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 . 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 . - . 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.. 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.. in DAA. -Naïve GT . 1-6 . POLARIS-2. Phase 3. . Treatment Naïve and . Treament. Experienced (DAA Naïve) . Jacobson IM, . et al. . Gastroenterology. 2017;153:113-22.. Source: Jacobson IM, et al. Gastroenterology. 2017;153:113-22.. 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, . 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. 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, . ASTRAL-4. Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.. Treatment Naïve and Treatment Experienced, Phase 3. Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis. ASTRAL-4: Study Features.