Sovalvir
Generic Name
Sovalvir
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sovalvir 400 mg tablet | ৳ 861.71 | ৳ 6,032.00 |
Description
Overview of the medicine
Sovalvir is an antiviral medication primarily used to treat chronic Hepatitis C virus (HCV) infection. It is a direct-acting antiviral (DAA) that targets and inhibits the viral RNA polymerase, preventing the virus from replicating.
Uses & Indications
Dosage
Adults
400 mg once daily, taken orally with or without food, in combination with other direct-acting antivirals as recommended by guidelines.
Elderly
No dose adjustment required for elderly patients.
Renal_impairment
No dose 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 requiring dialysis, due to insufficient data.
How to Take
Take orally once daily, with or without food. Swallow the tablet whole; do not chew, crush, or break it.
Mechanism of Action
Sovalvir (Sofosbuvir) is a nucleotide analog NS5B polymerase inhibitor. It is a prodrug that is intracellularly metabolized to its pharmacologically active uridine analog triphosphate. This active metabolite incorporates into the nascent HCV RNA by the NS5B polymerase and acts as a chain terminator, thereby inhibiting viral RNA replication.
Pharmacokinetics
Onset
Rapid reduction in HCV RNA levels, typically within hours of first dose.
Excretion
Primarily renal excretion of the main metabolite (GS-331007), accounting for approximately 80% of the dose. Fecal excretion accounts for about 14%.
Half life
Sofosbuvir: ~0.5 hours. Main circulating metabolite (GS-331007): ~18-19 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentration achieved within 0.5-2 hours. Bioavailability is high.
Metabolism
Extensively metabolized in the liver via cathepsin A and carboxylesterase 1, followed by phosphoramidate cleavage to form the active triphosphate form. The primary circulating inactive metabolite is GS-331007.
Side Effects
Contraindications
- Hypersensitivity to Sofosbuvir or any component of the formulation.
- Coadministration with strong P-gp inducers (e.g., Rifampin, St. John's Wort, Carbamazepine) is generally contraindicated due to reduced Sofosbuvir exposure.
Drug Interactions
Amiodarone
Serious symptomatic bradycardia may occur. Co-administration is not recommended. If unavoidable, cardiac monitoring is advised.
P-glycoprotein (P-gp) inhibitors (e.g., Ritonavir, Cyclosporine)
May increase Sofosbuvir exposure; however, no dose adjustment is usually required.
P-glycoprotein (P-gp) inducers (e.g., Rifampin, St. John's Wort, Carbamazepine, Phenytoin)
May significantly decrease Sofosbuvir plasma concentrations, leading to reduced therapeutic effect. Co-administration is generally contraindicated.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
No specific antidote for Sofosbuvir overdose. In case of overdose, patients should be monitored for signs and symptoms of toxicity. Treatment consists of general supportive measures. Hemodialysis can efficiently remove the predominant circulating metabolite GS-331007 (extraction ratio of 53%), but Sofosbuvir itself is not significantly removed by dialysis.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown a risk, but human data are limited. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Sofosbuvir and its metabolites are excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patent protected internationally, available generically in some countries (e.g., Bangladesh)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials (e.g., NEUTRINO, FISSION, POSITRON, FUSION) demonstrated high sustained virologic response (SVR) rates across various HCV genotypes, leading to its approval.
Lab Monitoring
- HCV RNA levels (viral load) at baseline and during/after treatment.
- Liver function tests (ALT, AST, bilirubin) at baseline and periodically.
- Complete blood count (CBC) if used with Ribavirin.
Doctor Notes
- Emphasize the importance of adherence to the full treatment course for optimal outcomes.
- Always use in combination with other direct-acting antivirals as per latest guidelines.
- Counsel patients on potential drug interactions, especially with amiodarone.
Patient Guidelines
- Take the medication exactly as prescribed by your doctor.
- Do not stop taking the medication early, even if you feel better, as this can lead to treatment failure.
- Attend all scheduled doctor's appointments and lab tests.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed and less than 18 hours have passed 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 regularly scheduled time. Do not take a double dose.
Driving Precautions
Sovalvir is generally not expected to impair the ability to drive or operate machinery. However, patients experiencing fatigue or headache should exercise caution.
Lifestyle Advice
- Maintain a healthy diet and lifestyle.
- Avoid alcohol consumption as it can worsen liver disease.
- Discuss any concerns or side effects with your healthcare provider promptly.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.