Sofosbuvir

This product is a compound preparation, and its components are: each tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir. Sofosbuvir Chemical name: L-alanine, N-[[P(S),2'R]-2'-deoxy-2'-fluoro-2'-methyl-P-phenyl-5'-uridyl]-, 1-methylethyl ester Chemical structure: Molecular formula: C22H29FN3O9P Molecular weight: 529.45 Leadipasvir Chemical name: Amino acid, N-[(1S)-1-[[(6S)-6-[5-[9,9-difluoro-7-[2-[(1R,3S,4S)-2-[(2S)-2-[(methyl ester )amino]-3-methyl-1-oxobutyl]-2-azabicyclo[2.2.1]hept-3-yl]-1H-benzimidazol-6-yl]-9H-fluoren-2-yl]-1H-imidazol-2-yl]-5-azaspiro[2.4]hept-5-yl]carbonyl]-2-methylpropyl]-, methyl ester complex with 2-acetone (1:1) (LDV-AS) Chemical structure: Molecular formula: C52H60F2N8O7 Molecular weight: 947.08 (LDV: 889, acetone: 58.08)

Since Ledipasvir-Sofosbuvir Tablets contain Ledipasvir and sofosbuvir, any interactions observed when these active ingredients are used alone may occur with the use of Ledipasvir-Sofosbuvir Tablets. Potential for Ledipasvir-Sofosbuvir Tablets to Affect Other Medications Ledipasvir is an in vitro inhibitor of the drug transporters P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-substrates of these transporters. Potential for Other Medications to Affect Ledipasvir-Sofosbuvir Tablets Ledipasvir and sofosbuvir are substrates of the drug transporters P-gp and BCRP, whereas GS-331007 is not. Drugs that are potent P-gp inducers (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital, and phenytoin) may significantly reduce plasma concentrations of Ledipasvir and sofosbuvir, resulting in reduced efficacy of Ledipasvir-Sofosbuvir Tablets, and therefore these drugs should be contraindicated when using Ledipasvir-Sofosbuvir Tablets (see [Contraindications]). Drugs that are moderate intestinal P-gp inducers (such as oxcarbazepine) may reduce the plasma concentrations of ledipasvir and sofosbuvir tablets, resulting in reduced efficacy of ledipasvir sofosbuvir tablets. It is not recommended to use such drugs together with ledipasvir sofosbuvir tablets (see [Precautions]), which can inhibit the plasma concentrations of PEP and BCRP63-3107: ledipasvir sofosbuvir tablets can be used in combination with PgP and BCRP inhibitors. Clinically significant drug interactions mediated by CYP450 or UGTIAI enzymes are not expected to occur with ledipasvir sofosbuvir tablets. Patients receiving vitamin K antagonists are advised to closely monitor the international normalized ratio (INR) because liver function may change during treatment with ledipasvir sofosbuvir tablets. Interactions between Ledipasvir and Sofosbuvir Tablets and Other Drugs Table 6 provides a list of drug interactions that have been identified or may be clinically significant (where the 90% confidence interval [CI] of the least squares geometric mean [GLSM] ratio is indicated as follows: within the predetermined equivalence limit range "→", above this range "↑" or below this range "↓"). The drug interactions are based on studies conducted using Ledipasvir and Sofosbuvir Tablets or Ledipasvir and Sofosbuvir as separate drugs, or are predicted to be possible drug interactions when using Ledipasvir and Sofosbuvir Tablets. This table is not all-inclusive.

The main ingredient of this product is sofosbuvir, and its chemical name is: (S)-isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)-(phenoxy)phosphoamino)propionate

Sofosbuvir is a nucleotide prodrug. After oral administration of Sovaldi, sofosbuvir is rapidly absorbed and undergoes extensive first-pass metabolism in the liver and intestine. Intracellular prodrug hydrolytic cleavage catalyzed by enzymes such as carboxylesterase 1 and sequential phosphorylation steps catalyzed by nucleotide kinases form pharmacologically active uridine nucleoside analog triphosphates. More than 90% of systemic exposure to drug-related substances comes from the major inactive circulating metabolite GS331007, which is produced via a metabolic pathway parallel and sequential to the formation of active metabolites (see instructions for details)

This product is a compound preparation, and its components are: each tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir.

Because Epclusa contains sofosbuvir and velpatasvir, any interactions observed with these active substances alone may occur with Epclusa. Potential for Epclusa to Affect Other Medications Velpatasvir is an inhibitor of the drug transporters P-gp, breast cancer resistance protein (BCRP), organic anion transporting polypeptide (OATP) 1B1, and OATP1B3. Co-administration of Epclusa with drugs that are substrates of these transporters may increase exposure to these drugs. See Table 3 for examples of interactions with sensitive substrates of P-gp (digoxin), BCRP (rosuvastatin), and OATP (pravastatin).