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The Phase 1 program evaluated DDIs between sofosbuvir/velpatasvir/voxilaprevir (S/V/V) and drug transporter and CYP probes, immunosuppressants, HIV antiretrovirals (ARV), and oral contraceptives (OC). S/V/V 400/100/ 100 mg ± VOX 100 mg was administered to healthy volunteers to achieve systemic VOX exposures observed across the HCV-infected patient population, as appropriate.
VOX AUC was ↑84% when administered with voriconazole; use of CYP3A inhibitors was permitted in Phase 3 trials. There was no effect on Cmax of voxilaprevir when combined.
The authors concluded that sofosbuvir/velpatasvir/voxilaprevir should be used with voriconazole only if risks are outweighed by benefits. Careful monitoring for safety and efficacy are warranted.
Garrison KL, Kirby B, Stamm LM, Ma G, Vu A. Drug-drug interaction profile of sofosbuvir/velpatasvir/voxilaprevir fixed-dose combination. Ilc: International Liver Conference. Amsterdam, Netherlands. 2017; April 2017.