Sofosbuvir and Velpatasvir Tablets

Pharmacological action: This product is a compound preparation of sofosbuvir and velpatasvir. Sofosbuvir is a hepatitis C nonstructural protein 5B-dependent RNA polymerase inhibitor and a nucleotide drug progenitor. Its metabolite GS-461203 (uridine analog triphosphate) can be embedded into HCV RNA by NSSB polymerase to terminate replication. GS-461203 is neither an inhibitor of human DNA and RNA polymerase nor an inhibitor of mitochondrial RNA polymerase. Velpatasvir is a hepatitis C nonstructural protein 5A-dependent RNA polymerase inhibitor. In vitro resistance selection and cross-resistance studies suggest that the mechanism of action of velpatasvir is to target NS5A. The 50% effective concentration (ECso) values of sofosbuvir and velpatasvir against full-length or chimeric replicons encoding NSSB and NSSA sequences in laboratory isolates are listed in Table 13.

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

This product is a film-coated tablet, which is white to brownish yellow after removing the coating. The film-coated tablet is debossed with "GSI\" on one side and "7916" on the other side.

This product is used to treat chronic hepatitis C virus (HCV) infection in adults (see [Dosage and Administration], [Precautions] and [Pharmacology and Toxicology]).

Dosage The recommended dose of Epclusa is one tablet taken orally once daily, with or without food (see [Pharmacokinetics]). If ribavirin is used in patients with genotype 3 infection with compensated cirrhosis (pre- or post-transplant), the recommended dose of ribavirin is 1000/1,200 mg (for body weight

Summary of Safety Profile The safety profile of Epclusa is based on pooled Phase 3 clinical study data in patients with HCV infection with genotype 1.2, 3, 4, 5, or 6 (with or without compensated cirrhosis), including 1,035 patients who received 12 weeks of Epclusa. For patients who received 12 weeks of Epclusa, the proportion of patients who permanently discontinued treatment due to adverse events was 0.2%, and the proportion of patients who experienced any serious adverse events was 3.2%. In clinical studies, headache, fatigue, and nausea were the most common (incidence ≥10%) treatment-emergent adverse events reported in patients who received 12 weeks of Epclusa. These and other adverse events were reported at a similar frequency in patients who received placebo and those who received Epclusa.

Hypersensitivity to the active ingredients or any of the excipients. Coadministration of strong P-glycoprotein (P-gp) inducers or strong cytochrome P450 (CYP) inducers (rifampin, rifabutin, St. John's wort [Hypericumperforatum], carbamazepine, phenobarbital, and phenytoin) with strong P-gD permeators and strong CYP inducers. Coadministration can significantly reduce the plasma concentrations of sofosbuvir or velpatasvir and may cause Epclusa to lose efficacy (see [Drug Interactions]).

Precautions for children: The safety and efficacy of Epelusa in children and adolescents under 18 years of age have not been established. No data are available. Precautions for the elderly: Clinical studies of Epclusa included 156 patients aged 65 years and older (12% of the total number of patients in the Phase 3 clinical study). The response rates of patients aged ≥ 65 years were similar between the treatment groups.

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).

Store below 30°C.

(400mg/100mg)*28 tablets*1 bottle

48 months