Mountain West AIDS Education and Training Center Updates to the HHS Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV Updated October 17, 2017 26 October 2017 Hillary Liss, MD No conflicts of interest This presentation is intended for educational use only, and does not in any way constitute medical consultation or advice related to any specific patient.
New HIV Treatment Guidelines Released October 17, 2017 Main changes listed here: - https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescenttreatment-guidelines/0
People-First Language Focus on the PERSON instead of the DISEASE Example: Person with HIV instead of HIV-infected person Goals - Reduce stigma and show respect for people living with HIV - Help with retention in care?
Initiation of Antiretroviral Therapy New subsection about same-day start of ART - Immediate Antiretroviral Therapy Initiation on the Day of HIV Diagnosis See Dr. Dhanireddy s excellent ECHO presentation from October 19, 2017 Improved rates viral suppression, retention in care, 1-year survival, but - Resource and labor-intensive, not always feasible Still considered investigational in US
What to Start No longer: - Recommended, Alternative, and Other Now: - Recommended Initial Regimens for Most People with HIV; and - Recommended Initial Regimens in Certain Clinical Situations
HHS Antiretroviral Therapy Guidelines: July 14, 2016 Recommended Regimens for ARV-Naïve Patients Backbone Anchor Drug Integrase Inhibitor 2 Nucleoside RTIs + Protease Inhibitor (Boosted) Source: 2016 HHS Antiretroviral Therapy Guidelines. AIDS Info.
HHS Antiretroviral Therapy Guidelines: October 17, 2017 Recommended Initial Regimens for Most People Backbone Anchor Drug 2 Nucleoside RTIs + Integrase Inhibitor NOTE: DARUNAVIR NO LONGER LISTED Source: 2017 HHS Antiretroviral Therapy Guidelines. AIDS Info.
HHS Antiretroviral Therapy Guidelines: October 17, 2017 Recommended Initial Regimens for Most People Class INSTI-Based Therapy Dolutegravir-Abacavir-Lamivudine* Dolutegravir + TDF-Emtricitabine Dolutegravir + TAF-Emtricitabine + Elvitegravir-Cobicistat-TAF-Emtricitabine + Elvitegravir-Cobicistat-TDF-Emtricitabine^ Raltegravir + TDF-Emtricitabine Raltegravir + TAF-Emtricitabine + *Abacavir only for patients who are HLA-B*5701 negative + Only for patients with pre-treatment estimated CrCl 30 ml/min ^Only for patients with pre-treatment estimated CrCl 70 ml/min Ratin g AI AI AI AI AI AI AII Source: 2017 HHS Antiretroviral Therapy Guidelines. AIDS Info.
HHS Antiretroviral Therapy Guidelines: October 17, 2017 Recommended Initial Regimens in Certain Clinical Situations Class Therapy Rating PI-Based NNRTI Darunavir/r or /c + TDF/TAF-Emtricitabine Atazanavir/r or /c + TDF/TAF-Emtricitabine Darunavir/r or /c + Abacavir-Lamivudine* Atazanavir/r or /c + Abacavir-Lamivudine* Efavirenz + TDF/TAF-Emtricitabine Rilpivirine + TDF/TAF-Emtricitabine* # INSTI-Based Raltegravir + Abacavir-Lamivudine* CII ABC/TDF/TAF sparing Darunavir/r + Raltegravir (BID) # Lopinavir/r + Lamivudine (BID) *Abacavir only for patients who are HLA-B*5701 negative + Only for patients with pre-treatment estimated CrCl 30 ml/min ^Only for patients with pre-treatment estimated CrCl 70 ml/min Only for patients with HIV RNA < 100,000 copies/ml # Only for patients with CD4 > 200 cells/mm 3 Source: 2017 HHS Antiretroviral Therapy Guidelines. AIDS Info. AI/AII BI BII CI/CIII BI/BII BI CI CI
Antiretroviral Regimen Considerations for Initial Therapy Based on Specific Clinical Scenarios (Table 7) Source: 2017 HHS Antiretroviral Therapy Guidelines. AIDS Info.
Antiretroviral Regimen Considerations for Initial Therapy Based on Specific Clinical Scenarios (Table 7) CD4 <200 HIV RNA >100,000 HLA-B*5701 positive Drug resistance results not yet available One-pill once-daily desired Food effects CKD Liver disease Osteoporosis Psychiatric illnesses HIV-associated dementia Narcotic replacement therapy High cardiac risk Cardiac QT c prolongation Hyperlipidemia Poor adherence or engagement in care Pregnancy HBV coinfection HCV treatment Treating TB with rifamycins
What Not to Use Emphasizes monotherapy should never be used - Virologic failure - Drug resistance Efavirenz no longer prohibited in the first trimester of pregnancy
Virologic Failure Definition of low-level viremia added - Confirmed detectable HIV RNA <200 copies/ml - Please see previous ECHO talk on Low-Level Viremia (5/12/16) Patients who typically have these HIV RNA levels (i.e. blips) do not require a change in treatment (AII). Although there is no consensus on how to manage these patients, the risk of emerging resistance is believed to be relatively low. Therefore, these patients should maintain on their current regimens and have HIV RNA levels monitored every 3 months to assess the need for changes in ART in the future (AIII). Source: 2017 HHS Antiretroviral Therapy Guidelines. AIDS Info.
Virologic Failure Managing Patients with Virologic Failure: restructured Managing Virologic Failure in Different Clinical Scenarios: updated New Table: Antiretroviral Options for Patients with Virologic Failure (table 10) - First regimen failure - Second regimen failure and beyond - Previously treated patients with suspected drug resistance, but limited or incomplete ART and resistance history
Antiretroviral Options for Patients with Virologic Failure (Table 10) Source: 2017 HHS Antiretroviral Therapy Guidelines. AIDS Info.
Regimen Switching in the Setting of Virologic Suppression Monotherapy with INSTI or PI should not be used Can CONSIDER 2-drug therapy for maintenance if sustained viral load suppression and no drug resistance (see previous ECHO talk 9/29/16) - Boosted PI + 3TC/FTC - DTG + RPV If HBV/HIV coinfection, switch regimen must also cover HBV Data from clinical trials involving other combinations under investigation - DRV/r + RAL - DTG + 3TC/FTC Added ARVs not recommended for maintenance therapy - Mostly monotherapy and 2-drug combinations
HBV/HIV and HCV/HIV Coinfection Reports of HBV reactivation in setting of HCV treatment - Recommend HBV therapy with NRTIs prior to and during HCV treatment New HCV Direct-Acting Antivirals and HIV ART Drug Interactions added - Table 12 updated
Adherence to the Continuum of Care Adherence to Antiretroviral Therapy section changed to: - ADHERENCE TO THE CONTINUUM OF CARE Importance of clinicians working with multidisciplinary team - Understand barriers to adherence to the continuum - Work with patients to overcome barriers New evidence-based interventions and best practices to improve adherence summarized - https://www.cdc.gov/hiv/research/interventionresearch/compendium/in dex.html Proven problems with adherenceàboosted DRV or DTG
Drug-Drug Interactions Removed: Drugs that Should not be Used with ARV agents (Table 18) - Now included in individual ARV tables Some drug classes added or expanded in tables - Oral anticoagulants - New oral hypoglycemic agents - Hormonal therapy for menopause and gender affirmation
Tips for Using the Guidelines Read the Panel s Recommendations at the beginning of each section Review the tables Dive deeper depending on interest and clinical cases When guidelines are updated, read What s New in the Guidelines (also all changes highlighted in yellow in the PDF of the guidelines) and you ll be up to speed! ContactUs@aidsinfo.nih.gov