Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Swindells S, Andrade-Villanueva J-F, Richmond GJ, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med 2020;382:1112-23. DOI: 10.1056/NEJMoa1904398 (PDF updated March 26, 2020) Susan Swindells, et al. Long-Acting Cabotegravir and Rilpivirine for HIV-1 (ATLAS Trial) SUPPLEMENTARY APPENDIX Contents Study Sites and Lead Investigators ............................................................................................................... 2 Eligibility Criteria ........................................................................................................................................... 6 Figure S1. Timeliness of Injections Relative to Target. ............................................................................... 14 Figure S2. Unadjusted Difference (LA Arm Minus CAR Arm) in Percentage Proportion with HIV-1 RNA ≥50 copies/mL at Week 48 (Snapshot) ± 95% CI. ............................................. 15 Figure S3. Incidence of Injection Site Reaction Adverse Events, LA Arm.................................................... 16 Table S1. Summary of Antiretroviral Agents Taken at Baseline. ................................................................ 17 Table S2. Reasons for Exclusion From the Per-Protocol Population .......................................................... 18 Table S3. Additional Secondary Endpoints ................................................................................................. 19 Table S4. Confirmed Virologic Failure. ........................................................................................................ 20 Table S5. On-treatment Adverse Events by System Organ Class and Maximum Toxicity Grade – Maintenance Phase ......................................................................................... 21 Table S6. Serious Adverse Events – Maintenance Phase. ........................................................................... 37 Table S7. Adverse Events Leading to Withdrawal – Maintenance Phase. .................................................. 38 Table S8. On-treatment Laboratory Abnormalities by Maximum Toxicity Grade – Maintenance Phase ....................................................................................................... 39 Table S9. Cabotegravir and Rilpivirine Plasma Concentrations in LA Recipients with Confirmed Virologic Failure. ............................................................................................... 40 Table S10. Change from Baseline in Total Treatment Satisfaction Score by Visit – Adjusted, Last Observation Carried Forward. ............................................................................................. 41 References .................................................................................................................................................. 42 1 Study Sites and Lead Investigators Lead Investigator Site USA 1 Judith Aberg Icahn School of Medicine at Mount Sinai, New York, NY 2 U Fritz Bredeek Metropolis Medical, San Francisco, CA 3 Robert Brennan Infectious Diseases Assoc of Central VA, Lynchburg, VA 4 Cynthia Brinson Central Texas Clinical Research, Austin, TX 5 Indira Brar Henry Ford Hospital, Detroit, MI 6 Douglas Cunningham Pueblo Family Physicians, Phoenix, AZ 7 Franco Felizarta Bakersfield, CA 8 Deborah Goldstein Whitman Walker Clinic, Washington, D.C. 9 Harold Katner Mercer University School of Medicine, Macon, GA 10 Rachel Presti Washington University School of Medicine, St. Louis, MO 11 Edgar Overton University of Alabama 1917 Clinic, Birmingham, AL 12 Alyssa Shon Evergreen Health, University of Buffalo, Buffalo, NY 13 Chris Bettacchi North Texas Infectious Disease Consultants, Dallas, TX 14 Princy Kumar Georgetown University Hospital, Washington, D.C. 15 Christopher Polk Infectious Disease Consultants, Charlotte, NC 16 Gary Simon Medical Faculty Associates, George Washington University, Washington, D.C. 17 David Wohl Medical Faculty Associates, George Washington University, Washington, D.C. 18 Mia Scott Apex Research, Denver, CO 19 Susan Swindells University of Nebraska Medical Center, Omaha, NE 20 Babafemi Taiwo Northwestern University, Chicago, IL 21 Anthony Mills Kaiser Permanente Medical Center, Los Angeles, CA 22 Peter Ruane Los Angeles, CA 23 Jerome De Vente Living Hope Clinical Foundation, Long Beach, CA 24 Margaret Hoffman-Terry Lehigh Valley Hospital, Allentown, PA 25 Chiu-Bin Hsiao Allegheny General Hospital, Pittsburgh, PA 26 Annie Luetkemeyer San Francisco General Hospital, San Francisco, CA 27 Martin Markowitz Aaron Diamond AIDS Research Center, New York, NY 28 Gerald Pierone AIDS Research & Treatment Center of the Treasure Coast, Vero Beach, FL 29 Gary Richmond Fort Lauderdale, FL 30 David Wheeler Clinical Alliance for Research & Education - Infectious Diseases, Annandale, VA 31 Carl Fichtenbaum University of Cincinnati College of Medicine, Cincinnati, OH 32 Gordon Crofoot Houston, TX 33 Hannah Olivet Community Research Initiative of New England, Boston, MA 34 Tanya Schreibman Comprehensive Care Clinic, Sarasota, FL 35 Kenneth Lichtenstein Eisenhower Medical Associates, Palm Springs, CA 2 Lead Investigator Site 36 Moti Ramgopal Fort Pierce, FL Canada 37 Jean-Guy Baril Clinique Medicale Quartier Latin, Montreal, Québec 38 Sylvie Trottier CHU de Québec Hôpital CHUL, Québec, Québec 39 Jonathan Angel The Ottawa Hospital-General Campus, Ottawa, Ontario 40 Alexander Wong Regina Qu’Appelle Health Region, Regina, Saskatchewan 41 Alexandra de Pokomandy Royal Victoria Hospital/McGill University Health Centre (MUHC), Montreal, Québec 42 Graham Smith Maple Leaf Research, Toronto, Ontario Mexico 43 Jaime-Federico Andrade- Hospital Civil de Guadalajara Fray Antonio Alcalde, Villanueva Guadalajara, Jalisco Argentina 44 Pedro Cahn Fundación Huésped, Buenos Aires 45 Isabel Cassetti Helios Salud, Buenos Aires 46 Norma Porteiro Fundación IDEAA, Buenos Aires 47 Sergio Lupo Instituto Caici, Rosario, Santa Fe France 48 Jean-Michel Molina Hôpital Saint Louis, Paris 49 Pierre Delobel Hôpital Purpan, Toulouse 50 Faïza Ajana Hôpital Gustave Dron, Tourcoing 51 Marie-Aude Khuong-Josses Hôpital Delafontaine, Saint Denis 52 Christine Katlama Hôpital de la Pitié-Salpêtrière, Paris 53 Pierre-Marie Girard Hôpital Saint Antoine, Paris 54 Yazdan Yazdanpanah Hôpital Bichat-Claude Bernard, Paris 55 Jacques Reynes Hôpital Gui de Chauliac, Montpellier Germany 56 Axel Baumgarten Zentrum für Infektiologie Berlin Prenzlauer Berg, Berlin 57 Matthias Stoll Medizinische Hochschule Hannover, Hannover 58 Juergen Rockstroh Rheinische Friedrich-Wilhelms Universitaet, Bonn 59 Christoph Stephan Klinikum der J-W-Goethe-Universitaet, Frankfurt am Main 60 Stefan Esser Universitaetsklinikum Essen, Essen 61 Thomas Lutz Infektio Research, Frankfurt 62 Hans Jaeger MUC Research GmbH, Muenchen 63 Olaf Degen Universitaetsklinikum Eppendorf, Hamburg 3 Lead Investigator Site 64 Keikawus Arasteh Epimed GmbH, Berlin 65 Hans-Juergen Stellbrink ICH Study Center, Hamburg Italy 66 Francesco Castelli Azienda Ospedaliera Spedali Civili, Brescia 67 Giuliano Rizzardini PO Ospedale Luigi Sacco - Polo Universitario, Milano Spain 68 Rafael Rubio Hospital 12 de Octubre, Madrid 69 Marisa Montes Hospital la Paz, Madrid 70 Pompeyo Viciana Hospital Universitario Virgen del Rocío, Sevilla Fernández 71 Maria Del Mar Masia Hospital General de Elche, Elche Canuto 72 Miguel Garcia Deltoro Hospital General Universitario, Valencia 73 Antonio Ocampo Hermida Complejo Hospitalario Universitario de Vigo–Hospital Álvaro Cunqueiro, Vigo 74 Manuel Castaño Hospital Carlos Haya, Malaga 75 Antonio Antela Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela 76 Eugenia Negredo Puigmal Hospital Germans Trias i Pujol, Badalona 77 Josep Mallolas Hospital Clinic I Provincial De Barcelona, Barcelona 78 Hernando Knobel Hospital del Mar, Barcelona 79 Vicens Falcó Ferrer Hospital Valle d’Hebrón, Barcelona 80 Antonio Rivero Román Hospital Reina Sofía, Córdoba 81 Santiago Moreno Guillen Hospital Ramón Y Cajal, Madrid Sweden 82 Anders Thalme Karolinska Universitetssjukhuset, Huddinge, Stockholm 83 Carl Johan Treutiger Karolinska Universitetssjukhuset, Huddinge, Stockholm 84 Magnus Gisslén Sahlgrenska Universitetssjukhuset/Östra, Göteborg Russian Federation 85 Vadim Pokrovsky Central Research Institute of Epidemiology, Moscow 86 Denis Gusev St. Petersburg City AIDS Centre, St. Petersburg 87 Olga Tsybakova Smolensk Regional AIDS Centre, Smolensk 88 Svetlana Volkova Sverdlovsk Regional AIDS Center, Ekaterinburg 89 Valery Kulagin Krasnodar’s Area AIDS Centre, Krasnodar 90 Oksana Chernova Tolyatti City AIDS Centre, Tolyatti 91 Olga Borodkina Kemerovo Regional AIDS Centre, Kemerovo 4 Lead Investigator Site 92 Firaya Nagimova Tatarstan Republican AIDS Centre, Kazan 93 Olga Tonkikh Lipetsk Regional AIDS Centre, Lipetsk 94 Alexey Yakovlev City Hospital of Infectious Diseases, St. Petersburg 95 Elena Belonosova Orel Regional AIDS Centre, Orel 96 Eugene Voronin Republican Hospital of Infectious Diseases, St. Petersburg 97 Andrey Shuldyakov Saratov Regional AIDS Centre, Saratov South Africa 98 Mohammed Tayob Mzansi Ethical Research Centre, Middelburg 99 Monja-Marie Nortje Moriana Clinical Research, Brandfort 100 Johannes Jurgens Josha Research, Bloemfontein Lombaard 101 Lelanie van Zyl Syzygy Clinical Research Services, Pretoria 102