Sofokast Plus ( Sofosbuvir, Daclatasvir) 400+60 mg 28 tab

Sofokast Plus (Sofosbuvir + Daclatasvir) 400 mg + 60 mg, 28 tablets

Manufacturer: Aprazer Healthcare Pvt. Ltd.
Country of origin: India
Dosage form: Film-coated tablets
Strength: Sofosbuvir 400 mg + Daclatasvir 60 mg
Pack: 28 tablets

Pharmacological group

Direct-acting antiviral combination therapy (DAA) for the treatment of chronic Hepatitis C virus (HCV) infection.

Pharmacological action

Sofokast Plus combines two potent antivirals acting at different stages of the HCV life cycle:

• Sofosbuvir — a nucleotide analogue inhibitor of NS5B RNA-dependent RNA polymerase, essential for viral replication.
• Daclatasvir — a potent NS5A inhibitor, blocking both viral RNA replication and virion assembly.

Together, they achieve a sustained virologic response (SVR) across all major HCV genotypes (1–6), including in patients with liver cirrhosis or prior treatment failure.

Indications

Treatment of chronic Hepatitis C (HCV) infection in adults:

• HCV genotypes 1 to 6.
• With or without cirrhosis (compensated or decompensated).
• Post liver transplantation.
• Coinfection with HIV (under medical supervision).

Composition

Each film-coated tablet contains:

• Active ingredients:
  • Sofosbuvir — 400 mg
  • Daclatasvir dihydrochloride — 60 mg
• Excipients: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, PEG, ferric oxide colorants.

Dosage and administration

• Take one tablet daily, orally, with water, with or without food.
• Do not crush or chew.
• Standard treatment duration: 12 weeks; may be extended to 24 weeks in specific clinical cases.
• May be used with Ribavirin in patients with cirrhosis or prior treatment failure.

Therapy should be prescribed and monitored by a hepatologist or infectious disease specialist.

Contraindications

• Hypersensitivity to Sofosbuvir, Daclatasvir or any excipient.
• Severe renal impairment (eGFR < 30 mL/min).
• Pregnancy and lactation.
• Pediatric patients under 18 years (safety not established).

Adverse reactions

Generally well tolerated. Common adverse effects include:

• Fatigue, headache, insomnia, dizziness, nausea, diarrhea.
• Mild liver enzyme elevation.
• When combined with Ribavirin: anemia, irritability, rash, pruritus.

Precautions

• Perform HCV genotyping and liver function tests prior to therapy.
• Avoid coadministration with strong enzyme inducers (rifampicin, carbamazepine, phenytoin, St. John’s Wort).
• Avoid concurrent use with other Sofosbuvir or Daclatasvir-containing medicines.
• Women of childbearing potential must use reliable contraception during therapy.

Drug interactions

• CYP3A4 / P-gp inducers decrease plasma levels of both agents.
• P-gp inhibitors may increase concentrations.
• Amiodarone may cause serious bradycardia when used concomitantly.

Storage

Store below 30 °C, in a dry, dark place.
Keep out of reach of children.

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