PPT-Ledipasvir-Sofosbuvir (

Harvoni Prepared by David H Spach MD and H Nina Kim MD MSc Last Updated December 15 2015 Background and Dosing LedipasvirSofosbuvir Harvoni LedipasvirSofosbuvir Harvoni. 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 . - . (. 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. (. . and HIV Coinfection. NIAID ERADICATE Trial. Phase . 2a. Treatment. Naïve and Treatment . Experienced. Osinusi. . A, et al. JAMA. 2015;313:1232-9. . HIV Coinfection. Source: . Osinusi. A, et al. . 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. 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.. 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. in Genotype 3. ASTRAL-3. Phase 3. . Treatment. . Naïve & Experienced. Foster GR, . et al. . N . Engl. J Med. . 2015. ;373:2608-17.. *Published in tandem with ASTRAL-2 Trial. Source: Foster GR, . NIAID Retreatment. Phase . 2a . Treatment. . Experienced. Osinusi. A, . et al. . Ann Intern Med. 2014;161:634-8.. Source: . Osinusi. A, et al. Ann Intern Med. 2014;161:634-8.. Ledipasvir-Sofosbuvir Retreatment of SOF RBV Failure in HCV GT 1. University of Chicago. Chicago, Illinois. Challenges in the Management and Treatment of HIV/Hepatitis C Virus Coinfection. FORMATTED: 05/02/2016. Chicago, Illinois: May 9, 2016. From . AI . Aronsohn. Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Phase 2 Curry MP, et al. Gastroenterology . 2015;148:100-7. Treatment Naïve and Treatment Experienced Liver Transplantation Source: Curry MP, et 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.