From the Guidelines
The initial treatment approach for outpatient HIV care should prioritize starting antiretroviral therapy (ART) as soon as possible after diagnosis, with a preferred first-line regimen consisting of an integrase strand transfer inhibitor (InSTI), such as bictegravir or dolutegravir, combined with two nucleoside or nucleotide reverse transcriptase inhibitors, as recommended by the 2025 International Antiviral Society-USA panel 1. This approach is supported by the most recent and highest quality evidence, which emphasizes the importance of early ART initiation in achieving optimal health outcomes and preventing HIV transmission. Key considerations in outpatient HIV care include:
- Baseline laboratory tests, such as CD4 count, HIV viral load, and resistance testing
- Screening for opportunistic infections and sexually transmitted infections
- Treatment adherence counseling and addressing potential barriers to care, including mental health issues, substance use, or housing instability
- Regular monitoring of laboratory tests and adjustment of the treatment regimen as needed to ensure viral suppression and prevent disease progression. The use of InSTIs, such as bictegravir or dolutegravir, in combination with nucleoside or nucleotide reverse transcriptase inhibitors, is recommended due to their high efficacy and favorable safety profile, as noted in the 2025 guidelines 1. Overall, the goal of outpatient HIV care is to provide comprehensive and patient-centered care that addresses the physical, emotional, and social needs of individuals living with HIV, with the ultimate goal of achieving viral suppression, preventing disease progression, and improving quality of life.
From the FDA Drug Label
BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in: adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir The initial treatment approach for outpatient HIV care may include BIKTARVY as a complete regimen for patients with no antiretroviral treatment history or for those who are virologically-suppressed on a stable antiretroviral regimen with no known or suspected resistance to bictegravir or tenofovir 2.
From the Research
Initial Treatment Approach for Outpatient HIV Care
The initial treatment approach for outpatient Human Immunodeficiency Virus (HIV) care involves the use of antiretroviral therapy (ART) as soon as possible 3. The choice of ART regimen depends on various factors, including the patient's viral load, CD4 cell count, and presence of any resistance-associated mutations.
Antiretroviral Therapy Regimens
Several studies have demonstrated the effectiveness of different ART regimens in outpatient HIV care, including:
- Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) 4, 5, 6
- Raltegravir/emtricitabine/tenofovir combination 7
- Dolutegravir-based three-drug regimens 5
Key Considerations
When selecting an ART regimen, the following factors should be considered:
- Efficacy: The ability of the regimen to suppress viral load and improve CD4 cell count
- Safety: The potential for adverse effects and toxicity
- Adherence: The ease of use and patient adherence to the regimen
- Resistance: The presence of resistance-associated mutations and the potential for developing resistance
Benefits of Early Treatment
Early initiation of ART has been shown to have several benefits, including:
- Reduced risk of transmission to others
- Improved immune function
- Reduced risk of opportunistic infections and cancers
- Improved quality of life
Real-World Effectiveness
Real-world studies have demonstrated the effectiveness of ART regimens in outpatient HIV care, with high rates of viral suppression and low discontinuation rates due to adverse effects 4, 5, 6.