Generic
Ledipasvir + Sofosbuvir
8 brands available in the market
At a glance
Ledipasvir + Sofosbuvir is a combination of two antiviral medicines used for the treatment of chronic hepatitis C virus (HCV) infection. It inhibits viral replication and helps resolve the infection.
Description
Ledipasvir is an HCV NS5A inhibitor and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase. Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. The triphosphate form of Sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in chain termination.
Indications
- Chronic hepatitis C virus (HCV) infection - genotypes 1, 4, 5, or 6
Therapeutic class
Hepatic Viral Infections (Hepatitis C)
Pharmacological class
NS5A Inhibitor + NS5B Polymerase Inhibitor
Pharmacology
Ledipasvir inhibits the HCV NS5A protein which is important for viral replication, assembly and secretion. Sofosbuvir's triphosphate metabolite is incorporated into the HCV RNA chain by HCV RNA polymerase, causing chain termination.
Mechanism of action
Reduces hepatitis C virus levels by inhibiting viral replication.
Dosage
Adult Dose (Oral):
- One tablet (Ledipasvir 90 mg + Sofosbuvir 400 mg) once daily
- With or without food
- Duration: Treatment-naive with or without cirrhosis: 12 weeks; Treatment-experienced without cirrhosis: 12 weeks; Treatment-experienced with cirrhosis: 24 weeks
Hepatic Impairment: Mild-severe: No dosage adjustment required
Administration
- Swallow tablet whole; do not chew, crush or break
- Take at the same time each day
- May be taken with or without food
Missed dose
If you miss a dose, take it as soon as possible. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Side effects
Common Side Effects:
- Fatigue
- Headache
- Nausea
- Diarrhea
- Insomnia
Precautions & warnings
- Caution when driving or activities requiring concentration (may cause dizziness and blurred vision)
- Serious bradycardia with Amiodarone - not recommended
- Monitor liver function and viral load regularly
- Limit or avoid alcohol
- Do not stop suddenly
Contraindications
- Hypersensitivity to Ledipasvir, Sofosbuvir, or any components of the product
Drug interactions
- Amiodarone: Serious bradycardia (not recommended)
- P-gp inducers (Rifampin, St. John's wort, Carbamazepine, Phenytoin): Reduced therapeutic effect
- Modafinil, Phenobarb, Oxcarbazepine, Rifabutin/Rifapentine
Food interactions
Safety with alcohol is not known; consult your doctor.
Use in pregnancy
Use in Pregnancy: Ledipasvir + Sofosbuvir is generally considered safe during pregnancy (FDA Category B). Animal studies have shown low or no adverse effects to the developing baby.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Ledipasvir + Sofosbuvir is probably safe during breastfeeding. Limited human data suggests no significant risk to the baby.
Pediatric use
Safety and effectiveness not established in pediatric patients.
Geriatric use
No overall differences in safety or effectiveness observed in geriatric patients; no dosage adjustment needed.
Renal / hepatic impairment
Renal Impairment: Use with caution in severe kidney disease; no dose adjustment in mild to moderate kidney disease.
Hepatic Impairment: Safe in liver disease; no dose adjustment required.
Overdose effects
No specific overdose information available; symptomatic and supportive measures should be employed.
Storage conditions
Keep out of reach of children; store in a cool and dry place, protected from light.
Chemical structure
Ledipasvir + Sofosbuvir