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
- Usual Dose:
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
- Not for monotherapy:
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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