The combination of sofosbuvir and daclatasvir is a potent, pan-genotypic regimen suitable for mass scale hepatitis C treatment especially in resource-limited countries such as Iran where newer expensive combinations are not available. The combination of these two drugs in a single pill has been first trialed in Iran. This study evaluated the sustained viral response rate (SVR) in 1380 patients treated with this combination in a multicenter trial throughout the country.

400mg sofosbuvir and 60mg daclatasvir were co-formulated into a fixed-dose combination (FDC) tablet (Sovodak, Rojan Pharma, Tehran, Iran). Patients from 45 centers were dosed for 12 or 24 weeks with or without ribavirin in line with existing guidelines. Response to treatment was evaluated 12 weeks after end of treatment (SVR12). ClinicalTrials.gov ID: NCT03200184.

1380 patients were recruited. Overall the patients were 21% female with mean age of 50 years. 37% were cirrhotic. 23% were treatment-experienced, 46% were genotype 1 and 40% were genotype 3. The intention-to-treat and per-protocol SVR12 rates were 94.1% and 98.6% respectively. Details are given in table. The safety profile was unremarkable, treatment was well tolerated, and compliance with the single tablet regimen was excellent.

Treatment with FDC of sofosbuvir and daclatasvir achieved high SVR12 rates equivalent to those seen in phase 3 trials of other pan-genotypic options and has been conducted at similar scale in a representative real-world population.