PPT-Ledipasvir-Sofosbuvir Retreatment with HCV Genotype 1
Author : danika-pritchard | Published Date : 2019-02-02
NIAID Retreatment Phase 2a Treatment Experienced Osinusi A et al Ann Intern Med 20141616348 Source Osinusi A et al Ann Intern Med 20141616348 LedipasvirSofosbuvir
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Ledipasvir-Sofosbuvir Retreatment with HCV Genotype 1: Transcript
NIAID Retreatment Phase 2a Treatment Experienced Osinusi A et al Ann Intern Med 20141616348 Source Osinusi A et al Ann Intern Med 20141616348 LedipasvirSofosbuvir Retreatment of SOF RBV Failure in HCV GT 1. + Sofosbuvir in HCV GT 1-4 and HIV Coinfection. ALLY-2 Study. Phase 3. . Treatment. -. Naïve . and . Treatment-Experienced. Wyles. DL, . et al. . N . Engl. J Med. 2015;373:714-25.. Source: . Wyles. + Ribavirin to Prevent Post-Transplant HCV Recurrence . Phase 2. Curry . MP, et al. Gastroenterology. 2014;September 24. [. Epub. ahead of print] . Treatment. Naïve and Treatment . Experienced. Liver Transplantation. + Sofosbuvir in HCV GT 1-4 and HIV Coinfection. ALLY-2 Study. Phase 3. . Treatment. -. Naïve . and . Treatment-Experienced. Wyles DL, . et al. . N Engl J Med. 2015;373:714-25.. Source: Wyles DL, et al. N Engl J Med. 2015;373:714-25.. (. Epclusa. ). Prepared by. : H. Nina Kim, MD MSc and David . Spach. , MD. Last . Updated: . July . 8, . 2016. Background and Dosing. Sofosbuvir-Velpatasvir. (. Epclusa. ). Sofosbuvir-Velpatasvir. (. Matthew Luu, Yuan Fang (Pearl) Cai, Shiming Sun, . Ziyi Cheng. PHM142 Fall . 2016. Coordinator. : Dr. Jeffrey Henderson. Instructor: Dr. David Hampson. What is Hepatitis C? . Flaviviridae. virus family. HIV Coinfection & HCV . GT 1,2,3. PHOTON-1 Trial. Phase . 3. Sulkowski. MS, et al. JAMA. 2014;312:353-61.. Treatment. Naïve and Treatment . Experienced. HIV Coinfection. Source: . Sulkowski. MS, et al. JAMA. 2014;312:353-61.. VALENCE Trial. Phase . 3. Treatment. Naïve and Treatment . Experienced. Zeuzem. S, et al. . N . Engl. J Med. 2014;370:1993-2001. Source: . Zeuzem. S, et al. N . Engl. J Med. 2014;370:1993-. 2001.. N = 69. >. 18 years. Failure to SOF/VEL . or SOF/VEL + VOX . (LEPTON study). Any genotype. Compensated cirrhosis allowed. No HBV or HIV co-infection. Open-label. SOF/VEL: 400/100 mg FDC QD ; RBV: weight based in twice daily dose . Open-label. Chronic HCV infection. Genotype 1 . Failure to achieve SVR. 12. . on a short-course of 1. st. line. LDV/SOF-containing regimen . No cirrhosis. N = 34. SVR. 12. Co-formulated ledipasvir-sofosbuvir (LDV 90 mg/SOF 400 mg) : 1 pill qd. . or 3 . LONESTAR-2. Phase 2. Treatment. . Experienced. Lawitz. . E, et al. . Hepatology. . 2015:61:769-75.. Source: . Lawitz. E, et al. . Hepatology. . . 2015:61:769-75.. Sofosbuvir + . PEG + RBV . ASTRAL-2*. Phase 3. . Treatment. . Naïve & Experienced. Foster GR, . et al. . N . Engl. J Med. . 2015. ;373:2608-17.. *Published in tandem with ASTRAL-3 Trial. Source: Foster GR, . et al. N . ASTRAL-1. Phase 3. . Treatment. . Naïve & Experienced. Feld JJ, . et al. . N . Engl. J Med. . 2015. ;373:2599-607.. Source: Feld . JJ. , et al. N . Engl. J Med. . 2015. ;373:2599-607.. Sofosbuvir-Velpatasvir. . with Advanced Liver Disease. ALLY-3+ Study. Phase 3. . Treatment. -. Naïve . and . Treatment-Experienced. Leroy V, . et al. . Hepatology 2016;63:1430-41.. Source: Leroy V, et al. Hepatology . 2016;63:1430-41.. mHCV Genotype II Key to symbols used Global Trade Item Number Manufacturer Reference Number Lot Number In Vitro Diagnostic Medical Device Internal Control Amplification Reagent Pack A Amp
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