Applying HIV Advances in Practice: What the Pharmacist Needs to Know

ASSESSING

PROS & CONS

OF ART REGIMENS L E S S T N IEN U O AT C T O P D N T V E N I W R H TM PA O H OU REA EX Y S T CES A HOI C This activity is jointly provided by Global Education Group and Integritas Communications.

This activity is supported by an educational grant from Gilead Sciences, Inc.

MELISSA BADOWSKI, PharmD, MPH, FCCP, BCIDP, BCPS

Dr. Melissa Badowski is a Clinical Associate Professor at the University of Illinois at Chicago, College of Pharmacy. She practices in an interdisciplinary telemedicine clinic where she provides HIV care to individuals in custody in the Illinois Department of Corrections. She also provides infectious diseases care at a university-based outpatient clinic.

JENNIFER COCOHOBA, PharmD, MAS

Dr. Jennifer Cocohoba is Professor of Clinical Pharmacy and Vice Chair of Faculty Development at the University of California, San Francisco (UCSF), School of Pharmacy, Department of Clinical Pharmacy. As a pharmacist for the UCSF Women’s HIV Program, she conducts medication consultations and leads quality assurance initiatives around prescribing. Her research interests focus on pharmacy-based interventions to improve adherence, medication use in people living with HIV, and sex differences in antiretroviral pharmacoepidemiology.

Clinical Associate Professor College of Pharmacy - Pharmacy Practice University of Illinois, Chicago Chicago, Illinois

Vice Chair of Faculty Development McKesson Professor of Pharmaceutical Technology Department of Clinical Pharmacy Clinical pharmacist for the UCSF Women’s HIV Program University of California, San Francisco San Francisco, California

TARGET AUDIENCE

CREDIT DESIGNATION

The educational design of this activity addresses the needs of clinical, specialty, and managed care pharmacists and pharmacy benefits managers involved in the care of patients with HIV infection.

Global Education Group designates this continuing education activity for 1.0 contact hour (0.10 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number 0530-9999-22-086-L02-P) This is a knowledge-based activity.

PROGRAM OVERVIEW The HIV treatment landscape has expanded significantly in recent years. There are now multiple available oral 2-drug regimens and 1 long-acting injectable, with the potential for more longacting injectables in the future. It is important for pharmacists to understand the risks, benefits, and selection criteria of both oral and injectable 2-drug regimens, particularly as they educate patients about appropriate use and any potential adverse events or drug-drug interactions.

Long-acting injectables are accompanied by infrastructure changes and requirements for further clinician education. Pharmacists play an important role in the multidisciplinary team and require updates about newer treatment options in HIV. Dr. Melissa Badowski and Dr. Jennifer Cocohoba discuss recently available and emerging antiretroviral therapy (ART) and the role pharmacists may play in patient management.

GLOBAL CONTACT INFORMATION For information about the accreditation of this program, please contact Global at 303-395-1782 or cme@globaleducationgroup.com.

INSTRUCTIONS TO RECEIVE CREDIT In order to receive credit for this activity, the participant must review the activity as well as successfully complete the posttest, by achieving a score of 70% or higher, and evaluation form.

Pharmacist learners: please check CPE monitor for credit within 30 days of the activity.

EDUCATIONAL OBJECTIVES

FEE INFORMATION & REFUND/CANCELLATION POLICY

After completing this activity, the participant should be better able to: • Describe pharmacologic characteristics that support the efficacy and viability of 2-drug oral and long-acting injectable ART regimens

There is no fee for this educational activity.

• Evaluate risks and benefits of 2-drug regimens to individualize for patients

Global Education Group (Global) adheres to the policies and guidelines, including the Standards for Integrity and Independence in Accredited CE, set forth to providers by the Accreditation Council for Continuing Medical Education (ACCME) and all other professional organizations, as applicable, stating those activities where continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous. All persons in a position to control the content of an accredited continuing education program provided by Global are required to disclose all financial relationships with any ineligible company within the past 24 months to Global. All financial relationships reported are identified as relevant and mitigated by Global in accordance with the Standards for Integrity and Independence in Accredited CE in advance of delivery of the activity to learners. The content of this activity was vetted by Global to assure objectivity and that the activity is free of commercial bias.

All relevant financial relationships have been mitigated.

• Review risks, benefits, and requirements for use of long-acting injectables to manage HIV

PROGRAM AGENDA • Persisting Challenges and Potential Solutions in HIV—An Overview • 2-Drug Regimens (2-DR): When and for Whom Are They Appropriate • Long-Acting Injectables: The Future of HIV Treatment?

PHARMACIST ACCREDITATION STATEMENT Global Education Group is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education with Commendation.

DISCLOSURES OF CONFLICTS OF INTEREST

The faculty have the following relevant financial relationships with ineligible companies: Melissa Badowski, PharmD, MPH, FCCP, BCIDP, BCPS Nothing to disclose Jennifer Cocohoba, PharmD, MAS Contracted research: ViiV Healthcare (provided directly to institution); Walgreens Company (provided directly to institution); PharmD

Fellowship Program: Genentech, Inc., Janssen Pharmaceuticals, Inc. The planners and managers have the following relevant financial relationships with ineligible companies: Lindsay Borvansky Nothing to disclose Andrea Funk Nothing to disclose Liddy Knight Nothing to disclose Ashley Cann Nothing to disclose Gena Dolson, MS Nothing to disclose Jim Kappler, PhD Nothing to disclose

DISCLOSURE OF UNLABELED USE This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Global Education Group (Global) and Integritas Communications do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications,

and warnings.

DISCLAIMER Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

CLINICAL PRACTICE GUIDELINES Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 recommendations of the International Antiviral Society– USA panel.

Saag MS, Gandhi RT, Hoy JF, et al. JAMA. 2020;324(16):1651-1669. https://jamanetwork.com/journals/jama/fullarticle/2771873

Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. US Department of Health and Human Services

Use of Injectable CAB/RPV LA as Replacement ART in Virally Suppressed Adults.

McGowan JP, Fine SM, Vail RM, et al. Baltimore (MD): Johns Hopkins University; 2022. https://www.ncbi.nlm.nih.gov/books/NBK572795/

Lenacapavir as part of a combination regimen in treatment-naïve people with HIV: Week 54 results.

Gupta SK, Sims J, Brinson C, et al. Conference on Retroviruses and Opportunistic Infection.

February 12-16, 2022. Abstract 138. https://www.croiconference.org/abstract/lenacapavir-as-part-of-a-combination-regimen-in-treatmentnaive-pwh-week-54-results/

https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/

PATIENT AND CAREGIVER RESOURCES AIDSMap Resources NAM Publications https://www.aidsmap.com/about-hiv

Resources for persons living with HIV Centers for Disease Control and Prevention https://www.cdc.gov/hiv/basics/livingwithhiv/resources.html

HIV resources National Institutes of Health https://www.oar.nih.gov/hiv-resources/public

SUGGESTED READINGS Drug utilization review.

Academy of Managed Care Pharmacy. https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/drugutilization-review

Experiences to date with the logistical management of long-acting cabotegravir and rilpivirine.

Johnson K, Sawkin MT. Drugs Context. 2022;11:2021-9-2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8903875/

ASHP statement on advocacy as a professional obligation.

Little J, Ortega M, Powell M, Hamm M. Am J Health Syst Pharm. 2019;76(4):251-253. https://academic.oup.com/ajhp/article-abstract/76/4/251/5305698

Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies.

Llibre JM, Hung CC, Brinson C, et al. Lancet. 2018;391(10123):839-849. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)33095-7/fulltext

Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection.

Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. N Engl J Med. 2020;382(12):1124-1135. https://www.nejm.org/doi/full/10.1056/NEJMoa1909512

Chaudhary K, Patel MM, Mehta PJ. Crit Rev Ther Drug Carrier Syst. 2019;36(2):137-181.

Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study.

https://www.dl.begellhouse.com/journals/3667c4ae6e8fd136,389e9bee07f1e347,064f469b5a3dd77b.html

Overton ET, Richmond G, Rizzardini G, et al. Lancet. 2021;396(10267):1994-2005.

Long-acting injectables: current perspectives and future promise.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32666-0/fulltext

Capsid inhibition with lenacapavir in multidrug-resistant HIV-1 infection.

Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. N Engl J Med. 2022;386(19):1793-1803. https://www.nejm.org/doi/full/10.1056/NEJMoa2115542

Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression.

Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. N Engl J Med. 2020;382(12):1112-1123. https://www.nejm.org/doi/full/10.1056/NEJMoa1904398

HIV and ischemic heart disease.

Vachiat A, McCutcheon K, Tsabedze N, et al. J Am Coll Cardiol. 2017;69(1):73-82. https://www.sciencedirect.com/science/article/pii/S0735109716369674

Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose 2-drug regimen versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults with human immunodeficiency virus type 1: phase 3, randomized, noninferiority TANGO study. van Wyk J, Ajana F, Bisshop F, et al. Clin Infect Dis. 2020;71(8):1920-1929. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643745/