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Safety of Sofosbuvir-Based Regimens for the Treatment of Chronic
HCV Infection in Patients with Mild or Moderate Renal Impairment
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HepDART, 8-12 December 2019, Kauai, Hawaii
Mark Sulkowski1, Francois Durand2, K Rajender Reddy3, Eric Lawitz4, Marc Bourlière5, Nelson Cheinquer6, Stacey Scherbakovsky6, Anand Chokkalingam6, Liyun Ni6, Anuj Gaggar6, Massimo Colombo7
1Professor of Medicine; Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; 2Hopital Beaujon, University Paris Diderot, Clichy, France; 3Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; 4Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas, USA; 5Hepato-Gastro-Enterologie, Hopital Saint Joseph, Marseille, France; 6Gilead Sciences, Inc.; 7Fondazione IRCCS Ca' Granda Osepdale Maggiore Policlinico, Milan, Italy
*The rate of treatment-emergent AEs in the system organ class (SOC) renal and urinary disorders or any preferred terms in that SOC that occurred in >1% of any group.
References
1. Enclosed. Gilead Sciences Inc, HARVONI® (ledipasvir and sofosbuvir) tablets, for oral use. U.S. Prescribing Information. Foster City, CA. In.
2. Enclosed. Gilead Sciences Inc, EPCLUSA® (sofosbuvir and velpatasvir) tablets, for oral use. US Prescribing Information. Foster City, CA. In.
3. Enclosed. Gilead Sciences Inc, VOSEVI® (sofosbuvir/velpatasvir/voxilaprevir [SOF/VEL/VOX]) tablets, for oral use. US Prescribing Information. Foster City, CA. In.
4. Gane EJ, Robson RA, Bonacini M, et al. Safety, Antiviral Efficacy, and Pharmacokinetics of Sofosbuvir in Patients With Severe Renal Impairment [Poster 966]. Paper presented at: The 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); November 07-11, 2014; Boston MA United States
5. Martin P, Gane E, Ortiz-Lasanta G, et al. Safety and Efficacy of Treatment With Daily Sofosbuvir 400 mg + Ribavirin 200 mg for 24 Weeks in Genotype 1 or 3 HCV-Infected Patients With Severe Renal Impairment [Poster 1128]. Paper presented at: American Association for the Study of Liver Diseases (AASLD); 13-17 November, 2015; San Francisco, CA.
6. Lawitz E, Landis CS, Maliakkal BJ, et al. Safety and Efficacy of Treatment With Once-Daily Ledipasvir/Sofosbuvir (90/400 mg) for 12 Weeks in Genotype 1 HCV-Infected Patients With Severe Renal Impairment [Poster 1587]. Paper presented at: The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 20-24 October, 2017; Washington, D. C.
7. Borgia SM, Dearden J, Lurie Y, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. Paper presented at: American Association for the Study of Liver Diseases (AASLD); 09-13 November, 2018; San Francisco, CA.
8. Enclosed. Gilead Sciences Inc, SOVALDI® (sofosbuvir) tablets, for oral use. US Prescribing Information. Foster City, CA. In.
9. Chuang WL, Hu TH, Buggisch P, et al. Ledipasvir/Sofosbuvir for 8, 12, or 24 Weeks Is Safe and Effective in Patients Undergoing Dialysis [Poster THU-144]. Paper presented at: EASL: The International Liver Congress; 10-14 April, 2019; Vienna, Austria.
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