These drugs are used in combination clinically for genotype 1 HCV, but not as first line therapy.
Simeprevir versus Sofosbuvir
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Study Design
Drug–drug interactions with simeprevir were evaluated in a phase II, randomized, openlabel study (the COSMOS study) of HCV treatment-experienced and treatment-nai ¨ve subjects. Subjects received simeprevir (150 mg once daily under fed conditions) and sofosbuvir (400 mg once daily) alone or in combination with RBV.
Study Results
An analysis of serial pharmacokinetic samples obtained from 22 subjects (10 male) demonstrated no clinically signi?cant effect of sofosbuvir on simeprevir exposure. In comparison with another study (data not presented) in which sofosbuvir was administered in the absence of simeprevir, the sofosbuvir Cmax and AUC24h were increased by 1.19- and 3.16-fold, respectively; the Cmax of the major metabolite of sofosbuvir, GS-331007, was decreased 31 %, and the AUC24h was unaffected.
Study Conclusions
The increases in sofosbuvir exposure were not considered clinically relevant because of the low transient exposure to this form of the drug relative to the total drug-related material. Simeprevir and sofosbuvir may be coadministered without dose adjustment.
References
Burgess S, Partovi N, Yoshida EM, Erb SR, Azalgara VM, Hussaini T. Drug interactions with direct-acting antivirals for hepatitis c: implications for hiv and transplant patients. Annals Of Pharmacotherapy. 2015; 6: 674-687.
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