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1. Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trialResearch in context

Author

Teresa H. Evering, Carlee Moser, Nikolaus Jilg, Justin Ritz, David A. Wohl, Jonathan Z. Li, David Margolis, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Eric S. Daar, Davey M. Smith, Michael D. Hughes, Kara W. Chew, Kara Chew, David (Davey) Smith, Eric Daar, David Wohl, Judith Currier, Joseph Eron, Michael Hughes, Mark Giganti, Lara Hosey, Jhoanna Roa, Nilam Patel, Kelly Colsh, Irene Rwakazina, Justine Beck, Scott Sieg, Jonathan Li, Courtney Fletcher, William Fischer, Rachel Bender Ignacio, Sandra Cardoso, Katya Corado, Prasanna Jagannathan, Alan Perelson, Sandy Pillay, Cynthia Riviere, Upinder Singh, Babafemi Taiwo, Joan Gottesman, Matthew Newell, Susan Pedersen, Joan Dragavon, Cheryl Jennings, Brian Greenfelder, William Murtaugh, Jan Kosmyna, Morgan Gapara, Akbar Shahkolahi, Verónica Lacal, Diego Salusso, Sebastian Nuñez, Marcelo Rodrigo Rodriguez, Luciana Laborde, Marcelo Papasidero, Luis Wehbe, Mariana Gonzalez, Felicitas Fernandez Voena, Tomas Alvarez, Amaru Lopez, Virginia Huhn, Ulises D'Andrea Nores, Pablo Dieser, Fernando Bordese, Marisa Mussi, Rodrigo de Carvalho Santana, Adriana Aparecida Tiraboschi Bárbaro, Breno Santos, Rita de Cássia Alves Lira, Andre Luiz Machado da Silva, Sandra Wagner Cardoso, Maria Pia Diniz Ribeiro, Nathália Soliva, Eduardo Vasconcellos, Jorge Eurico Ribeiro, Miriam Amaral Enéas, Jorge Pinto, Julia Fonseca de Morais Caporali, Flávia Gomes Faleiro Ferreira, Norma Erendira Rivera Martinez, Victor Casildo Bohorquez Lopez, Melchor Victor Frias, Krystle Fetalvero, Alyxzza Maranan, Jennifer Rosa, Thomas Coetzer, Maureen Mohata, Sr., Umesh Lalloo, Penelope Madlala, Larisha Pillay-Ramaya, Jaclyn Ann Bennet, Noluthando Mwelase, Nokuphiwa Mbhele, Frederick Petrick, Leonard Joubert, Rose Mbali, Sr., Natasha Joseph, Mmatsie Manentsa, Eugene van der Walt, Mduduzi Sandile Lawrance Masilela, Zinhle Zwane, Tendai Chiperera, Lerato Mohapi, Suri Moonsamy, Usha Singh, Kirsten McHarry, Elizma Snyman, Pieter Lennox, James Craig Innes, Oteng Letlape, Olebogeng Jonkane, William Brumskine, Tania Adonis, Ni Ni Sein, Modulakgotla Sebe, Yacoob Vahed, Nazreen Jeewa Hussen, Ismail Mitha, Vasundhara Cheekati, Purna Cheekati, Christie Lummus, Samuel Idarraga, Andrew Kim, David N. Pham, Wei-Hsin Kao, Michael M. Pfeffer, Miriam Batule Dominguez, Anju Malik, Anna Bryan, Melanie Arnold, Idania Fernandez, Cinzia Karpf, Aniuska Ruiz, David Taylor, Eric Folkens, Jennifer Manne, Sigal Yawetz, Cheryl Keenan, Emeka Eziri, Carl Fichtenbaum, Jenifer Baer, Sarah Trentman, Robert Call, Leroy Vaughan, Aaron Milstone, Jamie Alex Slandzicki, Jessica Wallan, Clinton Guillory, Nancy Andrews, Leslie Hughes, Jonathan Berardi, Celine Arar, Randall Quinn, Jorge P. Amaya, Marissa Gomez-Martinez, Luis Cantu, Monica Betancourt-Garcia, Nwora Lance Okeke, Charles M. Burns, Fadi Haddad, Victoria Haddad, Augusto Focil, Griselda Rosas, Susana Moyano, Yaneicy Gonzalez Rojas, Ahmad Aswad, Yevgeniy Bukhman, Manish Jain, Eugene Bukhman, Humam Farah, Rebekah McClain, Sadia Shaik, Timothy Hatlen, Deepa Gotur, Joseph Surber, Jeffrey Kingsley, April Pixler, Alex Zopo, Jack Herman, Craig Herman, Ramon Leon, Boris Nikolov, Fernando Gonzalez Vergara, Ana I. Gonzalez, Noemi Gonzalez, Michael Gelman, Olga Andriunas, Zarema Jagizarov, Jan Westerman, David Davis, Donna Sherer, Kelly Dooley, Becky Becker, Adaliah Wilkins, Jose Pérez, Eloy Roman, Heriberto Fernández, Bharat Mocherla, Kelly Beck, Valarie Maldonado, Jennifer Veltman, Rajesh Gandhi, Katrina Shea, Matthew Planchon, Laura Bogan Herpel, Kaushlendra K. Tripathi, Donald C. Day, John Pullman, Sr., Erin Williams-Leber, Misty Johnson, Michelle Hecker, Ann Avery, Keila Hoover, George W. Monlux, Elizabeth Juneja, Jr., Arthur Wernick, Karelia Ruiz, Maureen Hernández, Yadilys Pérez, Babafemi O. Taiwo, Claudia Hawkins, Baiba Berzins, Carlos Malvestutto, Heather Harber, Robyn Cicarella, Edwin DeJesus, Charlotte-Paige Rolle, Almena L. Free, Sallie D. Pulliam, Debra Weinstein, Rosa M. Suarez, Ezequiel Socorro, Estefania Socorro, Gene Neytman, Raymond Easley, Mariam Aziz, Joan Swiatek, Avish Nagpal, Breanna Kompelien, Kathryn McEvoy, Susan E. Hoover, Allison Lutz, Jessica Just, Manuel Hernandez, Yanly B. Victoria, Gabriel Rodriguez, Divya Pathak, Joshua J. Ordway, Megan Heffner, Patrick Weston, Khalilah Weston, Madhu Choudhary, Jennifer Sullivano, Olayemi Osiyemi, Myriam Izquierdo, Odelsey Torna, Brian Clemency, Renoj Varughese, Joshua Lynch, Aleen Khodabakhshian, Samantha Fortier, Christopher Coyne, Alexandrea Cronin, Constance Benson, Steven Hendrickx, Rosemarie Ramirez, Anne Luetkemeyer, Suzanne Hendler, Dennis Dentoni-Lasofsky, Mobeen Rathore, Saniyyah Mahmoudi, Amna Riaz, Mario Castro, Leslie Spikes, Chase Hall, Jonathan Oakes, Amy James Loftis, Pablo Tebas, William Short, Michael P. Dube, Saahir Khan, Luis M. Mendez, Sarah McGuffin, Chris Jonsson, Mamta K. Jain, Smruthi Senthil, Kimberly Turner-Gray, Sanjay Mehta, Mary Lewinski, Masoud Azizad, Christopher Chow, Lisa Nakatani, Derrick Williamson, Hisham Atriss, Matthew Caloura, Midhun Malla, Hannah Hazard-Jenkins, Aimee Wilkin, Jamraus Fayssoux, Hannah Seagle, Rachel Presti, and Alem Haile

Subjects
COVID-19, Monoclonal antibodies, Outpatient treatment, Clinical trial, Post COVID conditions, Long COVID, Medicine (General), R5-920
Abstract

Summary: Background: It is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID. Methods: Non-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo. Findings: Participants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53–0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID. Interpretation: Amubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID. Funding: National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.

Published
2024
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2. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study

Author

John H Beigel, Pablo Tebas, Marie-Carmelle Elie-Turenne, Ednan Bajwa, Todd E Bell, Charles B Cairns, Shmuel Shoham, Jaime G Deville, Eric Feucht, Judith Feinberg, Thomas Luke, Kanakatte Raviprakash, Janine Danko, Dorothy O'Neil, Julia A Metcalf, Karen King, Timothy H Burgess, Evgenia Aga, H Clifford Lane, Michael D Hughes, Richard T Davey, Joseph Quinn, Yan Jiang, Robyn Hoelle, Nicole Iovine, Robert Shawn Wills, Socorro Pata, Monique Huggins, Belinda Manukian, Carrie Holland, Kelsey Brait, Taylor Hunt, Christopher Stowell, Amy Slater, Mary Townsends, Eugenia B Quackenbush, Yara A Park, Paul Gaither Jordan, Cherie Blanchet, Kevin Chronowski, Kathleen Alvarez, Darin Ostrander, Terry Woessner, Sandra Thoman, James Lin, Alyssa Ziman, Kavita Shankar, Tom Blok, Don Batts, Bob Beck, Gail Massey, Carol Bradley, Patricia Carey, Jenifer Baer, Eva Moore Whitehead, Sharon Kohrs, Robert Giulitto, Christina Schofield, Mary Fairchok, Susan Chambers, Cindy Baker, null RN, Michelle Parker, Marta Harshbarger, M Hong Nguyen, Mary Ellen Carey, Julie Paronish, Frank Cornell, Jim Cramer, Diana Lynn Pakstis, Michael G Ison, Richard Wunderink, Marshall Glesby, Kirsis Ham, Valery Hughes, Melissa Cushing, Cheryl Goss, Joanne Grenade, Pauline K Park, Lena M Napolitano, Krishnan Raghavendran, Robert C Hyzy, Robertson Davenport, Kristin Brierley, Theresa Downs, Michelle Ng Gong, Joan Uehlinger, Michael Lin, Janice Fritsche, Tondria Green, Bruce McLeod, Deena Patel, Mary F Bavaro, Robert Deiss, Carolyn Brandt, Stephanie Cammarata, Allan Kremp, Karine Hollis-Perry, Tahaniyat Lalani, Susan Banks, Jacqueline Johnson, Jason Maguire, Janet McNiff, Leslie E Rigg, Anuradha Ganesan, Irma Barahona, Steven Spencer, David Stagliano, Timothy Burgess, Daniel Talmor, Monique Mohammed, Valerie Banner-Goodspeed, Robert Salata, Robert Finberg, Jennifer Wang, Karen Longtine, Jaclyn Longtine, Mellissa O'Neil, Philippe R Bauer, Ognjen Gajic, Suanne M Weist, Jonathan Sevransky, Mona Brown, John Roback, John Oropello, Bridget Twohig, Jeffrey Jhang, Rahgu Seethala, Wilbur H Chen, Magali Fontaine, Kapil Saharia, Jennifer Husson, Roberta DeBiasi, Jurran L Wilson, Valli Ree Criss, Jocelyn Voell, Susan Leitman, James Wade Atkins, Hemaxi Patel, Traci Paige, Cathy Cantilena, Donald Siegel, Faye DeMuth, Craig H Fletcher, J Peter R Pelletier, Hassan Alnuaimat, and Michelle Pourde

Subjects
0301 basic medicine, Pulmonary and Respiratory Medicine, Mechanical ventilation, Pediatrics, medicine.medical_specialty, Respiratory rate, business.industry, medicine.medical_treatment, Hazard ratio, medicine.disease, law.invention, Clinical trial, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Randomized controlled trial, law, Clinical endpoint, Medicine, 030212 general & internal medicine, business, Adverse effect, Stroke
Abstract

Summary Background Influenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza. Methods In this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain. Hospitalised children and adults (including pregnant women) with severe influenza A or B (defined as the presence of hypoxia or tachypnoea) were randomly assigned to receive either two units (or paediatric equivalent) of anti-influenza plasma plus standard care, versus standard care alone, and were followed up for 28 days. The primary endpoint was time to normalisation of patients' respiratory status (respiratory rate of ≤20 breaths per min for adults or age-defined thresholds of 20–38 breaths per min for children) and a room air oxygen saturation of 93% or more. This study is registered with ClinicalTrials.gov, number NCT01052480. Findings Between Jan 13, 2011, and March 2, 2015, 113 participants were screened for eligibility and 98 were randomly assigned from 20 out of 29 participating sites. Of the participants with confirmed influenza (by PCR), 28 (67%) of 42 in the plasma plus standard care group normalised their respiratory status by day 28 compared with 24 (53%) of 45 participants on standard care alone (p=0·069). The hazard ratio (HR) comparing plasma plus standard care with standard care alone was 1·71 (95% CI 0·96–3·06). Six participants died, one (2%) from the plasma plus standard care group and five (10%) from the standard care group (HR 0·19 [95% CI 0·02–1·65], p=0·093). Participants in the plasma plus standard care group had non-significant reductions in days in hospital (median 6 days [IQR 4–16] vs 11 days [5–25], p=0·13) and days on mechanical ventilation (median 0 days [IQR 0–6] vs 3 days [0–14], p=0·14). Fewer plasma plus standard care participants had serious adverse events compared with standard care alone recipients (nine [20%] of 46 vs 20 [38%] of 52, p=0·041), the most frequent of which were acute respiratory distress syndrome (one [2%] vs two [4%] patients) and stroke (one [2%] vs two [4%] patients). Interpretation Although there was no significant effect of plasma treatment on the primary endpoint, the treatment seemed safe and well tolerated. A phase 3 randomised trial is now underway to further assess this intervention. Funding National Institute of Allergy and Infectious Diseases, US National Institutes of Health.

Published
2017
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3. Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study

Author

Megan Telfer, Joseph Timpone, Tondria Green, Edward P. Acosta, Jay Dwyer, Michael P. DubCrossed Dsign, Ellen S. Chan, Paul E. Sax, David Rusin, Teri Flynn, Raphael J. Landovitz, Todd T. Brown, Carl J. Fichtenbaum, Amy Sbrolla, Jolene Noel-Connor, Cara Wilson, Roula Qaqish, Daniel Reirden, Pamela Poethke, Athe M. N. Tsibris, Olga I. Mendez, Babafemi Taiwo, Jorge Santana, Shelia B. Dunaway, Ge-Youl Kim, Yolanda Smith, Tim Lane, Joseph J. Eron, James F. Rooney, Mark Hite, Vanessa Cajahuaringa, Ilene Wiggins, Cheryl Keenan, Cornelius N Van Dam, Nina Lambert, Beverly E. Sha, Mark Rodrieguez, Orlando Roman, I. Martinez, Miriam Chicurel-Bayard, Cathi Basler, Karen Coleman, Laura A. Napolitano, Robert C. Kalayjian, Bryan Baugh, Fred Nicotera, Baiba Berzins, Roberto C. Arduino, Kathy Melbourne, Tamara James, Mary Adams, Charles Walworth, Kevin Robertson, Alan L. Landay, Princy Kumar, Melody Palmore, Andrea Weiss, Heera R. Jayvant, Christine Griesmer, Igho Ofotokun, Christos J. Petropoulos, Aleshia Thomas, John A. Davis, Pablo Tebas, Amy Gonzales, Patricia Walton, Constance A. Benson, Alex Reinhart, Brenda Jackson, Rose Kim, Bartolo Santos, Ighovwerha Ofotokun, Annie Luetkemeyer, Heather J. Ribaudo, Karin L. Klingman, Jenifer Baer, Amy Dill, Felicia Williams, Michael T. Yin, Christine Hurley, Hector Bolivar, Edward Seefried, Aadia Rana, Sheryl Storey, Margaret A. Fischl, Hannah Bernath, and Aristoteles E. Villamil

Subjects
Microbiology (medical), musculoskeletal diseases, Adult, Male, medicine.medical_specialty, Bone density, Anti-HIV Agents, Population, HIV Infections, Emtricitabine, Gastroenterology, Maraviroc, chemistry.chemical_compound, Bone Density, Cyclohexanes, Internal medicine, medicine, Humans, education, Pelvic Bones, Tenofovir, Darunavir, education.field_of_study, business.industry, virus diseases, Middle Aged, Triazoles, medicine.disease, Surgery, Osteopenia, Infectious Diseases, chemistry, HIV/AIDS, Ritonavir, Female, business, Viral load, medicine.drug
Abstract

Background. There is a need to prevent or minimize bone loss associated with antiretroviral treatment (ART) initiation. We compared maraviroc (MVC)- to tenofovir disoproxil fumarate (TDF)–containing ART. Methods. This was a double-blind, placebo-controlled trial. ART-naive subjects with human immunodeficiency virus type 1 RNA load (viral load [VL]) >1000 copies/mL and R5 tropism were randomized to MVC 150 mg or TDF 300 mg once daily (1:1), stratified by VL

Published
2015

4. Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings

Author

David Chilongozi, Sharla Faesen, Breno Santos, Mamta K. Jain, Pablo Tebas, Apsara Nair, Cynthia Riviere, Beatriz Grinsztejn, Sima Berendes, Steve Tabet, Joan Gormley, M. Graham Ray, Johnstone Kumwenda, Judith Feinberg, Todd Stroberg, Kenneth H. Mayer, Nikki Gettinger, Vicki L. Bailey, James Hakim, Selvamuthu Poongulali, Sandra W. Cardoso, Marineide Gonçalves de Melo, Karin L. Klingman, Rosie Mngqibisa, Thomas B. Campbell, Amneris E. Luque, Beverly Putnam, Thira Sirisanthana, Janice M. Fritsche, Ann Walawander, Ge Youl Kim, Roberto Corales, Richard B. Pollard, Ronald T. Mitsuyasu, Martha Silberman, Rita Alves Lira, Janet Forcht, Norbert Bischofberger, Ana Martinez, Barbara Brizz, Laura M. Smeaton, Asmita Gaikwad, Farida Amod, Srikanth Tripathy, Babafemi Taiwo, Anthony Chisada, Chiedza Maponga, Charles van der Horst, Michael Wulfsohn, Javier R. Lama, Taha E. Taha, Manuel Revuelta, Christine Hurley, David Currin, Wendy Snowden, Keith A. Pappa, Rosa Infante, T. Petersen, Donna V. McGregor, Susan Cu-Uvin, Susan A. Fiscus, Eric S. Daar, Jody Lawrence, P. Jan Geiseler, Irving F. Hoffman, Luis Lopez-Detres, Karen T. Tashima, Larisa Zifchak, Victor De Gruttola, Timothy P. Flanigan, Laura Moran, Farideh Said, Alberto La Rosa, Raman R. Gangakhedkar, Maria Palmer, Michael F. Para, Joel E. Gallant, Nancy Webb, Cecilia Kanyama, Wadzanai Samaneka, Jabin Sharma, Yvonne J. Bryson, Mark A. Winters, Ian Sanne, David Shugarts, Yun Chen, Sampada Dhayarkar, Peter N. Kazembe, Scott M. Hammer, Adriana Andrade, Robert T. Schooley, Beth D. Mullan, Henry H. Balfour, Patrice Severe, Beverly E. Sha, Madeline Torres, Cathi Basler, Andrew K. Cheng, Jolene Noel-Connor, Vladimir Berthaud, Jonathan Uy, Michael K. Klebert, Virginia Kayoyo, Donna Mildvan, David W. Haas, Joseph J. Eron, Cheryl Mogridge, David D. Celentano, Ruben Lopez, Ronald L. Barnett, Karin Nielsen, Helen Patterson, Renard S. Descallar, Jenifer Baer, Deise Lucia Faria, Cheryl Marcus, Khuanchai Supparatpinyo, Mina C. Hosseinipour, Newton Kumwenda, Yvette Delph, Smanga Ntshele, Edith Swann, Steven A. Safren, David M. Asmuth, Kelly Burke, Laurie Frarey, Joseph Steele, Gary M. Cox, Umesh G. Lalloo, Richard B. Pendame, Mary Adams, Bharat Ramratnam, Christine Wanke, James F. Rooney, Francis Martinson, Edde Loeliger, Anjali A. Joglekar, John Martin, Myron S. Cohen, Sheela Godbole, Robert C. Bollinger, Roy M. Gulick, Cynthia Firnhaber, Charles Flexner, William A. O'Brien, Suniti Solomon, Jorge Sanchez, Yue Chen, Susan H. Eshleman, Kathy J. Watson, N. Kumarasamy, David H. Haas, Ann C. Collier, Bartolo Santos, Suwat Chariyalertsak, Michelle S. Cespedes, Howard Jaffe, Judith S. Currier, and Deeks, Steven G

Subjects
Male, Comparative Effectiveness Research, Time Factors, Internationality, HIV Infections, Medical and Health Sciences, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Pregnancy, law, 030212 general & internal medicine, 0303 health sciences, education.field_of_study, Coinfection, Hazard ratio, virus diseases, General Medicine, 3. Good health, Infectious Diseases, Treatment Outcome, 6.1 Pharmaceuticals, Combination, HIV/AIDS, Medicine, Female, Patient Safety, Infection, medicine.drug, medicine.medical_specialty, Efavirenz, Anti-HIV Agents, Clinical Trials and Supportive Activities, Population, Antiretroviral Therapy, Emtricitabine, 03 medical and health sciences, Drug Therapy, Clinical Research, General & Internal Medicine, Internal medicine, PEARLS study team of the ACTG, medicine, Humans, Highly Active, Dosing, education, 030306 microbiology, business.industry, Evaluation of treatments and therapeutic interventions, Mycobacterium tuberculosis, Surgery, Atazanavir, Regimen, Withholding Treatment, chemistry, HIV-1, business, Follow-Up Studies
Abstract

BackgroundAntiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world.Methods and findings1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; pConclusionEFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen.Trial registrationwww.ClinicalTrials.gov NCT00084136. Please see later in the article for the Editors' Summary.

Published
2012
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