Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 and HIV Coinfection ION-4 Phase 3 Treatment Naïve and Treatment Experienced.

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Presentation transcript:

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 and HIV Coinfection ION-4 Phase 3 Treatment Naïve and Treatment Experienced Naggie S, et al. CROI. 2015; Abstract 152LB. HIV Coinfection

Hepatitis web study Source: Naggie S, et al. CROI. 2015; Abstract 152LB. Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV Coinfection ION-4 Trial: Features

Hepatitis web study Source: Naggie S, et al. CROI. 2015; Abstract 152LB. Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV Coinfection ION-4 Trial: Study Design Ledipasvir- Sofosbuvir Week Drug Dosing: Ledipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once daily Antiretrovirals allowed: tenofovir-emtricitabine plus either efavirenz, rilpivirine, or raltegravir SVR12 GT 1 or 4 N = 335

Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV Coinfection ION-4 Trial: Baseline Characteristics Baseline Characteristic Ledipasvir-Sofosbuvir (n = 335) Mean age, years 52 Male, n (%) 276 (82) African American, n (%) 115 (34) Hispanic or Latino, n (%) 56 (17%) Mean BMI, kg/m 2 26 IL28B CC, n (%) 81 (24) GT 1 (%) 327 (98) HCV treatment experienced, n (%) 185 (55) Cirrhosis, n (%) 67 (20%) Mean HCV RNA, log 10 IU/mL 6.7 ± 0.6 Median CD4 Count, cells/mm 3 (range)628 ( ) Source: Naggie S, et al. CROI. 2015; Abstract 152LB.

Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV Coinfection ION-4 Trial: Antiretroviral Regimens ION-4: HIV Antiretroviral Regimen Antiretroviral Agent Antiretroviral Received (n = 335) Tenofovir-emtricitabine335 (100) Efavirenz160 (48) Rilpivirine29 (9) Raltegravir146 (44) Source: Naggie S, et al. CROI. 2015; Abstract 152LB.

Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV Coinfection ION-4 Trial: Results ION-4: SVR12 Results Source: Naggie S, et al. CROI. 2015; Abstract 152LB. Prior Treatment StatusLiver Status 321/335142/150179/185258/26863/67

Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV Coinfection ION-4 Trial: Adverse Effects Source: Naggie S, et al. CROI. 2015; Abstract 152LB. Event Ledipasvir-Sofosbuvir (n = 335) Discontinuation due to adverse event0 Grade 3-4 Adverse Event14 (4%) Serious Adverse Event8 (2%) Headache83 (25%) Fatigue71 (21%) Diarrhea36 (11%) Nausea33 (10%) Arthralgia22 (7%) Upper respiratory tract infection18 (5%)

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.