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Sofovir 400mg

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Brand Name: Sofovir
International Trade Name: Sovaldi
Active Substance: Sofosbuvir
Strength: 400mg
Category: Hepatitis C
Manufacturer: Hetero Healthcare Ltd
Pack: 28 Tablets in a Bottle
Product Form: Tablet
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Sofovir 400mg (Sofosbuvir 400mg) – Overview

Sofovir is a direct-acting antiviral medication used to treat chronic hepatitis C virus (HCV) infection. Presented as a 400mg oral tablet, it is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase—an enzyme essential for viral replication.

 

Medical Uses / Indications

  • Indicated for:
    • Chronic HCV infection (adults and certain pediatric patients, depending on guidelines)
    • Used in combination with other antiviral agents (not as monotherapy)
  • HCV Genotypes:
    • Broad activity against multiple HCV genotypes (1, 2, 3, 4, 5, 6)
  • Treatment Goals:
    • Achieve sustained virologic response (SVR), considered a cure of hepatitis C

How Sofovir Works (Mechanism of Action)

Sofovir is a prodrug converted in the body to an active triphosphate form. This active metabolite inhibits the HCV NS5B RNA-dependent RNA polymerase by acting as a chain terminator during viral RNA replication, effectively blocking the virus from multiplying.

Dosage & Administration

    • Usual Dose:
      • 400mg orally, once daily, with or without food
    • Duration:
      • Typically 12 weeks (may vary depending on genotype, combination regimen, and patient factors)
    • Combination Therapy:
      • Always used in combination with other antivirals (e.g., ledipasvir, velpatasvir, daclatasvir, or ribavirin)
    • Special Populations:
      • Dose adjustment not generally required for mild-to-moderate renal/hepatic impairment; consult guidelines for severe cases

Possible Side Effects

Common Side Effects:
  • Fatigue
  • Headache
  • Nausea
  • Insomnia
Serious Side Effects:
  • Severe allergic reactions (rare)
  • Bradycardia (slow heart rate), especially when used with amiodarone
  • Reactivation of hepatitis B in co-infected patients

Drug Interactions

  • Strong inducers of P-glycoprotein:
    • May decrease sofosbuvir effectiveness (e.g., rifampin, St. John’s Wort)
  • Amiodarone:
    • Risk of serious symptomatic bradycardia when coadministered; avoid use together
  • Other DAAs and antivirals:
    • Consult specific combination regimens for interactions

Precautions

    • Not for monotherapy:
      • Always use with other antivirals
    • Hepatitis B co-infection:
      • Risk of HBV reactivation—screen before starting
    • Renal/Hepatic impairment:
      • Use with caution in severe impairment
    • Pregnancy & Breastfeeding:
      • Safety not well established; use only if clearly needed
    • Use in children:
      • Only as recommended by guidelines

Storage & Handling

    • Store at room temperature (20–25°C / 68–77°F)
    • Keep in the original container, tightly closed
    • Protect from moisture and light
    • Keep out of reach of children

Missed Dose

If you miss a dose:
    • Take it as soon as you remember on the same day.
    • If it is almost time for your next dose, skip the missed dose—do not double up.
    • Continue with your regular dosing schedule.

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