PPT-Ledipasvir-Sofosbuvir ( Harvoni

Author : sherrill-nordquist | Published Date : 2018-11-21

Slide deck prepared by David H Spach MD and H Nina Kim MD MSc Last Updated October 23 2014 Robe rt G Gish MD Professor Consultant Stanford University Medical

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Ledipasvir-Sofosbuvir ( Harvoni: Transcript

Slide deck prepared by David H Spach MD and H Nina Kim MD MSc Last Updated October 23 2014 Robe rt G Gish MD Professor Consultant Stanford University Medical Center Senior Medical Director St Josephs Hospital and Medical Center Liver Program Phoenix Arizona. JAMA 20153131232 9 HIV Coinfection brPage 2br Source Osinusi A et al JAMA 20153131232 9 Ledipasvir Sofosbuvir in GT1 with HIV Coinfection NIAID ERADICATE Trial Features NIAID ERADICATE Trial Design Open label phase 2 using fixed dose combination o . + . Sofosbuvir. in Genotype . 3. ALLY-3 Study. Phase 3. . Treatment. -. Naïve . and . Treatment-Experienced. Nelson DR, . et al. . . Hepatology. 2015;61:1127-35.. Source: . Nelson DR, et al. . ELECTRON (Overview): 6 parts, 22 arms. Phase . 2. Treatment. Naïve and Treatment . Experienced. Source: . Gilead Sciences, . Inc. Sofosbuvir. Summary of ELECTRON Trials Design (1 of 2). Part 1 . - . 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. Genotype . 2. . or 3 . FUSION. Trial. Phase . 3. *Note: Published . in . NEJM in tandem . with . POSITRON Trial (GT 2,3 Unable to receive PEG). Treatment. . Experienced. Jacobson I, et al. N . Engl. NIH SPARE. Phase . 2. Treatment. . Naïve . (unfavorable baseline treatment . characteristics). Osinusi. A, et al. JAMA. 2013;310:804-11.. Source: . Osinusi. A,. . et al. . JAMA. 2013;310:804-11.. SIRIUS. Phase . 2 . Treatment. . Experienced. Bourliere. M, et al. Lancet Infect Dis. . 2015;15:397-404.. Source: . Bourliere. . M, . et al. . Lancet Infect Dis. 2015;15:397-404.. Ledipasvir-Sofosbuvir in Treatment-Experienced . 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.. 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 . SOLAR-1 (Cohorts A and B). Phase . 2 . Treatment Naïve and Treatment Experienced. Charlton M, al. Gastroenterology. 2015; 149:649-59.. Source: Charlton M, . et al. . Gastroenterology. 2015; 149:649-59.. Genotype 1, never treated for HCV, no cirrhosis12 weeks (recommended): to (if HCV RNA is less than 6 million copies IU/mL, consider 8 weeks8 weeks: (if HCV RNA is less than 6 million copies IU/mL: 9 . 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.. Following Liver Transplantation. Phase 2. Charlton M, . et al. . Gastroenterology. 2015;148:108-17.. Treatment. Naïve and Treatment . Experienced. Liver Transplantation. Source: Charlton M, et al. Gastroenterology. 2015;148:108-17.. SOLAR-2. Source: . Manns. M, et al. Lancet Infect Dis. 2016;16:685-97.. Treatment Naïve and Treatment Experienced, Phase 2. Ledipasvir-Sofosbuvir + Ribavirin in Advanced Liver Disease. SOLAR-2: Features.

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