Ledipasvir 90 mg & Sofosbuvir 400 mg
Twinvir: Each tablet contains Ledipasvir INN 90 mg and Sofosbuvir INN 400 mg
It is a fixed-dose combination tablet containing Ledipasvir and Sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.
Ledipasvir and Sofosbuvir combination is indicated for the treatment of chronic hepatitis C (CHC) genotype 1, 4 & 6 infection in adults.
Dosage & Administration
• Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken orally once daily with or without food
• Recommended treatment duration:
Treatment-naïve with or without cirrhosis: 12 weeks
• Treatment-experienced without cirrhosis: 12 weeks
• Treatment-experienced with cirrhosis: 24 weeks
A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease.
The most common adverse reactions with treatment with Ledipasvir and Sofosbuvir combination for 8, 12, or 24 weeks are fatigue and headache.
• Bradycardia with Amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking Amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of Amiodarone with Ledipasvir and Sofosbuvir combination is not recommended. In patients without viable treatment options, cardiac monitoring is recommended
• Use with other drugs containing sofosbuvir, is not recommended
Use in Pregnancy & Lactation
Pregnancy Category B
There are no adequate and well-controlled studies with Ledipasvir and Sofosbuvir combination in pregnant women.
Ledipasvir and Sofosbuvir combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Ledipasvir and Sofosbuvir combination and its metabolites are present in human breast milk.
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Safety and effectiveness of Ledipasvir and Sofosbuvir combination have not been established in pediatric patients
• Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of Ledipasvir and Sofosbuvir combination with Amiodarone is not recommended
• P-gp inducers (e.g., Rifampin, St. John’s wort): May alter concentrations of Ledipasvir and Sofosbuvir. Use of Ledipasvir and Sofosbuvir combination with P-gp inducers is not recommended
Twinvir Blister pack: Each box contains 1 blister strip of 6 tablets.
Twinvir Container Pack: Each bottles contains 28 tablets.