Epclusa is an important antiviral drug for hepatitis C developed by Gilead Sciences, Inc., providing comprehensive treatment options for patients with chronic hepatitis C.
Epclusa Indications
Applicable Population
(1) Epclusa is indicated for the treatment of chronic hepatitis C virus genotypes 1, 2, 3, 4, 5, or 6 infection in adults aged 3 years and older and pediatric patients.
(2) Specifically, patients without cirrhosis or with compensated cirrhosis can use Epclusa as monotherapy.
(3) For patients with decompensated cirrhosis, a regimen of Epclusa combined with ribavirin is required.
(4) Before starting treatment, all patients must be tested for hepatitis B virus infection, including measuring hepatitis B surface antigen and hepatitis B core antibody.
Special Population Indications
(1) It is noteworthy that Epclusa also demonstrates good efficacy in patients co-infected with HCV/HIV-1, and its dosage and administration are recommended to be consistent with other patients.
(2) For treatment-naïve and previously treated liver transplant recipients, if there is no cirrhosis or with compensated cirrhosis, the recommended regimen is once-daily Epclusa for 12 weeks.
Epclusa Drug Specifications
Tablet Specifications
(1) 400 mg/100 mg tablets: Pink, rhomboid, film-coated tablets, marked "GSI" on one side and "7916" on the other.
(2) 200 mg/50 mg tablets: Pink, oval, film-coated tablets, marked "GSI" on one side and "S/V" on the other.
Oral Microcapsules Specifications
(1) Project Metadata-200 mg/50 mg oral microcapsules: White to off-white, film-coated microcapsules, unit dose packaging.
(2) 150 mg/37.5 mg oral microcapsules: White to off-white, film-coated microcapsules, packaged in unit dose form.
Composition:
(1) The active ingredients of Propofol include sofosbuvir and velpatasvir, which are HCV nucleotide analogue NS5B polymerase inhibitors and HCV NS5A inhibitors, respectively.
(2) Tablet excipients include copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablet film coating contains: iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
(3) The excipients of the oral microcapsules include: colloidal silica, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
(4) The film coating of the microcapsules contains: aminomethyl acrylate copolymer, colloidal silica, hydroxypropyl methylcellulose, L-tartaric acid, polyethylene glycol, stearic acid, talc, and titanium dioxide.
Epclusa Storage Method
Storage Environment Requirements
Epclusa requires storage under specific temperature conditions. Both tablets and oral microcapsules should be stored below 30°C (86°F).
Special Storage Instructions
(1) For tablet products, they must always be kept in their original container. This requirement is crucial for maintaining the stability and efficacy of the drug.
(2) Special care must be taken when storing oral microcapsules: Do not use microcapsules that have been opened or damaged.
