Hopetavir Tablet

Hopetavir 400 mg Tablet

Generic Name: Sofosbuvir
Strength: 400 mg
Dosage Form: Tablet
Manufacturer: Incepta Pharmaceuticals Ltd.
Pack Size: 1 × 6 tablets

Indications

Hopetavir (Sofosbuvir) is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Efficacy has been established in subjects with HCV genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma awaiting liver transplantation and those with HCV/HIV-1 co-infection.

• Monotherapy of Sofosbuvir is not recommended for treatment of CHC.
• Treatment regimen and duration are dependent on both viral genotype and patient population.

Pharmacology

Sofosbuvir is a nucleotide analog inhibitor that specifically inhibits HCV NS5B RNA-dependent RNA polymerase. Following intracellular metabolism to the pharmacologically active uridine analog triphosphate (GS-461203), Sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator, preventing further replication of HCV genetic material.

Dosage & Administration

One 400 mg tablet taken once daily with or without food, always in combination with other antivirals.

Recommended combination regimens (HCV mono-infected & HCV/HIV-1 co-infected):

• Genotype 1 or 4: Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks
• Genotype 2: Sofosbuvir + Ribavirin for 12 weeks
• Genotype 3: Sofosbuvir + Ribavirin for 24 weeks

For patients with HCC awaiting liver transplantation: Sofosbuvir + Ribavirin for up to 48 weeks or until transplantation.

Contraindications

When used in combination with Ribavirin or Peginterferon alfa/Ribavirin, all contraindications of those agents apply. Combination therapy is contraindicated in women who are pregnant or may become pregnant, and men whose female partners are pregnant, due to risks of birth defects and fetal death associated with Ribavirin.

Side Effects

Most common adverse events (≥20%) with Sofosbuvir + Ribavirin: fatigue and headache. With Sofosbuvir + Peginterferon alfa + Ribavirin: fatigue, headache, nausea, insomnia, anemia, pruritus, asthenia, rash, decreased appetite, chills, influenza-like illness, pyrexia, diarrhea, neutropenia, myalgia, irritability.

Precautions & Warnings

Bradycardia with amiodarone: Serious symptomatic bradycardia may occur in patients taking amiodarone with Sofosbuvir in combination with another direct-acting antiviral (DAA). Co-administration is not recommended. Cardiac monitoring is required if no alternative treatment options are available.

Drug Interactions

Reduced therapeutic effect with potent P-gp inducers (rifampicin, St. John's Wort, carbamazepine, phenytoin), modafinil, phenobarbitone/oxcarbazepine, rifabutin/rifapentine. P-gp and/or BCRP inhibitors may increase Sofosbuvir exposure.

Pregnancy & Lactation

Pregnancy Category B. No adequate well-controlled studies in pregnant women. Not known whether Sofosbuvir or its metabolites are present in human breast milk.

Use in Special Populations

Pediatric: Safety and efficacy not established in patients under 18 years. Geriatric: No dose adjustment required; response rates similar to younger patients.

Storage

Store in a cool, dry place. Protect from light. Keep out of reach of children.

Pricing

Unit Price: ৳600.00 per tablet (Pack of 6 tablets: ৳3,600.00)

Disclaimer: This product information is for reference purposes only and does not substitute professional medical advice, diagnosis, or treatment. Always consult a registered physician or qualified healthcare professional before taking any medication.