Real life efficacy of ledipasvir/sofosbuvir in hepatitis C genotype 4–infected patients with advanced liver fibrosis and decompensated cirrhosis

Twelve weeks of ledipasvir/sofosbuvir all‐oral regimen for patients with chronic hepatitis C genotype 2 infection: Integrated analysis of three clinical trials

“…decompensated cirrhosis) were not included in this analysis, LDV/SOF plus RBV has been shown to be efficacious and safe in genotype 1 and genotype 4 HCV patients with decompensated cirrhosis. 34,35 The use of LDV/SOF in patients with advanced chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1.73m 2 ) might be of concern to some physicians, as SOF and its metabolite GS-331007 are mainly eliminated through renal clearance. 36 However, a recent update to LDV/SOF's FDA prescribing information in March 2020 determined that no LDV/SOF dose adjustment is required in patients with any degree of renal impairment, including end-stage renal disease on dialysis, affirming that LDV/SOF could be used safely in this population.…”

Treatment efficacy of ledipasvir/sofosbuvir for 8 weeks in non-cirrhotic chronic hepatitis C genotype 4 patients

“…Efficacy of 12-week DAA-based, fixed-dose combination treatments for patients with HCV GT4 infection is similar among grazoprevir/elbasvir with or without RBV (97%–100%),[11] paritaprevir/ritonavir/ombitasvir with or without RBV (91%–100%),[15] LDV/SOF (93%–100%),[56712] and SOF/velpatasvir (95%–100%). [1314] Glecaprevir/pibrentasvir treatment for 8 or 12 weeks resulted in 99% to 100% of treatment naïve and -experienced, non-cirrhotic HCV GT4–infected patients achieving SVR12.…”

“…A recent real-world experience from Saudi Arabia with LDV/SOF in GT4 ( n = 213) revealed an SVR12 of 90% to 93% in decompensated and compensated patients. [7] Thus, it becomes obvious that 12 weeks of treatment duration with LDV/SOF is sufficient for cirrhotic patients, clearly leaving the door open for a shorter duration in non-cirrhotic GT4 patients.…”

“…In the afore-mentioned real-world cohort from Saudi Arabia, the use of RBV did not result in higher SVR12 rates in the overall cohort (91.8% vs. 94.0% without RBV), including in those with compensated cirrhosis (93.1% vs. 93.9% without RBV). [7]…”

“…A 12-week treatment regimen of LDV/SOF achieved 76% to 100% sustained virological response 12 weeks after the end of the treatment (SVR12) in patients with a range of baseline characteristics (treatment naïve or experienced, cirrhotic, or non-cirrhotic). [567] Treatment guidelines recommend a 12-week duration of LDV/SOF treatment for HCV GT4–infected patients who are either treatment-naïve, with or without cirrhosis, or treatment-experienced without cirrhosis. [48]…”