Initial Treatment Regimen for New HIV Diagnosis
For newly diagnosed HIV patients, an integrase strand transfer inhibitor (InSTI)-based regimen is recommended as first-line therapy, with immediate initiation of antiretroviral therapy (ART) as soon as possible after diagnosis if the patient is ready to commit to treatment. 1
Timing of ART Initiation
- ART should be initiated as soon as possible after HIV diagnosis, including immediately after diagnosis if the patient is ready to commit to treatment (evidence rating: AIa) 1
- Structural barriers that delay receipt of ART should be removed to allow newly diagnosed persons to receive ART at the first clinic visit after diagnosis 1
- Immediate ART initiation is associated with a 63% reduction in overall mortality among people living with HIV with CD4 counts >500 cells/μL 2
- Rapid ART initiation (within days of diagnosis) leads to improved rates of viral suppression and retention in care compared to standard of care 3, 4
Recommended Initial Regimens
First-Line Regimens (Listed in Alphabetical Order by InSTI Component)
- Bictegravir/tenofovir alafenamide/emtricitabine (evidence rating: AIa) 1, 5
- Dolutegravir/abacavir/lamivudine (evidence rating: AIa) 1, 5
- Dolutegravir plus tenofovir alafenamide/emtricitabine (evidence rating: AIa) 1, 5
Alternative Regimens (When First-Line Regimens Are Not Available or Not an Option)
- Darunavir/cobicistat (or ritonavir) plus tenofovir alafenamide (or tenofovir disoproxil fumarate)/emtricitabine (evidence rating: AIa) 1, 6
- Efavirenz/tenofovir disoproxil fumarate/emtricitabine (evidence rating: AIa) 1
- Elvitegravir/cobicistat/tenofovir alafenamide (or tenofovir disoproxil fumarate)/emtricitabine (evidence rating: AIa) 1
- Raltegravir plus tenofovir alafenamide (or tenofovir disoproxil fumarate)/emtricitabine (evidence rating: AIa) 1
- Rilpivirine/tenofovir alafenamide (or tenofovir disoproxil fumarate)/emtricitabine (if pretreatment HIV RNA level is <100,000 copies/mL and CD4 cell count is >200/μL) (evidence rating: AIa) 1
Pre-Treatment Evaluation
- Before starting ART, samples should be collected for HIV-1 RNA level, CD4 cell count, HIV genotype for resistance testing, and laboratory tests to exclude active viral hepatitis and assess general health 1
- HLA-B*5701 testing should be performed before using abacavir-containing regimens 1
- Treatment can be started before all results are available, particularly in rapid-start scenarios 1
Special Considerations
Opportunistic Infections
- For most opportunistic infections, ART should be initiated within 2 weeks of starting treatment for the opportunistic infection 1
- For tuberculosis with CD4 counts ≥50/μL, ART should be initiated within 2-8 weeks of starting TB treatment 1
- For cryptococcal meningitis, ART should be initiated 4-6 weeks after starting antifungal therapy 1
- For patients with TB receiving rifampin, recommended regimens include dolutegravir (50 mg twice daily), efavirenz (600 mg/day), or raltegravir (800 mg twice daily) plus 2 NRTIs 1
Pregnancy
- Recommended regimens during pregnancy include atazanavir/ritonavir, darunavir/ritonavir, dolutegravir, efavirenz, or raltegravir combined with appropriate NRTIs 1
- Dolutegravir is now considered safe for use during pregnancy based on current evidence 1
Tenofovir Formulation Considerations
- Tenofovir alafenamide (TAF) is preferred over tenofovir disoproxil fumarate (TDF) for individuals with or at risk for kidney or bone disease 1, 7
- TDF has more extensive long-term safety data and has demonstrated efficacy in multiple clinical trials 6, 7
Pitfalls and Caveats
- Non-nucleoside reverse transcriptase inhibitors (NNRTIs) and abacavir should not be used for rapid ART start scenarios due to potential resistance issues and need for HLA-B*5701 testing results 1
- Bictegravir should not be used with rifampin due to significant drug-drug interactions 1
- Initial 2-drug regimens are only recommended in rare situations where a patient cannot take abacavir, TAF, or TDF 1
- Close monitoring for adherence and virological response is needed, especially for patients with high viral loads or low CD4 counts 1
- Rapid ART initiation requires adequate staffing, specialized services, and careful selection of medical therapy 1, 8, 9