Hepatitis C Virus Treatment Response to Ledipasvir/Sofosbuvir Among Patients Co-Infected with HIV and HCV: Real-world Data in a Black Population

Abstract

BackgroundTreatment of Hepatitis C virus (HCV) infection for patients with Human Immunodeficiency Virus (HIV) has improved with direct acting antivirals (DAAs). However, outcomes among Black persons treated with ledipasvir/sofosbuvir (LDV/SOF) may be inferior to non-Blacks. We assessed responses to LDV/SOF in a cohort of Black HIV/HCV co-infected persons in Newark, New Jersey.MethodsRetrospective chart reviews were conducted for Black, genotype 1 (GT1), HIV/HCV co-infected patients treated with LDV/SOF at three hospitals in Newark, New Jersey between January 2014 and July 2016. Data collected included demographics, HCV treatment history, treatment duration and response.Results117 HIV/HCV co-infected Black patients started treatment with LDV/SOF but 5 had no follow up data and 5 prematurely discontinued treatment (1 due to side effects). We included 107 HIV/HCV co-infected patients who completed LDV/SOF at all three sites. The study population was 65% male, median age 58 years, 26% had cirrhosis and 77% had GT1a. 31% were treatment experienced but none with prior NS5a treatment. At baseline, median CD4 count was 680 cells/mm3, HIV viral load (VL) was < 40 in 94% and median HCV VL was 2257403 IU/ml. 29% of patients changed antiretroviral treatment (ART) before LDV/SOF treatment due to drug interactions (Table-1).Table-1:ART changes prior to LDV/SOF treatmentRegimenBaseline(N = 107)Switched(N = 31)Switched toFinal prior to treatment (N = 107)Integrase inhibitor (INSTI)4810INSTI65Protease inhibitor (PI)2814INSTI14Included efavirenz123INSTI54OtherOther190-236, 89, and 12 patients completed 8, 12, and 24 weeks of LDV/SOF respectively. Table-2 shows details of our sustained virologic response (SVR) data.Table-2:SVR12 Rates by Treatment Duration and ART class SVR12 Rates Relapse Overall93%7/107By duration8 weeks67%2/612 weeks96%4/8924 weeks92%1/12By ART ClassINSTI95%3/65PI93%1/14Included efavirenz80%1/5Other91%2/23ConclusionIn this real-world cohort of Black, GT1, HIV/HCV co-infected patients, LDV/SOF had high SVR12 rate of 93%. However, there were not enough patients in the 8 week arm to assess its efficacy. This data supports the overall high efficacy of LDV/SOF in a difficult-to-treat patient population.Disclosures J. Slim, Gilead: CME/CE, Consultant, Investigator and Speaker’s Bureau, Consulting fee, Research support and Speaker honorarium; Abbvie: CME/CE, Consultant and Investigator, Consulting fee, Research support and Speaker honorarium; Merck: CME/CE, Consultant and Investigator, Consulting fee, Research support and Speaker honorarium; ViiV: CME/CE, Consultant and Investigator, Consulting fee, Research support and Speaker honorarium; Janssen: CME/CE and Consultant, Consulting fee and Speaker honorarium; BMS: CME/CE, Speaker honorarium S. Swaminathan, Gilead Sciences: Grant Investigator and Scientific Advisor, Consulting fee and Research grant