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Potential for Sofosbuvir and Velpatasvir tablets to affect other medicinal products: Velpatasvir is an inhibitor of drug transporter P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3. Co-administration of Sofosbuvir and Velpatasvir tablets with medicinal products that are substrates of these transporters may increase the exposure of such medicinal products. See Table 17 for examples of interactions with sensitive substrates of P-gp (digoxin), BCRP (rosuvastatin), and OATP (pravastatin).
Potential for other medicinal products to affect Sofosbuvir and Velpatasvir tablets: Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP. Velpatasvir is also a substrate of drug transporter OATP1B. In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8 and CYP3A4 was observed. Medicinal products that are potent inducers of P-gp or potent inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may decrease plasma concentrations of sofosbuvir or velpatasvir leading to reduced therapeutic effect of sofosbuvir/velpatasvir. The use of such medicinal products with Sofosbuvir and Velpatasvir tablets is contraindicated (see Contraindications). Medicinal products that are moderate P-gp inducers or moderate CYP inducers (e.g. oxcarbazepine, modafinil or efavirenz) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Sofosbuvir and Velpatasvir tablets. Co-administration with such medicinal products is not recommended with Sofosbuvir and Velpatasvir tablets (see Precautions). Co-administration with medicinal products that inhibit P-gp or BCRP may increase sofosbuvir or velpatasvir plasma concentrations. Medicinal products that inhibit OATP, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentration of velpatasvir. Clinically significant medicinal product interactions with Sofosbuvir and Velpatasvir tablets mediated by P-gp, BCRP, OATP, or CYP450 inhibitors are not expected; Sofosbuvir and Velpatasvir tablets may be co-administered with P-gp, BCRP, OATP and CYP inhibitors.
Interactions between Sofosbuvir and Velpatasvir tablets and other medicinal products: Table 17 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within "↔", extended above "↑", or extended below "↓" the predetermined interaction boundaries). The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir or Sofosbuvir and Velpatasvir as individual agents, or are predicted medicinal product interactions that may occur with sofosbuvir/velpatasvir. The table is not all-inclusive. (See Tables 17a, 17b and 17c.)
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