Suvirus
Generic Name
Sofosbuvir + Velpatasvir
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
suvirus 400 mg tablet | ৳ 600.00 | ৳ 2,400.00 |
Description
Overview of the medicine
Suvirus is a fixed-dose combination of sofosbuvir and velpatasvir, used for the treatment of chronic Hepatitis C virus (HCV) infection in adults. It targets multiple genotypes of HCV.
Uses & Indications
Dosage
Adults
One tablet (400 mg sofosbuvir / 100 mg velpatasvir) orally once daily for 12 weeks.
Elderly
No dosage adjustment required for elderly patients.
Renal_impairment
No dosage adjustment required for mild to moderate renal impairment. Not recommended for severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease (ESRD) requiring dialysis.
How to Take
Take orally with or without food. Swallow the tablet whole. Do not chew or crush.
Mechanism of Action
Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor, and velpatasvir is an NS5A inhibitor. Together, they block viral replication at different stages, effectively reducing the viral load.
Pharmacokinetics
Onset
Rapid antiviral activity observed within hours; sustained virological response typically achieved after 12 weeks of treatment.
Excretion
Sofosbuvir metabolites are predominantly excreted via urine. Velpatasvir is primarily excreted via feces.
Half life
Sofosbuvir: ~0.5 hours (parent drug), ~18 hours (metabolite GS-331007); Velpatasvir: ~15 hours.
Absorption
Both sofosbuvir and velpatasvir are rapidly absorbed after oral administration, with peak plasma concentrations reached within 1-3 hours.
Metabolism
Sofosbuvir is metabolized in the liver to form the pharmacologically active nucleoside triphosphate. Velpatasvir is primarily metabolized by CYP3A4, CYP2B6, and CYP2C8.
Side Effects
Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Co-administration with strong P-gp inducers and/or moderate-to-strong CYP inducers (e.g., rifampin, St. John's Wort).
- Co-administration with amiodarone is not recommended due to risk of serious symptomatic bradycardia.
Drug Interactions
Rifampin
Significant decrease in sofosbuvir and velpatasvir plasma concentrations, leading to reduced therapeutic effect. Contraindicated.
Amiodarone
Risk of serious symptomatic bradycardia. Co-administration not recommended.
Antacids/H2-receptor antagonists/PPIs
Can reduce velpatasvir absorption. Separate administration or avoid concomitant use where appropriate.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management involves general supportive measures. Hemodialysis can remove the main circulating metabolite of sofosbuvir, but not velpatasvir.
Pregnancy & Lactation
Pregnancy: Limited data; use only if potential benefit outweighs risk. Lactation: Not known if excreted in human milk; decision to discontinue nursing or the drug should be made considering benefit to mother and risk to infant.
Side Effects
Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Co-administration with strong P-gp inducers and/or moderate-to-strong CYP inducers (e.g., rifampin, St. John's Wort).
- Co-administration with amiodarone is not recommended due to risk of serious symptomatic bradycardia.
Drug Interactions
Rifampin
Significant decrease in sofosbuvir and velpatasvir plasma concentrations, leading to reduced therapeutic effect. Contraindicated.
Amiodarone
Risk of serious symptomatic bradycardia. Co-administration not recommended.
Antacids/H2-receptor antagonists/PPIs
Can reduce velpatasvir absorption. Separate administration or avoid concomitant use where appropriate.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management involves general supportive measures. Hemodialysis can remove the main circulating metabolite of sofosbuvir, but not velpatasvir.
Pregnancy & Lactation
Pregnancy: Limited data; use only if potential benefit outweighs risk. Lactation: Not known if excreted in human milk; decision to discontinue nursing or the drug should be made considering benefit to mother and risk to infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA, DGDA
Patent Status
Patent protected (original manufacturer), generic versions available via compulsory licensing/licensing agreements
WHO Essential Medicine
YesClinical Trials
Extensive Phase 3 clinical trials (ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4) demonstrated high sustained virological response rates (SVR12) across all HCV genotypes, including patients with and without cirrhosis, and those with decompensated cirrhosis (with ribavirin).
Lab Monitoring
- Baseline and on-treatment HCV RNA levels.
- Liver function tests (ALT, AST, bilirubin) periodically.
- Renal function (eGFR) and electrolytes.
- For HBV co-infected patients: HBV DNA levels before, during, and after treatment.
Doctor Notes
- Emphasize HBV screening before initiation.
- Counsel patients on potential drug interactions, especially with amiodarone and rifampin.
- Regular monitoring of liver function tests is prudent, especially in patients with advanced liver disease.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine early, even if you feel better.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If a dose is missed and it has been less than 18 hours since the usual time, take it as soon as possible. If more than 18 hours have passed, skip the missed dose and take the next dose at the regular time. Do not take a double dose.
Driving Precautions
Suvirus has no or negligible influence on the ability to drive and use machines. However, if you experience fatigue or dizziness, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet and lifestyle.
- Avoid alcohol consumption as it can worsen liver damage.
- Practice safe sex to prevent transmission of HCV to others.
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