PPT-LDV/SOF

Openlabel Chronic HCV infection Genotype 1 Failure to achieve SVR 12 on a shortcourse of 1 st line LDVSOFcontaining regimen No cirrhosis N 34 SVR 12 Coformulated ledipasvirsofosbuvir LDV 90 mgSOF 400 mg 1 pill qd. Director, J6/CIO . United States Special Operations Command. SOF C4. “One Force, . One Environment”. UNCLASSIFIED. UNCLASSIFIED. 8,463. DEPLOYED. 80. LOCATIONS. 24/7. 64,000. . SOF. Unified Commands. Acquisition Perspective . to. . NDIA. James W. Cluck. Acquisition Executive &. Director, Center for . Acquisition and . Logistics (SOAL. ). 20 March 2009. Agenda. Mission. SOF Acquisition. Special Operations Peculiar. Placebo. LDV/SOF + placebo. Randomisation*. 1 : 1. Double-blind. SIRIUS . Study. : LDV/SOF ± RBV for genotype 1 and cirrhosis with non response to prior PI therapy. Design. W24. W12. ≥ 18 years. Chronic HCV infection. 400/100 mg . qd. N = 120. N = 120. W12. SOF + RBV. > . 18 years. Chronic HCV infection. Genotype . 2. Naïve . or pre-treatment. with IFN-based regimen. Compensated cirrhosis allowed**. No HBV or HIV co-infection. 400/100 mg . qd. N = 500. N = 100. W12. Placebo. >. 18 years. Chronic HCV infection. Genotype 1, 2, 4, 5 or 6. Naïve or pre-treatment. with IFN-based regimen. Compensated cirrhosis allowed**. No HBV or HIV co-infection. HCV WORLD CAB .  FEBRUARY 2014. BANGKOK, THAILAND. When to Treat HCV. . HCV Direct-Acting . Antivirals. (. DAAs. ) in . development. . OVERVIEW. Know your epidemic: what matters. 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. With Or Without Ribavirin Is Safe and Efficacious in Liver Transplant Recipients With HCV Recurrence: . Interim Results of a European Multicenter Compassionate Use Program. Herzer K,. 1. . Welzel. . in genotypes 1 or 3, with or without cirrhosis. >. 18 years. Chronic HCV infection. Genotype 1 or 3. HCV RNA > 10 000 IU. /ml. Treatment-naïve . Cirrhosis assessed by liver biopsy or noninvasive tests. 400/100/100 mg QD. N = 263. N = 152. W12. Placebo. >. 18 years. Chronic HCV infection. Genotype 1, 2, 3, 4, 5 or 6. NS5A inhibitor-experienced . for ≥ 4 weeks (exclusion if . discontinued due to an adverse. Randomisation. 1 : 1. 18-70 years. HCV genotype 1. Naïve or pre-treated. with IFN-based regimen. No cirrhosis. HCV RNA ≥ . 10.000 . IU. /ml. No prior therapy with PI. No HBV or HIV co-infection. OPTIMIST-1 Study: SMV SOF for genotype 1. 12. (HCV RNA < 25 IU/ml), . with. 95% CI. DCV 60 mg . qd. SOF 400 mg . qd. DCV 60 mg . qd. SOF 400 mg . qd. Not randomised. Open. -label. ALLY-3 . Study. : DCV SOF for HCV genotype 3. W12. IAPAC African Regional Capacity-Building Hub. Based in Johannesburg, South Africa. Mission: Strengthen clinician capacity to deliver HIV, HBV, and HCV treatment . Partners include:. . Supported through an educational grant from: . ≥ 18 years. Chronic HCV infection. Genotype 1 or 4. HCV RNA > 10 000 IU/ml. Treatment-naïve or pre-treated. w. ith PEG-IFN ± RBV. Cirrhosis (> 14.5 . kPa. on . FibroScan. ). Portal hypertension or liver .