Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV

These guidelines were updated by the U.S. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) based on key new clinical evidence on the use of antiretroviral therapy (ART) for the treatment of people with HIV.

New Chapter Added to the Guidelines

Cardiovascular and Metabolic Complications in People With HIV

With the success of ART, the life expectancy of people with HIV is approaching that of people without HIV. As a result, many people with HIV are experiencing age-related comorbidities. This new chapter aims to provide guidance on the prevention and management of cardiovascular disease and metabolic complications in people with HIV and includes the following sections:

• Introduction
• Immune Activation and Inflammation Among People With HIV Receiving Antiretroviral Therapy
• Cardiovascular Complications in People With HIV
• Statin Therapy as Primary Prevention of Atherosclerotic Disease in People With HIV
• Weight Gain in People With Treated HIV

Key Revisions to the Guidelines

Laboratory Testing for Initial Assessment and Monitoring of People With HIV Receiving Antiretroviral Therapy

Updates made to the Laboratory Testing section include the following:

• Updated recommended monitoring frequencies for CD4 T lymphocyte (CD4) cell count, basic metabolic panel, liver enzymes, and lipid profile (see Table 3).
• A new table (Table 4. Laboratory Monitoring If ART Is Deferred) provides guidance on initial laboratory assessments and recommended follow-up frequency if ART is deferred.

Plasma HIV-1 RNA (Viral Load) and CD4 Count Monitoring

Updates made to the Plasma HIV-1 RNA (Viral Load) and CD4 Count Monitoring section include the following:

• The Panel previously considered repeat HIV-1 RNA monitoring optional when ART was deferred. To support ongoing discussions about the benefits of ART, for both HIV treatment and the prevention of transmission to others, the Panel now recommends testing every 3 to 6 months when ART is deferred.
• Updated the rationale for the changes in recommended CD4 count monitoring frequency, as noted in Table 3

Initiation of Antiretroviral Therapy

Two new subsections have been added to the Initiation of Antiretroviral Therapy section:

• Early (Acute/Recent) HIV Infection: This subsection focuses on the importance of initiating ART as soon as possible, as ART can provide immunologic benefits for people with early HIV infection. Additionally, early HIV is a period of high infectivity, and ART substantially reduces the risk of transmission.
• Antiretroviral Therapy Initiation in Hospitalized People With HIV: This subsection discusses the benefits of initiating ART in people who receive an HIV diagnosis during hospitalization, while acknowledging that this may not be possible in all settings. Based on the discussion, the Panel recommends initiating ART during hospitalization whenever possible (BIII). The Panel notes that if ART is initiated before hospital discharge, clinicians should ensure sufficient ART supply is available until the outpatient clinic appointment.

The Elite HIV Controllers subsection was updated with two recommendations based on discussion of new observational studies regarding clinical outcomes of this population:

• The Panel strongly recommends ART for elite controllers with evidence of HIV-related complications, declining CD4 counts, intermittent detectable viral loads, or comorbidities (e.g., cardiovascular disease, cancer, hepatitis B virus/hepatitis C virus coinfection) or for those who are pregnant (AIII).
• The Panel also recommends initiation of ART for all other HIV elite controllers (BII).

Suboptimal CD4 Cell Recovery Despite Viral Suppression

This section—previously titled “Poor CD4 Cell Recovery and Persistent Inflammation Despite Viral Suppression”—has been renamed following the relocation of content on persistent inflammation to the new Immune Activation and Inflammation section. Additional updates to the Suboptimal CD4 Cell Recovery section include the following:

• Updated evidence on the clinical consequences of suboptimal CD4 recovery, including the increased risk of AIDS and non-AIDS events.
• The Panel notes that promptly initiating ART in people diagnosed early with HIV provides the best opportunity for maximal CD4 recovery.
• The Panel emphasizes that to date, there is no effective therapeutic intervention to improve CD4 count in people with suboptimal CD4 recovery.
• The Panel notes that efforts to decrease morbidity and mortality should focus on preventive care, addressing modifiable risk factors for chronic disease, and optimizing management of comorbidities.

Cost Considerations and Antiretroviral Therapy

Several new subsections have been added to the Cost Considerations and Antiretroviral Therapy section:

• Health Care Coverage to Maximize Access to Antiretroviral Therapy
• Medicare Beneficiaries With HIV
• Long-Acting Injectables
• 340B Drug Pricing Program, Prescription Drug Affordability, and Program Savings for People With HIV

Table 22a (Insurance and Health Program Prescription Drug Pricing and Access) and Table 22b (Monthly Average Prices of Commonly Used Antiretroviral Drugs) have been updated with the most recent information.

Other Updates

Minor updates have been made to the following sections of the guidelines:

• Antiretroviral Therapy to Prevent Sexual Transmission of HIV (Treatment as Prevention)
• Adverse Effects of Antiretroviral Medications
• Appendix A: Drug Characteristics Tables
• Appendix B: Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency