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This slide deck provides an overview of the Phase 3 HIV Coinfection Treatment with Ledipasvir-Sofosbuvir in GT1 or GT4, including study design, drug dosing, baseline characteristics, antiretroviral regimens, results, adverse effects, and conclusions.
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Phase 3 HIV Coinfection Treatment Naïve and Treatment Experienced Ledipasvir-Sofosbuvir in GT1 or GT4 and HIV CoinfectionION-4 Naggie S, et al. N Engl J Med 2015;378:705-13.
Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV CoinfectionION-4 Trial: Features Source: Naggie S, et al. N Engl J Med 2015;378:705-13.
Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV CoinfectionION-4 Trial: Study Design 0 12 24 Week GT 1 or 4N = 335 Ledipasvir- Sofosbuvir SVR12 Drug Dosing: Ledipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once dailyAntiretrovirals allowed: tenofovir-emtricitabineplus either efavirenz, rilpivirine, or raltegravir Source: Naggie S, et al. N Engl J Med 2015;378:705-13.
Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV CoinfectionION-4 Trial: Baseline Characteristics Source: Naggie S, et al. N Engl J Med 2015;378:705-13.
Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV CoinfectionION-4 Trial: Antiretroviral Regimens Source: Naggie S, et al. N Engl J Med 2015;378:705-13.
Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV CoinfectionION-4 Trial: Results ION-4: SVR12 Results by Genotype 321/335 240/250 74/77 8/8 Source: Naggie S, et al. N Engl J Med 2015;378:705-13.
Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV CoinfectionION-4 Trial: Results ION-4: SVR12 Results by Prior Treatment Status and Liver Status 321/335 142/150 179/185 258/268 63/67 Prior Treatment Status Liver Status Source: Naggie S, et al. N Engl J Med 2015;378:705-13.
Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV CoinfectionION-4 Trial: Adverse Effects Source: Naggie S, et al. N Engl J Med 2015;378:705-13.
Ledipasvir-Sofosbuvir in GT1 or GT4 with HIV CoinfectionION-4 Trial: Conclusions Source: Naggie S, et al. N Engl J Med 2015;378:705-13.
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.