Adult Antiretroviral Guidelines

US DHHS Guidelines with Australian Commentary

Appendix B: Drug Characteristics Table

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Appendix B: Drug Characteristics Table

DHHS Last Updated: September 2024Australian Commentary Last Updated: December 2024

Stribild – this product has been removed from the market in Australia, access to generic equivalents are NOT available. 

Atripla – this product has been removed from the market in Australia, access to generic equivalent is available and reimbursed via the PBS. 

Complera/Eviplera – this product has been removed from the market in Australia – access to generic equivalent is NOT available. Components of this regimen can be prescribed as TD*/FTC + RPV, both available and reimbursed via PBS. 

Delstrigo – currently not available in Australia. TGA registered 04/02/2019 but not accessible or reimbursed via PBS. 

Symfi and Symfi Lo – this product is not available in Australia – access to generic equivalent is NOT available. This regimen can be prescribed in its components based on ARVs available in Australia 

Cabenuva – note that only CAB 600/RPV 900 kit (Q8W dosing) is available in Australia for dosing. TGA registered 23/02/2021, accessible and reimbursed via PBS from 01/04/2022. Oral lead-in optional from 08/2022. 

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 Regimen
Dosing 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
Dovato
(DTG/3TC)
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
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 mg
One 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 = intramuscularly; 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 4. Characteristics of Non-Nucleoside Reverse Transcriptase Inhibitors

Doravirine – currently not available in Australia. TGA registered 21/07/2019 but not accessible or reimbursed via PBS (potential availability via MSD Compassionate). 

Nevirapine – extended-release formulation has been discontinued by the manufacturer. TGA advised of deletion from market 02/2024. Patients receiving treatment with extended-release tablets should be considered for transition to therapeutic alternatives. Access to generic equivalent of immediate-release formulation remains available and reimbursed via the PBS.

Efavirenz – this product has been removed from the market in Australia as it is discontinued by the manufacturer. Access to generic equivalents is NOT available. Access to co-formulated Tenofovir Disoproxil + Emtricitabine + Efavirenz generic equivalent is available and reimbursed via the PBS.

The following table includes dose recommendations for U.S. Food and Drug Administration (FDA)–approved non-nucleoside reverse transcriptase inhibitor (NNRTI) 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 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.

Generic Name (Abbreviation) Trade Name
Formulations
Dosing Recommendationsa
Elimination/ Metabolic Pathway
Serum Half-Life
Adverse Eventsb
Doravirine
(DOR)
Pifeltro
Pifeltro

  • 100-mg tablet

Also available as part of the STR Delstrigo (DOR/TDF/3TC)c

STRs That Contain DORc

  • Delstrigo (DOR/TDF/3TC)
Pifeltro

  • DOR 100 mg PO once daily

See Appendix A, Table 1 for dosing information for Delstrigo.
CYP3A4/5 substrate15 hoursNausea

Dizziness

Abnormal dreams
Efavirenz
(EFV)
Note: The branded product Sustiva has been discontinued.
Efavirenz (generic)
  • 600-mg tablet


STRs that Contain EFVc
  • EFV/TDF/FTC (generic)
  • Symfi (EFV 600 mg/TDF/3TC)
  • Symfi Lo (EFV 400 mg/TDF/3TC)
Efavirenz (generic)

  • EFV 600 mg PO once daily on an empty stomach, preferably at or before bedtime


See Appendix A, Table 1 for dosing information for STRs that contain EFV.
Metabolized by CYP2B6 (primary), 3A4, and 2A6

CYP3A4 mixed inducer/inhibitor (more an inducer than an inhibitor)

CYP2B6 and 2C19 inducer
40–55 hoursRashd

Neuropsychiatric symptomse

Serum transaminase elevations

Hyperlipidemia

QT interval prolongation

Use of EFV may lead to false-positive results with some cannabinoid and benzodiazepine screening assays.
Etravirine
(ETR)
Intelence
Intelence

  • 100-mg, and 200-mg tablets
Intelence

  • ETR 200 mg PO twice daily following a meal.
CYP3A4, 2C9, and 2C19 substrate

CYP3A4 inducer

CYP2C9 and 2C19 inhibitor
41 hoursRash, including Stevens-Johnson syndromed

HSRs, characterized by rash, constitutional findings, and sometimes organ dysfunction (including hepatic failure), have been reported.

Nausea
Rilpivirine
(RPV)
Edurant
Edurant

  • 25-mg tablet


STRs that Contain RPVc

  • Complera (RPV/TDF/FTC)

  • Juluca (DTG/RPV)

  • Odefsey (RPV/TAF/FTC)



Copackaged Intramuscular Regimen

  • Cabenuva (CAB plus RPV)
Edurant

  • RPV 25 mg PO once daily with food.


See Appendix A, Table 1 for dosing information for coformulated and copackaged regimens that contain RPV.
CYP3A4 substratePO: 50 hours

IM: 13-28 weeks

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

Also see Table 20.

See Appendix A, Table 1 for information about these formulations.

Rare cases of Stevens-Johnson syndrome have been reported with the use of most NNRTIs.

Adverse events can include dizziness, somnolence, insomnia, abnormal dreams, depression, suicidality (e.g., suicide, suicide attempt or ideation), confusion, abnormal thinking, impaired concentration, amnesia, agitation, depersonalization, hallucinations, and euphoria. Approximately 50% of people who are receiving EFV may experience any of these symptoms. Symptoms usually subside spontaneously after 2–4 weeks, but discontinuation of EFV may be necessary in a small percentage of people. Late-onset neurotoxicities, including ataxia and encephalopathy, have been reported.

Key: 3TC = lamivudine; ARV = antiretroviral; CAB = cabotegravir; CD4 = CD4 T lymphocyte; CYP = cytochrome P; DOR = doravirine; DTG = dolutegravir; EFV = efavirenz; ETR = etravirine; FTC = emtricitabine; HSR = hypersensitivity reaction; IM = intramuscular; IV = intravenous; NNRTI = non-nucleoside reverse transcriptase inhibitor; PO = orally; RPV = rilpivirine; STR = single-tablet regimen; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Appendix B, Table 5. Characteristics of Protease Inhibitors

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 the Archived Guidelines webpage on the Clinicalinfo website) or to the FDA product labels for information regarding these drugs.

Generic Name
(Abbreviation)
Trade Name
FormulationsDosing RecommendationsaElimination/ Metabolic PathwaySerum Half-LifeAdverse Eventsb
Atazanavir
(ATV)
Reyataz
(ATV/c)
Evotaz
Note: Generic products of ATV are available.
Reyataz
  • 200-mg, and 300-mg capsules

  • 50-mg oral powder/packet


Generic
  • 200-mg, and 300‑mg capsules


Evotaz
  • ATV 300-mg/COBI 150-mg tablet
Reyataz
In People Without Prior ARV Treatment
  • (ATV 300 mg plus RTV 100 mg) PO once daily with food; or

  • ATV 400 mg PO once daily with food.


With TDF or in ARV-Experienced People
  • (ATV 300 mg plus RTV 100 mg) PO once daily with food.

  • Unboosted ATV is not recommended.


With EFV in People Without Prior ARV Treatment
  • (ATV 400 mg plus RTV 100 mg) PO once daily with food.


Evotaz
  • One tablet PO once daily with food.

  • The use of ATV/c is not recommended for people who are taking TDF and who have baseline CrCl <70 mL/min (see Appendix B for the equation for calculating CrCl).


For dosing recommendations for patients who also are receiving H2 antagonists and PPIs, refer to Table 24a.
ATV
  • CYP3A4 inhibitor and substrate

  • Weak CYP2C8 inhibitor

  • UGT1A1 inhibitor


COBI
  • CYP3A inhibitor and substrate

  • CYP2D6 inhibitor


Dose adjustment is recommended in people with hepatic insufficiency (see Appendix B).
7 hoursIndirect hyperbilirubinemia
Cholelithiasis
Nephrolithiasis
Renal insufficiency
Serum transaminase elevations
Hyperlipidemia (especially with RTV boosting)
Skin rash
Hyperglycemia
Lipodystrophy
An increase in serum creatinine may occur when ATV is administered with COBI.
PR interval prolongation: First-degree symptomatic AV block has been reported. Use with caution in patients who have underlying conduction defects or who are on concomitant medications that can cause PR prolongation.
Darunavir
(DRV)
Prezista
(DRV/c)
Prezcobix
Prezista
  • 600-mg, and 800‑mg tablets

  • 100-mg/mL oral suspension


Prezcobix
  • DRV 800-mg/COBI 150-mg tablet


Also available as part of the STR Symtuza (DRV/c/TAF/FTC)
Prezista
In People Without Prior ARV Treatment or ARV-Experienced Treatment With No DRV Mutations
  • (DRV 800 mg plus RTV 100 mg) PO once daily with food.


In ARV-Experienced People With One or More DRV Resistance Mutations
  • (DRV 600 mg plus RTV 100 mg) PO twice daily with food.


Unboosted DRV is not recommended.

Prezcobix
  • One tablet PO once daily with food.

  • Not recommended for patients with one or more DRV resistance-associated mutations.

  • Coadministering Prezcobix and TDF is not recommended for people with baseline CrCl <70 mL/min (see Appendix B for the equation for calculating CrCl).


See Appendix A, Table 1 for dosing information for Symtuza.
DRV
  • CYP3A4 inhibitor and substrate

  • CYP2C9 inducer


COBI
  • CYP3A inhibitor and substrate

  • CYP2D6 inhibitor
15 hours when combined with RTV
7 hours when combined with COBI
Hepatotoxicity
Diarrhea, nausea
Headache
Hyperlipidemia
Serum transaminase elevation
Hyperglycemia
Fat maldistribution
An increase in serum creatinine may occur when DRV is administered with COBI.
Skin rash: DRV has a sulfonamide moiety; however, incidence and severity of rash are similar in those with or without a sulfonamide allergy—Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and erythema multiforme have been reported.
Ritonavir
(RTV)
Norvir
Note: Generic is available.
RTV was initially developed as a PI for HIV treatment but is now primarily used at a lower dose of 100 mg once or twice daily as a PK enhancer to increase the concentrations of other PIs.
Norvir
  • 100-mg tablet

  • 100-mg single packet oral powder


Also available as part of the FDC tablet Kaletra (LPV/r)
As a PK Booster (or Enhancer) for Other PIs
  • RTV 100–200 mg PO per day in one or two divided doses (refer to other PIs for specific dosing recommendations) with food.
2D6 substrate

Potent CYP3A4 and 2D6 inhibitor

Inducer of UGT1A1 and CYPs 1A2, 2C8, 2C9, and 2C19
3–5 hoursGI intolerance, nausea, vomiting, diarrhea
Paresthesia (circumoral and extremities)
Hyperlipidemia (especially hypertriglyceridemia)
Hepatitis
Asthenia
Dysgeusia
Hyperglycemia
Fat maldistribution

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

b Also see Table 20.

Key: ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; AV = atrioventricular; COBI = cobicistat; CrCl = creatinine clearance; CYP = cytochrome P; DRV = darunavir; DRV/c = darunavir/cobicistat; EFV = efavirenz; FDC = fixed-dose combination; FTC = emtricitabine; GI = gastrointestinal; H2 = histamine H2 receptor; LPV/r = lopinavir/ritonavir; PI = protease inhibitor; PK = pharmacokinetic; PO = orally; PPI = proton pump inhibitor; RTV = ritonavir; STR = single-tablet regimen; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; UGT1 = uridine diphosphate glucuronyl transferase 1 family

Appendix B, Table 6. Characteristics of Integrase Strand Transfer Inhibitors

DHHS Updated: September 12, 2024

Dolutegravir – NTD defect signal decreased from initial findings – data re: Tsepamo and IMPAACT, guidelines now support the use of DTG as preferred regimen for persons of childbearing potential, with an appropriate dual-nucleoside backbone.

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
FormulationsDosing RecommendationsSerum 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
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 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 11. Characteristics of the Capsid Inhibitor

DHHS Updated: September 12, 2024

Lenacapavir – this agent is currently not available in Australia. TGA registered 27/03/2023 but not accessible or reimbursed via PBS – accessible via approval pathway Gilead Sciences

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-LifeEliminationAdverse Eventsa
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

 

Emtriva (FTC) –this product has been removed from the market in Australia – access to generic equivalent is NOT available. 

Vemlidy (TAF) – this product is not available in Australia 

Descovy (TAF/FTC) – 

Dosing in Adults with Renal Insufficiency 

  • no dose adjustment required in adult patients with ESRD (estimated CrCl <15 mL/min) on haemodialysis 
  • On HD days, administer after dialysis. 
  • monitor for haematological effects due to reduced clearance of FTC component 

Tenofovir Disoproxil Fumarate/Lamivudine this product is not available in Australia – access to generic equivalent is NOT available. 

Doravirine – not available in Australia. TGA registered 21/07/2019 but not accessible or reimbursed via PBS (potential availability via MSD Compassionate) 

Delstrigo – not available in Australia. TGA registered 04/02/2019 but not accessible or reimbursed via PBS (potential availability via MSD Compassionate) 

Atripla –this product has been removed from the market in Australia– access to generic equivalent is available and reimbursed via PBS. 

Symfi and Symfi Lo – this product is NOT available in Australia– access to generic equivalent is NOT available. This regimen can be prescribed in its components based on ARVs available in Australia. 

Edurant (RPV) – note that patients receiving renal replacement therapy may be prescribed concomitant acid-suppressing medicines – PPIs contraindicate use, suggest review ART with a view to optimisation/switch. 

Cabenuva – note that only CAB 600/RPV 900 kit (Q8W dosing) is available in Australia for dosing. TGA registered 23/02/2021, accessible and reimbursed via PBS from 01/04/2022. Oral lead-in optional from 08/2022. 

Odefsey – patients receiving renal replacement therapy may be prescribed concomitant acid-suppressing medicines – PPIs contraindicate use, suggest review ART with a view to optimisation/switch. 

Complera/Eviplera – this product has been removed from the market in Australia– access to generic equivalent is NOT available. Components of this regimen can be prescribed as TD*/FTC + RPV, both available and reimbursed via PBS. 

  • atients receiving renal replacement therapy may be prescribed concomitant acid-suppressing medicines – PPIs contraindicate use, suggest review ART with a view to optimisation/switch. 

Juluca (DTG/RPV) – patients receiving renal replacement therapy may be prescribed concomitant cation-containing supplements (e.g. calcium or aluminium as phosphate binders) – note separation of INSTIs from concomitant cation-containing supplements. 

  • patients receiving renal replacement therapy may be prescribed concomitant acid-suppressing medicines – PPIs contraindicate use, suggest review ART with a view to optimisation/switch. 

Biktarvy – patients receiving renal replacement therapy may be prescribed concomitant cation-containing supplements (e.g. calcium or aluminium as phosphate binders) – note separation of INSTIs from concomitant cation-containing supplements. 

Cabotegravir (Vocabria) – approved as [optional] oral lead-in to assess tolerability prior to treatment with intramuscular cabotegravir and rilpivirine as suppressed switch strategy, and as oral bridging for intramuscular cabotegravir and rilpivirine for no greater than two consecutive months. TGA registered 16/02/2021, accessible and reimbursed via PBS

Stribild – this product has been removed from market in Australia – access to generic equivalent is NOT available. 

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.

Generic Name
(Abbreviation)
Trade Name
Usual DoseaDosing in Adults With Renal InsufficiencyDosing in Adults With Hepatic Impairment
Recommendations for FDCs based on CrCl level are outlined in the table below.
NRTIs
Abacavir
(ABC)
ABC 300 mg PO twice daily
or
ABC 600 mg PO once daily
No dose adjustment necessary.Child-Pugh Class A: ABC 200 mg PO twice daily (use oral solution)
Child-Pugh Class B or C:Contraindicated
Abacavir/Lamivudine
(ABC/3TC)
One tablet PO once dailyNot FDA recommended if CrCl <30 mL/min due to the 3TC component.
Note: There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on the FDC product. See the 3TC entry for more information.
Child-Pugh Class A: Patients with mild hepatic impairment require a dose reduction of ABC. Use the individual drugs instead of the FDC tablet in these patients.
Child-Pugh Class B or C:Contraindicated due to the ABC component
Emtricitabine
(FTC)
Emtriva
FTC 200-mg oral capsule once daily
or
FTC 240-mg (24-mL) oral solution once daily
Note:There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min who are not on HD. To allow people to remain on certain TAF-containing FDC products, some Panel members use full-dose, daily FTC in people with CrCl 15–‍29 mL/min who are not on HD.
Dose by FormulationNo dose recommendation.
CrCl (mL/min)CapsuleSolution
30–49bNo dose adjustment necessary.
15–29
(see Note)
200 mg every 72 hours80 mg every 24 hours
<15 (not on HD)
(see Note)
200 mg every 96 hours60 mg every 24 hours
On HDbNo dose adjustment necessary. On HD days, administer after dialysis.
Lamivudinec
(3TC)
Epivir
3TC 300 mg PO once daily
or
3TC 150 mg PO twice daily
Note: PK and safety data are limited on the use of 3TC doses higher than those recommended by the FDA in people with CrCl <30 mL/min. Clinicians may consider using the nearest available tablet strength (100 mg or 150 mg), as outlined in the “Alternative Dose” column (BIII) (see rationaled). There is insufficient evidence to recommend for or against the use of full-‍dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on certain ABC and/or DTG-containing FDC products.
CrCl (mL/min)Epivir Label DoseAlternative DosedNo dose adjustment necessary
15–29
(see Note)
1 × 150 mg, then 100 mg every 24 hours100–150 mg every 24 hours
5–14
(see Note)
1 × 150 mg, then 50 mg every 24 hours100–150 mg every 24 hours
<5 or on HD
(see Note)
1 × 50 mg, then 25 mg every 24 hours100–150 mg every 24 hours
Tenofovir Alafenamide
(TAF)
Vemlidy
Vemlidy is available as a 25-mg tablet for the treatment of HBV.CrCl (mL/min)DoseChild-Pugh Class A: No dose adjustment
Child-Pugh Class B or C:Not recommended
<15 and not on HDNot recommended
On HDNo dose adjustment necessary. On HD days, administer after dialysis.
Tenofovir Alafenamide/Emtricitabine
(TAF/FTC)
Descovy
TAF for HIV treatment is only available as a component of FDC tablets (i.e., in Descovy, Genvoya, Odefsey, Biktarvy, and Symtuza).
  • TAF 10 mg PO daily with EVG/c (Genvoya) or DRV/c (Symtuza)

  • TAF 25 mg PO daily in other FDC tablets
CrCl (mL/min)DoseChild-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No dose recommendation
15-29Not recommended
Note:
There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose FTC in people with CrCl 15–29 mL/min.
<15 (not on HD)Not recommended
On HDNo dose adjustment necessary. On HD days, administer after dialysis.
Tenofovir Disoproxil Fumarate
(TDF)
Viread
TDF 300 mg PO once dailyCrCl (mL/min)DoseNo dose adjustment necessary.
30–49300 mg every 48 hours
10–29300 mg twice weekly (every 72–96 hours)
<10 and not on HDNo recommendation
On HD300 mg every 7 days (administer after completion of HD)
Tenofovir Disoproxil Fumarate/Emtricitabine
(TDF/FTC)
Truvada
One tablet PO once dailyCrCl (mL/min)DoseNo dose recommendation.
30–49One tablet every 48 hours
<30 or on HDFDC of TDF/FTC not recommended
Tenofovir Disoproxil Fumarate/Lamivudine
(TDF/3TC)
Cimduo
One tablet PO once dailyCrCl (mL/min)DoseNo dose recommendation.
<50 or on HDFDC of TDF/FTC <not recommended
NNRTIs
Doravirine
(DOR)
Pifeltro
DOR 100 mg PO once dailyNo dose adjustment required in mild, moderate, or severe renal impairment. Has not been studied in individuals with ESRD or on HD.Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: Not studied
Doravirine/Tenofovir Disoproxil Fumarate/Lamivudine(DOR/TDF/3TC)
Delstrigo
One tablet PO once dailyFDC of DOR/TDF/3TC not recommended if CrCl <50 mL/min or on HDChild-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: Not studied
Efavirenz
(EFV)
EFV 600 mg PO once daily on an empty stomach, preferably at bedtimeNo dose adjustment necessary.No dose recommendation; use with caution in patients with hepatic impairment.
Efavirenz/Tenofovir Disoproxil Fumarate/Emtricitabine
(EFV/TDF/FTC)
One tablet PO once daily on an empty stomach, preferably at bedtimeFDC of EFV/TDF/3TC not recommended if CrCl <50 mL/min or on HDNo dose recommendation; use with caution in patients with hepatic impairment.
Efavirenz 600 mg/Tenofovir Disoproxil Fumarate/Lamivudine
(EFV/TDF/3TC)
Symfi
One tablet PO once daily on an empty stomach, preferably at bedtimeFDC of EFV/TDF/3TC not recommended if CrCl <50 mL/min or on HDNot recommended for patients with moderate or severe hepatic impairment. Use with caution in patients with mild hepatic impairment.
Efavirenz 400 mg/Tenofovir Disoproxil Fumarate/Lamivudine
(EFV/TDF/3TC)
Symfi Lo
One tablet PO once daily on an empty stomach, preferably at bedtimeFDC of EFV/TDF/3TC not recommended if CrCl <50 mL/min or on HDNot recommended for patients with moderate or severe hepatic impairment. Use with caution in patients with mild hepatic impairment.
Etravirine
(ETR)
Intelence
ETR 200 mg PO twice dailyNo dose adjustment necessary.Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No dose recommendation
Rilpivirine
(RPV PO)
Edurant
RPV 25 mg PO once daily with foodNo dose adjustment necessary.Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No dose recommendation
Rilpivirine IM plus Cabotegravir IM
(RPV IM and CAB IM)
Cabenuva
Monthly Dosing
  • Loading dose: RPV 900 mg/3 mL IM × 1 dose and CAB 600 mg/3 mL IM × 1 dose

  • Continuation phase: RPV 600 mg/2 mL IM every 4 weeks and CAB 400 mg/2 mL IM every 4 weeks


Every-2-Months Dosing
  • Loading dose: RPV 900 mg/3 mL IM and CAB 600 mg/3 mL IM monthly for 2 doses

  • Continuation phase: RPV 900 mg/3 mL IM and CAB 600 mg/3 mL IM every 2 months
No dose adjustment necessary for mild or moderate renal impairment.
For patients with severe renal impairment or on HD, increase monitoring for adverse events.
Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No recommendation
Rilpivirine/Tenofovir Alafenamide/Emtricitabine
(RPV/TAF/FTC)
Odefsey
One tablet PO once daily with foodIn People With CrCl 15–29 mL/min
  • Not recommended

  • Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min.


In People With CrCl <15 mL/min (not on HD)
  • Not recommended


In People on Chronic HD
  • No dose adjustment necessary. On HD days, administer after dialysis.
Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No dose recommendation
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine
(RPV/TDF/FTC)
Complera
One tablet PO once daily with foodFDC of RPV/TDF/FTC not recommended if CrCl <50 mL/min or on HDChild-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No dose recommendation
Rilpivirine/Dolutegravir
(RPV/DTG)
Juluca
One tablet PO once daily with foodNo dose adjustment necessary.
In patients with CrCl <30 mL/min, monitor closely for adverse effects.
Child-Pugh Class A or B:No dose adjustment
Child-Pugh Class C: No dose recommendation
PIs
Atazanavir
(ATV)
Reyataz
ATV 400 mg PO once daily with food
or
(ATV 300 mg plus RTV 100 mg) PO once daily with food
In People Without Prior ARV Treatment on HD
  • (ATV 300 mg plus RTV 100 mg) once daily with food


In ARV-Experienced People on HD
  • ATV and ATV/r are not recommended
Child-Pugh Class A: No dose adjustment
Child-Pugh Class B: ATV 300 mg once daily (unboosted) for ARV-naive patients only
Child-Pugh Class C: Not recommended RTV boosting is not recommended in patients with hepatic impairment.
Atazanavir/Cobicistat
(ATV/c)
Evotaz
One tablet PO once daily with foodIf Used With TDF
Not recommended if CrCl <70 mL/min
Not recommended in patients with hepatic impairment.
Darunavir
(DRV)
Prezista
In People Without Prior ARV Treatment or ARV- Experienced Treatment With No DRV Mutations
  • (DRV 800 mg plus RTV 100 mg) PO once daily with food.


In ARV-Experienced Patients With at Least One DRV Resistance Mutation
  • (DRV 600 mg plus RTV 100 mg) PO twice daily with food.
No dose adjustment necessary.In People with Mild-to-Moderate Hepatic Impairment: No dose adjustment
In People with Severe Hepatic Impairment: Not recommended
Darunavir/Cobicistat
(DRV/c)
Prezcobix
One tablet PO once daily with foodIf Used With TDF
Not recommended if CrCl <70 mL/min
Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: Not recommended
Darunavir/Cobicistat/Tenofovir Alafenamide/Emtricitabine
(DRV/c/TAF/FTC)
Symtuza
One tablet PO once daily with foodIn People With CrCl 15–29 mL/min
  • Not recommended

  • Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min.


In People With CrCl <15 mL/min (not on HD)
  • Not recommended


In People on Chronic HD
  • No dose adjustment necessary. On HD days, administer after dialysis.
Not recommended for patients with severe hepatic impairment.
Ritonavir
(RTV)
Norvir
As a PI-Boosting Agent
  • RTV 100–400 mg PO per day with food.
No dose adjustment necessary.Refer to recommendations for the primary (i.e., boosted) PI.
INSTIs
Bictegravir/Tenofovir Alafenamide/Emtricitabine
(BIC/TAF/FTC)
Biktarvy
One tablet PO once dailyIn People With CrCl 15–29 mL/min
  • Not recommended

  • Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min.


In People With CrCl <15 mL/min (not on HD)
  • Not recommended

    In People on Chronic HD
    • No dose adjustment necessary. On HD days, administer after dialysis
Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: Not recommended
Cabotegravir
(CAB PO)
Vocabria
Treatment (As Optional Oral Lead-In or As Oral Bridging)
  • CAB 30 mg PO once daily, given with RPV 25 mg PO, with food before switching to CAB IM and RPV IM


Pre-exposure Prophylaxis (Optional Oral Lead-In)
  • CAB 30 mg PO once daily before switching to CAB IM
No dose adjustment necessary.Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No recommendation
Cabotegravir
(CAB IM)
Apretude
Pre-exposure Prophylaxis
  • Loading dose: CAB 600 mg/3 mL IM monthly for 2 doses

  • Continuation phase: CAB 600 mg/3 mL IM every 2 months
No dose adjustment necessary.Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No recommendation
Cabotegravir IM plus Rilpivirine IM
(CAB IM plus RPV IM)
Cabenuva
Monthly Dosing
  • Loading dose: CAB 600 mg/3 mL IM × 1 dose and RPV 900 mg/‌3 mL IM × 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 Dosing
  • Loading dose: CAB 600 mg/3 mL IM and RPV 900 mg/3 mL IM monthly for 2 doses

  • Continuation phase: CAB 600 mg/3 mL IM and RPV 900 mg/3 mL IM every 2 month
No dose adjustment necessary for mild or moderate renal impairment.
For patients with severe renal impairment or on HD, increase monitoring for adverse events.
Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No recommendation
Dolutegravir
(DTG)
Tivicay
DTG 50 mg PO once daily
or
DTG 50 mg PO twice daily
No dose adjustment necessary.Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: Not recommended
Dolutegravir/Abacavir/Lamivudine
(DTG/ABC/3TC)
Triumeq
One tablet PO once dailyNot FDA recommended if CrCl <30 mL/min due to the 3TC component
Note:> There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on the FDC product.d
Child-Pugh Class A: Patients with mild hepatic impairment require a dose reduction of ABC. Use the individual drugs instead of the FDC tablet in these patients.
Child-Pugh Class B or C:Contraindicated due to the ABC component
Dolutegravir/Lamivudine
(DTG/3TC)
Dovato
One tablet PO once dailyNot FDA recommended if CrCl <30 mL/min due to the 3TC component
Note:There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on the FDC product.d
Child-Pugh Class C: Not recommended
Dolutegravir/Rilpivirine
(DTG/RPV)
Juluca
One tablet PO once daily with foodNo dose adjustment necessary.
In patients with CrCl <30 mL/min, monitor closely for adverse effects.
Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No dose recommendation
Elvitegravir/Cobicistat/Tenofovir Alafenamide/Emtricitabine
(EVG/c/TAF/FTC)
Genvoya
One tablet PO once daily with foodIn People With CrCl 15–29 mL/min
  • Not recommended

  • Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min.


In People With CrCl <15 mL/min (not on HD)
  • Not recommended


In People on Chronic HD
  • No dose adjustment necessary. On HD days, administer after dialysis.
In People With Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary
In People With Severe Hepatic Insufficiency: Not recommended
Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine
(EVG/c/TDF/FTC)
Stribild
One tablet PO once daily with foodEVG/c/TDF/FTC should not be initiated in people with CrCl <70 mL/min.
Discontinue EVG/c/TDF/FTC if CrCl declines to <50 mL/min while patient is on therapy.
In People with Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary
In People with Severe Hepatic Insufficiency: Not recommended
Raltegravir
(RAL)
Isentress
Isentress HD
RAL 400 mg PO twice daily (using Isentress formulation)
or
RAL 1,200 mg PO once daily (using Isentress HD formulation only)
No dose adjustment necessary.In People with Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary
In People with Severe Hepatic Insufficiency: No recommendation
Fusion Inhibitor
Enfuvirtide
(T-20)
Fuzeon
T-20 90 mg SQ twice dailyNo dose adjustment necessary.No dose adjustment necessary.
CCR5 Antagonist
Maraviroc
(MVC)
Selzentry
The recommended dose differs based on concomitant medications and potential for drug–drug interactions. See Appendix A, Table 8 for detailed dosing information.In People With CrCl <30 mL/min or People Who Are on HD
Without Potent CYP3A Inhibitors or Inducers<
  • MVC 300 mg twice daily; if postural hypotension occurs, reduce to MVC 150 mg twice daily


With Potent CYP3A Inducers or Inhibitors
  • Not recommended
No dose recommendations. MVC concentrations will likely be increased in people with hepatic impairment.
CD4 Post-Attachment Inhibitor
Ibalizumab
(IBA)
Trogarzo
Loading dose: IBA 2,000 mg IV
Maintenance dose: IBA 800 mg IV every 2 weeks
No dose adjustment recommended.No recommendation.
gp-120 Attachment Inhibitor
Fostemsavir
(FTR)
Rukobia
FTR 600 mg PO twice dailyNo dose adjustment recommended.No dose adjustment recommended.
Capsid Inhibitor
Lenacapavir
(LEN)
Sunlenca
Initiation Option 1
  • Day 1: 927 mg SQ x 1 dose plus 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)
No dose adjustment recommended.Child-Pugh Class A or B: No dose adjustment
Child-Pugh Class C: No recommendation

a Refer to Appendix B, Tables 1–10 for additional dosing information.

b The prescribing information for FTC (Emtriva) recommends adjusted doses for people with CrCl 30–49 mL/min and people on hemodialysis. However, the prescribing information for several FDC products that contain FTC (including Descovy, Biktarvy, Genvoya, and Odefsey) recommends that the standard dose (FTC 200 mg) can be given once daily in these people. The recommendations in this table incorporates the dosing guidance from the FDC products.

c The prescribing information for 3TC (Epivir) recommends dosage adjustment from 300 mg once daily to 150 mg once daily for people with CrCl 30–49 mL/min. However, the prescribing information for several FDC products that contain 3TC (including Epzicom, Dovato, and Triumeq) recommends no dose adjustment for CrCl 30–49 mL/min. The recommendation in this table incorporates the dosing guidance from the FDC products.

d Use of 3TC doses higher than those recommended by the FDA for people with CrCl <30 mL/min has been reported in clinical practice 1-4 and endorsed in the Guidelines for Chronic Kidney Disease in People With HIV for many years 5; limited published literature has supported the safety of this practice 2,3. 3TC has a wide therapeutic index with no established correlation between elevated concentrations and AEs. Serious AEs, such as lactic acidosis and severe hematologic toxicities, have been reported in rare cases; however, these effects typically occurred when 3TC was used in combination with older NRTIs (such as didanosine, stavudine, zidovudine). Clinicians may consider using the nearest available tablet strength (100 mg or 150 mg) to avoid the need for 3TC oral solution, thereby simplifying ARV regimens and facilitating adherence (BIII). See the Alternative Dose column in 3TC table entry. There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on certain FDC products.

Key: 3TC = lamivudine; ABC = abacavir; AE = adverse effect; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CAB = cabotegravir; COBI = cobicistat; CrCl = creatinine clearance; CYP = cytochrome P; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DTG = dolutegravir; EFV = efavirenz; ESRD = end stage renal disease; ETR = etravirine; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDC = fixed-dose combination; FTC = emtricitabine; FTR = fostemsavir; HBV = hepatitis B virus; HD = hemodialysis; IBA = ibalizumab; IM = intramuscular; INSTI = integrase strand transfer inhibitor; IV = intravenous; LEN = lenacapavir; MVC = maraviroc; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; PK: pharmacokinetic; PI = protease inhibitor; PO = orally; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SQ = subcutaneous; T-20 = enfuvirtide; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Creatinine Clearance Calculation

Male:

(140 − 𝑎𝑎𝑎𝑎𝑎𝑎 𝑖𝑖𝑖𝑖 𝑦𝑦𝑎𝑎𝑎𝑎𝑦𝑦𝑦𝑦)
× 𝑤𝑤𝑎𝑎𝑖𝑖𝑎𝑎ℎ𝑡𝑡 𝑖𝑖𝑖𝑖 𝑘𝑘𝑎𝑎

 

72 × 𝑦𝑦𝑎𝑎𝑦𝑦𝑠𝑠𝑠𝑠 𝑐𝑐𝑦𝑦𝑎𝑎𝑎𝑎𝑡𝑡𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑎𝑎

Female:

(140 − 𝑎𝑎𝑎𝑎𝑎𝑎 𝑖𝑖𝑖𝑖 𝑦𝑦𝑎𝑎𝑎𝑎𝑦𝑦𝑦𝑦)
× 𝑤𝑤𝑎𝑎𝑖𝑖𝑎𝑎ℎ𝑡𝑡 𝑖𝑖𝑖𝑖 𝑘𝑘𝑎𝑎 × 0.85

 

72 × 𝑦𝑦𝑎𝑎𝑦𝑦𝑠𝑠𝑠𝑠 𝑐𝑐𝑦𝑦𝑎𝑎𝑎𝑎𝑡𝑡𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑎𝑎

Child-Pugh Score

 

Component

Points Scored
123
EncephalopathyaNoneGrade 1–2Grade 3–4
AscitesNoneMild or controlled by diureticsModerate or refractory despite diuretics
Albumin>3.5 g/dL2.8–3.5 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/dL4–7 mg/dL>7 mg/dL
Prothrombin Time (Seconds Prolonged), or<44–6>6
International Normalized Ratio (INR)<1.71.7–2.3>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 is used for people who have Gilbert’s syndrome or who are taking atazanavir.

Child-Pugh ClassificationTotal Child-Pugh Scorea
Class A5–6 points
Class B7–9 points
Class C>9 points

a Sum of points for each component of the Child-Pugh Score.

References

  1. Bohjanen P, Johnson M, Szczech L, et al. Steady-state pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with end-stage renal disease receiving chronic dialysis. Antimicrob Agents Chemother. 2002;46(8):2387-2392. Available at: https://pubmed.ncbi.nlm.nih.gov/12121909.
  2. Fischetti B, Shah K, Taft D, Berkowitz L, Bakshi A, Cha A. Real-world experience with higher-than-recommended doses of lamivudine in patients with varying degrees of renal impairment. Open Forum Infect Dis. 2018;5(10):ofy225. Available at: https://pubmed.ncbi.nlm.nih.gov/30302352.
  3. Michienzi S, Schriever C, Badowski M. Abacavir/lamivudine/dolutegravir single tablet regimen in patients with human immunodeficiency virus and end-stage renal disease on hemodialysis. Int J STD AIDS. 2019;30(2):181-187. Available at: https://pubmed.ncbi.nlm.nih.gov/30381029.
  4. Wood B, Pozniak A. Dosing lamivudine or emtricitabine in renal impairment: new data confirm it’s time for updated guidance! AIDS.2021;35(8):1305-1307. Available at: https://pubmed.ncbi.nlm.nih.gov/34076616.
  5. Lucas G, Ross M, Stock P, et al. Clinical practice guideline for the management of chronic kidney disease in patients infected with HIV: 2014 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(9):e96-e138. Available at: https://academic.oup.com/cid/article/59/9/e96/422813.

AU Commentary: Table 1

Stribild – this product has been removed from the market in Australia, access to generic equivalents are NOT available.

Atripla – this product has been removed from the market in Australia– access to generic equivalent is available and reimbursed via the PBS.

Complera/Eviplera – this product has been removed from the market in Australia – access to generic equivalent is NOT available. Components of this regimen can be prescribed as TD*/FTC + RPV, both available and reimbursed via PBS.

Delstrigo – currently not available in Australia. TGA registered 04/02/2019 but not accessible or reimbursed via PBS.

Symfi and Symfi Lo – this product is not available in Australia – access to generic equivalent is NOT available. This regimen can be prescribed in its components based on ARVs available in Australia

Cabenuva – note that only CAB 600/RPV 900 kit (Q8W dosing) is available in Australia for dosing. TGA registered 23/02/2021, accessible and reimbursed via PBS from 01/04/2022. Oral lead-in optional from 08/2022.

AU Comment: Table 3

Emtriva –this product has been removed from the market in Australia– access to generic equivalent is NOT available.

Vemlidy – this product is NOT available in Australia.

Viread – generic equivalents available.

AU Comment: Doravirine

Doravirine – currently not available in Australia. TGA registered 21/07/2019 but not accessible or reimbursed via PBS (potential availability via MSD Compassionate).

AU Comment: Dolutegravir

Dolutegravir – NTD defect signal decreased from initial findings – data re: Tsepamo and IMPAACT, guidelines now support the use of DTG as preferred regimen for persons of childbearing potential, with an appropriate dual-nucleoside backbone.

AU Comment: Fostemsavir

Fostemsavir – this agent is currently not available in Australia. TGA registered 14/07/2021 but not accessible or reimbursed via PBS – accessible via approval pathway ViiV Healthcare.

AU Comment: Lenacapavir

Lenacapavir – this agent is currently not available in Australia. TGA registered 27/03/2023 but not accessible or reimbursed via PBS – accessible via approval pathway Gilead Sciences.

AU Commentary: Table 12

Emtriva (FTC) –this product has been removed from the market in Australia – access to generic equivalent is NOT available.

Vemlidy (TAF) – this product is not available in Australia

Descovy (TAF/FTC) –

Dosing in Adults with Renal Insufficiency

  • no dose adjustment required in adult patients with ESRD (estimated CrCl <15 mL/min) on haemodialysis
  • On HD days, administer after dialysis.
  • monitor for haematological effects due to reduced clearance of FTC component

Tenofovir Disoproxil Fumarate/Lamivudine – this product is not available in Australia – access to generic equivalent is NOT available.

Doravirine – not available in Australia. TGA registered 21/07/2019 but not accessible or reimbursed via PBS (potential availability via MSD Compassionate)

Delstrigo – not available in Australia. TGA registered 04/02/2019 but not accessible or reimbursed via PBS (potential availability via MSD Compassionate)

Atripla –this product has been removed from the market in Australia– access to generic equivalent is available and reimbursed via PBS.

Symfi and Symfi Lo – this product is NOT available in Australia– access to generic equivalent is NOT available. This regimen can be prescribed in its components based on ARVs available in Australia.

Edurant (RPV) – note that patients receiving renal replacement therapy may be prescribed concomitant acid-suppressing medicines – PPIs contraindicate use, suggest review ART with a view to optimisation/switch.

Cabenuva – note that only CAB 600/RPV 900 kit (Q8W dosing) is available in Australia for dosing. TGA registered 23/02/2021, accessible and reimbursed via PBS from 01/04/2022. Oral lead-in optional from 08/2022.

Odefsey – patients receiving renal replacement therapy may be prescribed concomitant acid-suppressing medicines – PPIs contraindicate use, suggest review ART with a view to optimisation/switch.

Complera/Eviplera – this product has been removed from the market in Australia– access to generic equivalent is NOT available. Components of this regimen can be prescribed as TD*/FTC + RPV, both available and reimbursed via PBS.

  • patients receiving renal replacement therapy may be prescribed concomitant acid-suppressing medicines – PPIs contraindicate use, suggest review ART with a view to optimisation/switch.

Juluca (DTG/RPV) – patients receiving renal replacement therapy may be prescribed concomitant cation-containing supplements (e.g. calcium or aluminium as phosphate binders) – note separation of INSTIs from concomitant cation-containing supplements.

  • patients receiving renal replacement therapy may be prescribed concomitant acid-suppressing medicines – PPIs contraindicate use, suggest review ART with a view to optimisation/switch.

Biktarvy – patients receiving renal replacement therapy may be prescribed concomitant cation-containing supplements (e.g. calcium or aluminium as phosphate binders) – note separation of INSTIs from concomitant cation-containing supplements.

Cabotegravir (Apretude) – this agent is currently NOT available in Australia. TGA registered 11/08/2022 but not accessible or reimbursed via PBS – accessible via approval pathway ViiV Healthcare.

Stribild – this product has been removed from market in Australia – access to generic equivalent is NOT available.