What’s New in the Guidelines? (Last updated May 30, 2018; last reviewed May 30, 2018)
Recommendations Regarding Use of Dolutegravir in Adults and Adolescents with HIV who are Pregnant or Of Child Bearing Potential, a joint statement from the HHS Antiretroviral Guideline Panels, was released on May 30, 2018.
- On Tuesday, March 27, 2018 the Panel issued this statement on bictegravir
- Based on input from the community, the Adult and Adolescent Guidelines have been updated to include People-First Language. People-First Language is a way of reducing stigma and showing respect for individuals who are living with HIV by focusing on the person instead of the disease (e.g., where the Guidelines might have said “HIV-infected person” in the past, this will now be written as “person with HIV”). The use of People-First Language may also assist as a strategy for retention-in-care measures.
Initiation of Antiretroviral Therapy
- A new subsection was added to discuss the data on the efficacy and feasibility of immediate antiretroviral therapy (ART) initiation on the day of HIV diagnosis.
What to Start
- The classifications of ART regimens recommended for initial therapy have been changed from Recommended, Alternative, and Other to:
- Recommended Initial Regimens for Most People with HIV; and
- Recommended Initial Regimens in Certain Clinical Situations.
Specific regimens are listed in Table 6 of the guidelines.
- Integrase strand transfer inhibitor (INSTI)-based regimens are recommended as initial therapy for most people with HIV. Non-nucleoside reverse transcriptase inhibitor (NNRTI)- and protease inhibitor (PI)- based regimens, including darunavir-based regimens, are recommended in certain clinical situations.
- Since the last revision, longer-term safety data have clarified the relative advantages of tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF). TAF has less bone and kidney toxicity, and is therefore particularly advantageous in people at risk for those conditions; TDF is associated with lower lipid levels. Safety, cost, and access are among the factors to consider when choosing between TAF and TDF.
- Updates have been made throughout the section with new safety and clinical trial data.
- Under the section on Other Antiretroviral Regimens for Initial Therapy When Abacavir, Tenofovir Alafenamide, and Tenofovir Disoproxil Fumarate Cannot Be Used, a new subsection has been added to discuss ongoing clinical trials of various treatment strategies.
What Not to Use
- The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) emphasizes that monotherapy with any antiretroviral (ARV) drug should not be used due to increased risk of virologic failure and drug resistance.
- The Panel no longer prohibits the use of efavirenz during the first trimester of pregnancy.
- A definition of “low-level viremia” was added to the text.
- The section on Managing Patients with Virologic Failure was restructured, and the section on Managing Virologic Failure in Different Clinical Scenarios was updated.
- The new Table 10 provides guidance on ARV options for patients with virologic failure.
- Clinicians are advised to maintain patients with hepatitis B virus (HBV)/HIV coinfection on ARV drugs that are active against HBV when switching ART regimens upon virologic failure.
- Links to potential investigational agents for patients with insufficient treatment options have been added to the document.
Regimen Switching in the Setting of Virologic Suppression
- The Panel emphasizes that using PI or INSTI monotherapy as maintenance therapy has been associated with high rates of virologic failure and is therefore not recommended.
- The Panel also notes that, traditionally, the Guidelines have recommended starting ART-naive patients on a regimen consisting of at least three active drugs. However, several studies have now noted that persons with HIV who have sustained viral suppression with no drug resistance may be maintained on regimens including only two active drugs. Results from clinical trials using two-drug maintenance therapy are discussed in this section.
- The section also stresses that when considering a regimen switch in a person with HBV/HIV coinfection, it is important to maintain drugs active against HBV infection in the new regimen.
- Clinical trial data involving several ARV combinations that are currently under investigation are discussed in this section.
- Several ARV combinations that are not recommended for use in maintenance therapy are also included in this section.
Hepatitis B Virus/HIV Coinfection and Hepatitis C Virus/HIV Coinfection
- Both sections have been updated to discuss recent reports regarding reactivation of HBV infection in persons with HBV/hepatitis C virus (HCV) coinfection after starting interferon-free HCV therapy.
- The Panel recommends that individuals with chronic HBV infection should receive treatment for HBV with nucleoside reverse transcriptase inhibitors (NRTIs) that are active against both HIV and HBV before starting HCV therapy.
- For the HCV section, interactions between new HCV direct-acting agents and ARV drugs have been added to Table 12.
Adherence to the Continuum of Care
- The previous Adherence to Antiretroviral Therapy section has been extensively revised to not only include adherence to therapy, but also adherence to the entire HIV care continuum. As such, the title of this section has been changed to Adherence to the Continuum of Care.
- The section stresses the importance of clinicians working collaboratively with a multidisciplinary team to understand barriers to adherence to the continuum, as well as working with patients to overcome those barriers.
- New evidence-based interventions and best practices to improve adherence are summarized.
- Given their high genetic barriers to resistance, dolutegravir and boosted darunavir are mentioned as medications to consider in persons with proven problems with adherence. Drug Interactions
- The old Table 18 has been removed from this document. Drugs that are contraindicated or not recommended for use are now all included in the individual ARV drug class tables.
- Throughout the tables, a number of drug classes have been added or expanded, including oral anticoagulants, new oral hypoglycemic agents, and hormonal therapy for menopausal management and gender affirmation.
Additional updates have been made to the following sections:
- Laboratory Testing
- Acute and Recent (Early) HIV Infection
- Adverse Effects of Antiretroviral Agents
- Cost Considerations and Antiretroviral Therapy
- Appendix tables Prevention of Secondary HIV Transmission
- This section has been removed from the guidelines, as most of the information is discussed in the Initiation of Antiretroviral Therapy section