Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in HCV Genotype 4 NIAID SYNERGY (Genotype 4) Phase 2 Treatment Naïve and Treatment Experienced.

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Presentation transcript:

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in HCV Genotype 4 NIAID SYNERGY (Genotype 4) Phase 2 Treatment Naïve and Treatment Experienced Kohli A, et al. Lancet Infect Dis. 2015:15:

Hepatitis web study Source: Kohli A, et al. Lancet Infect Dis. 2015:15: Ledipasvir-Sofosbuvir in Genotype 4 NIAID SYNERGY (GT4) Trial: Features

Hepatitis web study Source: Kohli A, et al. Lancet Infect Dis. 2015:15: Ledipasvir-Sofosbuvir in Genotype 4 NIAID SYNERGY (GT4) Trial : Features Genotype 4 Treatment Naïve (n = 13) Treatment Experienced (n = 8) n = 21 Ledipasvir-Sofosbuvir Drug Dosing Ledipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once daily Week SVR12

Hepatitis web study Ledipasvir-Sofosbuvir in Genotype 4 NIAID SYNERGY (GT4) Trial : Key Baseline Characteristics Sex: Male 67% Race: 43% Black; 52% White; 5% Native American Country of Origin: 29% Egypt; 24% United States Treatment Experience: 62% naïve; 38% experienced HCV RNA > 800,000 IU/mL: 62% Source: Kohli A, et al. Lancet Infect Dis. 2015:15:

Hepatitis web study Ledipasvir-Sofosbuvir in Genotype 4 NIAID SYNERGY (GT4) Trial: Results NIH SYNERGY: SVR 12, Intent to Treat Analysis Source: Kohli A, et al. Lancet Infect Dis. 2015:15: /21* *1 patient did not complete 12 weeks of treatment due to drug non-adherence 12/13*8/8

Hepatitis web study Source: Kohli A, et al. Lancet Infect Dis. 2015:15: Ledipasvir-Sofosbuvir in Genotype 4 NIAID SYNERGY (GT4) Trial : Interpretation Interpretation: “Ledipasvir and sofosbuvir treatment for 12 weeks was well tolerated by patients with HCV genotype 4 and resulted in 100% SVR for all patients who received all 12 weeks of study drugs, irrespective of previous treatment status and underlying liver fibrosis. This is the first report of a single-pill, all-oral, interferon-free, ribavirin- free treatment for patients with HCV genotype 4.”

Hepatitis web study Hepatitis web study This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention.