BEM/RZR demonstrated statistical non-inferiority compared to the fixed-dose combination of sofosbuvir and velpatasvir (SOF/VEL) in the modified intent-to-treat (mITT) population, achieving the trial’s primary endpoint.
This combination resulted in meaningful improvement in secondary endpoints including a ≥2-point reduction in the NAFLD Activity Score (NAS), and ≥1-grade reductions in steatosis, hepatocellular ballooning and lobular inflammation.
Through three or five years of follow-up, dependent on cohort, HCC was observed in 21 patients (1.0 percent in the TAF group; 1.9 percent in the TDF group), with a median time to onset of 104 weeks.
Eight of 12 patients achieved primary endpoint of sustained virologic response (SVR) 12, which is considered a cure, using only 6 weeks of Epclusa’s therapy combined with only 2 weeks of CC-31244
High efficacy and improvement in CPT class with sofosbuvir/velpatasvir plus ribavirin for 12 weeks in patients with CPT C decompensated cirrhosis (poster #0138)
The ASTRAL study results demonstrate that a 12-week course of therapy with the first fixed-dose combination of two pan-genotypic compounds can provide high cure rates for patients with all HCV genotypes,
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Known as
SOF/VEL
ClinicalTrials.gov intervention name — accepted as the source's own labelNCT02781558 ↗
Known as
sofosbuvir/velpatasvir
“The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and...” NCT02781558 ↗