What is the initial treatment approach for a patient seeking care at an Antiretroviral Therapy (ART) center?

Initial Treatment Approach at an ART Center

Antiretroviral therapy should be initiated as soon as possible after HIV diagnosis, ideally at the first clinic visit on the same day, unless the patient is not ready to commit to treatment. 1, 2

Timing of ART Initiation

Immediate ART initiation (same day to within 7 days) is the standard of care, supported by randomized trials showing improved viral suppression (85% vs 75% at 1 year) and retention in care when therapy is started rapidly. 1

• In successful rapid-start programs, 71% of patients started ART the same day of eligibility, with time from diagnosis to viral suppression decreasing by more than 50%. 1
• Structural barriers (staffing, services availability, ART distribution systems) must be addressed to enable same-day initiation. 1
• Treatment may begin before baseline laboratory results are available, though samples should be drawn first. 1, 2

Critical Pre-Treatment Requirements

Before initiating ART, draw the following samples (treatment can start before results return): 1, 2, 3

• HIV-1 RNA level (viral load)
• CD4 cell count
• HIV genotype for resistance testing (NRTI, NNRTI, PI)
• HLA-B*5701 testing if abacavir-containing regimen is anticipated
• Hepatitis B and C serology
• Basic chemistry panel and liver function tests

HLA-B*5701 must be negative before prescribing any abacavir-containing regimen to prevent potentially life-threatening hypersensitivity reactions. 1, 3

Recommended Initial Regimens

The preferred first-line regimen for most patients is an integrase strand transfer inhibitor (InSTI) plus two nucleoside reverse transcriptase inhibitors (NRTIs). 1, 2, 3

First-Line Options (Listed Alphabetically)

Bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) - Single tablet, no boosting required, high barrier to resistance. 1, 2, 3

Dolutegravir plus tenofovir alafenamide/emtricitabine (DTG + TAF/FTC) - High efficacy, strong resistance profile, no boosting required. 1, 2, 3

Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) - Single tablet option, but requires negative HLA-B*5701 test. 1, 3

Key Advantages of InSTI-Based Regimens

• Bictegravir and dolutegravir do not require pharmacologic boosting (ritonavir or cobicistat), reducing drug interactions. 1
• These regimens have high barriers to resistance with no emergence of resistant virus in initial therapy studies. 1
• Dolutegravir has substantially more data and longer-term experience (approved 2013) compared to bictegravir (approved 2018). 1

Alternative Regimens When InSTIs Are Not an Option

If InSTI-based regimens cannot be used: 1

• Darunavir/cobicistat plus TAF/emtricitabine
• Darunavir boosted with ritonavir plus TAF/emtricitabine
• Efavirenz/TDF/emtricitabine (higher rates of CNS adverse effects and rash than InSTIs) 1

NNRTIs and abacavir should not be used for rapid ART start due to the need for HLA-B*5701 results and higher risk of adverse effects. 1

Special Considerations for ART Initiation

Active Opportunistic Infections

For most opportunistic infections, start ART within the first 2 weeks after diagnosis. 1, 2

Tuberculosis co-infection: 1

• CD4 <50/μL: Start ART within first 2 weeks of TB treatment
• CD4 ≥50/μL: Start ART within 2-8 weeks of TB treatment
• Use efavirenz (600 mg/day), raltegravir (800 mg twice daily), or dolutegravir (50 mg twice daily) with rifamycin-based TB regimens 1

Cryptococcal meningitis: Start ART within 2 weeks of diagnosis in high-resource settings with optimal antifungal therapy and aggressive intracranial pressure management. Monitor carefully for immune reconstitution inflammatory syndrome. 1, 2

Concurrent malignancy: Initiate ART immediately while cancer staging and molecular testing are performed. 1

Primary Prophylaxis Requirements

Pneumocystis pneumonia prophylaxis is required for patients with CD4 counts <200/μL. 1

Mycobacterium avium complex prophylaxis is no longer recommended if effective ART is initiated, as incidence and mortality are sufficiently low with viral suppression. 1

Cryptococcal disease prophylaxis is not recommended in settings where incidence is low. 1

Monitoring After ART Initiation

Measure viral load 4-6 weeks after starting ART to assess initial response. 2, 3

• Once viral suppression is achieved, monitor every 3 months until suppression is maintained for at least 1 year. 2
• After 1 year of viral suppression, monitoring can be reduced to every 6 months. 2

Critical Pitfalls to Avoid

Do not delay ART initiation - Delaying treatment leads to poorer outcomes, increased risk of HIV transmission, and decreased likelihood of achieving viral suppression. 1, 2

Do not use two-drug regimens (e.g., dolutegravir/lamivudine) for initial therapy in patients with active opportunistic infections - These have not been studied in this setting. 1

Do not prescribe abacavir without confirming negative HLA-B*5701 - This can cause life-threatening hypersensitivity reactions. 1, 3

Avoid tenofovir disoproxil fumarate (TDF) in patients with renal impairment or osteoporosis - Prefer tenofovir alafenamide (TAF) in these populations. 1, 3

Counsel patients about potential weight gain with InSTI-based regimens, particularly with dolutegravir or bictegravir combined with TAF, and provide information about diet and exercise modifications. 1