Epclusa (sofosbuvir/velpatasvir) is an important anti-hepatitis C virus (HCV) medication developed by Gilead Sciences, Inc. (U.S.), providing comprehensive treatment options for patients with chronic hepatitis C.

Indications of Epclusa (Sofosbuvir/Velpatasvir)

Target Population Scope

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infections in adult and pediatric patients aged 3 years and older.

Specific scenarios include:Patients with no cirrhosis or compensated cirrhosis may receive Epclusa as monotherapy directly.

For patients with decompensated cirrhosis, a regimen of Epclusa in combination with ribavirin is required.

Before initiating treatment, all patients must undergo testing for hepatitis B virus (HBV) infection, including measurement of hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).

Indications for Special Populations

Notably, Epclusa also demonstrates favorable efficacy in patients with HCV/HIV-1 coinfection, and its recommended dosage and administration are consistent with those for other patients.

For liver transplant recipients (both treatment-naive and treatment-experienced) with no cirrhosis or compensated cirrhosis, the recommended regimen is Epclusa once daily for 12 weeks.

Dosage Specifications and Properties of Epclusa (Sofosbuvir/Velpatasvir)

Tablet Specifications

400 mg/100 mg tablets: Pink, diamond-shaped, film-coated tablets, engraved with "GSI" on one side and "7916" on the other side.

200 mg/50 mg tablets: Pink, oval-shaped, film-coated tablets, engraved with "GSI" on one side and "S/V" on the other side.

Oral Pellet Specifications

200 mg/50 mg oral pellets: White to off-white, film-coated pellets, supplied in unit-dose packaging.

150 mg/37.5 mg oral pellets: White to off-white, film-coated pellets, supplied in unit-dose packaging.

Composition

The active ingredients of Epclusa include sofosbuvir and velpatasvir. These two components belong to HCV nucleotide analog NS5B polymerase inhibitor and HCV NS5A inhibitor, respectively.

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.

Excipients of the oral pellets include: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The film coating of the pellets contains: amino methacrylate copolymer, colloidal silicon dioxide, hypromellose, L-tartaric acid, polyethylene glycol, stearic acid, talc, and titanium dioxide.

Storage Methods for Epclusa (Sofosbuvir/Velpatasvir)

Storage Environment Requirements

Epclusa must be stored under specific temperature conditions. Both tablets and oral pellets should be stored below 30°C (86°F).

Special Storage Instructions

For tablet products, they must always be kept in the original container. This requirement is crucial for maintaining the stability and effectiveness of the medication.

A special note for the storage of oral pellets: Do not use pellets from opened or damaged packaging.