Summary

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• Epclusa (sofosbuvir and velpatasvir) is indicated for the treatment of adult and pediatric patients aged 3 years and older with chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, and for the treatment of adult and pediatric patients aged 3 years and older with chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection with decompensated cirrhosis, in combination with ribavirin.
• This summary is based on the review of eight systematic review(s)/meta-analysis(es). ^[1-8]
• Sustained Virological Response (SVR12): SOF/VEL achieved SVR12 rates of 94.2% (95% CI: 90.7-97.7%) in the general population, 91.0% (95% CI: 87.7-93.9%) in decompensated cirrhosis, 97.69% (95% CI: 95.71-98.92%) in ESRD patients, and 95.08% (95% CI: 90.88-98.13%) in HCV genotype 3 patients.
• Comparison of SOF/VEL with Other Treatments: SOF/VEL demonstrated higher SVR12 rates compared to SOF/LED (86.3%, p=0.004) and SOF/DCV (82.4%, p<0.001) in patients with decompensated cirrhosis. SOF/VEL also outperformed SOF/VEL/VOX in HCV genotype 3 with SVR12 rates of 95.08% vs. 84.97% (95% CI: 73.32-93.91%).
• Subgroup Analysis: Adolescents treated with SOF/VEL showed a 95% SVR12 rate, older children 93%, and young children 83%. Decompensated cirrhosis patients had a 91.0% SVR12 rate, and ESRD patients on RRT had a 97.69% SVR12 rate.
• Sofosbuvir/Velpatasvir (SOF/VEL): Reported adverse events in 30% of patients, with serious adverse events in 3.82%. No serious adverse events attributable to SOF/VEL in patients with end-stage renal disease.
• SOF/VEL in Decompensated Cirrhosis: Adding ribavirin significantly increased the frequency of adverse events from 52.9% to 89.2%.
• Evaluations of specific population types, including adolescents, older children, young children, decompensated cirrhotic patients, patients with ESRD on RRT, and patients with HCV Genotype 3 and 6, indicate varying SVR12 rates and adverse events, with younger children showing higher AE rates and ribavirin increasing adverse events in decompensated cirrhosis.