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 mg | One tablet PO once daily |
Genvoya (EVG/c/TAF/FTC) | Elvitegravir 150 mg/cobicistat 150 mg/tenofovir alafenamide 10 mg/emtricitabine 200 mg | One tablet PO once daily with food |
Stribild (EVG/c/TDF/FTC) | Elvitegravir 150 mg/cobicistat 150 mg/tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg | One tablet PO once daily with food |
Triumeq (DTG/ABC/3TC) | Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg | One tablet PO once daily |
INSTI Plus One NRTI | ||
Dovato (DTG/3TC) | Dolutegravir 50 mg/lamivudine 300 mg | One tablet PO once daily |
INSTI Plus One NNRTI | ||
Dovato (DTG/3TC) | Cabenuva 600-mg/900-mg kit contains:
Cabenuva 400-mg/600-mg kit contains:
| Optional Lead-in with Oral CAB and RPV
Monthly IM CAB and RPV
Every 2-Month IM CAB and RPV
|
Juluca (DTG/RPV) | Dolutegravir 50 mg/rilpivirine 25 mg | One tablet PO once daily with food |
INSTI Plus One NNRTI | ||
Cabenuva (CAB IM and RPV IM) | Cabenuva 600-mg/900-mg kit contains:
Cabenuva 400-mg/600-mg kit contains:
| Optional Lead-in with Oral CAB and RPV
Monthly IM CAB and RPV
Every 2-Month IM CAB and RPV
|
Juluca (DTG/RPV) | Dolutegravir 50 mg/rilpivirine 25 mg | One tablet PO once daily with food |
NNRTI Plus Two NRTIs | ||
Atripla (EFV/TDF/FTC) | Efavirenz 600 mg/tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg | One 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 mg | One tablet PO once daily with food |
Delstrigo (DOR/TDF/3TC) | Doravirine 100 mg/tenofovir disoproxil fumarate 300 mg/lamivudine 300 mg | One tablet PO once daily |
Odefsey (RPV/TAF/FTC) | Rilpivirine 25 mg/tenofovir alafenamide 25 mg/emtricitabine 200 mg | One tablet PO once daily with food |
Symfi (EFV/TDF/3TC) | Efavirenz 600 mg/tenofovir disoproxil fumarate 300 mg/lamivudine 300 mg | One 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 mg | One 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
Also available as part of the STR Delstrigo (DOR/TDF/3TC)c STRs That Contain DORc
| Pifeltro
See Appendix A, Table 1 for dosing information for Delstrigo. | CYP3A4/5 substrate | 15 hours | Nausea Dizziness Abnormal dreams |
Efavirenz (EFV) Note: The branded product Sustiva has been discontinued. | Efavirenz (generic)
STRs that Contain EFVc
| Efavirenz (generic)
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 hours | Rashd 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
| Intelence
| CYP3A4, 2C9, and 2C19 substrate CYP3A4 inducer CYP2C9 and 2C19 inhibitor | 41 hours | Rash, 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
STRs that Contain RPVc
Copackaged Intramuscular Regimen
| Edurant
See Appendix A, Table 1 for dosing information for coformulated and copackaged regimens that contain RPV. | CYP3A4 substrate | PO: 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.
b Also see Table 20.
c See Appendix A, Table 1 for information about these formulations.
d Rare cases of Stevens-Johnson syndrome have been reported with the use of most NNRTIs.
e 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 | Formulations | Dosing Recommendationsa | Elimination/ Metabolic Pathway | Serum Half-Life | Adverse Eventsb |
---|---|---|---|---|---|
Atazanavir (ATV) Reyataz (ATV/c) Evotaz Note: Generic products of ATV are available. | Reyataz
Generic
Evotaz
| Reyataz In People Without Prior ARV Treatment
With TDF or in ARV-Experienced People
With EFV in People Without Prior ARV Treatment
Evotaz
For dosing recommendations for patients who also are receiving H2 antagonists and PPIs, refer to Table 24a. | ATV
COBI
Dose adjustment is recommended in people with hepatic insufficiency (see Appendix B). | 7 hours | Indirect 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
Prezcobix
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
In ARV-Experienced People With One or More DRV Resistance Mutations
Unboosted DRV is not recommended. Prezcobix
See Appendix A, Table 1 for dosing information for Symtuza. | DRV
COBI
| 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
Also available as part of the FDC tablet Kaletra (LPV/r) | As a PK Booster (or Enhancer) for Other PIs
| 2D6 substrate Potent CYP3A4 and 2D6 inhibitor Inducer of UGT1A1 and CYPs 1A2, 2C8, 2C9, and 2C19 | 3–5 hours | GI 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 | Formulations | Dosing Recommendations | Serum Half-Life | Elimination | Adverse Eventsa |
---|---|---|---|---|---|
Enfuvirtide (T-20) Fuzeon | Fuzeon
| Fuzeon
| 3.8 hours | Expected 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 | Formulation | Dosing Recommendations | Serum Half-Life | Elimination | Adverse Eventsa |
---|---|---|---|---|---|
Lenacapavir (LEN) Sunlenca | 300-mg tablet Single-dose 463.5-mg/1.5-mL vial for injection | Initiation Option 1
Initiation Option 2
Maintenance Dosing
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 Dosea | Dosing in Adults With Renal Insufficiency | Dosing 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 daily | Not 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 Formulation | No dose recommendation. | |||
CrCl (mL/min) | Capsule | Solution | ||||
30–49b | No dose adjustment necessary. | |||||
15–29 (see Note) | 200 mg every 72 hours | 80 mg every 24 hours | ||||
<15 (not on HD) (see Note) | 200 mg every 96 hours | 60 mg every 24 hours | ||||
On HDb | No 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 Dose | Alternative Dosed | No dose adjustment necessary | |
15–29 (see Note) | 1 × 150 mg, then 100 mg every 24 hours | 100–150 mg every 24 hours | ||||
5–14 (see Note) | 1 × 150 mg, then 50 mg every 24 hours | 100–150 mg every 24 hours | ||||
<5 or on HD (see Note) | 1 × 50 mg, then 25 mg every 24 hours | 100–150 mg every 24 hours | ||||
Tenofovir Alafenamide (TAF) Vemlidy | Vemlidy is available as a 25-mg tablet for the treatment of HBV. | CrCl (mL/min) | Dose | Child-Pugh Class A: No dose adjustment Child-Pugh Class B or C:Not recommended |
||
<15 and not on HD | Not recommended | |||||
On HD | No 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).
| CrCl (mL/min) | Dose | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation |
||
15-29 | 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 FTC in people with CrCl 15–29 mL/min. |
|||||
<15 (not on HD) | Not recommended | |||||
On HD | No dose adjustment necessary. On HD days, administer after dialysis. | |||||
Tenofovir Disoproxil Fumarate (TDF) Viread | TDF 300 mg PO once daily | CrCl (mL/min) | Dose | No dose adjustment necessary. | ||
30–49 | 300 mg every 48 hours | |||||
10–29 | 300 mg twice weekly (every 72–96 hours) | |||||
<10 and not on HD | No recommendation | |||||
On HD | 300 mg every 7 days (administer after completion of HD) | |||||
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) Truvada | One tablet PO once daily | CrCl (mL/min) | Dose | No dose recommendation. | ||
30–49 | One tablet every 48 hours | |||||
<30 or on HD | FDC of TDF/FTC not recommended | |||||
Tenofovir Disoproxil Fumarate/Lamivudine (TDF/3TC) Cimduo | One tablet PO once daily | CrCl (mL/min) | Dose | No dose recommendation. | ||
<50 or on HD | FDC of TDF/FTC <not recommended | |||||
NNRTIs | ||||||
Doravirine (DOR) Pifeltro | DOR 100 mg PO once daily | No 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 daily | FDC of DOR/TDF/3TC not recommended if CrCl <50 mL/min or on HD | Child-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 bedtime | No 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 bedtime | FDC of EFV/TDF/3TC not recommended if CrCl <50 mL/min or on HD | No 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 bedtime | FDC of EFV/TDF/3TC not recommended if CrCl <50 mL/min or on HD | Not 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 bedtime | FDC of EFV/TDF/3TC not recommended if CrCl <50 mL/min or on HD | Not 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 daily | No 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 food | No 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
Every-2-Months Dosing
| 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 food | In People With CrCl 15–29 mL/min
In People With CrCl <15 mL/min (not on HD)
In People on Chronic HD
| 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 food | FDC of RPV/TDF/FTC not recommended if CrCl <50 mL/min or on HD | Child-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 food | No 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
In ARV-Experienced People on HD
| 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. |
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Atazanavir/Cobicistat (ATV/c) Evotaz | One tablet PO once daily with food | If 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
In ARV-Experienced Patients With at Least One DRV Resistance Mutation
| No dose adjustment necessary. | In People with Mild-to-Moderate Hepatic Impairment: No dose adjustment In People with Severe Hepatic Impairment: Not recommended |
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Darunavir/Cobicistat (DRV/c) Prezcobix | One tablet PO once daily with food | If 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 |
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Darunavir/Cobicistat/Tenofovir Alafenamide/Emtricitabine (DRV/c/TAF/FTC) Symtuza | One tablet PO once daily with food | In People With CrCl 15–29 mL/min
In People With CrCl <15 mL/min (not on HD)
In People on Chronic HD
| Not recommended for patients with severe hepatic impairment. | |||
Ritonavir (RTV) Norvir | As a PI-Boosting Agent
| 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 daily | In People With CrCl 15–29 mL/min
In People With CrCl <15 mL/min (not on HD)
| Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended |
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Cabotegravir (CAB PO) Vocabria | Treatment (As Optional Oral Lead-In or As Oral Bridging)
Pre-exposure Prophylaxis (Optional Oral Lead-In)
| No dose adjustment necessary. | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation |
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Cabotegravir (CAB IM) Apretude | Pre-exposure Prophylaxis
| No dose adjustment necessary. | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation |
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Cabotegravir IM plus Rilpivirine IM (CAB IM plus RPV IM) Cabenuva | Monthly Dosing
Every 2-Month Dosing
| 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 |
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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 |
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Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) Triumeq | One tablet PO once daily | Not 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 |
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Dolutegravir/Lamivudine (DTG/3TC) Dovato | One tablet PO once daily | Not 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 food | No 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 |
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Elvitegravir/Cobicistat/Tenofovir Alafenamide/Emtricitabine (EVG/c/TAF/FTC) Genvoya | One tablet PO once daily with food | In People With CrCl 15–29 mL/min
In People With CrCl <15 mL/min (not on HD)
In People on Chronic HD
| In People With Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary In People With Severe Hepatic Insufficiency: Not recommended |
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Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine (EVG/c/TDF/FTC) Stribild | One tablet PO once daily with food | EVG/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 |
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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 |
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Fusion Inhibitor | ||||||
Enfuvirtide (T-20) Fuzeon | T-20 90 mg SQ twice daily | No 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<
With Potent CYP3A Inducers or Inhibitors
| 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 daily | No dose adjustment recommended. | No dose adjustment recommended. | |||
Capsid Inhibitor | ||||||
Lenacapavir (LEN) Sunlenca | Initiation Option 1
Initiation Option 2
Maintenance Dosing
| 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) 72 × 𝑦𝑦𝑎𝑎𝑦𝑦𝑠𝑠𝑠𝑠 𝑐𝑐𝑦𝑦𝑎𝑎𝑎𝑎𝑡𝑡𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑎𝑎 | Female: (140 − 𝑎𝑎𝑎𝑎𝑎𝑎 𝑖𝑖𝑖𝑖 𝑦𝑦𝑎𝑎𝑎𝑎𝑦𝑦𝑦𝑦) 72 × 𝑦𝑦𝑎𝑎𝑦𝑦𝑠𝑠𝑠𝑠 𝑐𝑐𝑦𝑦𝑎𝑎𝑎𝑎𝑡𝑡𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑎𝑎 |
Child-Pugh Score | |||
Component | Points Scored | ||
1 | 2 | 3 | |
Encephalopathya | None | Grade 1–2 | Grade 3–4 |
Ascites | None | Mild or controlled by diuretics | Moderate or refractory despite diuretics |
Albumin | >3.5 g/dL | 2.8–3.5 g/dL | <2.8 g/dL |
Total Bilirubin, or | <2 mg/dL (<34 μmol/L) | 2–3 mg/dL (34–50 μmol/L) | >3 mg/dL (>50 μmol/L) |
Modified Total Bilirubinb | <4 mg/dL | 4–7 mg/dL | >7 mg/dL |
Prothrombin Time (Seconds Prolonged), or | <4 | 4–6 | >6 |
International Normalized Ratio (INR) | <1.7 | 1.7–2.3 | >2.3 |
a Encephalopathy Grades
Grade 1: Mild confusion, anxiety, restlessness, fine tremor, slowed coordination
Grade 2: Drowsiness, disorientation, asterixis
Grade 3: Somnolent but rousable, marked confusion, incomprehensible speech, incontinence, hyperventilation
Grade 4: Coma, decerebrate posturing, flaccidity
b Modified total bilirubin is used for people who have Gilbert’s syndrome or who are taking atazanavir.
Child-Pugh Classification | Total Child-Pugh Scorea |
Class A | 5–6 points |
Class B | 7–9 points |
Class C | >9 points |
a Sum of points for each component of the Child-Pugh Score.
References
- 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.
- 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.
- 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.
- 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.
- 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: Cimduo
Cimduo – this product is NOT available in Australia.
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.