Abstract
BackgroundWe investigated real-world effectiveness and safety of sofosbuvir and the nonstructural protein 5A inhibitors in the treatment of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, or 6.MethodsWe analyzed data from 1021 patients with HCV infection (506 with genotype 1; 16 with genotype 2; 314 with genotype 3; 13 with genotype 4; 166 with genotype 6) who received 12 to 24 weeks of daclatasvir plus sofosbuvir (n = 767), ledipasvir/sofosbuvir (n = 197), or sofosbuvir/velpatasvir (n = 57), with or without ribavirin in 12 centers across Thailand to estimate sustained virologic response at post-treatment week 12 (SVR12).ResultsOverall, SVR12 rate was 98.0% (95% confidence interval [CI], 96.7–98.8%) with daclatasvir plus sofosbuvir, 97.9% (95% CI, 94.8–99.2%) with ledipasvir/sofosbuvir, and 96.5% (95% CI, 88.1–99.0%) with sofosbuvir/velpatasvir. SVR12 was achieved by 99.2% (95% CI, 97.9–99.7%) of subjects with genotype 1 infection, 100% (95% CI, 78.5–100%) of those with genotype 2 infection, 96.7% (95% CI, 94.0–98.2%) of those with genotype 3 infection, 90.9% (95% CI, 62.3–98.4%) of those with genotype 4 infection, and 96.7% (95% CI 92.5–98.6%) of those with genotype 6 infection. Patients with advanced liver disease were at risk of treatment failure. Only four patients discontinued treatment before week 4 due to non-hepatic adverse events.ConclusionsIn this large cohort of patients with various HCV genotypes managed in the real-world practice setting, daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir achieved high SVR rates with good safety profile, comparable to those observed in clinical trials.
Highlights
We investigated real-world effectiveness and safety of sofosbuvir and the nonstructural protein 5A inhibitors in the treatment of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, or 6
Chronic hepatitis C virus (HCV) infection is recognized as a common cause of chronic liver disease leading to cirrhosis, hepatocellular carcinoma (HCC), and liver-related mortality across the world [1]
We reported here on our multicenter experience, which included a large number of patients infected with HCV genotypes 1, 2, 3, 4, or 6, who received SOF and nonstructural protein 5A (NS5A) inhibitors combination therapy, with or without ribavirin
Summary
We investigated real-world effectiveness and safety of sofosbuvir and the nonstructural protein 5A inhibitors in the treatment of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, or 6. Chronic hepatitis C virus (HCV) infection is recognized as a common cause of chronic liver disease leading to cirrhosis, hepatocellular carcinoma (HCC), and liver-related mortality across the world [1]. Several sofosbuvir (SOF)-based regimens have demonstrated their excellent efficacy and safety for treating chronic HCV infection. Combining SOF with the nonstructural protein 5A (NS5A) inhibitors, e.g., ledipasvir (LDV), daclatasvir (DAC), or velpatasvir (VEL) has shown remarkable efficacy with SVR rates at post-treatment week 12 exceeding 95% in clinical trials [5,6,7,8,9,10,11,12,13]. Even though the demonstrated safety and efficacy of the combination therapy in registrational trials is paramount, the continued safety and effectiveness of these regimens in diverse clinical care settings are of great importance
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