Erratum to: SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter Phase III Clinical Trial

BACKGROUND The combination of sofosbuvir and daclatasvir is a potent, pangenotypic regimen suitable for mass-scale hepatitis C treatment, especially in resource-limited countries where newer, expensive combinations are not available. This has been widely tested on genotype 4. However, Phase III trials this other genotypes have cost prohibitive. With the introduction generic, low-cost daclatasvir, large-scale studies now possible. METHODS Sofosbuvir at 400 mg 60 were coformulated into fixed-dose (FDC) tablet (Sovodak, Rojan Pharma, Tehran, Iran). Patients from 46 centers dosed 12 or 24 weeks with without ribavirin, line existing guidelines. Responses to treatment evaluated after end (for sustained virological response Week 12; SVR12). RESULTS There 1361 patients recruited. Overall, 21% female, mean age 50 years; 39% cirrhotic; 22% treatment-experienced; 47% 1, 41% 3, 2% genotypes. was known 10% patients. intention-to-treat per-protocol SVR12 rates 94.7% 98.8%, respectively. safety profile unremarkable, well tolerated, compliance single-tablet excellent. CONCLUSIONS FDC achieved high rates, equivalent those seen options, conducted similar scale representative, real-world population under $100 per patient, which makes elimination protocols countries. CLINICAL TRIALS REGISTRATION NCT03200184.