Tu1503 – Usage of Ppi Reduces the Svr Rate for Hiv-Hcv Coinfected Patients Using Ledipasvir/Sofosbuvir: A Real-World Study from Multicenter Va Cohort

Background and Aims Patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV) have more rapid liver disease progression and worse outcomes than patients monoinfected with either HBV or HCV.Cases of HBV reactivation during HCV treatment have been reported in the IFN era and with directly acting antivirals (DAAs).This study evaluated the safety and efficacy of an all-oral treatment with ledipasvir (LDV)/sofosbuvir (SOF) for 12 weeks in patients with chronic HCV and HBV coinfection.Here we present the final study results through follow up Week 108.Methods 111 patients chronically infected with HCV genotype (GT) 1 or GT2 and HBV (positive for serum HBsAg) were enrolled into this open-label study to receive LDV 90 mg/SOF 400 mg (once daily) for 12 weeks.Following treatment, patients were monitored for safety (HBV DNA reactivation) and efficacy for a total of 108 weeks.HBV DNA reactivation is defined as a post-baseline increase from baseline to>=LLOQ or>1 log10 IU/mL in patients that were< LLOQ or>= LLOQ at baseline, respectively.Results Baseline characteristics included: mean age 55 years, 62% female, 67% treatment naive, 84% without cirrhosis, 61% GT1, and HBeAg negative (99%) with a mean baseline HBV DNA of 2.1 log10 IU/mL.SVR12 was 100% and through week 96 of post treatment follow up; there were no viral relapses.HBV DNA reactivation occurred in 73% of patients; 12% of whom also had a corresponding ALT increase>2x ULN.To date, 8 patients have started HBV therapy per Taiwanese treatment guidelines.The majority (86%) of HBV reactivations occurred by post treatment week 12, followed by an additional 11% by the end of Year 1 and 3% by the end of Year 2. 90% of HBV reactivations were asymptomatic with no patient developing clinical symptoms.Through 96 weeks of follow up, 19 patients had serious adverse events (AEs); 1 patient withdrew consent, and 2 patients died; none were considered drug related.The most common AEs reported (≥5% of patients) were headache, fatigue, upper respiratory infection, dizziness, malaise, nephrolithiasis, myalgia and HBV reactivation.Full data through FU-108 for all patients will be provided.Conclusions n patients with chronic HCV/HBV infection, LDV/SOF for 12 weeks resulted in an SVR12 rate of 100%.Although most patients had an increase in HBV DNA, only 8 subjects started HBV therapy.LDV/SOF treatment for HBV/HCV coinfected patients remains a highly effective, safe and tolerable regimen in patients with HCV/HBV coinfection.