What FDA‑approved fixed‑dose combination available in the United States can replace tenofovir disoproxil fumarate + lamivudine + dolutegravir (TLD) for this patient?

Switching from TLD to a US FDA-Approved Regimen

For a virologically-suppressed patient on TLD (tenofovir disoproxil fumarate/lamivudine/dolutegravir) from Africa, switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF, brand name Biktarvy) as the most direct US equivalent single-tablet regimen. 1, 2

Primary Recommended Option

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is the optimal choice because:

• It maintains the same drug class structure as TLD: an integrase strand transfer inhibitor (INSTI) plus two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) 1, 2
• It is a once-daily, single-tablet regimen that preserves the convenience of TLD 1, 2
• Bictegravir has comparable efficacy to dolutegravir with a high genetic barrier to resistance 1
• TAF (tenofovir alafenamide) has improved bone and renal safety compared to TDF (tenofovir disoproxil fumarate), which is particularly advantageous for long-term treatment 1, 3
• It is FDA-approved and listed as a generally recommended initial regimen with AIa evidence rating 1, 2

Alternative Single-Tablet Options

If BIC/FTC/TAF is not available or contraindicated, consider these FDA-approved alternatives:

Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC)

• Maintains dolutegravir as the anchor drug, providing continuity from TLD 1, 4
• Single-tablet regimen with once-daily dosing 1, 4
• Critical caveat: HLA-B*5701 testing is mandatory before initiating abacavir; patients who test positive must not receive this regimen 1
• Should be avoided in patients with or at high risk for cardiovascular disease; prefer tenofovir-containing regimens in these cases 1

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/c/FTC/TAF)

• Single-tablet INSTI-based regimen with AIa evidence rating 1
• Must be taken with food, unlike TLD which can be taken without food 1
• More drug interactions due to cobicistat boosting compared to dolutegravir or bictegravir 1

Multi-Tablet Alternative

Dolutegravir plus emtricitabine/tenofovir alafenamide (DTG + FTC/TAF)

• Maintains dolutegravir from the original TLD regimen 1
• Two tablets daily instead of one, but preserves the same anchor drug 1
• AIa evidence rating as a generally recommended initial regimen 1

Important Considerations Before Switching

For Virologically-Suppressed Patients

• Review complete ART treatment history, prior resistance testing results (if available), and tolerability of current regimen 1
• Check HIV viral load 1 month after switching to ensure virologic suppression is maintained 1
• No resistance testing is required if the patient is virologically suppressed on TLD with no history of virologic failure 1

For Patients with Hepatitis B Co-infection

• Must continue a tenofovir-containing regimen (either TAF or TDF) as both emtricitabine and tenofovir have activity against HBV 1, 5
• BIC/FTC/TAF or DTG + FTC/TAF are preferred options to maintain HBV suppression 1, 5
• Dolutegravir/abacavir/lamivudine should be avoided as it lacks tenofovir and will not adequately suppress HBV 1, 5
• Monitor closely for hepatitis B exacerbation if any tenofovir-containing therapy is discontinued 2

Renal Function Considerations

• TAF-containing regimens (BIC/FTC/TAF or DTG + FTC/TAF) are preferred over TDF-containing regimens in patients with or at risk for kidney disease 1, 3
• TDF is not recommended for individuals with or at risk for bone disease (osteopenia or osteoporosis) 1
• BIC/FTC/TAF can be used in patients with creatinine clearance ≥30 mL/min 2

Pregnancy Considerations

• All recommended regimens can be used in pregnancy, though dolutegravir had interim reports of potential neural tube defects when initiated before conception 1
• Lower exposures of bictegravir occur during pregnancy; viral load should be monitored closely 2

Common Pitfalls to Avoid

• Do not switch to raltegravir-based or NNRTI-based regimens if there is any history of NRTI resistance, as these have lower genetic barriers to resistance 1
• Do not use dolutegravir/abacavir/lamivudine without HLA-B*5701 testing due to risk of severe hypersensitivity reaction 1
• Do not discontinue tenofovir in patients with HBV co-infection without alternative HBV-suppressive therapy, as this can cause severe hepatitis B exacerbation 1, 2
• Ensure the patient understands the new regimen to avoid inadvertent dosing errors, particularly if switching from a single-tablet to multi-tablet regimen 1

Monitoring After Switch

• Check HIV viral load at 1 month post-switch to confirm maintained virologic suppression 1
• Continue monitoring every 3 months until viral load remains <50 copies/mL for 1 year, then every 6 months 1
• Monitor for any new adverse effects or drug interactions with the new regimen 1