In this population of patients with advanced liver disease, ledipasvir/sofosbuvir plus ribavirin treatment was generally safe and well tolerated with low rates of treatment-related serious adverse events and treatment discontinuation due to adverse events.
In patients receiving a broad range of sofosbuvir-containing regimens, SVR rates higher in patients without detectable Week 4 HCV RNA vs with detectable Week 4 HCV RNA; further analysis required.
Early efficacy data from this small patient group, which included patients on hemodialysis, suggests treatment effective in subtype 1a and 1b populations.
In patients with genotype 3 HCV infection, sofosbuvir plus pegIFN/RBV more effective than sofosbuvir plus RBV regimens regardless of treatment history or cirrhosis.
SVR12 rates were 88% in treatment-naive patients and 79% in treatment-experienced patients—higher than historical controls with earlier approved DAA plus peginterferon/ribavirin-based regimens.
Rates of anemia-related AEs, worsening renal function, and renal and urinary AEs increased across patient groups with decreasing renal function.
While the 12-week regimen was effective regardless of HCV genotype 1 subtype or presence of Q80K mutation, efficacy was diminished when treatment was shortened to 8 weeks.
In this observational cohort study, higher SVR12 rates with 12 weeks of sofosbuvir plus daclatasvir than sofosbuvir/ledipasvir among patients with genotype 3 HCV infection.
In this open-label trial, SVR12 rates were numerically lower in patients with vs without baseline NS5A RAVs and in patients who received 12 vs 8 weeks of previous ledipasvir/sofosbuvir-based therapy.
Among patients with genotype 1 HCV infection, sofosbuvir plus simeprevir was selected most commonly and associated with 74% SVR12.
Ledipasvir/sofosbuvir effective with very low rates of serious adverse events and no treatment-related discontinuations in patients with genotype 4 or 5 HCV infection.
Incidence of HCV reinfection 4.7/100 person-years among patients who relapsed to injection drug use vs 1.8/100 person-years among those with any previous injection drug use.
In multivariate analysis, black race only factor associated with treatment failure.
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