Common TitleNIAID ERADICATE
Official Title Virologic Response following Combined Ledipasvir and Sofosbuvir Administration in Patients with HCV Genotype 1 and HIV Co-Infection
Purpose / DescriptionERADICATE is an open-label, nonrandomized, phase 2 trial investigating the safety and efficacy of a 12-week regimen of ledipasvir-sofosbuvir in HCV treatment-naive patients with genotype 1 chronic hepatitis C who are coinfected with HIV. The study enrolled 50 patients and divided them into two cohorts: (a) those not receiving antiretroviral therapy (n=13), and (b) those receiving antiretroviral therapy (n=37). The patients on antiretroviral therapy were allowed to receive tenofovir-emtricitabine plus either efavirenz, raltegravir, rilpivirine, rilpivirine plus raltegravir, or efavirenz plus raltegravir. Data for patients not taking antiretroviral therapy showed 13 (100%) of 13 achieved an SVR12. For patients taking antiretroviral therapy, 36 (97%) of 37 achieved an SVR12. These findings suggest that ledipasvir-sofosbuvir is very effective in patients with genotype 1 HCV and HIV coinfection. The hepatitis C regimen was well tolerated and no patient discontinued hepatitis C therapy.
Phase Phase II
ClinicalTrials.gov NCT01878799
Treatments
Ledipasvir-Sofosbuvir

Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)