LAUSR

Abstract Background Treatment 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. Methods Retrospective 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. Results 117 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 treatment Regimen Baseline(N = 107) Switched(N = 31) Switched to Final prior to treatment
(N = 107) Integrase inhibitor (INSTI) 48 10 INSTI 65 Protease inhibitor (PI) 28 14 INSTI 14 Included efavirenz 12 3 INSTI 5 4 Other Other 19 0 - 23 6, 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 Overall 93% 7/107 By duration 8 weeks 67% 2/6 12 weeks 96% 4/89 24 weeks 92% 1/12 By ART Class INSTI 95% 3/65 PI 93% 1/14 Included efavirenz 80% 1/5 Other 91% 2/23 Conclusion In 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