG/3TC)		Dolutegravir 50 mg/lamivudine 300 mgOne tablet PO once daily
INSTI Plus One NNRTI
Cabenuva
(CAB IM and RPV IM)

Cabenuva 600-mg/900-mg kit contains:

  • CAB 600-mg/3-mL vial and RPV 900-mg/3-mL vial

Cabenuva 400-mg/600-mg kit contains:

  • CAB 400-mg/2-mL vial and RPV 600-mg/2-mL vial

Optional Lead-in with Oral CAB and RPV

  • CAB 30 mg PO and RPV 25 mg PO once daily with food for 4 weeks

Monthly IM CAB and RPV

  • Loading dose: CAB 600 mg/3 mL IM × 1 dose and RPV 900 mg/‌3 mL IM for 1 dose
  • Continuation phase: CAB 400 mg/2 mL IM every 4 weeks and RPV 600 mg/2 mL IM every 4 weeks

Every 2-Month IM CAB and RPV

  • Loading dose: CAB 600 mg/3 mL IM and RPV 900 mg/3 mL IM once monthly for 2 doses
  • Continuation phase: CAB 600 mg/3 mL IM and RPV 900 mg/3 mL IM every 2 months
Juluca
(DTG/RPV)		Dolutegravir 50 mg/rilpivirine 25 mgOne tablet PO once daily with food
NNRTI Plus Two NRTIs
Atripla
(EFV/TDF/FTC)		Efavirenz 600 mg/tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mgOne tablet PO once daily on an empty stomach, preferably at bedtime
Complera
(RPV/TDF/FTC)		Rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mgOne tablet PO once daily with food
Delstrigo
(DOR/TDF/3TC)		Doravirine 100 mg/tenofovir disoproxil fumarate 300 mg/lamivudine 300 mgOne tablet PO once daily
Odefsey
(RPV/TAF/FTC)		Rilpivirine 25 mg/tenofovir alafenamide 25 mg/emtricitabine 200 mgOne tablet PO once daily with food
Symfi
(EFV/TDF/3TC)		Efavirenz 600 mg/tenofovir disoproxil fumarate 300 mg/lamivudine 300 mgOne tablet PO once daily on an empty stomach, preferably at bedtime
Symfi Lo
(EFV/TDF/3TC)		Efavirenz 400 mg/tenofovir disoproxil fumarate 300 mg/lamivudine 300 mgOne tablet PO once daily on an empty stomach, preferably at bedtime
PI Plus Two NRTIs
Symtuza
(DRV/c/TAF/FTC)		Darunavir 800 mg/cobicistat 150 mg/tenofovir alafenamide 10 mg/emtricitabine 200 mgOne tablet PO once daily with food
a For dose adjustments in people with renal or hepatic insufficiency, see Appendix B, Table 12. When no food restriction is listed, the product can be taken with or without food.

Key: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; BIC = bictegravir; CAB = cabotegravir; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FTC = emtricitabine; IM = intramuscular; INSTI = integrase strand transfer inhibitor; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; PI = protease inhibitor; PO = orally; RPV = rilpivirine; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Appendix B, Table 2. Nucleoside Reverse Transcriptase Inhibitor-Based, Fixed-Dose Combination Tablets for Use as Part of an Antiretroviral Regimen

Updated: May 26, 2023
Reviewed: September 12, 2024

The following table includes dose recommendations for U.S. Food and Drug Administration (FDA)–approved dual nucleoside reverse transcriptase inhibitor fixed-dose combination (FDC) products for adults with HIV. For information regarding the use of these medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines. These FDC tablets are not complete regimens and must be administered in combination with other antiretroviral drugs. FDC products that contain zidovudine (ZDV) have been removed from this table. Please refer to the FDA product labels for information regarding ZDV-containing FDCs. Please see the class-specific drug characteristics tables (Appendix B, Tables 3, 4, 5, and 6) for details about the individual drugs contained in these FDC products, including information on elimination and metabolic pathways, serum and intracellular half-lives, and adverse effects. The FDC tablets in this table are listed by trade name.

Trade Name
(Abbreviation)		ARV Drugs Included in the FDC TabletDosing Recommendationa
TAF or TDF Plus an NRTI
Descovy
(TAF/FTC)		Tenofovir alafenamide 25 mg/emtricitabine 200 mgOne tablet PO once daily
Cimduo
(TDF/3TC)		Tenofovir disoproxil fumarate 300 mg/lamivudine 300 mgOne tablet PO once daily
Truvada
(TDF/FTC)		Tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mgOne tablet PO once daily
Other NRTI-Based, FDC Tablets

Epzicom
(ABC/3TC)

Note: Generic product is available.

Abacavir 600 mg/lamivudine 300 mgOne tablet PO once daily
a For dose adjustments in patients with renal or hepatic insufficiency, see Appendix B, Table 12. All FDC tablets listed in this table can be taken without regard to food.

Key: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; FDC = fixed-dose combination; FTC = emtricitabine; NRTI = nucleoside reverse transcriptase inhibitor; PO = orally; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Appendix B, Table 3. Characteristics of Nucleoside Reverse Transcriptase Inhibitors

Updated: May 26, 2023
Reviewed: September 12, 2024

The following table includes dose recommendations for U.S. Food and Drug Administration (FDA)–approved nucleoside reverse transcriptase inhibitor products for adults with HIV. For information regarding the use of these medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines. The older nucleoside reverse transcriptase inhibitors didanosine (ddI) and stavudine (d4T) have been discontinued in the United States. Zidovudine (ZDV) is no longer used commonly in clinical practice. Therefore, these antiretrovirals have been removed from this table. Please refer to the U.S. FDA product label for ZDV for information regarding this drug.

View full version of Appendix B, Table 3.
Table 3. Characteristics of Nucleoside Reverse Transcriptase Inhibitors
  
  
  
  

Appendix B, Table 4. Characteristics of Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Updated: September 12, 2024
Reviewed: September 12, 2024

The following table includes dose recommendations for U.S. Food and Drug Administration (FDA)–approved non-nucleoside reverse transcriptase inhibitor products (NNRTI) for adults with HIV. For information regarding the use of these medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines. The older NNRTIs delavirdine (DLV) and nevirapine (NVP) are not listed in this table; DLV has been discontinued and NVP is no longer commonly used in clinical practice in the United States.

View full version of Appendix B, Table 4.
Appendix B, Table 4. Characteristics of Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
  
  
  
  

Appendix B, Table 5. Characteristics of Protease Inhibitors

Updated: September 12, 2024
Reviewed: September 12, 2024

The following table includes dose recommendations for U.S. Food and Drug Administration (FDA)–approved protease inhibitor products for adults with HIV. For information regarding the use of these medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines. The older protease inhibitors indinavir (IDV) and saquinavir (SQV) have been discontinued in the United States; fosamprenavir (FPV), lopinavir/ritonavir (LPV/r), nelfinavir (NFV), and tipranavir (TPV) are no longer used commonly in clinical practice. These agents have been removed from this table. Please refer to the July 10, 2019, version of the guidelines (found in the Adult and Adolescent Antiretroviral Archived Guidelines section of Clinicalinfo) or to the U.S. Food and DrugFDA product labels for information regarding these drugs.

View full version of Appendix B, Table 5.
Table 5. Characteristics of Protease Inhibitors
  
  
  
  

Appendix B, Table 6. Characteristics of Integrase Inhibitors

Updated: September 12, 2024
Reviewed: September 12, 2024

The following table includes dose recommendations for U.S. Food and Drug Administration (FDA)–approved integrase strand transfer inhibitor products for adults with HIV. Not all products are FDA-approved for adolescents with HIV. For information regarding the use of these medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines.

Generic Name
(Abbreviation)
Trade Name		FormulationsDosing RecommendationsaElimination/
Metabolic Pathways		Serum Half-LifeAdverse Eventsb
Bictegravir
(BIC)		BIC is available only as a component of the STR Biktarvy (BIC/TAF/FTC).c

Biktarvy

  • One tablet PO once daily

CYP3A4 substrate

UGT1A1-mediated glucuronidation

~17 hours

Diarrhea

Nausea

Headache

Weight gain

Cabotegravir
(CAB)

Available as part of the copackaged IM long-acting regimen Cabenuva (CAB IM and RPV IM)

  • 400-mg/2-mL vial
  • 600-mg/3-mL vial

Also available as an individual product for IM long-acting pre-exposure prophylaxis Apretude (CAB IM)

  • 600-mg/3-mL vial

Also available in oral tablet formulation Vocabria (CAB PO)

  • 30-mg tablet
  • Must be obtained from manufacturer for oral lead-in and oral bridging during administration of Cabenuva (CAB IM/RPV IM)
See Appendix B, Table 1 for dosing information for coformulated and copackaged regimens that contain CAB.UGT1A1 and UGT1A9-mediated glucuronidation

Oral: 41 hours

IM: 6–12 weeks

 

IM formulation only: Injection-site reactions (e.g., pain, induration, swelling, nodules)

The following AEs were reported when CAB was administered in combination with RPV: 

Headache

Nausea

Abnormal dreams

Anxiety

Insomnia

Depressive disorders

Hepatotoxicity

Dolutegravir
(DTG)
Tivicay

Tivicay

  • 50-mg tablet

STRs that Contain DTGc

  • Dovato (DTG/3TC)
  • Juluca (DTG/RPV)
  • Triumeq (DTG/ABC/3TC)

In People Without Prior ARV Treatment or ARV-Experienced People Who Had Never Received INSTIs

  • DTG 50 mg PO once daily

In People Without Prior ARV Treatment or ARV-Experienced People Who Had Never Received INSTIs When Coadministered With EFV, FPV/r, TPV/r, or Rifampin

  • DTG 50 PO mg twice daily

In INSTI-Experienced People With Certain INSTI Mutations (See Product Label) or With Clinically Suspected INSTI Resistance

  • DTG 50 mg PO twice daily

See Appendix B, Table 1 for dosing information for STRs that contain DTG.

UGT1A1-mediated glucuronidation

Minor substrate of CYP3A4

~14 hours

Insomnia

Headache

Depression disorders and suicidal ideation (rare; usually occurs in people with preexisting psychiatric conditions)

Weight gain

Hepatotoxicity

HSRs, including rash, constitutional symptoms, and organ dysfunction (including liver injury), have been reported.

Elvitegravir
(EVG)

EVG is only available as a component of an STR tablet that also contains COBI, FTC, and either TDF or TAF.

STRs That Contain EVGc

  • Genvoya (EVG/c/TAF/FTC)
  • Stribild (EVG/c/TDF/FTC)

Genvoya

  • One tablet PO once daily with food
  • See Appendix B, Table 12 for recommendations on dosing in persons with renal insufficiency.

Stribild

  • One tablet PO once daily with food
  • Not recommended for people with baseline CrCl <70 mL/min (see Appendix B, Table 12 for the CrCl calculation equation).

EVG

  • CYP3A and UGT1A1/3 substrate

COBI

  • CYP3A inhibitor and substrate
  • CYP2D6 inhibitor
EVG/c: ~13 hours

Nausea

Diarrhea

Depression and suicidal ideation (rare; usually occurs in people with preexisting psychiatric conditions)

Raltegravir
(RAL)
Isentress
Isentress HD

Isentress

  • 400-mg tablet
  • 100-mg single-use packet for oral suspension

Isentress HD

  • 600-mg tablet

Isentress

  • 400 mg PO twice daily

With Rifampin

  • 800 mg PO twice daily

Isentress HD

In People Without Prior ARV Treatment or ARV-Experienced People With Virologic Suppression on a Regimen Containing RAL 400 mg Twice Daily

  • 1,200 mg (two 600-mg tablets) PO once daily

With Rifampin

  • Not recommended
UGT1A1-mediated glucuronidation~9 hours

Rash, including Stevens-Johnson syndrome, HSR, and toxic epidermal necrolysis

Nausea

Headache

Diarrhea

Pyrexia

CPK elevation, muscle weakness, and rhabdomyolysis

Weight gain

Insomnia

Depression and suicidal ideation (rare; usually occurs in people with preexisting psychiatric conditions)

a For dose adjustments in patients with hepatic insufficiency, see Appendix B, Table 12. When no food restriction is listed, the antiretroviral drug can be taken with or without food.

b Also see Table 20.

c See Appendix B, Table 1 for information about these formulations.

Key: 3TC = lamivudine; ABC = abacavir; AE= adverse event; ARV = antiretroviral; BIC = bictegravir; CAB = cabotegravir; COBI = cobicistat; CPK = creatine phosphokinase; CrCl = creatinine clearance; CYP = cytochrome P; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FPV/r = fosamprenavir/ritonavir; FTC = emtricitabine; HSR = hypersensitivity reaction; IM = intramuscular; INSTI = integrase strand transfer inhibitor; NTD = neural tube defect; PO = orally; RAL = raltegravir; RPV = rilpivirine; STR = single-tablet regimen; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV/r = tipranavir/ritonavir; UGT1 = uridine diphosphate glucuronyl transferase 1 family

Appendix B, Table 7. Characteristics of the Fusion Inhibitor

Updated: May 26, 2023
Reviewed: September 12, 2024

The following table includes dose recommendations for the U.S. Food and Drug Administration (FDA)–approved fusion inhibitor. For additional information regarding the use of this medication in adolescents with HIV, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines.

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationSerum Half-LifeEliminationAdverse Eventsa
Enfuvirtide
(T-20)
Fuzeon

Fuzeon

  • Injectable; supplied as lyophilized powder.
  • Each vial contains 108 mg of T-20; reconstitute with 1.1 mL of sterile water for injection for delivery of approximately 90 mg/1 mL.
  • Refer to prescribing information for storage instruction.

Fuzeon

  • T-20 90 mg/1 mL SQ twice daily
3.8 hoursExpected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool.

Local injection site reactions (e.g., pain, erythema, induration, nodules and cysts, pruritus, ecchymosis) in almost 100% of all people

Increased incidence of bacterial pneumonia

HSR occurs in <1% of people. Symptoms may include rash, fever, nausea, vomiting, chills, rigors, hypotension, or elevated serum transaminases. Rechallenge is not recommended.

a Also see Table 20.

Key: HSR = hypersensitivity reaction; SQ = subcutaneous; T-20 = enfuvirtide

Appendix B, Table 8. Characteristics of the CCR5 Antagonist

Updated: May 26, 2023
Reviewed: September 12, 2024

The following table includes dose recommendations for the U.S. Food and Drug Administration (FDA)–approved CCR5 antagonist. For additional information regarding the use of this medication in adolescents with HIV, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines.

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationsaSerum Half-LifeElimination/
Metabolic Pathway		Adverse Eventsb
Maraviroc
(MVC)
Selzentry

Selzentry

  • 150-mg and 300‑mg tablets
  • 20-mg/1-mL oral solution

Selzentry

  • MVC 150 mg PO twice daily when given with drugs that are strong CYP3A inhibitors (with or without CYP3A inducers), including PIs (except TPV/r)
  • MVC 300 mg PO twice daily when given with NRTIs, T‑20, TPV/r, NVP, RAL, and other drugs that are not strong CYP3A inhibitors or inducers
  • MVC 600 mg PO twice daily when given with drugs that are CYP3A inducers, including EFV, ETR, etc. (without a CYP3A inhibitor)

Take MVC without regard to food.

14–18 hoursCYP3A4 substrate

Abdominal pain

Cough

Dizziness

Musculoskeletal symptoms

Pyrexia

Rash

Upper respiratory tract infections

Hepatotoxicity, which may be preceded by severe rash or other signs of systemic allergic reactions

Orthostatic hypotension, especially in people with severe renal insufficiency

a For dose adjustments in people with hepatic insufficiency, see Appendix B, Table 12.

b Also see Table 20.

Key: CYP = cytochrome P; EFV = efavirenz; ETR = etravirine; MVC = maraviroc; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; PI = protease inhibitor; PO = orally; RAL = raltegravir; T-20 = enfuvirtide; TPV/r = tipranavir/ritonavir

Appendix B, Table 9. Characteristics of CD4 Post-Attachment Inhibitor

Updated: May 26, 2023
Reviewed: September 12, 2024

The following table includes dose recommendations for the U.S. Food and Drug Administration (FDA)–approved CD4 post-attachment inhibitor. Ibalizumab is not FDA approved for use in adolescents with HIV.

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationsSerum Half-LifeElimination/ Metabolic PathwayAdverse Eventsa
Ibalizumab
(IBA)
Trogarzo

Trogarzo

  • Single-dose 2‑mL vial containing 200 mg/1.33 mL (150 mg/mL) of ibalizumab

Trogarzo

  • Administer a single loading dose of IBA 2,000-mg IV infusion over 30 minutes, followed by a maintenance dose of IBA 800-mg IV infusion over 15 minutes or IV push over 30 seconds every 2 weeks.
  • See prescribing information for additional instructions for preparing, storing, and administering IBA, and for monitoring people who are receiving IBA.
~64 hoursNot well defined

Diarrhea

Dizziness

Nausea

Rash

HSRs, including anaphylaxis and infusion-related reactions, have been reported.

a Also see Table 20.

Key: HSR = hypersensitivity reaction; IBA = ibalizumab; IV = intravenous

Appendix B, Table 10. Characteristics of the gp120 Attachment Inhibitor

Updated: May 26, 2023
Reviewed: September 12, 2024

The following table includes dose recommendations for the U.S. Food and Drug Administration (FDA)–approved gp120 attachment inhibitor. Fostemsavir is not FDA approved for use in adolescents with HIV.

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationsSerum Half-LifeElimination/ Metabolic PathwayAdverse Eventsa
Fostemsavir 
(FTR) 
Rukobia
  • 600-mg extended-release tablets
  • FTR 600 mg PO twice daily
11 hoursHydrolysis (esterases), CYP3A4

Nausea

Transaminase elevation; transient bilirubin elevation

Sleep disturbance, dizziness

QTc prolongation was seen at four times the recommended dose. Use with caution in people with preexisting heart disease, QTc prolongation, or concomitant use of medications that may prolong QTc interval.

a Also see Table 20.

Key: CYP = cytochrome P; FTR = fostemsavir; PO = orally; QTc = corrected QT interval

Appendix B, Table 11. Characteristics of the Capsid Inhibitor

Updated: September 12, 2024
Reviewed: September 12, 2024

The following table includes dose recommendations for the U.S. Food and Drug Administration (FDA)–approved capsid inhibitor. Lenacapavir is not FDA approved for use in adolescents with HIV. 

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationsSerum Half-LifeElimination/ Metabolic PathwayAdverse Events
Lenacapavir
(LEN)
Sunlenca
  • 300-mg tablet
  • Single-dose 463.5-mg/1.5-mL vial for injection

Initiation Option 1

  • Day 1: 927 mg SQ x 1 dose + 600 mg PO x 1 dose
  • Day 2: 600 mg PO x 1 dose

Initiation Option 2

  • Day 1: 600 mg PO x 1 dose
  • Day 2: 600 mg PO x 1 dose
  • Day 8: 300 mg PO x 1 dose
  • Day 15: 927 mg SQ x 1 dose

Maintenance Dosing

  • 927 mg by SQ injection every 6 months from the date of the last injection (+/-2 weeks)
  • Note: Each SQ dose requires two injections. 

PO: 10–12 days

SQ: 8–12 weeks

Substrate of P-‍glycoprotein, CYP3A (minor), UGT1A1 (minor)

CYP3A4 inhibitor (moderate)

Injection site reactions, including nodules and induration 

Nausea, diarrhea, headache

a Also see Table 20.

Key: CYP = cytochrome P; LEN = lenacapavir; PO = orally; SQ = subcutaneous

Appendix B, Table 12. Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency

Updated: September 12, 2024
Reviewed: September 12, 2024

Not all products are Food and Drug Administration (FDA)–approved for adolescents with HIV. For information regarding the use of these medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines.

The older antiretroviral drugs fosamprenavir (FPV), lopinavir/ritonavir (LPV/r) , nelfinavir (NFV), nevirapine (NVP), tipranavir (TPV), and zidovudine (ZDV) have been removed from this table. Please refer to the FDA product labels for these drugs for recommendations on dosing in adults and adolescents with renal or hepatic insufficiency.

See the reference section at the end of this table for creatinine clearance calculation formulas and criteria for Child-Pugh classification.

View full version of Appendix B, Table 12.
Table 12. Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency
  
  
  
  

To view a table, please click on the corresponding link:

Appendix B, Table 1. Coformulated and Copackaged Antiretroviral Regimens

Updated: September 12, 2024
Reviewed: September 12, 2024

Trade Name
(Abbreviation)		ARV Drugs Included in the RegimenDosing Recommendationa
INSTI Plus Two NRTIs
Biktarvy
(BIC/TAF/FTC)		Bictegravir 50 mg/tenofovir alafenamide 25 mg/emtricitabine 200 mgOne tablet PO once daily
Genvoya
(EVG/c/TAF/FTC)		Elvitegravir 150 mg/cobicistat 150 mg/tenofovir alafenamide 10 mg/‌emtricitabine 200 mgOne tablet PO once daily with food
Stribild
(EVG/c/TDF/FTC)		Elvitegravir 150 mg/cobicistat 150 mg/‌tenofovir disoproxil fumarate 300 mg/‌emtricitabine 200 mgOne tablet PO once daily with food
Triumeq
(DTG/ABC/3TC)		Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mgOne tablet PO once daily
INSTI Plus One NRTI
Dovato
(DTG/3TC)		Dolutegravir 50 mg/lamivudine 300 mgOne tablet PO once daily
INSTI Plus One NNRTI
Cabenuva
(CAB IM and RPV IM)

Cabenuva 600-mg/900-mg kit contains:

  • CAB 600-mg/3-mL vial and RPV 900-mg/3-mL vial

Cabenuva 400-mg/600-mg kit contains:

  • CAB 400-mg/2-mL vial and RPV 600-mg/2-mL vial

Optional Lead-in with Oral CAB and RPV

  • CAB 30 mg PO and RPV 25 mg PO once daily with food for 4 weeks

Monthly IM CAB and RPV

  • Loading dose: CAB 600 mg/3 mL IM × 1 dose and RPV 900 mg/‌3 mL IM for 1 dose
  • Continuation phase: CAB 400 mg/2 mL IM every 4 weeks and RPV 600 mg/2 mL IM every 4 weeks

Every 2-Month IM CAB and RPV

  • Loading dose: CAB 600 mg/3 mL IM and RPV 900 mg/3 mL IM once monthly for 2 doses
  • Continuation phase: CAB 600 mg/3 mL IM and RPV 900 mg/3 mL IM every 2 months
Juluca
(DTG/RPV)		Dolutegravir 50 mg/rilpivirine 25 mgOne tablet PO once daily with food
NNRTI Plus Two NRTIs
Atripla
(EFV/TDF/FTC)		Efavirenz 600 mg/tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mgOne tablet PO once daily on an empty stomach, preferably at bedtime
Complera
(RPV/TDF/FTC)		Rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mgOne tablet PO once daily with food
Delstrigo
(DOR/TDF/3TC)		Doravirine 100 mg/tenofovir disoproxil fumarate 300 mg/lamivudine 300 mgOne tablet PO once daily
Odefsey
(RPV/TAF/FTC)		Rilpivirine 25 mg/tenofovir alafenamide 25 mg/emtricitabine 200 mgOne tablet PO once daily with food
Symfi
(EFV/TDF/3TC)		Efavirenz 600 mg/tenofovir disoproxil fumarate 300 mg/lamivudine 300 mgOne tablet PO once daily on an empty stomach, preferably at bedtime
Symfi Lo
(EFV/TDF/3TC)		Efavirenz 400 mg/tenofovir disoproxil fumarate 300 mg/lamivudine 300 mgOne tablet PO once daily on an empty stomach, preferably at bedtime
PI Plus Two NRTIs
Symtuza
(DRV/c/TAF/FTC)		Darunavir 800 mg/cobicistat 150 mg/tenofovir alafenamide 10 mg/emtricitabine 200 mgOne tablet PO once daily with food
a For dose adjustments in people with renal or hepatic insufficiency, see Appendix B, Table 12. When no food restriction is listed, the product can be taken with or without food.

Key: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; BIC = bictegravir; CAB = cabotegravir; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FTC = emtricitabine; IM = intramuscular; INSTI = integrase strand transfer inhibitor; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; PI = protease inhibitor; PO = orally; RPV = rilpivirine; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Appendix B, Table 2. Nucleoside Reverse Transcriptase Inhibitor-Based, Fixed-Dose Combination Tablets for Use as Part of an Antiretroviral Regimen

Updated: May 26, 2023
Reviewed: September 12, 2024

Trade Name
(Abbreviation)		ARV Drugs Included in the FDC TabletDosing Recommendationa
TAF or TDF Plus an NRTI
Descovy
(TAF/FTC)		Tenofovir alafenamide 25 mg/emtricitabine 200 mgOne tablet PO once daily
Cimduo
(TDF/3TC)		Tenofovir disoproxil fumarate 300 mg/lamivudine 300 mgOne tablet PO once daily
Truvada
(TDF/FTC)		Tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mgOne tablet PO once daily
Other NRTI-Based, FDC Tablets

Epzicom
(ABC/3TC)

Note: Generic product is available.

Abacavir 600 mg/lamivudine 300 mgOne tablet PO once daily
a For dose adjustments in patients with renal or hepatic insufficiency, see Appendix B, Table 12. All FDC tablets listed in this table can be taken without regard to food.

Key: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; FDC = fixed-dose combination; FTC = emtricitabine; NRTI = nucleoside reverse transcriptase inhibitor; PO = orally; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Appendix B, Table 3. Characteristics of Nucleoside Reverse Transcriptase Inhibitors

Updated: May 26, 2023
Reviewed: September 12, 2024

View full version of Appendix B, Table 3.
Table 3. Characteristics of Nucleoside Reverse Transcriptase Inhibitors
  
  
  
  

Appendix B, Table 4. Characteristics of Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Updated: September 12, 2024
Reviewed: September 12, 2024

View full version of Appendix B, Table 4.
Appendix B, Table 4. Characteristics of Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
  
  
  
  

Appendix B, Table 5. Characteristics of Protease Inhibitors

Updated: September 12, 2024
Reviewed: September 12, 2024

View full version of Appendix B, Table 5.
Table 5. Characteristics of Protease Inhibitors
  
  
  
  

Appendix B, Table 6. Characteristics of Integrase Inhibitors

Updated: September 12, 2024
Reviewed: September 12, 2024

Generic Name
(Abbreviation)
Trade Name		FormulationsDosing RecommendationsaElimination/
Metabolic Pathways		Serum Half-LifeAdverse Eventsb
Bictegravir
(BIC)		BIC is available only as a component of the STR Biktarvy (BIC/TAF/FTC).c

Biktarvy

  • One tablet PO once daily

CYP3A4 substrate

UGT1A1-mediated glucuronidation

~17 hours

Diarrhea

Nausea

Headache

Weight gain

Cabotegravir
(CAB)

Available as part of the copackaged IM long-acting regimen Cabenuva (CAB IM and RPV IM)

  • 400-mg/2-mL vial
  • 600-mg/3-mL vial

Also available as an individual product for IM long-acting pre-exposure prophylaxis Apretude (CAB IM)

  • 600-mg/3-mL vial

Also available in oral tablet formulation Vocabria (CAB PO)

  • 30-mg tablet
  • Must be obtained from manufacturer for oral lead-in and oral bridging during administration of Cabenuva (CAB IM/RPV IM)
See Appendix B, Table 1 for dosing information for coformulated and copackaged regimens that contain CAB.UGT1A1 and UGT1A9-mediated glucuronidation

Oral: 41 hours

IM: 6–12 weeks

 

IM formulation only: Injection-site reactions (e.g., pain, induration, swelling, nodules)

The following AEs were reported when CAB was administered in combination with RPV: 

Headache

Nausea

Abnormal dreams

Anxiety

Insomnia

Depressive disorders

Hepatotoxicity

Dolutegravir
(DTG)
Tivicay

Tivicay

  • 50-mg tablet

STRs that Contain DTGc

  • Dovato (DTG/3TC)
  • Juluca (DTG/RPV)
  • Triumeq (DTG/ABC/3TC)

In People Without Prior ARV Treatment or ARV-Experienced People Who Had Never Received INSTIs

  • DTG 50 mg PO once daily

In People Without Prior ARV Treatment or ARV-Experienced People Who Had Never Received INSTIs When Coadministered With EFV, FPV/r, TPV/r, or Rifampin

  • DTG 50 PO mg twice daily

In INSTI-Experienced People With Certain INSTI Mutations (See Product Label) or With Clinically Suspected INSTI Resistance

  • DTG 50 mg PO twice daily

See Appendix B, Table 1 for dosing information for STRs that contain DTG.

UGT1A1-mediated glucuronidation

Minor substrate of CYP3A4

~14 hours

Insomnia

Headache

Depression disorders and suicidal ideation (rare; usually occurs in people with preexisting psychiatric conditions)

Weight gain

Hepatotoxicity

HSRs, including rash, constitutional symptoms, and organ dysfunction (including liver injury), have been reported.

Elvitegravir
(EVG)

EVG is only available as a component of an STR tablet that also contains COBI, FTC, and either TDF or TAF.

STRs That Contain EVGc

  • Genvoya (EVG/c/TAF/FTC)
  • Stribild (EVG/c/TDF/FTC)

Genvoya

  • One tablet PO once daily with food
  • See Appendix B, Table 12 for recommendations on dosing in persons with renal insufficiency.

Stribild

  • One tablet PO once daily with food
  • Not recommended for people with baseline CrCl <70 mL/min (see Appendix B, Table 12 for the CrCl calculation equation).

EVG

  • CYP3A and UGT1A1/3 substrate

COBI

  • CYP3A inhibitor and substrate
  • CYP2D6 inhibitor
EVG/c: ~13 hours

Nausea

Diarrhea

Depression and suicidal ideation (rare; usually occurs in people with preexisting psychiatric conditions)

Raltegravir
(RAL)
Isentress
Isentress HD

Isentress

  • 400-mg tablet
  • 100-mg single-use packet for oral suspension

Isentress HD

  • 600-mg tablet

Isentress

  • 400 mg PO twice daily

With Rifampin

  • 800 mg PO twice daily

Isentress HD

In People Without Prior ARV Treatment or ARV-Experienced People With Virologic Suppression on a Regimen Containing RAL 400 mg Twice Daily

  • 1,200 mg (two 600-mg tablets) PO once daily

With Rifampin

  • Not recommended
UGT1A1-mediated glucuronidation~9 hours

Rash, including Stevens-Johnson syndrome, HSR, and toxic epidermal necrolysis

Nausea

Headache

Diarrhea

Pyrexia

CPK elevation, muscle weakness, and rhabdomyolysis

Weight gain

Insomnia

Depression and suicidal ideation (rare; usually occurs in people with preexisting psychiatric conditions)

a For dose adjustments in patients with hepatic insufficiency, see Appendix B, Table 12. When no food restriction is listed, the antiretroviral drug can be taken with or without food.

b Also see Table 20.

c See Appendix B, Table 1 for information about these formulations.

Key: 3TC = lamivudine; ABC = abacavir; AE= adverse event; ARV = antiretroviral; BIC = bictegravir; CAB = cabotegravir; COBI = cobicistat; CPK = creatine phosphokinase; CrCl = creatinine clearance; CYP = cytochrome P; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FPV/r = fosamprenavir/ritonavir; FTC = emtricitabine; HSR = hypersensitivity reaction; IM = intramuscular; INSTI = integrase strand transfer inhibitor; NTD = neural tube defect; PO = orally; RAL = raltegravir; RPV = rilpivirine; STR = single-tablet regimen; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV/r = tipranavir/ritonavir; UGT1 = uridine diphosphate glucuronyl transferase 1 family

Appendix B, Table 7. Characteristics of the Fusion Inhibitor

Updated: May 26, 2023
Reviewed: September 12, 2024

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationSerum Half-LifeEliminationAdverse Eventsa
Enfuvirtide
(T-20)
Fuzeon

Fuzeon

  • Injectable; supplied as lyophilized powder.
  • Each vial contains 108 mg of T-20; reconstitute with 1.1 mL of sterile water for injection for delivery of approximately 90 mg/1 mL.
  • Refer to prescribing information for storage instruction.

Fuzeon

  • T-20 90 mg/1 mL SQ twice daily
3.8 hoursExpected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool.

Local injection site reactions (e.g., pain, erythema, induration, nodules and cysts, pruritus, ecchymosis) in almost 100% of all people

Increased incidence of bacterial pneumonia

HSR occurs in <1% of people. Symptoms may include rash, fever, nausea, vomiting, chills, rigors, hypotension, or elevated serum transaminases. Rechallenge is not recommended.

a Also see Table 20.

Key: HSR = hypersensitivity reaction; SQ = subcutaneous; T-20 = enfuvirtide

Appendix B, Table 8. Characteristics of the CCR5 Antagonist

Updated: May 26 2023
Reviewed: September 12, 2024

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationsaSerum Half-LifeElimination/
Metabolic Pathway		Adverse Eventsb
Maraviroc
(MVC)
Selzentry

Selzentry

  • 150-mg and 300‑mg tablets
  • 20-mg/1-mL oral solution

Selzentry

  • MVC 150 mg PO twice daily when given with drugs that are strong CYP3A inhibitors (with or without CYP3A inducers), including PIs (except TPV/r)
  • MVC 300 mg PO twice daily when given with NRTIs, T‑20, TPV/r, NVP, RAL, and other drugs that are not strong CYP3A inhibitors or inducers
  • MVC 600 mg PO twice daily when given with drugs that are CYP3A inducers, including EFV, ETR, etc. (without a CYP3A inhibitor)

Take MVC without regard to food.

14–18 hoursCYP3A4 substrate

Abdominal pain

Cough

Dizziness

Musculoskeletal symptoms

Pyrexia

Rash

Upper respiratory tract infections

Hepatotoxicity, which may be preceded by severe rash or other signs of systemic allergic reactions

Orthostatic hypotension, especially in people with severe renal insufficiency

a For dose adjustments in people with hepatic insufficiency, see Appendix B, Table 12.

b Also see Table 20.

Key: CYP = cytochrome P; EFV = efavirenz; ETR = etravirine; MVC = maraviroc; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; PI = protease inhibitor; PO = orally; RAL = raltegravir; T-20 = enfuvirtide; TPV/r = tipranavir/ritonavir

Appendix B, Table 9. Characteristics of CD4 Post-Attachment Inhibitor

Updated: May 26, 2023
Reviewed: September 12, 2024

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationsSerum Half-LifeElimination/ Metabolic PathwayAdverse Eventsa
Ibalizumab
(IBA)
Trogarzo

Trogarzo

  • Single-dose 2‑mL vial containing 200 mg/1.33 mL (150 mg/mL) of ibalizumab

Trogarzo

  • Administer a single loading dose of IBA 2,000-mg IV infusion over 30 minutes, followed by a maintenance dose of IBA 800-mg IV infusion over 15 minutes or IV push over 30 seconds every 2 weeks.
  • See prescribing information for additional instructions for preparing, storing, and administering IBA, and for monitoring people who are receiving IBA.
~64 hoursNot well defined

Diarrhea

Dizziness

Nausea

Rash

HSRs, including anaphylaxis and infusion-related reactions, have been reported.

a Also see Table 20.

Key: HSR = hypersensitivity reaction; IBA = ibalizumab; IV = intravenous

Appendix B, Table 10. Characteristics of the gp120 Attachment Inhibitor

Updated: May 26 2023
Reviewed: September 12, 2024

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationsSerum Half-LifeElimination/ Metabolic PathwayAdverse Eventsa
Fostemsavir 
(FTR) 
Rukobia
  • 600-mg extended-release tablets
  • FTR 600 mg PO twice daily
11 hoursHydrolysis (esterases), CYP3A4

Nausea

Transaminase elevation; transient bilirubin elevation

Sleep disturbance, dizziness

QTc prolongation was seen at four times the recommended dose. Use with caution in people with preexisting heart disease, QTc prolongation, or concomitant use of medications that may prolong QTc interval.

a Also see Table 20.

Key: CYP = cytochrome P; FTR = fostemsavir; PO = orally; QTc = corrected QT interval

Appendix B, Table 11. Characteristics of the Capsid Inhibitor

Updated: September 12, 2024
Reviewed: September 12, 2024

Generic Name
(Abbreviation)
Trade Name		FormulationDosing RecommendationsSerum Half-LifeElimination/ Metabolic PathwayAdverse Events
Lenacapavir
(LEN)
Sunlenca
  • 300-mg tablet
  • Single-dose 463.5-mg/1.5-mL vial for injection

Initiation Option 1

  • Day 1: 927 mg SQ x 1 dose + 600 mg PO x 1 dose
  • Day 2: 600 mg PO x 1 dose

Initiation Option 2

  • Day 1: 600 mg PO x 1 dose
  • Day 2: 600 mg PO x 1 dose
  • Day 8: 300 mg PO x 1 dose
  • Day 15: 927 mg SQ x 1 dose

Maintenance Dosing

  • 927 mg by SQ injection every 6 months from the date of the last injection (+/-2 weeks)
  • Note: Each SQ dose requires two injections. 

PO: 10–12 days

SQ: 8–12 weeks

Substrate of P-‍glycoprotein, CYP3A (minor), UGT1A1 (minor)

CYP3A4 inhibitor (moderate)

Injection site reactions, including nodules and induration 

Nausea, diarrhea, headache

a Also see Table 20.

Key: CYP = cytochrome P; LEN = lenacapavir; PO = orally; SQ = subcutaneous

Appendix B, Table 12. Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency

Updated: September 12, 2024
Reviewed: September 12, 2024

View full version of Appendix B, Table 12.
Table 12. Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency
  
  
  
  

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