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1. Safety, pharmacodynamics, and antiviral activity of selgantolimod in viremic patients with chronic hepatitis B virus infection

Author

Janssen, Harry L., Lim, Young-Suk, Kim, Hyung Joon, Sowah, Leonard, Tseng, Cheng-Hao, Coffin, Carla S., Elkhashab, Magdy, Ahn, Sang Hoon, Nguyen, Anh-Hoa, Chen, Diana, Wallin, Jeffrey J., Fletcher, Simon P., McDonald, Circe, Yang, Jenny C., Gaggar, Anuj, Brainard, Diana M., Fung, Scott, Kim, Yoon Jun, Kao, Jia-Horng, Chuang, Wan-Long, Brooks, Anna E., and Dunbar, P. Rod

Published
2024
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2. Compassionate Use of Remdesivir for Patients with Severe Covid-19

Author

Grein, Jonathan, Ohmagari, Norio, Shin, Daniel, Diaz, George, Asperges, Erika, Castagna, Antonella, Feldt, Torsten, Green, Gary, Green, Margaret L, Lescure, François-Xavier, Nicastri, Emanuele, Oda, Rentaro, Yo, Kikuo, Quiros-Roldan, Eugenia, Studemeister, Alex, Redinski, John, Ahmed, Seema, Bernett, Jorge, Chelliah, Daniel, Chen, Danny, Chihara, Shingo, Cohen, Stuart H, Cunningham, Jennifer, D'Arminio Monforte, Antonella, Ismail, Saad, Kato, Hideaki, Lapadula, Giuseppe, L'Her, Erwan, Maeno, Toshitaka, Majumder, Sumit, Massari, Marco, Mora-Rillo, Marta, Mutoh, Yoshikazu, Nguyen, Duc, Verweij, Ewa, Zoufaly, Alexander, Osinusi, Anu O, DeZure, Adam, Zhao, Yang, Zhong, Lijie, Chokkalingam, Anand, Elboudwarej, Emon, Telep, Laura, Timbs, Leighann, Henne, Ilana, Sellers, Scott, Cao, Huyen, Tan, Susanna K, Winterbourne, Lucinda, Desai, Polly, Mera, Robertino, Gaggar, Anuj, Myers, Robert P, Brainard, Diana M, Childs, Richard, and Flanigan, Timothy

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Emerging Infectious Diseases, Lung, Clinical Trials and Supportive Activities, Clinical Research, Prevention, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adenosine Monophosphate, Administration, Intravenous, Adult, Aged, Aged, 80 and over, Alanine, Antiviral Agents, Betacoronavirus, COVID-19, Canada, Compassionate Use Trials, Coronavirus Infections, Europe, Female, Humans, Japan, Male, Middle Aged, Pandemics, Pneumonia, Viral, Respiration, Artificial, SARS-CoV-2, United States, Young Adult, COVID-19 Drug Treatment, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundRemdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2.MethodsWe provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness caused by infection with SARS-CoV-2. Patients were those with confirmed SARS-CoV-2 infection who had an oxygen saturation of 94% or less while they were breathing ambient air or who were receiving oxygen support. Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment. This report is based on data from patients who received remdesivir during the period from January 25, 2020, through March 7, 2020, and have clinical data for at least 1 subsequent day.ResultsOf the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.ConclusionsIn this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.).

Published
2020

3. Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection

Author

Rosenthal, Philip, Schwarz, Kathleen B, Gonzalez‐Peralta, Regino P, Lin, Chuan‐Hao, Kelly, Deidre A, Nightingale, Scott, Balistreri, William F, Bansal, Sanjay, Jonas, Maureen M, Massetto, Benedetta, Brainard, Diana M, Hsueh, Chia‐Hsiang, Shao, Jiang, Parhy, Bandita, Davison, Suzanne, Feiterna‐Sperling, Cornelia, Gillis, Lynette A, Indolfi, Giuseppe, Sokal, Etienne M, Murray, Karen F, and Wirth, Stefan

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Hepatitis - C, Hepatitis, Liver Disease, Clinical Trials and Supportive Activities, Infectious Diseases, Chronic Liver Disease and Cirrhosis, Clinical Research, Emerging Infectious Diseases, Pediatric, Digestive Diseases, Management of diseases and conditions, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 7.1 Individual care needs, Infection, Good Health and Well Being, Antiviral Agents, Child, Child, Preschool, Drug Combinations, Female, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Male, Ribavirin, Sofosbuvir, Sustained Virologic Response, Treatment Outcome, Medical Biochemistry and Metabolomics, Immunology, Gastroenterology & Hepatology, Clinical sciences
Abstract

Currently, the only approved hepatitis C virus (HCV) treatment for children aged

Published
2020

4. Clinical targeting of HIV capsid protein with a long-acting small molecule

Author

Link, John O., Rhee, Martin S., Tse, Winston C., Zheng, Jim, Somoza, John R., Rowe, William, Begley, Rebecca, Chiu, Anna, Mulato, Andrew, Hansen, Derek, Singer, Eric, Tsai, Luong K., Bam, Rujuta A., Chou, Chien-Hung, Canales, Eda, Brizgys, Gediminas, Zhang, Jennifer R., Li, Jiayao, Graupe, Michael, Morganelli, Philip, Liu, Qi, Wu, Qiaoyin, Halcomb, Randall L., Saito, Roland D., Schroeder, Scott D., Lazerwith, Scott E., Bondy, Steven, Jin, Debi, Hung, Magdeleine, Novikov, Nikolai, Liu, Xiaohong, Villaseñor, Armando G., Cannizzaro, Carina E., Hu, Eric Y., Anderson, Robert L., Appleby, Todd C., Lu, Bing, Mwangi, Judy, Liclican, Albert, Niedziela-Majka, Anita, Papalia, Giuseppe A., Wong, Melanie H., Leavitt, Stephanie A., Xu, Yili, Koditek, David, Stepan, George J., Yu, Helen, Pagratis, Nikos, Clancy, Sheila, Ahmadyar, Shekeba, Cai, Terrence Z., Sellers, Scott, Wolckenhauer, Scott A., Ling, John, Callebaut, Christian, Margot, Nicolas, Ram, Renee R., Liu, Ya-Pei, Hyland, Rob, Sinclair, Gary I., Ruane, Peter J., Crofoot, Gordon E., McDonald, Cheryl K., Brainard, Diana M., Lad, Latesh, Swaminathan, Swami, Sundquist, Wesley I., Sakowicz, Roman, Chester, Anne E., Lee, William E., Daar, Eric S., Yant, Stephen R., and Cihlar, Tomas

Published
2020
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5. Sofosbuvir and Ribavirin for Hepatitis C in Patients With HIV Coinfection

Author

Sulkowski, Mark S, Naggie, Susanna, Lalezari, Jacob, Fessel, Walford Jeffrey, Mounzer, Karam, Shuhart, Margaret, Luetkemeyer, Anne F, Asmuth, David, Gaggar, Anuj, Ni, Liyun, Svarovskaia, Evguenia, Brainard, Diana M, Symonds, William T, Subramanian, G Mani, McHutchison, John G, Rodriguez-Torres, Maribel, and Dieterich, Douglas

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Emerging Infectious Diseases, Liver Disease, Clinical Research, Digestive Diseases, Hepatitis - C, Genetics, Clinical Trials and Supportive Activities, HIV/AIDS, Infectious Diseases, Hepatitis, Chronic Liver Disease and Cirrhosis, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Administration, Oral, Adult, Aged, Antiviral Agents, Coinfection, Drug Administration Schedule, Drug Therapy, Combination, Female, Genotype, HIV Infections, Hepacivirus, Hepatitis C, Humans, Male, Middle Aged, RNA, Viral, Ribavirin, Sofosbuvir, Treatment Outcome, Uridine Monophosphate, Viral Load, Young Adult, PHOTON-1 Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ImportanceTreatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.ObjectiveTo determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.Design, setting, and participantsOpen-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants.InterventionsTreatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks.Main outcomes and measuresThe primary study outcome was the proportion of patients with SVR (serum HCV

Published
2014

6. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis

Author

Esteban, Rafael, Pineda, Juan A., Calleja, Jose Luis, Casado, Marta, Rodríguez, Manuel, Turnes, Juan, Morano Amado, Luis Enrique, Morillas, Rosa Maria, Forns, Xavier, Pascasio Acevedo, Juan Manuel, Andrade, Raul J., Rivero, Antonio, Carrión, José Antonio, Lens, Sabela, Riveiro-Barciela, Mar, McNabb, Brian, Zhang, Gulan, Camus, Gregory, Stamm, Luisa M., Brainard, Diana M., Subramanian, G. Mani, and Buti, Maria

Published
2018
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8. Efficacy of Ledipasvir and Sofosbuvir Treatment of HCV Infection in Patients Coinfected With HBV

Author

Liu, Chun-Jen, Chuang, Wan-Long, Sheen, I-Shyan, Wang, Horng-Yuan, Chen, Chi-Yi, Tseng, Kuo-Chih, Chang, Ting-Tsung, Massetto, Benedetta, Yang, Jenny C., Yun, Chohee, Knox, Steven J., Osinusi, Anu, Camus, Gregory, Jiang, Deyuan, Brainard, Diana M., McHutchison, John G., Hu, Tsung-Hui, Hsu, You-Chun, Lo, Gin-Ho, Chu, Chi-Jen, Chen, Jyh-Jou, Peng, Cheng-Yuan, Chien, Ron-Nan, and Chen, Pei-Jer

Published
2018
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9. Persistence of Virologic Response after Liver Transplant in Hepatitis C Patients Treated with Ledipasvir / Sofosbuvir Plus Ribavirin Pretransplant

Author

Yoshida, Eric M., Kwo, Paul, Agarwal, Kosh, Duvoux, Christophe, Durand, François, Peck-Radosavljevic, Markus, Lilly, Leslie, Willems, Bernard, Vargas, Hugo, Kumar, Princy, Brown Jr., Robert S., Horsmans, Yves, De-Oertel, Shampa, Arterburn, Sarah, Dvory-Sobol, Hadas, Brainard, Diana M., McHutchison, John G., Terrault, Norah, Rizzetto, Mario, and Müllhaupt, Beat

Published
2017
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10. Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities

Author

Brown, Geri, Cheung, Ramsey, Fuchs, Michael, Gilliam, Bruce, Ho, Sam, Jeffers, Lennox, Kaplan, David, Lim, Joseph, Monto, Alexander, Morgan, Timothy, Naggie, Susanna, Pandya, Prashant, Peyton, Adam, Rimland, David, Shaikh, Obaid, Talwani, Rohit, Yoffee, Boris, Cartwright, Emily, Ho, Samuel B., Kaplan, David E., Byrne, Sean, Moon, Scott, Copans, Amanda, Rossaro, Lorenzo, Roy, Anupma, Le, Hadley, Dvory-Sobol, Hadas, Zhu, Yanni, Brainard, Diana M., Guyer, William, and Morgan, Timothy R.

Published
2017
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11. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial

Author

Lawitz, Eric, Reau, Nancy, Hinestrosa, Federico, Rabinovitz, Mordechai, Schiff, Eugene, Sheikh, Aasim, Younes, Ziad, Herring, Robert, Jr., Reddy, K. Rajender, Tran, Tram, Bennett, Michael, Nahass, Ronald, Yang, Jenny C., Lu, Sophia, Dvory-Sobol, Hadas, Stamm, Luisa M., Brainard, Diana M., McHutchison, John G., Pearlman, Brian, Shiffman, Mitchell, Hawkins, Trevor, Curry, Michael, and Jacobson, Ira

Published
2016
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12. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial

Author

Gane, Edward J., Kowdley, Kris V., Pound, David, Stedman, Catherine A.M., Davis, Mitchell, Etzkorn, Kyle, Gordon, Stuart C., Bernstein, David, Everson, Gregory, Rodriguez-Torres, Maribel, Tsai, Naoky, Khalid, Omer, Yang, Jenny C., Lu, Sophia, Dvory-Sobol, Hadas, Stamm, Luisa M., Brainard, Diana M., McHutchison, John G., Tong, Myron, Chung, Raymond T., Beavers, Kimberly, Poulos, John E., Kwo, Paul Y., and Nguyen, Mindie H.

Published
2016
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15. P-6 SOFOSBUVIR CONTAINING REGIMENS ARE SAFE AND EFFECTIVE IN ADOLESCENTS WITH CHRONIC HEPATITIS C INFECTION

Author

Wirth, Stefan, Gonzalez-Peralta, Regino, Rosenthal, Philip, Hardikar, Winita, Wen, Jessica, Jonas, Maureen M., Mittal, Naveen, Whitworth, Mary, Arnon, Ronen, Lin, Chuan-Hao, Lobzin, Yury, Romero, Rene, Chulanov, Vladimir, Subbarao, Girish, Teckman, Jeffrey, Morozov, Vyacheslav, Bassetti, Eric, Kersey, Kathryn, Massetto, Benedetta, Zhu, Yanni, German, Polina, Brainard, Diana M., Bansal, Sanjay, Murray, Karen F., Schwarz, Kathleen, and Balistreri, William

Published
2021
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16. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study

Author

Hagins, Debbie, primary, Kumar, Princy, additional, Saag, Michael, additional, Wurapa, Anson K., additional, Brar, Indira, additional, Berger, Daniel, additional, Osiyemi, Olayemi, additional, Hileman, Corrilynn O., additional, Ramgopal, Moti N., additional, McDonald, Cheryl, additional, Blair, Christiana, additional, Andreatta, Kristen, additional, Collins, Sean E., additional, Brainard, Diana M., additional, and Martin, Hal, additional

Published
2021
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17. Compassionate Use of Remdesivir in Children With Severe COVID-19

Author

Goldman, D, Aldrich, M, Hagmann, S, Bamford, A, Camacho-Gonzalez, A, Lapadula, G, Lee, P, Bonfanti, P, Carter, C, Zhao, Y, Telep, L, Pikora, C, Naik, S, Marshall, N, Katsarolis, I, Das, M, Dezure, A, Desai, P, Cao, H, Chokkalingam, A, Osinusi, A, Brainard, D, Méndez-Echevarría, A, Goldman, David L, Aldrich, Margaret L, Hagmann, Stefan H F, Bamford, Alasdair, Camacho-Gonzalez, Andres, Lapadula, Giuseppe, Lee, Philip, Bonfanti, Paolo, Carter, Christoph C, Zhao, Yang, Telep, Laura, Pikora, Cheryl, Naik, Sarjita, Marshall, Neal, Katsarolis, Ioannis, Das, Moupali, DeZure, Adam, Desai, Polly, Cao, Huyen, Chokkalingam, Anand P, Osinusi, Anu, Brainard, Diana M, Méndez-Echevarría, Ana, Goldman, D, Aldrich, M, Hagmann, S, Bamford, A, Camacho-Gonzalez, A, Lapadula, G, Lee, P, Bonfanti, P, Carter, C, Zhao, Y, Telep, L, Pikora, C, Naik, S, Marshall, N, Katsarolis, I, Das, M, Dezure, A, Desai, P, Cao, H, Chokkalingam, A, Osinusi, A, Brainard, D, Méndez-Echevarría, A, Goldman, David L, Aldrich, Margaret L, Hagmann, Stefan H F, Bamford, Alasdair, Camacho-Gonzalez, Andres, Lapadula, Giuseppe, Lee, Philip, Bonfanti, Paolo, Carter, Christoph C, Zhao, Yang, Telep, Laura, Pikora, Cheryl, Naik, Sarjita, Marshall, Neal, Katsarolis, Ioannis, Das, Moupali, DeZure, Adam, Desai, Polly, Cao, Huyen, Chokkalingam, Anand P, Osinusi, Anu, Brainard, Diana M, and Méndez-Echevarría, Ana

Abstract

OBJECTIVES: Remdesivir shortens time to recovery in adults with severe coronavirus disease 2019 (COVID-19), but its efficacy and safety in children are unknown. We describe outcomes in children with severe COVID-19 treated with remdesivir. METHODS: Seventy-seven hospitalized patients ,18 years old with confirmed severe acute respiratory syndrome coronavirus 2 infection received remdesivir through a compassionateuse program between March 21 and April 22, 2020. The intended remdesivir treatment course was 10 days (200 mg on day 1 and 100 mg daily subsequently for children $40 kg and 5 mg/kg on day 1 and 2.5 mg/kg daily subsequently for children ,40 kg, given intravenously). Clinical data through 28 days of follow-up were collected. RESULTS: Median age was 14 years (interquartile range 7-16, range ,2 months to 17 years). Seventy-nine percent of patients had $1 comorbid condition. At baseline, 90% of children required supplemental oxygen and 51% required invasive ventilation. By day 28 of follow-up, 88% of patients had a decreased oxygen-support requirement, 83% recovered, and 73% were discharged. Among children requiring invasive ventilation at baseline, 90% were extubated, 80% recovered, and 67% were discharged. There were 4 deaths, of which 3 were attributed to COVID-19. Remdesivir was well tolerated, with a low incidence of serious adverse events (16%). Most adverse events were related to COVID-19 or comorbid conditions. Laboratory abnormalities, including elevations in transaminase levels, were common; 61% were grades 1 or 2. CONCLUSIONS: Among 77 children treated with remdesivir for severe COVID-19, most recovered and the rate of serious adverse events was low.

Published
2021

18. Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality

Author

Olender, Susan A, primary, Walunas, Theresa L, additional, Martinez, Esteban, additional, Perez, Katherine K, additional, Castagna, Antonella, additional, Wang, Su, additional, Kurbegov, Dax, additional, Goyal, Parag, additional, Ripamonti, Diego, additional, Balani, Bindu, additional, De Rosa, Francesco G, additional, De Wit, Stéphane, additional, Kim, Shin-Woo, additional, Diaz, George, additional, Bruno, Raffaele, additional, Mullane, Kathleen M, additional, Lye, David Chien, additional, Gottlieb, Robert L, additional, Haubrich, Richard H, additional, Chokkalingam, Anand P, additional, Wu, George, additional, Diaz-Cuervo, Helena, additional, Brainard, Diana M, additional, Lee, I-Heng, additional, Hu, Hao, additional, Lin, Lanjia, additional, Osinusi, Anu O, additional, Bernardino, Jose I, additional, and Boffito, Marta, additional

Published
2021
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19. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19

Author

Spinner, Christoph D., Gottlieb, Robert L., Criner, Gerard J., Arribas López, José Ramón, Cattelan, Anna Maria, Soriano Viladomiu, Alex, Ogbuagu, Onyema, Malhotra, Prashant, Mullane, Kathleen M., Castagna, Antonella, Chai, Louis Yi Ann, Roestenberg, Meta, Tsang, Owen Tak Yin, Bernasconi, Enos, Le Turnier, Paul, Chang, Shan-Chwen, SenGupta, Devi, Hyland, Robert H., Osinusi, Anu O., Cao, Huyen, Blair, Christiana, Wang, Hongyuan, Gaggar, Anuj, Brainard, Diana M., McPhail, Mark J., Bhagani, Sanjay, Ahn, Mi Young, Sanyal, Arun J., Huhn, Gregory, and Marty, Francisco M.

Subjects
General Medicine
Published
2020
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20. Sofosbuvir and Ribavirin Therapy for Children 3 to <12 Years Old With Hepatitis C Virus Genotype 2 or 3 Infection

Author

Rosenthal, Philip, Schwarz, Kathleen B., Gonzalez-Peralta, Regino P., Lin, Chuan-Hao, Kelly, Deidre A., Nightingale, Scott, Balistreri, William F., Bansal, Sanjay, Jonas, Maureen M., Massetto, Benedetta, Brainard, Diana M., Hsueh, Chia-Hsiang, Shao, Jiang, Parhy, Bandita, Davison, Suzanne, Feiterna-Sperling, Cornelia, Gillis, Lynette A., Indolfi, Giuseppe, Sokal, Etienne, Murray, Karen F., Wirth, Stefan, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, and UCL - (SLuc) Service de gastro-entérologie et hépatologie pédiatrique

Subjects
Hepatology
Abstract

Currently, the only approved hepatitis C virus (HCV) treatment for children aged

Published
2020

21. Remdesivir for 5 or 10 Days in Patients With Severe Covid-19

Author

Goldman, Jason D., Lye, David C.B., Hui, David S., Marks, Kristen M., Bruno, Raffaele, Montejano, Rocio, Spinner, Christoph D., Galli, Massimo, Ahn, Mi‑Young, Nahass, Ronald G., Chen, Yao-Shen, SenGupta, Devi, Hyland, Robert H., Osinusi, Anu O., Cao, Huyen, Blair, Christiana, Wei, Xuelian, Gaggar, Anuj, Brainard, Diana M., Towner, William J., Muñoz Gutiérrez, José, Mullane, Kathleen M., Marty, Francisco M., Tashima, Karen T., Diaz, George, Subramanian, Aruna, and GS-US-540-5773 Investigators

Subjects
Adult, Male, Adenosine monophosphate, Coronavirus disease 2019 (COVID-19), Pneumonia, Viral, 030204 cardiovascular system & hematology, Pharmacology, Antiviral Agents, Drug Administration Schedule, Betacoronavirus, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Clinical trials, Humans, Medicine, In patient, 030212 general & internal medicine, Pandemics, Aged, Alanine, biology, SARS-CoV-2, business.industry, Oxygen Inhalation Therapy, COVID-19, General Medicine, Middle Aged, medicine.disease, biology.organism_classification, Adenosine Monophosphate, In vitro, COVID-19 Drug Treatment, Hospitalization, Clinical trial, Pneumonia, Treatment Outcome, Editorial, chemistry, RNA Polymerase Inhibitor, Original Article, Female, Coronavirus Infections, business, Assaigs clínics
Abstract

Background Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). Methods We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. Results In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P=0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P=0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). Conclusions In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.)

Published
2020

22. Sofosbuvir and Ribavirin Therapy for Children 3 to <12 Years Old With Hepatitis C Virus Genotype 2 or 3 Infection

Author

UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de gastro-entérologie et hépatologie pédiatrique, Rosenthal, Philip, Schwarz, Kathleen B., Gonzalez-Peralta, Regino P., Lin, Chuan-Hao, Kelly, Deidre A., Nightingale, Scott, Balistreri, William F., Bansal, Sanjay, Jonas, Maureen M., Massetto, Benedetta, Brainard, Diana M., Hsueh, Chia-Hsiang, Shao, Jiang, Parhy, Bandita, Davison, Suzanne, Feiterna-Sperling, Cornelia, Gillis, Lynette A., Indolfi, Giuseppe, Sokal, Etienne, Murray, Karen F., Wirth, Stefan, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de gastro-entérologie et hépatologie pédiatrique, Rosenthal, Philip, Schwarz, Kathleen B., Gonzalez-Peralta, Regino P., Lin, Chuan-Hao, Kelly, Deidre A., Nightingale, Scott, Balistreri, William F., Bansal, Sanjay, Jonas, Maureen M., Massetto, Benedetta, Brainard, Diana M., Hsueh, Chia-Hsiang, Shao, Jiang, Parhy, Bandita, Davison, Suzanne, Feiterna-Sperling, Cornelia, Gillis, Lynette A., Indolfi, Giuseppe, Sokal, Etienne, Murray, Karen F., and Wirth, Stefan

Abstract

Currently, the only approved hepatitis C virus (HCV) treatment for children aged <12 years is pegylated-interferon plus ribavirin. In an open-label study, we evaluated the safety and efficacy of sofosbuvir plus ribavirin for 12 weeks in children aged 3 to <12 years chronically infected with genotype 2 or for 24 weeks in patients with genotype 3. Patients aged 3 to <6 years weighing <17 kg received sofosbuvir 150 mg, and patients aged 3 to <6 years weighing ≥17 kg and all patients aged 6 to <12 years received sofosbuvir 200 mg once daily. Intensive pharmacokinetic sampling conducted in each age group confirmed the appropriateness of sofosbuvir doses. For all patients, ribavirin dosing was determined by baseline weight (up to 1400 mg/day, two divided doses). The primary efficacy endpoint was sustained virologic response 12 weeks after therapy (SVR12). 54 patients were enrolled (41 aged 6 to <12 years and 13 aged 3 to <6 years). Most were treatment-naive (98%) and infected perinatally (94%). All but one patient achieved SVR12 (53/54, 98%, 95% CI 90-100%). The patient who did not achieve SVR12 was a 4 year-old who discontinued treatment after three days due to 'abnormal drug taste'. The most commonly reported adverse events in patients aged 6 to <12 years were vomiting (32%) and headache (29%) and in patients aged 3 to <6 years, vomiting (46%) and diarrhea (39%). One 3 year-old patient had a serious adverse event of accidental ribavirin overdose requiring hospitalization for monitoring; this patient completed treatment and achieved SVR12. CONCLUSION: Sofosbuvir plus ribavirin was well-tolerated and highly effective in children aged 3 to <12 years with chronic HCV genotype 2 or 3 infection

Published
2020

23. 548. Baseline characteristics associated with clinical improvement and mortality in hospitalized patients with moderate COVID-19

Author

Castagna, Antonella, primary, Hui, David Shu Cheong, additional, Mullane, Kathleen M, additional, Jain, Mamta, additional, Galli, Massimo, additional, Chang, Shan-Chwen, additional, Hyland, Robert H, additional, SenGupta, Devi, additional, Cao, Huyen, additional, Huang, Hailin, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Lübbert, Christoph, additional, Lye, David Chien Boon, additional, Aberg, Judith A, additional, Elorza, Enrique Navas, additional, Tashima, Karen T, additional, and McPhail, Mark, additional

Published
2020
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24. 1046. Week 48 Outcomes from the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African American Adults with HIV

Author

Hagins, Debbie, primary, Kumar, Princy, additional, Saag, Michael, additional, Wurapa, Anson K, additional, Brar, Indira, additional, Berger, Daniel, additional, Osiyemi, Olayemi, additional, Hileman, Corrilynn, additional, Ramgopal, Moti, additional, McDonald, Cheryl, additional, Blair, Christiana, additional, Andreatta, Kristen, additional, Collins, Sean E, additional, Brainard, Diana M, additional, and Martin, Hal, additional

Published
2020
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25. 72. Remdesivir vs Standard Care in Patients with Moderate covid-19

Author

Marty, Francisco M, primary, Malhotra, Prashant, additional, Gottlieb, Robert L, additional, Tashima, Karen T, additional, Galli, Massimo, additional, Chai, Louis Yi Ann, additional, SenGupta, Devi, additional, Hyland, Robert H, additional, Wang, Hongyuan, additional, Zhong, Lijie, additional, Cao, Huyen, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Brown, Michael, additional, Goikoetxea, Ane Josune, additional, Jain, Mamta, additional, Hui, David Shu Cheong, additional, Bernasconi, Enos, additional, and Spinner, Christoph, additional

Published
2020
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27. 73. Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated with Remdesivir

Author

Diaz, George, primary, Arribas, Jose Ramon, additional, Robinson, Philip A, additional, Cattelan, Anna Maria, additional, Tashima, Karen T, additional, Tsang, Owen Tak-Yin, additional, Chen, Yao-Shen, additional, SenGupta, Devi, additional, Vendrame, Elena, additional, Blair, Christiana, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Chin, Bum Sik, additional, Spinner, Christoph, additional, Criner, Gerard J, additional, Muñoz, Jose, additional, Lye, David Chien Boon, additional, and Gottlieb, Robert L, additional

Published
2020
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30. 561. Safety of Remdesivir vs Standard Care in Patients with Moderate Covid-19

Author

Criner, Gerard J, primary, Criner, Gerard J, additional, Ahn, Mi Young, additional, Huhn, Gregory, additional, Subramanian, Aruna, additional, Lumbreras, Carlos, additional, Schmiedel, Stefan, additional, Hyland, Robert H, additional, Suri, Vithika, additional, Cao, Huyen, additional, Wang, Hongyuan, additional, SenGupta, Devi, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Chen, Yao-Shen, additional, Günthard, Huldrych, additional, Sanz-Moreno, D Jose, additional, Aberg, Judith A, additional, Nicastri, Emanuele, additional, and Tsang, Owen Tak-Yin, additional

Published
2020
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31. 1002. A Daily Single Tablet Regimen (STR) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically-Suppressed Adults Living with HIV and End Stage Renal Disease on Chronic Hemodialysis

Author

Eron, Joseph J, primary, Wilkin, Aimee, additional, Ramgopal, Moti, additional, Osiyemi, Olayemi, additional, McKellar, Mehri, additional, Slim, Jihad, additional, Asmuth, David, additional, DeJesus, Edwin, additional, German, Polina, additional, Blair, Christiana, additional, Carter, Christoph C, additional, Brainard, Diana M, additional, Collins, Sean E, additional, and Martin, Hal, additional

Published
2020
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32. 557. Impact of Concomitant Hydroxychloroquine Use on Safety and Efficacy of Remdesivir in Moderate COVID-19 Patients

Author

Arribas, Jose Ramon, primary, Arribas, Jose Ramon, additional, Sanyal, Arun J, additional, Soriano, Alex, additional, Chin, Bum Sik, additional, Kalimuddin, Shirin, additional, Schreiber, Stefan, additional, Elboudwarej, Emon, additional, Tian, Yuan, additional, Hyland, Robert H, additional, SenGupta, Devi, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Lübbert, Christoph, additional, Lye, David Chien Boon, additional, Aberg, Judith A, additional, Elorza, Enrique Navas, additional, Tashima, Karen T, additional, and McPhail, Mark, additional

Published
2020
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33. 318. Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) in Hispanic/Latinx and Black Participants: Efficacy, Bone and Renal Safety Results from a Pooled Analysis of 7 Clinical Trials

Author

DeJesus, Edwin, primary, Federico Andrade Villanueva, Jaime, additional, Ramon Arribas Lopez, Jose, additional, Brinson, Cynthia, additional, Crofoot, Gordon, additional, Daar, Eric S, additional, Koenig, Ellen, additional, Podzamczer, Daniel, additional, Ramgopal, Moti, additional, Santana, Jorge, additional, Santiago, Lizette, additional, Tebas, Pablo, additional, Zorrilla, Carmen, additional, Guo, Susan, additional, Liu, Ya-Pei, additional, Zhong, Lijie, additional, Brainard, Diana M, additional, Carter, Christoph C, additional, Temme, Lauren, additional, and Das, Moupali, additional

Published
2019
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34. 1288. Bone Safety Outcomes with F/TAF vs. F/TDF for PrEP in the DISCOVER Trial

Author

Wohl, David, primary, Ruane, Peter, additional, Hosek, Sybil, additional, Creticos, Catherine, additional, Morris, Sheldon, additional, Phoenix, John, additional, Ramgopal, Moti, additional, Brinson, Cynthia, additional, Tremblay, Cecile, additional, Carter, Christoph C, additional, Wong, Pamela, additional, Brainard, Diana M, additional, McCallister, Scott, additional, Das, Moupali, additional, and Thompson, Melanie A, additional

Published
2019
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35. 1962. Renal Outcomes for Participants Taking F/TAF vs. F/TDF for HIV PrEP in the DISCOVER Trial

Author

Mills, Anthony, primary, Workowski, Kimberly, additional, Campbell, Thomas, additional, Benson, Paul, additional, Crofoot, Gordon, additional, Salazar, Laura, additional, Ogbuagu, Onyema, additional, Shalit, Peter, additional, Trottier, Benoit, additional, Carter, Christoph C, additional, Wong, Pamela, additional, Brainard, Diana M, additional, McCallister, Scott, additional, Das, Moupali, additional, and Doblecki-Lewis, Susanne, additional

Published
2019
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36. 2490. Longer-Term Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed Adults Living With HIV and End-Stage Renal Disease on Chronic Hemodialysis

Author

Eron, Joseph J, primary, Lelievre, Jean-Daniel, additional, Kalayjian, Robert, additional, Slim, Jihad, additional, Wurapa, Anson K, additional, Stephens, Jeffrey L, additional, McDonald, Cheryl, additional, Cua, Eric, additional, Wilkin, Arjun, additional, McKellar, Mehri, additional, Cox, Stephanie, additional, Majeed, Sophia, additional, Blair, Christiana, additional, Carter, Christoph C, additional, SenGupta, Devi, additional, Brainard, Diana M, additional, and Das, Moupali, additional

Published
2019
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39. Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies

Author

Grebely, Jason, primary, Feld, Jordan J, additional, Wyles, David, additional, Sulkowski, Mark, additional, Ni, Liyun, additional, Llewellyn, Joe, additional, Mir, Heshaam M, additional, Sajed, Nika, additional, Stamm, Luisa M, additional, Hyland, Robert H, additional, McNally, John, additional, Brainard, Diana M, additional, Jacobson, Ira, additional, Zeuzem, Stefan, additional, Bourlière, Marc, additional, Foster, Graham, additional, Afdhal, Nezam, additional, and Dore, Gregory J, additional

Published
2018
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40. Persistence of Virologic Response after Liver Transplant in Hepatitis C Patients Treated with Ledipasvir / Sofosbuvir Plus Ribavirin Pretransplant

Author

Yoshida, Eric M, Kwo, Paul, Agarwal, Kosh, Duvoux, Christophe, Durand, François, Peck-Radosavljevic, Markus, Lilly, Leslie, Willems, Bernard, Vargas, Hugo, Kumar, Princy, Brown, Robert S, Horsmans, Yves, De-Oertel, Shampa, Arterburn, Sarah, Dvory-Sobol, Hadas, Brainard, Diana M, McHutchison, John G, Terrault, Norah, Rizzetto, Mario, Müllhaupt, Beat, Yoshida, Eric M, Kwo, Paul, Agarwal, Kosh, Duvoux, Christophe, Durand, François, Peck-Radosavljevic, Markus, Lilly, Leslie, Willems, Bernard, Vargas, Hugo, Kumar, Princy, Brown, Robert S, Horsmans, Yves, De-Oertel, Shampa, Arterburn, Sarah, Dvory-Sobol, Hadas, Brainard, Diana M, McHutchison, John G, Terrault, Norah, Rizzetto, Mario, and Müllhaupt, Beat

Abstract

INTRODUCTION Recurrence of HCV infection in patients with chronic hepatitis C virus (HCV) at the time of liver transplantation is nearly universal and reduces the likelihood of graft and patient survival. MATERIALS AND METHODS We evaluated outcomes of 17 patients (16 with HCV genotype 1 and 1 with genotype 4) who received up to 12 or 24 weeks of ledipasvir/sofosbuvir plus ribavirin prior to or up to the time of liver transplant in the SOLAR-1 and SOLAR-2 trials. In all patients, HCV RNA was < 15 IU/mL prior to transplant. At screening, 6 patients were Child-Pugh-Turcotte (CPT) class B and 11 were CPT class C. Seven patients underwent transplant prior to completing assigned treatment, with 4 treated for < 12 weeks. The primary endpoint was posttransplant virologic response 12 weeks after transplant (pTVR12) in patients with HCV RNA < 15 IU/mL at their last measurement prior to transplant. RESULTS Overall, 94% (16/17) achieved pTVR12. All who achieved pTVR12 received at least 11 weeks of treatment. The single patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. The patient had HCV RNA < 15 IU/mL at post-transplant week 2 but died 15 days post-transplant because of multi-organ failure and septic shock. CONCLUSION Among a small population of HCV patients with decompensated cirrhosis, virologic response to ledipasvir / sofosbuvir plus ribavirin prior to liver transplantation was maintained after transplantation, even if treatment was stopped early. Administration of ledipasvir / sofosbuvir plus ribavirin before liver transplant can prevent post-transplant HCV recurrence.

Published
2017

41. No Evidence of Reactivation of Hepatitis B Virus Among Patients Treated With Ledipasvir-Sofosbuvir for Hepatitis C Virus Infection

Author

Sulkowski, Mark S., Chuang, Wan-Long, Kao, Jia-Horng, Yang, Jenny C., Gao, Bing, Brainard, Diana M., Han, Kwang-Hyub, and Gane, Edward

Subjects
virus diseases, Brief Reports, digestive system diseases
Abstract

Postmarketing cases of hepatitis B virus (HBV) reactivation during hepatitis C treatment have been reported. We analyzed serum samples from patients in a clinical trial of ledipasvir-sofosbuvir in Taiwan and Korea. Of the 173 patients enrolled, 103 (60%) had been previously infected with HBV. None showed evidence of HBV reactivation.

Published
2016

42. Sofosbuvir and ribavirin in HCV genotypes 2 and 3

Author

Zeuzem, Stefan, Dusheiko, Geoffrey, Salupere, Riina, Mangia, Alessandra, Flisiak, Robert, Hyland, Robert H., Illeperuma, Ari, Svarovskaia, Evguenia, Brainard, Diana M., Symonds, William T., Subramanian, G.Mani, McHutchison, John G., Weiland, Ola, Reesink, Hendrik W, Ferenci, Peter, Hézode, Christophe, Esteban, Rafael, Forns, Xavier, VALENCE Investigators., Saarland University [Saarbrücken], Center for Hepatology, Royal Free Hospital-University College School of Medicine, IRCCS Casa Sollievo della Sofferenza Hospital, Gilead Sciences, Inc. [Foster City, CA, USA], Dept of internal medicine III, Medizinische Universität Wien = Medical University of Vienna, Service d'hépato-gastro-entérologie [APHP Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Hospital General, Universitario Valle de Hebron, the VALENCE Investigators, University College School of Medicine-Royal Free Hospital [London, UK], Istituto di Ricovero e Cura a Carattere Scientifico, Ospedale Casa Sollievo della Sofferenza [San Giovanni Rotondo] (IRCCS), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Hôpital Henri Mondor-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Vall d'Hebron University Hospital [Barcelona], DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, Facolta' di MEDICINA e CHIRURGIA, AREA MIN. 06 - Scienze mediche, Zeuzem, Stefan, Dusheiko, Geoffrey M., Salupere, Riina, Mangia, Alessandra, Flisiak, Robert, Hyland, Robert H., Illeperuma, Ari, Svarovskaia, Evguenia, Brainard, Diana M., Symonds, William T., Subramanian, G. Mani, Mchutchison, John G., Weiland, Ola, Reesink, Hendrik W., Ferenci, Peter, Heźode, Christophe, Esteban, Rafael, Gastroenterology and Hepatology, and Universitat de Barcelona

Subjects
Male, Sofosbuvir, Drug Resistance, Hepacivirus, medicine.disease_cause, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Clinical trials, Genotype, 030212 general & internal medicine, Viral, Adult, Aged, Antiviral Agents, Drug Resistance, Viral, Drug Therapy, Combination, Female, Hepatitis C, Chronic, Humans, Middle Aged, RNA, Viral, Ribavirin, Uridine Monophosphate, Viral Load, Chronic, Medicaments antivírics, ComputingMilieux_MISCELLANEOUS, Settore MED/12 - Gastroenterologia, Medicine (all), virus diseases, General Medicine, Hepatitis C, 3. Good health, Combination, 030211 gastroenterology & hepatology, Viral load, medicine.drug, Human, medicine.medical_specialty, Farmacologia, Hepatitis C virus, Therapeutics, Placebo, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, Antiviral Agent, Pharmacology, Hepaciviru, business.industry, medicine.disease, Terapèutica, Virology, digestive system diseases, Regimen, Antiviral agents, chemistry, RNA, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Assaigs clínics
Abstract

none 17 si BACKGROUND: In clinical trials, treatment with a combination of the nucleotide polymerase inhibitor sofosbuvir and the antiviral drug ribavirin was associated with high response rates among patients with hepatitis C virus (HCV) genotype 2 infection, with lower response rates among patients with HCV genotype 3 infection. METHODS: We conducted a study involving patients with HCV genotype 2 or 3 infection, some of whom had undergone previous treatment with an interferon-based regimen. We randomly assigned 91 patients with HCV genotype 2 infection and 328 with HCV genotype 3 infection, in a 4:1 ratio, to receive sofosbuvir-ribavirin or placebo for 12 weeks. On the basis of emerging data from phase 3 trials indicating that patients with HCV genotype 3 infection had higher response rates when they were treated for 16 weeks, as compared with 12 weeks, the study was unblinded, treatment for all patients with genotype 3 infection was extended to 24 weeks, the placebo group was terminated, and the goals of the study were redefined to be descriptive and not include hypothesis testing. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Of the 419 patients who were enrolled and treated, 21% had cirrhosis and 58% had received previous interferon-based treatment. The criterion for a sustained virologic response was met in 68 of 73 patients (93%; 95% confidence interval [CI], 85 to 98) with HCV genotype 2 infection who were treated for 12 weeks and in 213 of 250 patients (85%; 95% CI, 80 to 89) with HCV genotype 3 infection who were treated for 24 weeks. Among patients with HCV genotype 3 infection, response rates were 91% and 68% among those without and those with cirrhosis, respectively. The most common adverse events were headache, fatigue, and pruritus. CONCLUSIONS: Therapy with sofosbuvir-ribavirin for 12 weeks in patients with HCV genotype 2 infection and for 24 weeks in patients with HCV genotype 3 infection resulted in high rates of sustained virologic response. Copyright © 2014 Massachusetts Medical Society. Zeuzem, Stefan; Dusheiko, Geoffrey M.; Salupere, Riina; Mangia, Alessandra; Flisiak, Robert; Hyland, Robert H.; Illeperuma, Ari; Svarovskaia, Evguenia; Brainard, Diana M.; Symonds, William T.; Subramanian, G. Mani; Mchutchison, John G.; Weiland, Ola; Reesink, Hendrik W.; Ferenci, Peter; Heźode, Christophe; Esteban, Rafael Zeuzem, Stefan; Dusheiko, Geoffrey M.; Salupere, Riina; Mangia, Alessandra; Flisiak, Robert; Hyland, Robert H.; Illeperuma, Ari; Svarovskaia, Evguenia; Brainard, Diana M.; Symonds, William T.; Subramanian, G. Mani; Mchutchison, John G.; Weiland, Ola; Reesink, Hendrik W.; Ferenci, Peter; Heźode, Christophe; Esteban, Rafael

Published
2014

43. P16 SOF/VEL/VOX for 8 or 12 weeks results in high SVR12 rates: an integrated analysis of the POLARIS-1, POLARIS-2, POLARIS-3 AND POLARIS-4 studies

Author

Roberts, Stuart K., primary, Cooper, Curtis L., additional, Lawitz, Eric, additional, Rajender Reddy, K., additional, Thompson, Alex J., additional, Zeuzem, Stefan, additional, Jacobson, Ira M., additional, Ruane, Peter, additional, Hyland, Robert H., additional, Stamm, Luisa M., additional, Han, Lingling, additional, Brainard, Diana M., additional, Bräu, Norbert, additional, Asselah, Tarik, additional, Willems, Bernard E., additional, Flamm, Steven, additional, Bourlière, Marc, additional, Foster, Graham R., additional, Gane, Edward J., additional, Manns, Michael, additional, Gordon, Stuart C., additional, and Kowdley, Kris, additional

Published
2017
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44. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials

Author

Jacobson, Ira M., primary, Lawitz, Eric, additional, Gane, Edward J., additional, Willems, Bernard E., additional, Ruane, Peter J., additional, Nahass, Ronald G., additional, Borgia, Sergio M., additional, Shafran, Stephen D., additional, Workowski, Kimberly A., additional, Pearlman, Brian, additional, Hyland, Robert H., additional, Stamm, Luisa M., additional, Svarovskaia, Evguenia, additional, Dvory-Sobol, Hadas, additional, Zhu, Yanni, additional, Subramanian, G. Mani, additional, Brainard, Diana M., additional, McHutchison, John G., additional, Bräu, Norbert, additional, Berg, Thomas, additional, Agarwal, Kosh, additional, Bhandari, Bal Raj, additional, Davis, Mitchell, additional, Feld, Jordan J., additional, Dore, Gregory J., additional, Stedman, Catherine A.M., additional, Thompson, Alexander J., additional, Asselah, Tarik, additional, Roberts, Stuart K., additional, and Foster, Graham R., additional

Published
2017
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45. The emergence of NS5B resistance associated substitution S282T after sofosbuvir‐based treatment

Author

Gane, Edward J., primary, Metivier, Sophie, additional, Nahass, Ronald, additional, Ryan, Michael, additional, Stedman, Catherine A., additional, Svarovskaia, Evguenia S., additional, Mo, Hongmei, additional, Doehle, Brian, additional, Dvory‐Sobol, Hadas, additional, Hedskog, Charlotte, additional, Lin, Ming, additional, Brainard, Diana M., additional, Yang, Jenny C., additional, McHutchison, John G., additional, Sulkowski, Mark, additional, Younes, Ziad, additional, and Lawitz, Eric, additional

Published
2017
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48. Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections

Author

Gane, Edward J., primary, Schwabe, Christian, additional, Hyland, Robert H., additional, Yang, Yin, additional, Svarovskaia, Evguenia, additional, Stamm, Luisa M., additional, Brainard, Diana M., additional, McHutchison, John G., additional, and Stedman, Catherine A., additional

Published
2016
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49. Prevalence of Resistance-Associated Substitutions in HCV NS5A, NS5B, or NS3 and Outcomes of Treatment With Ledipasvir and Sofosbuvir

Author

Sarrazin, Christoph, primary, Dvory-Sobol, Hadas, additional, Svarovskaia, Evguenia S., additional, Doehle, Brian P., additional, Pang, Phillip S., additional, Chuang, Shu-Min, additional, Ma, Julie, additional, Ding, Xiao, additional, Afdhal, Nezam H., additional, Kowdley, Kris V., additional, Gane, Edward J., additional, Lawitz, Eric, additional, Brainard, Diana M., additional, McHutchison, John G., additional, Miller, Michael D., additional, and Mo, Hongmei, additional

Published
2016
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50. Efficacy of Sofosbuvir Plus Ribavirin With or Without Peginterferon-Alfa in Patients With Hepatitis C Virus Genotype 3 Infection and Treatment-Experienced Patients With Cirrhosis and Hepatitis C Virus Genotype 2 Infection

Author

Foster, Graham R., primary, Pianko, Stephen, additional, Brown, Ashley, additional, Forton, Daniel, additional, Nahass, Ronald G., additional, George, Jacob, additional, Barnes, Eleanor, additional, Brainard, Diana M., additional, Massetto, Benedetta, additional, Lin, Ming, additional, Han, Bin, additional, McHutchison, John G., additional, Subramanian, G. Mani, additional, Cooper, Curtis, additional, and Agarwal, Kosh, additional

Published
2015
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