Australian Commentary to the US DHHS Guidelines for the use of Antiretroviral Agents in Adults and Adolescents with HIV

US DHHS Guidelines with Australian Commentary

Table of Contents

Appendix B: Drug Characteristics Table

DHHS Last Updated: May 2023Australian Commentary Last Updated: July 2023

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.

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