Co-administration of ledipasvir/sofosbuvir (90/400 mg single dose) and doravirine (100 mg single dose) increased doravirine AUC, Cmax and C24 by 15%, 11% and 24%, respectively. Ledipasvir AUC and Cmax decreased by 8% and 9%; sofosbuvir AUC increased by 4% but Cmax decreased by 11%; AUC and Cmax of GS-331007 both increased by 3%. No dose adjustment is required.

No clinically significant changes in drug concentrations were observed when doravirine was co-administered with ledipasvir and sofosbuvir.

Co-administration of doravirine (100 mg single dose) and ledipasvir/sofosbuvir (90/400 mg single dose) was studied in 14 healthy subjects. Doravirine AUC, Cmax and C24 increased by 15%, 11% and 24%, respectively. Ledipasvir AUC and Cmax decreased by 8% and 9% respectively. Sofosbuvir AUC increased by 4% and Cmax decreased by 11%; AUC and Cmax of GS-331007 (the major circulating sofosbuvir metabolite) both increased by 3%. The modest increases in doravirine exposure are not clinically meaningful based on the therapeutic profile of doravirine and coadministration of doravirine with ledipasvir/sofosbuvir was generally well tolerated.