Description

Sofosbuvir is an oral direct-acting antiviral (DAA) that targets the hepatitis C virus (HCV) by inhibiting the NS5B RNA polymerase, essential for viral replication. It serves as a key component in combination regimens for treating chronic hepatitis C.

Prescription

Prescription-only medication — Sofosbuvir must be used under medical supervision and in combination with other antivirals like ribavirin, daclatasvir, peginterferon, etc..

Dosage

• Standard adult dose: One 400 mg tablet taken orally once daily, with or without food .
• Treatment regimens vary (12–24 weeks) depending on HCV genotype, cirrhosis status, co-infections, and transplant status.

Therapeutic Category

HCV nucleotide analog NS5B polymerase inhibitor — a direct-acting antiviral used to treat chronic hepatitis C.

Active Ingredients / Composition

Each tablet contains 400 mg of sofosbuvir (the active ingredient). Inactive formulation components vary by manufacturer (not commonly detailed publicly).

Variant

• 400 mg film-coated tablets are the primary form .
• Alternative formulations include 200 mg or 150 mg pellets for pediatric use.

Consume Type

Oral administration, swallowed whole with water; may be taken with or without food.

Directions / Usage

Administer once daily as part of a multi-drug regimen (e.g., with ribavirin ± peginterferon or other DAAs). Treatment duration—typically 12 or 24 weeks—depends on genotype and clinical factors like cirrhosis or liver transplantation status . Dose adjustments may be needed for renal impairment.

Common Side Effects

• Common: Fatigue, headache, nausea, insomnia, anemia (when combined with ribavirin) .
• Concerns: Reactivation of hepatitis B in co-infected patients, and cases of bradycardia when co-administered with amiodarone and other DAAs.
  

Package Type

Typically packaged as film-coated tablets in blister packs or bottles; pediatric forms may come in pellet packets .

Storage Advice

Store at room temperature, away from heat, moisture, and direct light; keep in original container, out of reach of children .

Safety Advice

• Use only as directed in combination therapy — not to be used as monotherapy.
• Screen for hepatitis B before initiating treatment to monitor for reactivation .
• Avoid co-administration with amiodarone plus DAAs due to risk of severe bradycardia.
• Ribavirin-containing regimens require effective contraception, as ribavirin is teratogenic.

Product Substitutes

• Brand-name: Sovaldi® (Gilead Sciences).
• Generic versions are produced under license in several countries and often used in national HCV treatment programs .

Manufacturer / Marketer

• Original developer: Gilead Sciences (via acquisition of Pharmasset) — markets under brand Sovaldi.
• Generic production: Licensed to companies such as Mylan in India .
  

Country of Origin

• Originally developed and marketed by Gilead Sciences (USA) 
• Licensed generics manufactured in countries like India, with wider distribution to low- and middle-income regions