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Table 2

Effect of new direct-acting antivirals in pregnancy and Food and Drug Administration Pregnancy Categories

DrugEmbryotoxicity and/or teratogenicity1Dose-escalation2Transfer across placentaTransfer into milkFDA Pregnancy Category3
SofosbuvirNo28-foldYesYesB
SimeprevirYes4-foldYesYesC
DaclatasvirYes4-foldYesYesNA4
LedipasvirNoMaternal toxic dosesYesYesB
ViekiraxOmbitasvirYes4-foldMinimalYesB
Paritaprevir32-fold
Ritonavir8-fold
DasabuvirNo48-foldMinimalYesB
1Based on animal studies;
2Dose escalation above therapeutic dose;
3FDA Pregnancy Category without association with ribavirin. NA: Not available; FDA: The Food and Drug Administration.
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