SOFOSBUVIR+ VELPATASVIR

Sofosbuvir + Velpatasvir Tablet

Sofosbuvir + Velpatasvir is an antiviral combination therapy used for the treatment of chronic hepatitis C virus (HCV) infection. It is a fixed-dose combination (FDC) tablet that provides a highly effective, once-daily, pan-genotypic regimen for HCV.

Description

• Generic Name: Sofosbuvir + Velpatasvir

• Available Strengths: Sofosbuvir 400 mg + Velpatasvir 100 mg tablet

• Therapeutic Class: Direct-Acting Antivirals (DAAs)

• Route of Administration: Oral

Indications

• Used to treat chronic hepatitis C virus (HCV) infection in adults and children ≥6 years old or weighing at least 17 kg.

• Effective against all HCV genotypes (1–6).

• Can be used with or without ribavirin depending on the severity of liver disease (especially in patients with decompensated cirrhosis).

Mechanism of Action

• Sofosbuvir: A nucleotide analog inhibitor of the HCV RNA-dependent RNA polymerase (NS5B). It prevents viral replication.

• Velpatasvir: An HCV NS5A inhibitor that blocks viral RNA replication and virion assembly.

• Together, they stop HCV from multiplying and reduce viral load to undetectable levels.

Dosage & Administration

• Standard dose: 1 tablet (Sofosbuvir 400 mg + Velpatasvir 100 mg) once daily.

• Duration: Usually 12 weeks (may be extended to 24 weeks with ribavirin in severe cases).

• Can be taken with or without food.

• Should be taken at the same time every day.

Side Effects

Common:

• Headache

• Fatigue

• Nausea

• Insomnia

• Diarrhea

Serious (rare):

• Reactivation of hepatitis B (screening required before treatment)

• Severe allergic reactions

• Bradycardia (especially when taken with amiodarone)

Precautions

• Patients should be tested for HBV coinfection before starting therapy.

• Avoid use with strong inducers of P-gp and CYP inducers (like rifampin, carbamazepine, St. John’s Wort) as they reduce effectiveness.

• Safe in mild to moderate kidney impairment, but use with caution in severe kidney disease.

• Pregnancy: Use only if clearly needed and prescribed by a doctor.

• Breastfeeding: Limited data available; consult physician.

Storage

• Store at 20°C – 25°C (room temperature).

• Protect from moisture and direct sunlight.

• Keep out of reach of children.

FAQs

Q1. What is Sofosbuvir + Velpatasvir used for?
A: It is used to treat chronic hepatitis C infection in adults and children, effective against all genotypes of the virus.

Q2. How long does treatment last?
A: Usually 12 weeks, but in some cases (especially with cirrhosis), it may be extended to 24 weeks along with ribavirin.

Q3. Can Sofosbuvir + Velpatasvir cure hepatitis C?
A: Yes, it is considered a curative treatment in most cases, achieving sustained virologic response (SVR).

Q4. What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it’s close to the next scheduled dose, skip the missed dose. Do not double dose.

Q5. Is it safe to take with other medicines?
A: Some medicines (like rifampin, phenytoin, amiodarone, antacids) may interact. Always consult your doctor about other medications before starting therapy.

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Reference:-

• European Medicines Agency (EMA) – Epclusa (Sofosbuvir + Velpatasvir)
  The EPAR (European Public Assessment Report) provides comprehensive regulatory assessment, indications, and dosage details.
  https://www.ema.europa.eu/en/medicines/human/EPAR/epclusa European Medicines Agency (EMA)

• U.S. FDA – Approval Announcement for Epclusa (Sofosbuvir/Velpatasvir)
  Official FDA press release confirming approval for treating all hepatitis C genotypes, including dosing specifics.
  https://www.fda.gov/news-events/press-announcements/us-fda-approves-epclusa-sofosbuvirvelpatasvir-treatment-chronic-hepatitis-c accp1.orgGilead

• Drugs.com – Epclusa (Sofosbuvir/Velpatasvir) FDA Approval History
  Timeline and historical summary of U.S. approvals, including label expansions and pediatric indications.
  https://www.drugs.com/history/epclusa.html Drugs.com

• CenterWatch – Epclusa (Sofosbuvir + Velpatasvir) Overview
  Synopsis of the fixed-dose combination, including approved dosage and patient population.
  https://www.centerwatch.com/directories/1067-fda-approved-drugs/listing/3465-epclusa-sofosbuvir-and-velpatasvir