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Supplementary Appendix Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med 2020;382:1124-35. DOI: 10.1056/NEJMoa1909512 Chloe Orkin, et al. Long-acting Cabotegravir and Rilpivirine After Oral Induction for HIV-1 Infection Supplementary Appendix Contents Principal Investigators and Study Sites ................................................................................................... 2 Eligibility criteria ..................................................................................................................................... 6 Induction and Maintenance Phase Time and Events Schedule ............................................................ 11 Study Endpoints .................................................................................................................................... 13 Figure S1. Adherence to LA Dosing Schedule, Maintenance Phase ...................................................... 15 Figure S2. Effects of Baseline Parameters and Stratification Criteria on HIV-1 RNA ≥50 copies/mL at Week 48 (Snapshot). ............................................................. 16 Figure S3. Frequency of Injection Site Reactions by Study Week, LA Arm, Safety Population. ............ 17 Figure S4. Plasma Pharmacokinetic Profiles of Cabotegravir and Rilpivirine for Participants with Confirmed Virologic Failure. .................................................................... 18 Table S1. Confirmed Virologic Failure (CVF) Through Week 48 ............................................................ 19 Table S2. Prevalence of HIV-1 Subtypes and L74I at Baseline (ITT-E Population) ................................ 20 Table S3. Participants With Adverse Events by System Organ Class and Maximum Toxicity Grade – Maintenance Phase .................................................................. 22 Table S4. Serious Adverse Events – Maintenance Phase ...................................................................... 42 Table S5. Adverse Events Leading to Withdrawal – Maintenance Phase ............................................. 43 Table S6. Emergent Laboratory Abnormalities by Maximum Toxicity Grade – Maintenance Phase ................................................................................................. 44 Table S7. Patient-Reported Outcomes ................................................................................................. 45 References ............................................................................................................................................ 46 1 Principal Investigators and Study Sites Lead Investigator Site USA 1 Judith Aberg Icahn School of Medicine at Mount Sinai, New York, NY 2 John Baxter Cooper Health System, Camden, NJ 3 Chris Bettacchi North Texas Infectious Disease Consultants, Dallas, TX 4 Robert Brennan Infectious Diseases Assoc of Central VA, Lynchburg, VA 5 Cynthia Brinson Central Texas Clinical Research, Austin, TX 6 Thomas Campbell University of Colorado, Denver, CO 7 Jerome De Vente Living Hope Clinical Foundation, Long Beach, CA 8 Franco Felizarta Bakersfield, CA 9 Deborah Goldstein Whitman Walker Clinic, Washington, D.C. 10 William Keith Henry Hennepin County Medical Center, Minneapolis, MN 11 Harold Katner Mercer University School of Medicine, Macon, GA 12 Cheryl McDonald Tarrant County Infectious Disease Assoc, Fort Worth, TX 13 Cheryl Newman Georgia Regents University, Augusta, GA 14 Roberto Ortiz Bliss Health System, Orlando, FL 15 Edgar Overton University of Alabama 1917 Clinic, Birmingham, AL 16 Gary Richmond Fort Lauderdale, FL 17 Peter Ruane Los Angeles, CA 18 Natasha Rybak The Miriam Hospital, Providence, RI 19 Anita Scribner Longview, TX 20 James Sims III St. Hope Foundation, Bellaire, TX 21 Susan Swindells University of Nebraska Medical Center, Omaha, NE 22 William Towner Kaiser Permanente Medical Center, Los Angeles, CA Canada 23 Jonathan Angel The Ottawa Hospital-General Campus, Ottawa, ON 24 Brian Conway Vancouver ID Research and Care Centre Society, Vancouver, BC 25 Graham Smith Maple Leaf Research, Toronto, ON 26 Jason Szabo Clinique Medicale L'Actuel, Montreal, QC 27 Darrell Tan St. Michael's Hospital, Toronto, ON 28 Sharon Walmsley University Health Network, Toronto, ON France 29 Olivier Bouchaud Hôpital Avicenne, Bobigny 30 Pierre-Marie Girard Hôpital Saint Antoine, Paris 31 Christine Katlama Hôpital de la Pitié-Salpêtrière, Paris 32 Jean-Michel Livrozet Hôpital Edouard Herriot, Lyon 33 Jean-Michel Molina Hôpital Saint Louis, Paris 2 Lead Investigator Site 34 Patrick Philibert Hôpital Européen, Marseille 35 Gilles Pialoux Hôpital Tenon, Paris 36 Yazdan Yazdanpanah Hôpital Bichat-Claude Bernard, Paris Germany 37 Keikawus Arasteh Epimed GmbH, Berlin 38 Axel Baumgarten Zentrum für Infektiologie Berlin Prenzlauer Berg, Berlin 39 Johannes Bogner Klinikum Innenstadt, München 40 Olaf Degen Universitaetsklinikum Eppendorf, Hamburg 41 Stefan Esser Universitaetsklinikum Essen, Essen 42 Hans Jaeger MUC Research GmbH, München 43 Thomas Lutz Infektio Research, Frankfurt 44 Juergen Rockstroh Rheinische Friedrich-Wilhelms Universitaet, Bonn 45 Hans-Jürgen Stellbrink ICH Study Center, Hamburg 46 Christoph Stephan Klinikum der J-W-Goethe-Universitaet, Frankfurt am Main 47 Matthias Stoll Medizinische Hochschule Hannover, Hannover Italy 48 Andrea Antinori Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani, IRCCS, Roma 49 Francesco Castelli Azienda Ospedaliera Spedali Civili, Brescia 50 Adriano Lazzarin IRCCS Ospedale San Raffaele, Milano 51 Guglielmo Migliorino Nuovo Ospedale San Gerardo, Monza 52 Giuliano Rizzardini PO Ospedale Luigi Sacco - Polo Universitario, Milano Netherlands 53 Wouter F.W. Bierman UMC Groningen, Groningen 54 Ilja M. Hoepelman UMC Utrecht, Utrecht 55 Jan G. den Hollander Maasstad Ziekenhuis, Rotterdam Spain 56 Enrique Bernal Morell Hospital Reina Sofía, Murcia 57 Mª Angeles Castro Iglesias Complejo Hospitalario Universitario A Coruña, La Coruña 58 María del Carmen Fariñas Hospital Marques de Valdecilla, Santander Álvarez 59 Carlos Enrique Galera Hospital Virgen de la Arrixaca, Murcia Peñaranda 60 Mercedes García Gasalla Hospital Son LlatzerPalma de Mallorca 61 Juan Luis Gomez Sirvent Hospital Universitario de Canarias, La Laguna-Tenerife 62 Juan González García Hospital La Paz, Madrid 3 Lead Investigator Site 63 Miguel Górgolas Fundacion Jimenez Diaz, Madrid Hernández-Mora 64 José Hernandez-Quero Complejo Hospitalario Universitario de Granada, Granada 65 Sofía Ibarra Ugarte Hospital de Basurto, Bilbao 66 Ana Isabel Marino Callejo Hospital Arquitecto Marcide, Ferrol (A Coruña) 67 Maria Del Mar Masiá Hospital General de Elche, Elche (Alicante) 68 Gracia Mateo García Hospital Santa Cruz y San Pablo, Barceloa 69 Máximo Miguelez Hospital Universitario Nuestra Señora de Candelaria, Santa Morales Cruz de Tenerife 70 Daniel Podzamczer Palter Ciudad Sanitaria y Universitaria de Bellvitge, Barcelona 71 Federico Pulido Ortega Hospital 12 Octubre, Madrid 72 Mª Angeles Ribas del Hospital de Son Espases, Palma de Mallorca Blanco 73 Inés María Suárez García Hospital Infanta Sofia, San Sebastian de los Reyes Russian Federation 74 Elena Belonosova Orel Regional AIDS Centre, Orel 75 Olga Borodkina Kemerovo Regional AIDS Centre, Kemerovo 76 Oksana Chernova Tolyatti City AIDS Centre, Tolyatti 77 Denis Gusev St. Petersburg City AIDS Centre, St. Petersburg 78 Valery Kulagin Krasnodar’s Area AIDS Centre, Krasnodar 79 Firaya Nagimova Tatarstan Republican AIDS Centre AIDS, Kazan 80 Vadim Pokrovsky Central Research Institute of Epidemiology, Moscow 81 Andrey Shuldyakov Saratov Regional AIDS Centre, Saratov 82 Olga Tonkikh Lipetsk Regional AIDS Centre, Lipetsk 83 Olga Tsybakova Smolensk Regional AIDS Centre, Smolensk 84 Svetlana Volkova Sverdlovsk Regional AIDS Center, Ekaterinburg 85 Eugene Voronin Republican Hospital of Infectious Diseases, St. Petersburg 86 Alexey Yakovlev City Hospital of Infectious Diseases, St. Petersburg United Kingdom 87 Sris Allan City of Coventry Health Centre, Coventry 88 Margaret Johnson Royal Free Hospital, London 89 Chloe Orkin Queen Mary University, London 90 Sarah Pett Central and North West London NHS Trust, London 91 Steve Taylor Heartlands Hospital, Birmingham 92 Janet Wilson Leeds General Infirmary, Leeds 93 Alan Winston St Mary's Hospital London South Africa 94 Ayesha Bassa Mzansi Ethical Research Centre, Middelburg 4 Lead Investigator Site 95 Gulam Latiff Durban 96 Johannes Jurgens Josha Research, Bloemfontein Lombaard 97 Essack Mitha Newtown Clinical Research Centre, Johannesburg 98 Rosie Mngqibisa Enhancing Care Foundation, Wentworth 99 Monja-Marie Nortje Moriana Clinical Research, Brandfort 100 Yashna Singh Groote Schur Hospital, Cape Town 101 Lelanie van Zyl Syzygy Clinical Research Services, Pretoria Japan 102 Shinichi Oka National Center for Global Health and Medicine, Tokyo 103 Takuma Shirasaka National Hospital Organization Osaka National Hospital, Osaka 104 Yoshiyuki Yokomaku National Hospital Organization Nagoya Medical Center, Aichi 5 Eligibility criteria INCLUSION CRITERIA AGE 1. HIV-1 infected, ART-naive men or women aged 18 years or greater at the time of signing the informed consent. TYPE OF PARTICIPANT AND DIAGNOSIS INCLUDING DISEASE SEVERITY 2. HIV-1 infection as documented by Screening plasma HIV-1 RNA 1000 c/mL; 3. Antiretroviral-naive
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