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1. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials

Author

Martins, Marcelo D, Cahn, Pedro E, Lopardo, Gustavo D, Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard J, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Schmied, Brigitte, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L, Conway, Brian, Rachlis, Anita, Smith, Graham H R, Perez Cortes, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E, Chahin Anania, Carolina Eugenia, Reyes, Marcelo J. Wolff, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Slama, Laurence, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K, Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes Richard, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Wiese, Carmen, Gori, Andrea, Migliorino, Guglielmo Marco, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona M, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim V, Zakharova, Natalia, Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatiana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, de Jager, Marleen, Segorb, Joaquin Portilla, Gatell Artigas, Josep Maria, Mallolas Masferrer, Josep, Guillen, Santiago Moreno, Perez Elias, Maria Jesus, Arribas Lopez, Jose R, Puigmal, Eugenia Negredo, Podzamczer Palter, Daniel, Ortega, Frederico Pulido, Garcia, Jesus Troya, de los Santos Gil, Ignacio, Berenguer, Juan, Nelson, Mark Richard, Williams, Ian G, Johnson, Margaret A, Khoo, Saye, Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Lwanga, Julianne, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Hagins, Debbie P, Osiyemi, Olayemi O, Prelutsky, David James, Ramgopal, Moti N, Scarsella, Anthony J, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J, Sims III, James, Clay, Patrick G, Bellos, Nicholaos C, Thompson, Melanie A, Montero, Jose, McDonald, Cheryl K, Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E, Valdes, Martin, Tashima, Karen T, Robbins, William J, Elion, Richard A, Goldstein, Deborah, Slim, Jihad, Lalezari, Jacob Paul, Pushkin, Richard, Lalla-Reddy, Sujata N, Win, Sanda S, Ruane, Peter Jerome, Mills, Anthony Martin, Cade, Jerry L, Campo, Rafael, Dietz, Craig A, Hoffman-Terry, Margaret, Blick, Gary, Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P, Daar, Eric, Kumar, Princy N, Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O, Santiago, Lizette, Santana-Bagur, Jorge L, Vandekerckhove, Linos, Florence, Eric, De Wit, Stephane, Derdelinckx, Inge, Vandercam, Bernard, Belkhir, Leila, De Wet, Joseph, Lebouche, Bertrand, Trottier, Benoit, Longpre, Daniele, Szabo, Jason, LeBlanc, Roger P, Jensen, Werner, Gonzalez, Alvaro Rojas, Beltran, Carlos, Sussmann, Otto Alberto, Velez, Juan Diego, Onate, Jose Millan, Nielsen, Henrik, Degen, Olaf, Stephan, Christoph, Arathoon, Eduardo, Lopez, Rudy Manuel, Rojas Alvarado, Evelyn Michelle, Gonzalez Patzan, Luis Demetrio, Meija, Carlos R, Pinzon, Rodolfo, Parchment, Charles, Sthoeger, Zev, Chowers, Michal, Riesenberg, Klaris, Shahar, Eduardo, Levy, Itzchak, Quintero Perez, Nora Patricia, Andrade-Villanueva, Jaime Federico, Crabtree Ramirez, Brenda Eloisa, Rijnders, Bart, den Hollander, Jan G, Handy, Rupert, Morales, Nilo Bonifacio, Hidalgo, Jose Alfredo, Infante, Rosa Mercedes, Matos Prado, Eduardo Demetrio, Campos, Pablo E, Ticona Chaves, Eduardo Romulo, Pinedo, Yvett, Pacheco, Patricia, Maltez, Fernando Manuel, Cunha, Jose, Neves, Isabel, Serrao, Rosario, Melendez-Rivera, Ivan, Mendoza-Rodriguez, Rafael O, Maldonado-Rivera, Sandra, Ortiz-Lasanta, Grisell, Kizhlo, Svetlana, Freud, Hernando Knobel, Moreno, Jose Sanz, Mendez, Francisco Vera, Mohapi, Lerato, Mitha, Essack Aziz, Mahomed, Akbar Anvar, Fouche, Leon Frederik, Kaplan, Richard, Siddique, Naeem, Hoosen, Farzana, Rassool, Mohammed Siddique, Baraldi, Ezio, Calmy, Alexandra, Cavassini, Matthias, Fehr, Jan, Tsai, Hung-Chin, Lin, Hsi-Hsun, Huang, Chun-Kai, Ko, Wen-Chien, Lin, Yu-Hui, Chen, Su-Jung, Hung, Chien-Ching, Avihingsanon, Anchalee, Kiertiburanakul, Sasisopin, Ratanasuwan, Winai, Supparatpinyo, Khuanchai, Chetchotisakd, Ploenchan, Changpradub, Dhitiwat, Orkin, Chloe, Fox, Ashini, Winston, Alan, Ustianowski, Andrew, Yangco, Bienvenido G, Asmuth, David Michael, Vigil, Karen J, Berger, Daniel S, Bhatti, Laveeza, Campbell, Thomas, Casey, Kathleen K, Liu, Edward, Crofoot, Gordon E, Cunningham, Douglas, Feinberg, Judith, Fichtenbaum, Carl, Balamban Felizarta, Franco Antonio, Jefferson, Thomas T, Johnson, Marc Alexander, Lewis, Stanley T, Luque, Amneris E, Novak, Richard M, Sloan, Louis, Sweet, Donna E, Towner, William J, Zane, Ryan, Riedel, David J, Loftus, Richard Anton, Shon, Alyssa So Young, Mogyoros, Miguel, Tebas, Pablo, Scott, Mia Louise, Parenti, David M, Inciarte Portillo, Alexy, Cahn, Pedro, Lombaard, Johannes, Kumar, Sushma, Campbell, Havilland, Wan, Hong, Teal, Valerie, Jin Xu, Zhi, Asante-Appiah, Ernest, Sklar, Peter, Teppler, Hedy, and Lahoulou, Rima

Published
2024
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2. Brief Report: Short-Term Adherence Marker to PrEP Predicts Future Nonretention in a Large PrEP Demo Project: Implications for Point-of-Care Adherence Testing.

Author

Spinelli, Matthew A, Glidden, David V, Anderson, Peter L, Gandhi, Monica, Cohen, Stephanie, Vittinghoff, Eric, Coleman, Megan E, Scott, Hyman, Bacon, Oliver, Elion, Richard, Kolber, Michael A, Buchbinder, Susan P, and Liu, Albert Y

Subjects
Public Health, Health Sciences, Behavioral and Social Science, Infectious Diseases, Sexually Transmitted Infections, Adenine, Adult, Anti-HIV Agents, Dried Blood Spot Testing, Emtricitabine, Female, HIV Infections, Homosexuality, Male, Humans, Male, Medication Adherence, Organophosphates, Point-of-Care Testing, Pre-Exposure Prophylaxis, Proportional Hazards Models, Prospective Studies, Tenofovir, PrEP, adherence, retention in care, persistence, dried blood spot, Clinical Sciences, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

BACKGROUND:Objective adherence metrics for tenofovir (TFV) disoproxil fumarate/emtricitabine(FTC)-based PrEP were critical for interpretation of efficacy in PrEP clinical trials, and there is increasing interest in using drug levels to tailor interventions for reengagement and adherence. Point-of-care immunoassays (POC) for TFV, which examine short-term adherence, are in development. However the ability of poor short-term and long-term adherence to predict future PrEP non-retention is unknown. SETTING:Secondary data analysis of a large, prospective multi-site U.S. PrEP demonstration project METHODS:: An adjusted Cox-proportional hazards model examined the relationship of dried blood spot (DBS) levels of FTC-triphosphate (FTC-TP) or TFV-diphosphate (TFV-DP), measures of short-term and long-term PrEP adherence, respectively, with future study non-retention. RESULTS:Overall, 294 individuals (median age 33 years) contributed drug levels within the U.S. PrEP demonstration project. By study end, 27% were lost to follow-up, 25% had at least one undetectable FTC-TP level indicating poor short-term adherence, and 29% had a drug level indicating sub-optimal long-term adherence (TFV-DP

Published
2019

3. Recent Abacavir Use Increases Risk of Type 1 and Type 2 Myocardial Infarctions Among Adults With HIV

Author

Elion, Richard A, Althoff, Keri N, Zhang, Jinbing, Moore, Richard D, Gange, Stephen J, Kitahata, Mari M, Crane, Heidi M, Drozd, Daniel R, Stein, James H, Klein, Marina B, Eron, Joseph J, Silverberg, Michael J, Mathews, William C, Justice, Amy C, Sterling, Timothy R, Rabkin, Charles S, Mayor, Angel M, Klein, Daniel B, Horberg, Michael A, Bosch, Ronald J, Eyawo, Oghenowede, and Palella, Frank J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Sexually Transmitted Infections, Heart Disease - Coronary Heart Disease, Cardiovascular, HIV/AIDS, Prevention, Aging, Heart Disease, Infectious Diseases, Infection, Good Health and Well Being, Adult, Aged, Antirheumatic Agents, CD4 Lymphocyte Count, Cohort Studies, Dideoxynucleosides, Female, HIV Infections, Humans, Male, Middle Aged, Myocardial Infarction, North America, Risk Assessment, Risk Factors, HIV, abacavir, myocardial infarction, causal inference, North American AIDS Cohort Collaboration on Research and Design of IeDEA, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

BackgroundThere is persistent confusion as to whether abacavir (ABC) increases the risk of myocardial infarction (MI), and whether such risk differs by type 1 (T1MI) or 2 (T2MI) MI in adults with HIV.MethodsIncident MIs in North American Cohort Collaboration on Research and Design participants were identified from 2001 to 2013. Discrete time marginal structural models addressed channeling biases and time-dependent confounding to estimate crude hazard ratio (HR) and adjusted hazard ratio (aHR) and 95% confidence intervals; analyses were performed for T1MI and T2MI separately. A sensitivity analysis evaluated whether Framingham risk score (FRS) modified the effect of ABC on MI occurrence.ResultsEight thousand two hundred sixty-five adults who initiated antiretroviral therapy contributed 29,077 person-years and 123 MI events (65 T1MI and 58 T2MI). Median follow-up time was 2.9 (interquartile range 1.4-5.1) years. ABC initiators were more likely to have a history of injection drug use, hepatitis C virus infection, hypertension, diabetes, impaired kidney function, hyperlipidemia, low (

Published
2018

4. Changes in Kidney Function Associated With Daily Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Preexposure Prophylaxis Use in the United States Demonstration Project

Author

Tang, Eric C, Vittinghoff, Eric, Anderson, Peter L, Cohen, Stephanie E, Doblecki-Lewis, Susanne, Bacon, Oliver, Coleman, Megan E, Buchbinder, Susan P, Chege, Wairimu, Kolber, Michael A, Elion, Richard, Shlipak, Michael, and Liu, Albert Y

Subjects
Public Health, Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Kidney Disease, Sexually Transmitted Infections, HIV/AIDS, Infectious Diseases, Clinical Research, Renal and urogenital, Good Health and Well Being, Adolescent, Adult, Aged, Anti-HIV Agents, Creatinine, Disease Transmission, Infectious, Emtricitabine, Female, Glomerular Filtration Rate, HIV Infections, Homosexuality, Male, Humans, Kidney Function Tests, Male, Metabolic Clearance Rate, Middle Aged, Pre-Exposure Prophylaxis, Prospective Studies, Proteins, Renal Insufficiency, Tenofovir, Transgender Persons, United States, Urinalysis, Young Adult, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

BackgroundHIV preexposure prophylaxis (PrEP) using daily oral tenofovir-disoproxil-fumarate/emtricitabine (TDF/FTC) is effective for preventing HIV acquisition, but concerns remain about its potential kidney toxicity. This study examined kidney function in individuals using PrEP in real-world clinical settings.SettingDemonstration project in 2 sexually transmitted infection clinics and a community health center.MethodsWe evaluated kidney function among men who have sex with men and transgender women taking tenofovir-disoproxil-fumarate/emtricitabine PrEP for up to 48 weeks. Serum creatinine and urine dipstick for protein were obtained at 12-week intervals. Kidney function was estimated using creatinine clearance (CrCl) (Cockcroft-Gault) and estimated glomerular filtration rate (eGFR) (CKD-EPI).ResultsFrom October 2012 to January 2014, we enrolled 557 participants (median age 33). Mean creatinine increased from baseline to week 12 by 0.03 mg/dL (4.6%) (P < 0.0001); mean CrCl decreased by 4.8 mL/min (3.0%) (P < 0.0001). These changes remained stable through week 48 (P = 0.81, P = 0.71 respectively). There were 75/478 (15.7%) participants who developed worsening proteinuria at week 12 compared with baseline (P < 0.0001), and this percent remained stable through week 48 (P = 0.73). Twenty-five participants (5.1%) developed new-onset eGFR

Published
2018

6. Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen

Author

Gandhi, Monica, Murnane, Pamela M, Bacchetti, Peter, Elion, Richard, Kolber, Michael A, Cohen, Stephanie E, Horng, Howard, Louie, Alexander, Kuncze, Karen, Koss, Catherine A, Anderson, Peter L, Buchbinder, Susan, and Liu, Albert

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Behavioral and Social Science, Prevention, Infectious Diseases, Adult, Aged, Anti-HIV Agents, Blood Chemical Analysis, Drug Utilization, Female, HIV Infections, Hair, Humans, Male, Medication Adherence, Middle Aged, Pre-Exposure Prophylaxis, Tenofovir, Transgender Persons, United States, Young Adult, creatinine clearance, enhancing preexposure prophylaxis in community, hair concentrations, HIV prevention, pharmacologic measures, preexposure prophylaxis, preexposure prophylaxis US Demo project, tenofovir/emtricitabine, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveThe US preexposure prophylaxis (PrEP) Demonstration Project (U.S. Demo) evaluated MSM on PrEP postmarketing and found low seroconversion rates. The objective of this study is to examine hair levels as an adherence measure to PrEP.DesignUsing an 'opt-in' design, participants of PrEP Demo were invited to enroll into a substudy where hair was collected quarterly.MethodsTenofovir concentrations were measured in hair by liquid chromatography/tandem mass spectrometry. Hair levels consistent with ≥4 doses/week (protective in other studies) defined adequate adherence. Mixed effects multivariate logistic regression models examined factors associated with ≥4 doses/week. Separate mixed effects models evaluated the relationship between hair PrEP levels and changes in creatinine clearance (CrCl) over time.ResultsOverall, 58% of U.S. Demo participants enrolled into this opt-in study; reasons for nonparticipation included insufficient hair (61%) and concerns about hairstyle (27%). Hair and dried blood spots levels consistent with ≥4 doses/week were highly concordant (84%). Hair levels showed adequate adherence in 87% of 875 person-visits (among 280 participants). Factors associated with adequate adherence in multivariate models were amphetamine use [adjusted odds ratio (aOR) 2.59 (0.97-6.9, P 0.06)], condomless receptive anal sex [aOR 2.28 (1.19-4.40, P 0.01)], and stable housing [aOR 2.63 (1.03-6.67), P 0.04]. Hair levels of tenofovir showed a monotonic relationship with decline in CrCl (P 0.01 for trend).ConclusionIn this substudy of the U.S. PrEP demonstration project, hair and dried blood spots levels were highly concordant and hair concentrations demonstrated adequate adherence 87% of the time, with stable housing and high-risk behavior associated with higher adherence. Daily PrEP drug taking is associated with modest declines in CrCl.

Published
2017

7. Increased Risk of Myocardial Infarction in HIV-Infected Individuals in North America Compared With the General Population

Author

Drozd, Daniel R, Kitahata, Mari M, Althoff, Keri N, Zhang, Jinbing, Gange, Stephen J, Napravnik, Sonia, Burkholder, Greer A, Mathews, William C, Silverberg, Michael J, Sterling, Timothy R, Heckbert, Susan R, Budoff, Matthew J, Van Rompaey, Stephen, Delaney, Joseph AC, Wong, Cherise, Tong, Weiqun, Palella, Frank J, Elion, Richard A, Martin, Jeffrey N, Brooks, John T, Jacobson, Lisa P, Eron, Joseph J, Justice, Amy C, Freiberg, Matthew S, Klein, Daniel B, Post, Wendy S, Saag, Michael S, Moore, Richard D, and Crane, Heidi M

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Health Sciences, Infectious Diseases, Heart Disease, Cardiovascular, Prevention, Clinical Research, Atherosclerosis, HIV/AIDS, Sexually Transmitted Infections, Infection, Good Health and Well Being, Adult, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Comorbidity, Female, HIV Infections, Humans, Incidence, Male, Middle Aged, Myocardial Infarction, North America, Proportional Hazards Models, Risk Assessment, Risk Factors, Viral Load, Clinical Sciences, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

BackgroundPrevious studies of cardiovascular disease (CVD) among HIV-infected individuals have been limited by the inability to validate and differentiate atherosclerotic type 1 myocardial infarctions (T1MIs) from other events. We sought to define the incidence of T1MIs and risk attributable to traditional and HIV-specific factors among participants in the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) and compare adjusted incidence rates (IRs) to the general population Atherosclerosis Risk in Communities (ARIC) cohort.MethodsWe ascertained and adjudicated incident MIs among individuals enrolled in 7 NA-ACCORD cohorts between 1995 and 2014. We calculated IRs, adjusted incidence rate ratios (aIRRs), and 95% confidence intervals of risk factors for T1MI using Poisson regression. We compared aIRRs of T1MIs in NA-ACCORD with those from ARIC.ResultsAmong 29,169 HIV-infected individuals, the IR for T1MIs was 2.57 (2.30 to 2.86) per 1000 person-years, and the aIRR was significantly higher compared with participants in ARIC [1.30 (1.09 to 1.56)]. In multivariable analysis restricted to HIV-infected individuals and including traditional CVD risk factors, the rate of T1MI increased with decreasing CD4 count [≥500 cells/μL: ref; 350-499 cells/μL: aIRR = 1.32 (0.98 to 1.77); 200-349 cells/μL: aIRR = 1.37 (1.01 to 1.86); 100-199 cells/μL: aIRR = 1.60 (1.09 to 2.34);

Published
2017

8. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial

Author

Hagins, Debbie P., Osiyemi, Olayemi O., Prelutsky, David James, Ramgopal, Moti N., Scarsella, Anthony John, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J., Sims, James, III, Clay, Patrick G., Bellos, Nicholaos C., Thompson, Melanie A., Montero, Jose, McDonald, Cheryl K., Creticos, Catherine, Shamblaw, David, Mogyoros, Miguel, Terrelonge, Antonio E., Valdes, Martin, Tashima, Karen T., Robbins, William J., Felizarta, Franco Antonio, Elion, Richard A., Slim, Jihad, Win, Sandra S., Lalla-Reddy, Sujata N., Ruane, Peter Jerome, Mills, Anthony, Cade, Jerry L., Dietz, Craig A., Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P., Daar, Eric, Kumar, Princy N., Swindells, Susan, Castro, Jose Guillermo, Melendez-Rivera, Ivan, Morales-Ramirez, Javier O., Santiago, Lizette, Santana-Bagur, Jorge L., Martins, Marcelo, Cahn, Pedro Enrique, Lopardo, Gustavo D., Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard James, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L., Conway, Brian, Rachlis, Anita, Smith, Graham H.R., Perez, Carlos, Afani, Alejandro, Campos, Maria Isabel, Chahin, Carolina Eugenia, Wolff Reyes, Marcelo, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K., Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Gori, Andrea, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona Manuela, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim Valentinovich, Zakharova, Natalia V., Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatyana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, de Jager, Marleen, Portilla Segorb, Joaquin, Mallolas, Josep, Perez Elias, Maria Jesus, Gatell, Josep M., Arribas Lopez, Jose Ramon, Negredo Puigmal, Eugenia, Podzamczer Palter, Daniel, Pulido Ortega, Federico, Troya Garcia, Jesus, De los Santos Gil, Ignacio, Berenguer Berenguer, Juan, Williams, Ian G., Johnson, Margaret A., Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Squires, Kathleen, Sax, Paul E, Cahn, Pedro, Lombaard, Johan, Lai, Ming-Tain, Rodgers, Anthony, Lupinacci, Lisa, Kumar, Sushma, Sklar, Peter, Hanna, George J, Hwang, Carey, and Martin, Elizabeth Anne

Published
2020
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9. Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services

Author

Liu, Albert Y, Cohen, Stephanie E, Vittinghoff, Eric, Anderson, Peter L, Doblecki-Lewis, Susanne, Bacon, Oliver, Chege, Wairimu, Postle, Brian S, Matheson, Tim, Amico, K Rivet, Liegler, Teri, Rawlings, M Keith, Trainor, Nikole, Blue, Robert Wilder, Estrada, Yannine, Coleman, Megan E, Cardenas, Gabriel, Feaster, Daniel J, Grant, Robert, Philip, Susan S, Elion, Richard, Buchbinder, Susan, and Kolber, Michael A

Subjects
Biomedical and Clinical Sciences, Public Health, Health Sciences, Clinical Sciences, Sexually Transmitted Infections, Minority Health, Behavioral and Social Science, Clinical Research, Prevention, Infectious Diseases, Women's Health, HIV/AIDS, Health Disparities, Sexual and Gender Minorities (SGM/LGBT*), Clinical Trials and Supportive Activities, Infection, Good Health and Well Being, Adenine, Adolescent, Adult, Anti-HIV Agents, Bisexuality, Chlamydia Infections, Community Health Services, District of Columbia, Female, Florida, Gonorrhea, HIV Infections, Homosexuality, Male, Humans, Male, Medication Adherence, Middle Aged, Organophosphates, Pre-Exposure Prophylaxis, Prospective Studies, Reproductive Health, San Francisco, Sexual Behavior, Syphilis, Tenofovir, Transgender Persons, Unsafe Sex, Young Adult, Opthalmology and Optometry, Public Health and Health Services, Clinical sciences, Health services and systems
Abstract

ImportanceSeveral randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM).ObjectiveTo assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States.Design, setting, and participantsDemonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015.InterventionsA combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring.Main outcomes and measuresConcentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition.ResultsOverall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P

Published
2016

10. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial

Author

Martins, Marcelo, Cahn, Pedro Enrique, Lopardo, Gustavo D., Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard James, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L., Conway, Brian, Rachlis, Anita, Smith, Graham H.R., Perez, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E., Chahin, Carolina Eugenia, Wolff Reyes, Marcelo, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K., Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Gori, Andrea, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona Manuela, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim Valentinovich, Zakharova, Natalia V., Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatyana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, Portilla, Joaquin, Gatell, Josep Maria, Perez, Maria Jesus, Arribas, Jose Ramon, Negredo, Eugenia, Podzamczer, Daniel, Pulido, Federico, Troya, Jesus, De los Santos, Ignacio, Berenguer, Juan, Williams, Ian G., Johnson, Margaret A., Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Taylor, Steven John, Kegg, Stephen, Hagins, Debbie P., Osiyemi, Olayemi O., Prelutsky, David James, Ramgopal, Moti N., Dretler, Robin, DeJesus, Edwin, Sloan, Louis, Lewis, Stanley T., Clay, Patrick G., Bellos, Nicholaos C., Thompson, Melanie A., Montero, Jose, McDonald, Cheryl K., Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E., Valdes, Martin, Tashima, Karen T., Robbins, William J., Felizarta, Franco Antonio, Elion, Richard A., Slim, Jihad, Lalezari, Jacob Paul, Lalla-Reddy, Sujata N., Ruane, Peter Jerome, Mills, Anthony, Cade, Jerry L., Campo, Rafael E., Dietz, Craig A., Blick, Gary, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P., Daar, Eric, Kumar, Princy N., Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O., Santiago, Lizette, Santana-Bagur, Jorge L., Squires, Kathleen, Sax, Paul E, Cahn, Pedro, Lombaard, Johan, Lai, Ming-Tain, Xu, Xia, Rodgers, Anthony, Lupinacci, Lisa, Kumar, Sushma, Sklar, Peter, Nguyen, Bach-Yen, Hanna, George J, and Hwang, Carey

Published
2018
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11. Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial

Author

Markowitz, Martin, Frank, Ian, Grant, Robert M, Mayer, Kenneth H, Elion, Richard, Goldstein, Deborah, Fisher, Chester, Sobieszczyk, Magdalena E, Gallant, Joel E, Van Tieu, Hong, Weinberg, Winkler, Margolis, David A, Hudson, Krischan J, Stancil, Britt S, Ford, Susan L, Patel, Parul, Gould, Elizabeth, Rinehart, Alex R, Smith, Kimberly Y, and Spreen, William R

Published
2017
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14. Renal safety of tenofovir alafenamide vs tenofovir disoproxil fumarate: A pooled analysis of 26 clinical trials

Author

Gupta, Samir K., Post, Frank A., Arribas, José R., Jr, Joseph J. Eron, Wohl, David A., Clarke, Amanda E., Sax, Paul E., Stellbrink, Hans-Jürgen, Esser, Stefan, Pozniak, Anton L., Podzamczer, Daniel, Waters, Laura, Orkin, Chloe, Rockstroh, Jürgen K., Mudrikova, Tatiana, Negredo, Eugenia, Elion, Richard A., Guo, Susan, Zhong, Lijie, Carter, Christoph, Martin, Hal, Brainard, Diana, Sengupta, Devi, and Das, Moupali

Published
2019
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16. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study

Author

Mills, Anthony, Arribas, Jose R, Andrade-Villanueva, Jaime, DiPerri, Giovanni, Van Lunzen, Jan, Koenig, Ellen, Elion, Richard, Cavassini, Matthias, Madruga, Jose Valdez, Brunetta, Jason, Shamblaw, David, DeJesus, Edwin, Orkin, Chloe, Wohl, David A, Brar, Indira, Stephens, Jeffrey L, Girard, Pierre-Marie, Huhn, Gregory, Plummer, Andrew, Liu, Ya-Pei, Cheng, Andrew K, and McCallister, Scott

Published
2016
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17. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials

Author

Orkin, Chloe, Molina, Jean-Michel, Cahn, Pedro, Lombaard, Johannes, Supparatpinyo, Khuanchai, Kumar, Sushma, Campbell, Havilland, Wan, Hong, Teal, Valerie, Jin Xu, Zhi, Asante-Appiah, Ernest, Sklar, Peter, Teppler, Hedy, Lahoulou, Rima, Martins, Marcelo D, Cahn, Pedro E, Lopardo, Gustavo D, Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard J, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Schmied, Brigitte, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L, Conway, Brian, Rachlis, Anita, Smith, Graham H R, Perez Cortes, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E, Chahin Anania, Carolina Eugenia, Reyes, Marcelo J. Wolff, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Slama, Laurence, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K, Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes Richard, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Wiese, Carmen, Gori, Andrea, Migliorino, Guglielmo Marco, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona M, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim V, Zakharova, Natalia, Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatiana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, de Jager, Marleen, Segorb, Joaquin Portilla, Gatell Artigas, Josep Maria, Mallolas Masferrer, Josep, Guillen, Santiago Moreno, Perez Elias, Maria Jesus, Arribas Lopez, Jose R, Puigmal, Eugenia Negredo, Podzamczer Palter, Daniel, Ortega, Frederico Pulido, Garcia, Jesus Troya, de los Santos Gil, Ignacio, Berenguer, Juan, Nelson, Mark Richard, Williams, Ian G, Johnson, Margaret A, Khoo, Saye, Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Lwanga, Julianne, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Hagins, Debbie P, Osiyemi, Olayemi O, Prelutsky, David James, Ramgopal, Moti N, Scarsella, Anthony J, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J, Sims III, James, Clay, Patrick G, Bellos, Nicholaos C, Thompson, Melanie A, Montero, Jose, McDonald, Cheryl K, Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E, Valdes, Martin, Tashima, Karen T, Robbins, William J, Elion, Richard A, Goldstein, Deborah, Slim, Jihad, Lalezari, Jacob Paul, Pushkin, Richard, Lalla-Reddy, Sujata N, Win, Sanda S, Ruane, Peter Jerome, Mills, Anthony Martin, Cade, Jerry L, Campo, Rafael, Dietz, Craig A, Hoffman-Terry, Margaret, Blick, Gary, Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P, Daar, Eric, Kumar, Princy N, Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O, Santiago, Lizette, Santana-Bagur, Jorge L, Vandekerckhove, Linos, Florence, Eric, De Wit, Stephane, Derdelinckx, Inge, Vandercam, Bernard, Belkhir, Leila, De Wet, Joseph, Lebouche, Bertrand, Trottier, Benoit, Longpre, Daniele, Szabo, Jason, LeBlanc, Roger P, Jensen, Werner, Gonzalez, Alvaro Rojas, Beltran, Carlos, Sussmann, Otto Alberto, Velez, Juan Diego, Onate, Jose Millan, Nielsen, Henrik, Degen, Olaf, Stephan, Christoph, Arathoon, Eduardo, Lopez, Rudy Manuel, Rojas Alvarado, Evelyn Michelle, Gonzalez Patzan, Luis Demetrio, Meija, Carlos R, Pinzon, Rodolfo, Parchment, Charles, Sthoeger, Zev, Chowers, Michal, Riesenberg, Klaris, Shahar, Eduardo, Levy, Itzchak, Quintero Perez, Nora Patricia, Andrade-Villanueva, Jaime Federico, Crabtree Ramirez, Brenda Eloisa, Rijnders, Bart, den Hollander, Jan G, Handy, Rupert, Morales, Nilo Bonifacio, Hidalgo, Jose Alfredo, Infante, Rosa Mercedes, Matos Prado, Eduardo Demetrio, Campos, Pablo E, Ticona Chaves, Eduardo Romulo, Pinedo, Yvett, Pacheco, Patricia, Maltez, Fernando Manuel, Cunha, Jose, Neves, Isabel, Serrao, Rosario, Melendez-Rivera, Ivan, Mendoza-Rodriguez, Rafael O, Maldonado-Rivera, Sandra, Ortiz-Lasanta, Grisell, Kizhlo, Svetlana, Freud, Hernando Knobel, Moreno, Jose Sanz, Mendez, Francisco Vera, Mohapi, Lerato, Mitha, Essack Aziz, Mahomed, Akbar Anvar, Fouche, Leon Frederik, Kaplan, Richard, Siddique, Naeem, Hoosen, Farzana, Rassool, Mohammed Siddique, Baraldi, Ezio, Calmy, Alexandra, Cavassini, Matthias, Fehr, Jan, Tsai, Hung-Chin, Lin, Hsi-Hsun, Huang, Chun-Kai, Ko, Wen-Chien, Lin, Yu-Hui, Chen, Su-Jung, Hung, Chien-Ching, Avihingsanon, Anchalee, Kiertiburanakul, Sasisopin, Ratanasuwan, Winai, Supparatpinyo, Khuanchai, Chetchotisakd, Ploenchan, Changpradub, Dhitiwat, Orkin, Chloe, Fox, Ashini, Winston, Alan, Ustianowski, Andrew, Yangco, Bienvenido G, Asmuth, David Michael, Vigil, Karen J, Berger, Daniel S, Bhatti, Laveeza, Campbell, Thomas, Casey, Kathleen K, Liu, Edward, Crofoot, Gordon E, Cunningham, Douglas, Feinberg, Judith, Fichtenbaum, Carl, Balamban Felizarta, Franco Antonio, Jefferson, Thomas T, Johnson, Marc Alexander, Lewis, Stanley T, Luque, Amneris E, Novak, Richard M, Sloan, Louis, Sweet, Donna E, Towner, William J, Zane, Ryan, Riedel, David J, Loftus, Richard Anton, Shon, Alyssa So Young, Mogyoros, Miguel, Tebas, Pablo, Scott, Mia Louise, Parenti, David M, and Inciarte Portillo, Alexy

Abstract

In two phase 3 trials for first-line therapy in adults with HIV-1, doravirine showed non-inferior efficacy, a favourable safety profile, and a superior lipid profile to darunavir and efavirenz through to 48 and 96 weeks. Here we report 192-week results from both studies.

Published
2024
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20. HIV Policy: The Path Forward—A Joint Position Paper of the HIV Medicine Association of the Infectious Diseases Society of America and the American College of Physicians

Author

Lubinski, Christine, Aberg, Judith, Bardeguez, Arlene D., Elion, Richard, Emmanuel, Patricia, Kuritzkes, Daniel, Saag, Michael, Squires, Kathleen E., Weddle, Andrea, Rainey, Jennifer, Zerehi, M. Renee, Ralston, J. Fred, Fleming, David A., Bronson, David, Cooke, Molly, Cutler, Charles, Ejnes, Yul, Gluckman, Robert, Liebow, Mark, Musana, Kenneth, Mayer, Mark E., Purtle, Mark W., Reynolds, P. Preston, Viswanathan, Lavanya, Weiss, Kevin B., and Yehia, Baligh

Published
2009
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22. Ombitasvir, Paritaprevir Co-dosed With Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected With HIV-1: A Randomized Trial

Author

Sulkowski, Mark S., Eron, Joseph J., Wyles, David, Trinh, Roger, Lalezari, Jay, Wang, Chia, Slim, Jihad, Bhatti, Laveeza, Gathe, Joseph, Ruane, Peter J., Elion, Richard, Bredeek, Fritz, Brennan, Robert, Blick, Gary, Khatri, Amit, Gibbons, Krystal, Hu, Yiran B., Fredrick, Linda, Schnell, Gretja, Pilot-Matias, Tami, Tripathi, Rakesh, Da Silva-Tillmann, Barbara, McGovern, Barbara, Campbell, Andrew L., and Podsadecki, Thomas

Published
2015
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23. Rilpivirine Versus Efavirenz with Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-Naïve HIV-1-Infected Patients with HIV-1 RNA ≤100,000 Copies/mL: Week 96 Pooled ECHO/THRIVE Subanalysis

Author

Behrens, Georg, Rijnders, Bart, Nelson, Mark, Orkin, Chloe, Cohen, Calvin, Mills, Anthony, Elion, Richard A., Vanveggel, Simon, Stevens, Marita, Rimsky, Laurence, Thorpe, David, Bosse, Matthew, White, Kirsten, Zhong, Lijie, DeMorin, Jennifer, and Chuck, Susan K.

Published
2014
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24. Antiviral activity, pharmacokinetics, and dose response of the HIV-1 integrase inhibitor GS-9137 (JTK-303) in treatment-naive and treatment-experienced patients

Author

Dejesus, Edwin, Berger, Daniel, Markowitz, Martin, Cochen, Calvin, Hawkins, Trevor, Ruane, Peter, Elion, Richard, Farthing, Charles, Lijie Zhong, Cheng, Andrew K., McColl, Damian, and Kearney, Brian P.

Subjects
Integrase inhibitors -- Research, Integrase inhibitors -- Health aspects, Pharmacokinetics -- Research, Viral drug resistance -- Research, HIV patients -- Health aspects, Health
Abstract

A study was conducted to establish that GS-9137 is a potent low nano-molar strand transfer inhibitor of HIV-1 integrase, evaluating its antiviral activity, tolerability, pharmacokinetics, and pharmacodynamics in a randomized, double-blind, placebo-controlled monotherapy study in 40 HIV-1-infected patients. The results showed that GS-9137 demonstrated substantial short-term antiviral activity and was well tolerated as monotherapy, warranting further study.

Published
2006

29. LB-7. Weight Change in Suppressed People with HIV (PWH) Switched from Either Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) to Tenofovir Alafenamide (TAF)

Author

Sax, Paul, primary, Althoff, Keri N, additional, Brown, Todd T, additional, Radtchenko, Janna, additional, Diaz Cuervo, Helena, additional, Ramgopal, Moti, additional, Santiago, Steven, additional, Moyle, Graeme, additional, Mounzer, Karam, additional, and Elion, Richard, additional

Published
2020
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31. Real-world efficacy of direct acting antiviral therapies in patients with HIV/HCV

Author

Patel, Sonia Vibhakar, primary, Jayaweera, Dushyantha T., additional, Althoff, Keri N., additional, Eron, Joseph J., additional, Radtchenko, Janna, additional, Mills, Anthony, additional, Moyle, Graeme, additional, Santiago, Steven, additional, Sax, Paul E., additional, Gillman, Jason, additional, Mounzer, Karam, additional, Elion, Richard A., additional, and Huhn, Gregory D., additional

Published
2020
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37. Short-Term Adherence Marker to PrEP Predicts Future Non-Retention in a Large PrEP Demo Project: Implications for Point-of-Care Adherence Testing

Author

Spinelli, Matthew A, Glidden, David V, Anderson, Peter L, Gandhi, Monica, Cohen, Stephanie, Vittinghoff, Eric, Coleman, Megan E, Scott, Hyman, Bacon, Oliver, Elion, Richard, Kolber, Michael A, Buchbinder, Susan P, and Liu, Albert Y

Subjects
Adult, Male, Anti-HIV Agents, Clinical Sciences, HIV Infections, Medication Adherence, Clinical Research, Virology, Emtricitabine, Humans, Prospective Studies, adherence, Tenofovir, Proportional Hazards Models, retention in care, Prevention, Adenine, Homosexuality, persistence, dried blood spot, Organophosphates, PrEP, Point-of-Care Testing, Public Health and Health Services, HIV/AIDS, Female, Pre-Exposure Prophylaxis, Dried Blood Spot Testing
Abstract

BACKGROUND:Objective adherence metrics for tenofovir (TFV) disoproxil fumarate/emtricitabine(FTC)-based PrEP were critical for interpretation of efficacy in PrEP clinical trials, and there is increasing interest in using drug levels to tailor interventions for reengagement and adherence. Point-of-care immunoassays (POC) for TFV, which examine short-term adherence, are in development. However the ability of poor short-term and long-term adherence to predict future PrEP non-retention is unknown. SETTING:Secondary data analysis of a large, prospective multi-site U.S. PrEP demonstration project METHODS:: An adjusted Cox-proportional hazards model examined the relationship of dried blood spot (DBS) levels of FTC-triphosphate (FTC-TP) or TFV-diphosphate (TFV-DP), measures of short-term and long-term PrEP adherence, respectively, with future study non-retention. RESULTS:Overall, 294 individuals (median age 33 years) contributed drug levels within the U.S. PrEP demonstration project. By study end, 27% were lost to follow-up, 25% had at least one undetectable FTC-TP level indicating poor short-term adherence, and 29% had a drug level indicating sub-optimal long-term adherence (TFV-DP

Published
2019

39. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial

Author

Molina, Jean-Michel, primary, Squires, Kathleen, additional, Sax, Paul E, additional, Cahn, Pedro, additional, Lombaard, Johan, additional, DeJesus, Edwin, additional, Lai, Ming-Tain, additional, Rodgers, Anthony, additional, Lupinacci, Lisa, additional, Kumar, Sushma, additional, Sklar, Peter, additional, Hanna, George J, additional, Hwang, Carey, additional, Martin, Elizabeth Anne, additional, Hagins, Debbie P., additional, Osiyemi, Olayemi O., additional, Prelutsky, David James, additional, Ramgopal, Moti N., additional, Scarsella, Anthony John, additional, Dretler, Robin, additional, Bettacchi, Christopher J., additional, Sims, James, additional, Clay, Patrick G., additional, Bellos, Nicholaos C., additional, Thompson, Melanie A., additional, Montero, Jose, additional, McDonald, Cheryl K., additional, Creticos, Catherine, additional, Shamblaw, David, additional, Mogyoros, Miguel, additional, Terrelonge, Antonio E., additional, Valdes, Martin, additional, Tashima, Karen T., additional, Robbins, William J., additional, Felizarta, Franco Antonio, additional, Elion, Richard A., additional, Slim, Jihad, additional, Win, Sandra S., additional, Lalla-Reddy, Sujata N., additional, Ruane, Peter Jerome, additional, Mills, Anthony, additional, Cade, Jerry L., additional, Dietz, Craig A., additional, Rubin, David Scott, additional, Mayer, Cynthia, additional, Rondon, Juan Carlos, additional, Cook, Paul P., additional, Daar, Eric, additional, Kumar, Princy N., additional, Swindells, Susan, additional, Castro, Jose Guillermo, additional, Melendez-Rivera, Ivan, additional, Morales-Ramirez, Javier O., additional, Santiago, Lizette, additional, Santana-Bagur, Jorge L., additional, Martins, Marcelo, additional, Cahn, Pedro Enrique, additional, Lopardo, Gustavo D., additional, Porteiro, Norma, additional, Bloch, Mark Theo, additional, Baker, David Alfred, additional, Roth, Norman, additional, Moore, Richard James, additional, Finlayson, Robert James, additional, McMahon, James, additional, Rieger, Armin, additional, Zoufaly, Alexander, additional, Hartl, Sylvia, additional, Zangerle, Robert, additional, Smaill, Fiona, additional, Walmsley, Sharon L., additional, Conway, Brian, additional, Rachlis, Anita, additional, Smith, Graham H.R., additional, Perez, Carlos, additional, Afani, Alejandro, additional, Campos, Maria Isabel, additional, Chahin, Carolina Eugenia, additional, Wolff Reyes, Marcelo, additional, Gerstoft, Jan, additional, Weis, Nina, additional, Laursen, Alex Lund, additional, Molina, Jean-Michel, additional, Yazdanpanah, Yazdan, additional, Cotte, Laurent, additional, Raffi, Francois, additional, Morlat, Philippe, additional, Girard, Pierre-Marie, additional, Katlama, Christine, additional, Rockstroh, Juergen K., additional, Arasteh, Keikawus, additional, Esser, Stefan, additional, Stoehr, Albrecht, additional, Stellbrink, Hans-Juergen, additional, Stoll, Matthias, additional, Schuermann, Dirk, additional, Faetkenheuer, Gerd, additional, Bogner, Johannes, additional, Lutz, Thomas, additional, Baumgarten, Axel, additional, Jaeger, Hans, additional, Gori, Andrea, additional, Coltan, Gabriel, additional, Constandis, Felicia, additional, Erscoiu, Simona Manuela, additional, Prisacariu, Liviu-Jany, additional, Rugina, Sorin, additional, Streinu-Cercel, Adrian, additional, Pokrovsky, Vadim Valentinovich, additional, Zakharova, Natalia V., additional, Shuldyakov, Andrey Anatolyevich, additional, Ryamova, Elena Pavlovna, additional, Kulagin, Valeriy Viktorovich, additional, Tsybakova, Olga Aleksandrovna, additional, Orlova-Morozova, Elena, additional, Nagimova, Firaya, additional, Voronin, Evgeniy, additional, Shimonova, Tatyana Evgenyevna, additional, Kozyrev, Oleg Anatolyevich, additional, Orrell, Catherine, additional, Lombaard, Johannes Jurgens, additional, de Jager, Marleen, additional, Portilla Segorb, Joaquin, additional, Mallolas, Josep, additional, Perez Elias, Maria Jesus, additional, Gatell, Josep M., additional, Arribas Lopez, Jose Ramon, additional, Negredo Puigmal, Eugenia, additional, Podzamczer Palter, Daniel, additional, Pulido Ortega, Federico, additional, Troya Garcia, Jesus, additional, De los Santos Gil, Ignacio, additional, Berenguer Berenguer, Juan, additional, Williams, Ian G., additional, Johnson, Margaret A., additional, Schembri, Gabriel, additional, Clarke, Amanda, additional, Gompels, Mark, additional, Fox, Julie Meriel, additional, Taylor, Steven John, additional, Dockrell, David Harold, additional, and Kegg, Stephen, additional

Published
2020
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42. Weight loss as a predictor of survival and disease progression in HIV infection

Author

Wheeler, David A., Gibert, Cynthia L., Launer, Cynthia A., Muurahainen, Norma, Elion, Richard A., Abrams, Donald I., and Bartsch, Glenn E.

Subjects
HIV patients -- Health aspects, Weight loss -- Health aspects, Opportunistic infections -- Risk factors, Health
Abstract

Weight loss by an HIV patient, whether mild or severe, seems to be associated with impending death. This may be connected with increased death risk or with increased risk of opportunistic infection. The increase in the relative risk of death for those who lost 5% to 10% of body weight over four months was significant. Opportunistic infections increased significantly in this group including cytomegalovirus infections, Pneumocystis carinii pneumonia, and Mycobacterium avium complex. For those who lost 0% to 5% of their body weight, risk was also increased.

Published
1998

43. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: A pooled analysis of 26 clinical trials

Author

MS Interne Geneeskunde, Infection & Immunity, Gupta, Samir K., Post, Frank A., Arribas, José R., Eron, Joseph J., Wohl, David A., Clarke, Amanda E., Sax, Paul E., Stellbrink, Hans Jürgen, Esser, Stefan, Pozniak, Anton L., Podzamczer, Daniel, Waters, Laura, Orkin, Chloe, Rockstroh, Jürgen K., Mudrikova, Tatiana, Negredo, Eugenia, Elion, Richard A., Guo, Susan, Zhong, Lijie, Carter, Christoph, Martin, Hal, Brainard, Diana, Sengupta, Devi, Das, Moupali, MS Interne Geneeskunde, Infection & Immunity, Gupta, Samir K., Post, Frank A., Arribas, José R., Eron, Joseph J., Wohl, David A., Clarke, Amanda E., Sax, Paul E., Stellbrink, Hans Jürgen, Esser, Stefan, Pozniak, Anton L., Podzamczer, Daniel, Waters, Laura, Orkin, Chloe, Rockstroh, Jürgen K., Mudrikova, Tatiana, Negredo, Eugenia, Elion, Richard A., Guo, Susan, Zhong, Lijie, Carter, Christoph, Martin, Hal, Brainard, Diana, Sengupta, Devi, and Das, Moupali

Published
2019

44. Safety and efficacy of ombitasvir – 450/r and dasabuvir and ribavirin in HCV/HIV‐1 co‐infected patients receiving atazanavir or raltegravir ART regimens

Author

Eron, Joseph J., Lalezari, Jay, Slim, Jihad, Gathe, Joseph, Ruane, Peter J., Wang, Chia, Elion, Richard, Blick, Gary, Khatri, Amit, Hu, Yiran B., Gibbons, Krystal, Fredrick, Linda, Co, Melannie, D' Amico, Ronald, Da Silva?Tillmann, Barbara, Trinh, Roger, and Sulkowski, Mark S.

Subjects
Antiviral agents -- Patient outcomes, Prognosis -- Evaluation, Hepatitis C -- Development and progression -- Drug therapy, HIV infection -- Development and progression -- Drug therapy, Health
Abstract

Objective: Whether concomitant HIV antiretroviral therapy (ART) affects the safety and efficacy of interferon‐free HCV therapies or whether HCV treatment may negatively affect HIV control is unclear. We assessed the 3 direct‐acting antiviral (3D) regimen of ombitasvir, ABT‐450 (identified by AbbVie and Enanta; co‐dosed with ritonavir) and dasabuvir with ribavirin (RBV) in HCV/HIV‐1 co‐infected patients with and without cirrhosis, including HCV treatment‐experienced, receiving atazanavir (ATV)‐ or raltegravir (RAL)‐based ART therapy. Methods: HCV genotype 1‐positive treatment‐naïve or pegIFN/RBV‐experienced patients, with or without Child‐Pugh A cirrhosis, CD4+ count ≥200 cells/mm[sup.3] or CD4 + % ≥14%, and plasma HIV‐1 RNA suppressed on stable ART received open‐label 3D + RBV for 12 or 24 weeks. Rates of HCV‐sustained virologic response at post‐treatment weeks 4 and 12 (SVR4 and SVR12, respectively) and bilirubin‐related adverse events (AEs) are reported from post‐hoc analyses for subgroups defined by treatment duration and ART regimen. Results: The SVR12 rate for patients receiving 12 weeks of 3D + RBV was 93.5% with comparable rates in patients receiving either ATV (93.8%) or RAL therapy (93.3%) (Table 1). The SVR4 rate for the 24‐week arm was 96.9% with a single virologic breakthrough at treatment week 16 in a patient receiving RAL therapy. Patients receiving concomitant ATV had more AEs related to indirect hyperbilirubinemia including ocular icterus, jaundice and grade 3 or 4 elevations in total bilirubin (predominantly indirect). No patient discontinued the study due to AEs, and no serious AEs were reported during or after treatment. No patient had a confirmed plasma HIV‐1 RNA value ≥200 copies/mL during the treatment period. Conclusions: In this first study to evaluate an IFN‐free regimen in HCV genotype 1‐positive treatment‐naïve and experienced patients with HIV‐1 co‐infection, including those with cirrhosis, high rates of SVR were comparable to those with HCV monoinfection. Indirect hyperbilirubinemia was consistent with the known ABT‐450 inhibition of the OATP1B1 bilirubin transporter, RBV‐related haemolytic anaemia and inhibitory effect of ATV on bilirubin conjugation. The laboratory abnormalities and AEs observed did not negatively affect treatment response or lead to treatment discontinuation., Table 1: Efficacy and safety of 12 or 24‐week 3D+RBV in HCV/HIV coinfected patients subgrouped by HIV ART regimen 12‐week 3D + RBV 12‐week 3D + RBV 24‐week 3D + [...]

Published
2014
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45. Supplementing Antiretroviral Therapy

Author

Carter, George M., Elion, Richard, Kuebel, Mark, Mindes, Janet, Nambiar, Devan, Shull, Jane, Silenzio, Vince, and Wootton, Jackie

Published
2002

47. 550. Adherence and Persistency With Modern Single vs. Multi-Tablet Antiretroviral (ARV) Regimens in First Treatment of HIV in Clinical Practice

Author

Mills, Anthony, primary, Priest, Julie, additional, Musallam, Alexander, additional, Althoff, Keri, additional, Eron, Joseph, additional, Huhn, Greg, additional, Jayaweera, Dushyantha, additional, Mounzer, Karam, additional, Moyle, Graeme, additional, Mrus, Joe, additional, Rampogal, Moti, additional, Santiago, Steven, additional, Sax, Paul, additional, Voskuhl, Gene, additional, Oglesby, Alan, additional, and Elion, Richard, additional

Published
2018
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48. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial

Author

Molina, Jean-Michel, primary, Squires, Kathleen, additional, Sax, Paul E, additional, Cahn, Pedro, additional, Lombaard, Johan, additional, DeJesus, Edwin, additional, Lai, Ming-Tain, additional, Xu, Xia, additional, Rodgers, Anthony, additional, Lupinacci, Lisa, additional, Kumar, Sushma, additional, Sklar, Peter, additional, Nguyen, Bach-Yen, additional, Hanna, George J, additional, Hwang, Carey, additional, Martins, Marcelo, additional, Cahn, Pedro Enrique, additional, Lopardo, Gustavo D., additional, Porteiro, Norma, additional, Bloch, Mark Theo, additional, Baker, David Alfred, additional, Roth, Norman, additional, Moore, Richard James, additional, Finlayson, Robert James, additional, McMahon, James, additional, Rieger, Armin, additional, Zoufaly, Alexander, additional, Hartl, Sylvia, additional, Zangerle, Robert, additional, Smaill, Fiona, additional, Walmsley, Sharon L., additional, Conway, Brian, additional, Rachlis, Anita, additional, Smith, Graham H.R., additional, Perez, Carlos, additional, Afani, Alejandro, additional, Campos Barker, Maria Isabel E., additional, Chahin, Carolina Eugenia, additional, Wolff Reyes, Marcelo, additional, Gerstoft, Jan, additional, Weis, Nina, additional, Laursen, Alex Lund, additional, Molina, Jean-Michel, additional, Yazdanpanah, Yazdan, additional, Cotte, Laurent, additional, Raffi, Francois, additional, Morlat, Philippe, additional, Girard, Pierre-Marie, additional, Katlama, Christine, additional, Rockstroh, Juergen K., additional, Arasteh, Keikawus, additional, Esser, Stefan, additional, Stoehr, Albrecht, additional, Stellbrink, Hans-Juergen, additional, Stoll, Matthias, additional, Schuermann, Dirk, additional, Faetkenheuer, Gerd, additional, Bogner, Johannes, additional, Lutz, Thomas, additional, Baumgarten, Axel, additional, Jaeger, Hans, additional, Gori, Andrea, additional, Coltan, Gabriel, additional, Constandis, Felicia, additional, Erscoiu, Simona Manuela, additional, Prisacariu, Liviu-Jany, additional, Rugina, Sorin, additional, Streinu-Cercel, Adrian, additional, Pokrovsky, Vadim Valentinovich, additional, Zakharova, Natalia V., additional, Shuldyakov, Andrey Anatolyevich, additional, Ryamova, Elena Pavlovna, additional, Kulagin, Valeriy Viktorovich, additional, Tsybakova, Olga Aleksandrovna, additional, Orlova-Morozova, Elena, additional, Nagimova, Firaya, additional, Voronin, Evgeniy, additional, Shimonova, Tatyana Evgenyevna, additional, Kozyrev, Oleg Anatolyevich, additional, Orrell, Catherine, additional, Lombaard, Johannes Jurgens, additional, Botes, Margaretha Elizabeth, additional, Portilla, Joaquin, additional, Gatell, Josep Maria, additional, Perez, Maria Jesus, additional, Arribas, Jose Ramon, additional, Negredo, Eugenia, additional, Podzamczer, Daniel, additional, Pulido, Federico, additional, Troya, Jesus, additional, De los Santos, Ignacio, additional, Berenguer, Juan, additional, Williams, Ian G., additional, Johnson, Margaret A., additional, Schembri, Gabriel, additional, Clarke, Amanda, additional, Gompels, Mark, additional, Fox, Julie Meriel, additional, Taylor, Steven John, additional, Kegg, Stephen, additional, Hagins, Debbie P., additional, Osiyemi, Olayemi O., additional, Prelutsky, David James, additional, Ramgopal, Moti N., additional, Dretler, Robin, additional, Sloan, Louis, additional, Lewis, Stanley T., additional, Clay, Patrick G., additional, Bellos, Nicholaos C., additional, Thompson, Melanie A., additional, Montero, Jose, additional, McDonald, Cheryl K., additional, Creticos, Catherine, additional, Shamblaw, David, additional, Terrelonge, Antonio E., additional, Valdes, Martin, additional, Tashima, Karen T., additional, Robbins, William J., additional, Felizarta, Franco Antonio, additional, Elion, Richard A., additional, Slim, Jihad, additional, Lalezari, Jacob Paul, additional, Lalla-Reddy, Sujata N., additional, Ruane, Peter Jerome, additional, Mills, Anthony, additional, Cade, Jerry L., additional, Campo, Rafael E., additional, Dietz, Craig A., additional, Blick, Gary, additional, Mayer, Cynthia, additional, Rondon, Juan Carlos, additional, Cook, Paul P., additional, Daar, Eric, additional, Kumar, Princy N., additional, Swindells, Susan, additional, Castro, Jose Guillermo, additional, Morales-Ramirez, Javier O., additional, Santiago, Lizette, additional, and Santana-Bagur, Jorge L., additional

Published
2018
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50. The PrEP revolution: from clinical trials to routine practice: Implementation 'view from the US

Author

Elion, Richard and Coleman, Megan

Subjects
Male, Clinical Trials as Topic, Anti-HIV Agents, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Disease Transmission, Infectious, Humans, Female, HIV Infections, Pre-Exposure Prophylaxis, Chemoprevention, Delivery of Health Care, Article, United States
Abstract

This article describes the use of tenofovir/emtricitabine (Truvada) as prevention for exposure to HIV [preexposure prophylaxis (PrEP)] infection in the USA. The use of PrEP and the challenges of implementation are very instructive as other countries adopt this intervention and it becomes a fundamental part of worldwide efforts for HIV prevention and much can be learned from the first 3 years in the USA.Randomized trials and demonstration projects have shown the benefits of PrEP for men and women who are at risk for HIV. Numerous studies have showed that the level of prevention is excellent when the drug is taken at least four times weekly, once adequate levels are obtained. However, adherence remains a critical issue as well as tailoring delivery models for specific populations. Six recent studies are discussed, that support excellent efficacy and significantly support PrEP as a means of prevention. These projects have shown high acceptance of PrEP with excellent adherence by individuals demonstrated by those at risk remaining free of HIV over extended periods of time.The USA faces three significant challenges in scaling up PrEP. The first challenge in implementation in the USA is to get individuals to recognize the actual risks that their behaviors represent and to engage with providers to address these issues. The second challenge is getting a population of providers to recognize the exact same issues and offer PrEP in a compassionate, nonjudgmental fashion. The third challenge is identifying the set of providers and locations to scale-up the response in a timely, cost-effective fashion.

Published
2016

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