Medicine details
| Image |  |
| Name | Twinvir |
| Dosage | Tablet |
| Generic Name | Ledipasvir + Sofosbuvir |
| Classes |
Antiinfective Agent Antiviral Agent Antiviral Combination |
| Diseases |
Hepatitis C Infectious Disease |
| Company | Incepta Pharmaceuticals Ltd. |
Drug Package Details
| Strength | |
| Storage Condition | |
| Origin Country | Bangladesh |
| Commercial Pack | 28 |
| Price per pack | ৳ 28,000.00 |
| Cost per pack | ৳ 24,640.00 |
| Package unit | 7 tabs strip |
| Price per unit | ৳ 1,000.00 |
| Cost per unit | ৳ 880.00 |
| Discount | 0 |
| Coupon | |
| Remarks |
Ledipasvir + Sofosbuvir
Ledipasvir + Sofosbuvir is a combination of two antiviral drugs. Ledipasvir is an inhibitor of the Hepatitis C Virus (HCV) NS5A protein, which is required for viral RNA replication and virus assembly. Although the precise mechanism of action is unknown, it is thought to prevent NS5A hyperphosphorylation, which is required for viral production.
Sofosbuvir is an inhibitor of the Hepatitis C Virus RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate, which can be incorporated into HCV RNA by the polymerase and acts as a chain terminator.
Ledipasvir + Sofosbuvir is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older:
- Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
- Genotype 1 infection with decompensated cirrhosis, in combination with ribavirin
- Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
- Testing prior to the initiation of therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.
- Recommended treatment regimen and duration in patients 3 years of age and older:
| HCV Genotype | Patient Population | Regimen and Duration |
| Genotype 1 | Treatment-naive without cirrhosis or with compensated cirrhosis (Child-Pugh A) | Ledipasvir + Sofosbuvir 12 weeks |
| Treatment-experienced without cirrhosis | Ledipasvir + Sofosbuvir 12 weeks | |
| Treatment-experienced with compensated cirrhosis (ChildPugh A) | Ledipasvir + Sofosbuvir 24 weeks | |
| Treatment-naive and treatmentexperienced with decompensated cirrhosis (ChildPugh B or C) | Ledipasvir + Sofosbuvir + ribavirin 12 weeks | |
| Genotype 1 or 4 | Treatment-naive and treatmentexperienced liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) | Ledipasvir + Sofosbuvir + ribavirin 12 weeks |
| Genotype 4, 5, or 6 | Treatment-naive and treatmentexperienced without cirrhosis or with compensated cirrhosis (Child-Pugh A | Ledipasvir + Sofosbuvir 12 weeks |
- Recommended dosage in adults: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food.
- Recommended dosage in pediatric patients 3 years and older: Recommended dosage of Ledipasvir + Sofosbuvir in pediatric patients 3 years of age and older is based on weight.
- HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables in the full prescribing information.
- If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications.
- A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease.
- Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
- Reactivation of the Hepatitis B Virus: Before starting HCV treatment, all patients should be tested for evidence of current or prior HBV infection. During HCV treatment and post-treatment follow-up, monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare. As clinically indicated, initiate appropriate patient management for HBV infection.
- Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia can occur in patients taking amiodarone, especially if they are also taking beta blockers or have underlying cardiac comorbidities or advanced liver disease. Amiodarone and Ledipasvir + Sofosbuvir should not be taken together. Cardiovascular monitoring is advised in patients who do not have other viable treatment options.
Contraindication
If used in combination with ribavirin, all contraindications to ribavirin also apply to Ledipasvir + Sofosbuvir combination therapy.
None known.
None known.
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