Real-World HCV Study Finds Sofosbuvir/Ledipasvir Safe, Effective

In Taiwan, real-world data on the effectiveness and safety of sofosbuvir/ledipasvir (SOF/LDV) with or without ribavirin (RBV) in patients with hepatitis C virus (HCV) are limited. A recent study looked to evaluate the real-world effectiveness of HCV treatment in patients with genotype 1 (HCV-1) infection.

The trial retrospectively enrolled 273 patients with chronic HCV-1 who received SOF/LDV for 8, 12, or 24 weeks with or without RBV. Among the 88 (32.2%) patients receiving RBV, all received the treatment for 12 weeks, including 25 who underwent liver transplantation, 25 with decompensated cirrhosis, and 39 with compensated cirrhosis.

Additionally, of the 272 patients with available HCV RNA data at week 4 of treatment, 218 (80.2%) of them had undetectable serum HCV RNA. The study identified 2 end points to evaluate effectiveness: evaluable population (EP) analysis, which assessed sustained virologic response at 12 weeks of therapy (SVR₁₂) for patients who received at least 1 dosage of treatment, and per-protocol population (PP) analysis, which assessed SVR₁₂ by excluding non-SVR₁₂ patients due to nonvirologic failure. Patients were considered failing to achieve SVR₁₂ if they lacked data.

Overall, the study found that sustained virologic response rates at 12 weeks of therapy were 96.7% (264 of 273 patients; 95% CI, 93.9%-98.3%) by EP analysis, and 97.5% (264 of 271 patients; 95% CI, 94.8%-98.8%) by PP analysis. Among patients who failed to achieve SCR₁₂, 7 (2.6%) relapsed and 2 (0.7%) were lost to follow up.

In terms of safety, 12 (4.4%) of patients experienced on-treatment serious adverse events. The most common adverse events included fatigue (27.1%), headache (20.5%), nausea (17.9%), and insomnia (13.9%).

Overall, the researchers were able to conclude that SOF/LDV treatment with or without RBV had “excellent” safety and effectiveness for patients with HCV-1 infection in Taiwan. The study authors wrote that SOF/LDV treatment with or without RBV for 9 to 24 weeks is well tolerated and achieves a high SVR₁₂ rate, which may improve the care of such patients in Taiwan.

Reference

Liu CH, Liu CJ, Su TH, et al. Real-world effectiveness and safety of sofosbuvir and ledipasvir with or without ribavirin for patients with hepatitis C virus genotype 1 infection in Taiwan [published December 21, 2018]. PLoS One. doi: 10.1371/journal.pone.0209299.