What are the indications for Antiretroviral (ARV) therapy?

From the Guidelines

Antiretroviral therapy (ARV) is indicated for all individuals diagnosed with HIV infection, regardless of CD4 count or clinical stage, and should be started as soon as possible after diagnosis. The standard first-line regimen typically consists of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INSTI), such as bictegravir or dolutegravir, with 2 (and in some cases 1) nucleoside or nucleotide reverse transcriptase inhibitors 1. Common combinations include tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) with emtricitabine (FTC) or lamivudine (3TC).

Key Considerations

• Treatment should begin as soon as possible after diagnosis to suppress viral replication, preserve immune function, prevent disease progression, and reduce transmission risk.
• For post-exposure prophylaxis (PEP), a 28-day course of ARVs should be started within 72 hours of exposure.
• For pre-exposure prophylaxis (PrEP), daily TDF/FTC or TAF/FTC is recommended for high-risk individuals.
• ARVs work by targeting different stages of the HIV life cycle, preventing viral replication and allowing immune recovery.
• Regular monitoring of viral load, CD4 count, and potential side effects is essential for managing therapy effectively.
• Treatment is lifelong, and adherence is crucial to prevent viral resistance and maintain viral suppression.

Special Considerations

• Recommendations are made for those with particular clinical circumstances, such as pregnancy and active opportunistic diseases, as well as for those unable to take InSTIs 1.
• Regimens may need to be changed for virologic failure, adverse effects, convenience, or cost, among other reasons.
• Long-acting injectable therapy is available for those who prefer not to take daily oral medications and for people struggling with adherence to daily therapy 1.

Evidence-Based Recommendations

The most recent and highest quality study, published in 2025, provides the basis for these recommendations 1. This study outlines the current standard of care for HIV treatment and prevention, including the use of ARVs for all individuals diagnosed with HIV infection, regardless of CD4 count or clinical stage.

From the FDA Drug Label

1 INDICATIONS & USAGE Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.

INDICATIONS AND USAGE Efavirenz is a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.(1)

1 INDICATIONS AND USAGE ‑ TIVICAY and TIVICAY PD are indicated in combination with: other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑ 1) infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve)aged at least 4 weeks and weighing at least 3 kg

The antiretroviral (ARV) indication for the given drugs is for the treatment of HIV-1 infection in:

• Adults
• Pediatric patients at least 3 months old and weighing at least 3.5 kg for efavirenz
• Pediatric patients aged at least 4 weeks and weighing at least 3 kg for dolutegravir The drugs should be used in combination with other antiretroviral agents 2, 2, 3.

From the Research

ARV Indication

The indication for Antiretroviral (ARV) therapy is a crucial aspect of HIV-1 infection management. Several studies have investigated the efficacy and safety of various ARV regimens.

• The EMERALD study 4 demonstrated the safety and efficacy of a single-tablet regimen of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide for the treatment of HIV-1 infection in adults with viral suppression.
• The NADIA study 5 compared the efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection, showing that dolutegravir is non-inferior to darunavir but is at greater risk of resistance in second-line therapy.
• The ADVANCE study 6 compared the efficacy and safety of two antiretroviral first-line combinations (dolutegravir combined with emtricitabine and either tenofovir disoproxil fumarate or tenofovir alafenamide) with a third regimen (efavirenz combined with emtricitabine and tenofovir disoproxil fumarate), establishing non-inferiority in all three comparisons.
• A retrospective and descriptive study 7 evaluated the effectiveness and clinical tolerance of a combination containing tenofovir disoproxil fumarate-emtricitabine-efavirenz in treatment-naive patients infected with HIV-1, showing good effectiveness and clinical tolerance.
• A review article 8 discussed the chemistry and pharmacology of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, and summarized trials conducted on antiretroviral therapy (ART)-naïve and -experienced people living with HIV, demonstrating that the single-tablet regimen of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide is an effective, well-tolerated, and safe antiretroviral regimen.

Key Findings

• Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide is a safe and effective single-tablet regimen for the treatment of HIV-1 infection in adults with viral suppression 4, 8.
• Dolutegravir is non-inferior to darunavir but is at greater risk of resistance in second-line therapy 5.
• Tenofovir disoproxil fumarate-emtricitabine-efavirenz is an effective and well-tolerated combination for treatment-naive patients infected with HIV-1 7.
• The choice of ARV regimen depends on various factors, including viral load, CD4 cell count, and patient tolerance 5, 6, 8.