P-11 REAL-WORLD DATA WITH PANGENOTYPIC DIRECT-ACTING ANTIVIRALS IN LATINAMERICA: PRELIMINARY RESULTS OF THE SVR10K STUDY

Yes, Gilead-sponsored research A previous real-world data (RWD) analysis demonstrated high effectiveness of sofosbuvir/velpatasvir (SOF/VEL) without ribavirin in > 6,000 HCV patients from 12 clinical cohorts across Australia, Canada, Europe & USA. Expand this research initiative with the ongoing SVR10K study, to include even more patients from additional geographical areas, which will allow to show SOF/VEL effectiveness across multiple diverse populations, including Latin-American (LATAM) region. This RWD analysis includes patients ≥ 18 years treated with SOF/VEL without RBV for 12 weeks, as decided by the treating HCP, from 13 sites across Brazil, Colombia, Hong Kong, Mexico, Singapore, Sweden, Spain, Taiwan, and the United Arab Emirates. Age, sex, treatment experienced (TE), cirrhosis stage (no decompensated included), genotype, coinfections, time to treatment initiation (TTI) from HCV diagnosis, and SVR were analyzed for LATAM region. Overall, 7,027 patients have been included up to now, 13% (n=890) of them from four sites in the LATAM region (Table). There, median age was 54.5 [IQR 43.2-63.5], where males 51%, and age > 50 years in 62%. Genotype 3 was present in 14%, cirrhotic (CC) 34%, TE 8%, while HIV, HBV and HDV coinfection was reported in 7.2%, 0.3%, and 0.0%, respectively. The TTI was available in 94%, with 28% having ≤30 days (In Brazil 57%). In terms of effectiveness, SVR was achieved in 99.6% of the treated population (n=788); being 98.2% in GT3 patients (n=112), 99.6% in CC patients (n=279), and 97.4% in GT3 CC patients (n=38). Results on treatment effectiveness in LATAM region did not differ from RWD studies of patients in the North-Western countries, reinforcing that HCV treatment guidelines are globally applicable, and supporting the efficacy of panfibrotic, pangenotypic, and pangeographic DAA therapy. Although with positive signs, there is still a significant room for improvement in the time to treatment initiation in the LATAM region.