What is the recommended initial Antiretroviral Therapy (ART) regimen for a patient newly diagnosed with HIV/AIDS?

Initial Antiretroviral Therapy for Newly Diagnosed HIV

Start antiretroviral therapy (ART) immediately upon HIV diagnosis—ideally at the first clinic visit or even same-day—using an integrase strand transfer inhibitor (INSTI)-based regimen as first-line treatment. 1, 2, 3

Timing of ART Initiation

Initiate ART as soon as possible after HIV diagnosis, including same-day start, unless the patient is not ready to commit to therapy. 1, 2 This approach has demonstrated:

• Faster viral suppression (median 1.8 months vs. 4.3 months with delayed start) 4
• Superior rates of viral suppression compared to standard of care 5
• Better retention in care and improved linkage to treatment 5, 6
• Lower total healthcare costs over time (e.g., $109,456 vs. $116,870 at 36 months for rapid vs. delayed start) 7

Remove structural barriers that delay ART receipt to allow treatment initiation at the first clinic visit. 1, 2

First-Line Recommended Regimens

Generally Recommended Initial Regimens (Listed Alphabetically)

The following INSTI-based regimens are preferred for most patients:

• Bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) - preferred for most patients due to high efficacy, favorable side effect profile, and high barrier to resistance 1, 8, 3
• Dolutegravir plus tenofovir alafenamide/emtricitabine (DTG + TAF/FTC) - highly effective with strong resistance profile 1, 8, 3
• Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) - requires HLA-B*5701 testing before use 1, 8

Alternative Regimens When First-Line Options Unavailable

• Darunavir/cobicistat plus TAF/emtricitabine 1, 8
• Darunavir boosted with ritonavir plus TAF/emtricitabine 1, 8
• Raltegravir plus TAF/emtricitabine 1
• Elvitegravir/cobicistat/TAF/emtricitabine 1

Pre-Treatment Laboratory Testing

Draw baseline laboratories before starting ART, but do NOT delay treatment while waiting for results. 1, 2 Required baseline tests include:

• HIV-1 RNA level (viral load) 1, 2
• CD4 cell count 1, 2
• HIV genotype for resistance testing (NRTI, NNRTI, PI) 1, 2
• Hepatitis B and C screening 1, 2
• Basic chemistries 1, 2

Critical exception: HLA-B*5701 testing MUST be available before starting abacavir-containing regimens to prevent potentially life-threatening hypersensitivity reactions. 1, 2, 8

Regimen Selection for Rapid/Same-Day Start

For rapid ART start (within 7 days), use:

• Bictegravir/TAF/emtricitabine 2, 8
• Dolutegravir plus TAF/emtricitabine 2, 8
• Raltegravir plus TAF/emtricitabine 2

AVOID for rapid start:

• NNRTIs (e.g., efavirenz, rilpivirine) - require baseline testing 1, 2
• Abacavir-containing regimens - require HLA-B*5701 results first 1, 2
• Dolutegravir/abacavir/lamivudine - requires HLA-B*5701 testing 2, 8
• Rilpivirine-based regimens - require baseline viral load <100,000 copies/mL and CD4 >200/μL 1, 2

Special Clinical Situations

Opportunistic Infections

For most opportunistic infections, start ART within 2 weeks of initiating OI treatment. 1, 2, 3

Critical exceptions:

• Tuberculosis with CD4 ≥50 cells/μL: Start ART within 2-8 weeks of TB treatment initiation 1, 2, 3
• Tuberculosis with CD4 <50 cells/μL: Start ART within 2 weeks of TB treatment initiation 1, 2, 3
• Cryptococcal meningitis: Delay ART for 4-6 weeks after starting antifungal therapy 1, 2, 3

For active tuberculosis on rifamycin-based treatment, use:

• Dolutegravir 50 mg twice daily plus 2 NRTIs 1
• Efavirenz 600 mg daily plus 2 NRTIs 1
• Raltegravir 800 mg twice daily plus 2 NRTIs 1
• Do NOT use bictegravir with rifampin due to drug-drug interactions 1

Pregnancy

Pregnant individuals should initiate ART immediately for their own health and to reduce vertical transmission risk. 1, 2

Recommended regimens during pregnancy:

• Dolutegravir (combined with TAF/FTC or TDF/FTC) 1, 8, 3
• Atazanavir/ritonavir plus TAF/FTC or TDF/FTC 1
• Darunavir/ritonavir plus TAF/FTC or TDF/FTC 1
• Raltegravir plus TAF/FTC or TDF/FTC 1

Malignancy

Start ART immediately upon cancer diagnosis, with careful attention to drug-drug interactions. 1, 2, 3

Prophylaxis Considerations

Initiate Pneumocystis pneumonia prophylaxis for patients with CD4 <200 cells/μL. 1, 2, 3

MAC prophylaxis is no longer recommended if effective ART is initiated. 1, 2, 3

Cryptococcal prophylaxis is not recommended in high-resource settings with low disease prevalence. 1, 2, 3

Special Considerations for Regimen Selection

Renal Impairment

Avoid TDF-containing regimens in patients with or at risk for kidney disease; prefer TAF-based regimens. 1, 8

Bone Disease

Avoid TDF in patients with osteopenia or osteoporosis; prefer TAF-based regimens. 1, 8

Hepatitis B Co-infection

Use regimens containing TAF or TDF plus FTC or 3TC. 8, 3

Avoid dolutegravir/lamivudine (DTG/3TC) two-drug regimen in HBV co-infection. 8

Common Pitfalls to Avoid

Do NOT delay ART initiation waiting for complete laboratory results (except HLA-B*5701 if using abacavir). 1, 2, 8

Do NOT use abacavir without confirmed negative HLA-B*5701 testing - this can cause potentially life-threatening hypersensitivity reactions. 1, 2, 8

Do NOT start ART early in cryptococcal meningitis - wait 4-6 weeks after antifungal therapy initiation unless specific clinical criteria are met. 1, 2, 3

Do NOT use NNRTIs or abacavir for same-day/rapid start - these require baseline laboratory review. 1, 2

Do NOT overlook drug interactions, particularly with cobicistat-boosted regimens or in patients taking rifampin for tuberculosis. 1, 8

Expected Clinical Outcomes

With INSTI-based regimens initiated rapidly:

• 79% achieve viral suppression by week 12 when ART is started at intake visit 9
• 82% achieve viral suppression by week 24 9
• 88% achieve viral suppression by week 48 9
• Time to viral suppression is significantly shorter with INSTI-based regimens compared to PI-based regimens 9

Median CD4 count increases of 162 cells/mm³ are expected with dolutegravir-based regimens. 10