Skip to main content
. 2018 Jul 19;9(4):522–538. doi: 10.1016/j.jceh.2018.07.004

Table 1.

Characteristics of DAAs Approved by the European Medicines Agency (EMA).a

Active substance (commercial name) Year of approval Dosage Administration Genotype
Sofosbuvir (Sovaldi) 2014 400 mg 12 wks (SOF + PegIFN/RBV) 1, 2, 3, and 4
12 wks (SOF + RBV)
24 wks (SOF + RBV)
Until the transplantation 24 wks (SOF + RBV)
Until the transplantation 48 wks (SOF + RBV)
12 wks (SOF + SIM + RBV)
24 wks (SOF + SIM + RBV)
Simeprevir (Olysio) 2015 150 mg 12 wks (SIM + PegIFN/RBV) + 12 wks (PegIFN/RBV) 1 and 4
12 wks (SIM + PegIFN/RBV) + 36 wks (PegIFN/RBV)
12 wks (SIM + SOF)
12 wks (SIM + SOF) + 12 wks (SIM + SOF)
Daclatasvir (Daklinza) 2015 60 mg 12 wks (DACL + SOF ± RBV) 1, 3, and 4
24 wks (DACL + SOF ± RBV)
24 wks (DACL + PegIFN + RBV) + 24 wks (PegIFN/RBV)
Ledipasvir/sofosbuvir (Harvoni) 2014 90 mg/400 mg 8 wks (Led/SOF) 1,3, and 4
12 wks (Led/SOF ± RBV)
24 wks (Led/SOF ± RBV)
Ombitasvir/paritaprevir/ritonavir (Viekirax) 2015 12.5 mg/75 mg/250 mg 12 wks (ombitasvir/paritaprevir/ritonavir + RBV) 1 and 4
24 wks (ombitasvir/paritaprevir/ritonavir + RBV)
Dasabuvir (Exviera) 2015 50 mg 12 wks (ombitasvir/paritaprevir/ritonavir + DAS) 1 and 4
24 wks (ombitasvir/paritaprevir/ritonavir + DAS)
12 wks (ombitasvir/paritaprevir/ritonavir + DAS + RBV)
24 wks (ombitasvir/paritaprevir/ritonavir + DAS + RBV)
Grazoprevir/elbasvir (Zepatier) 2016 100 mg/50 mg 8 wks (GRA + ELB) 1 and 4
12 wks (GRA + ELB ± RBV)
Velpatasvir/sofosbuvir (Epclusa) 2016 100 mg/400 mg 12 wks (Valp + SOF ± RBV) 1, 2, 3, 4, 5, and 6
Asunaprevir/daclatasvir/beclabuvir Soon be available 1, 2, 3, 4, and 5

Wks, weeks; SOF, sofosbuvir; RBV, ribavirin; IFN, interferon; SIM, simeprevir; DACL, daclatasvir; Led, ledipasvir; DAS, dasabuvir; GRA, grazoprevir; ELB, elbasvir; Valp, velpatasvir.

a

Faldaprevir 120 mg was withdrawn during the marketing authorization procedure.