PPT-Sofosbuvir-Velpatasvir

Epclusa Prepared by H Nina Kim MD MSc and David Spach MD Last Updated July 8 2016 Background and Dosing SofosbuvirVelpatasvir Epclusa SofosbuvirVelpatasvir . . + . 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 . - . + 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. 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. 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.. 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.. Harvoni. ). Prepared by: . David H. Spach, MD and H. Nina Kim, MD MSc. Last . Updated: . December 15, 2015. Background and Dosing. Ledipasvir-Sofosbuvir (. Harvoni. ). Ledipasvir-Sofosbuvir (. Harvoni. rd. DAA in HCV Genotype 1 . NIAID SYNERGY: Genotype 1. Phase . 2. Treatment. . Naïve . (unfavorable baseline treatment . characteristics). Kohli. . A, et al. . Lancet. 2015:385:1107-13.. Source. 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.. for 12 weeks in liver transplant recipients with genotype 1-4. Agarwal K. J . Hepatol. . 2018;69:603-7. SOF/VEL: 400/100 mg 1 . tablet. QD. Liver transplant recipients. Recurrent HCV infection after transplantation. . 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.. Kristen M. Marks, MD. Assistant Professor. Weill Cornell Medical College . New York, New York. Financial Relationships With Commercial Entities. Dr Marks was awarded research grants, paid to her institution, from Bristol-Myers Squibb, Gilead Sciences, . 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.