Sofokast-Plus (Sofosbuvir 400 mg + Daclatasvir 60 mg)

Sofokast-Plus is formulated as film-coated tablets:

• Dosage Form & Packaging: Plastic bottle containing 28 film-coated tablets, packaged in a sealed cardboard box with a tamper-evident hologram.
• Active Ingredients: Daclatasvir — 60 mg, Sofosbuvir — 400 mg.
• Excipients: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, film coating (hypromellose, titanium dioxide, macrogol, colorants).

Pharmacodynamics: Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, blocking viral RNA synthesis. Daclatasvir is an inhibitor of the HCV non-structural protein 5A (NS5A), which is essential for viral replication and virion assembly. Dual target inhibition blocks viral replication and minimizes resistance development.

Pharmacokinetics: Both active substances are rapidly absorbed after oral administration. Peak plasma concentrations are reached in 0.5–2 hours for sofosbuvir and 1–2 hours for daclatasvir. Sofosbuvir is mainly eliminated renally, whereas daclatasvir is excreted primarily via feces.

Sofokast-Plus is indicated for:

• 🔹 Chronic Hepatitis C: Treatment of chronic HCV infection (Genotypes 1, 2, 3, and 4) in adult patients.
• 🔹 Complex Patient Populations: Suitable for patients without cirrhosis or with compensated cirrhosis (Child-Pugh Class A), as well as HCV/HIV co-infected individuals.

Administration guidelines for Sofokast-Plus:

• 👤 The standard recommended dose is 1 tablet once daily.
• 💊 Swallow the tablet whole with water. Do not chew, crush, or split the tablet.
• ⏰ Take consistently at the same time every day, with or without food.
• ⏱️ Standard treatment duration is 12 weeks (may be extended to 24 weeks in specific cases with cirrhosis or prior treatment failure based on medical advice).

Sofokast-Plus is contraindicated in:

• ❌ Hypersensitivity to daclatasvir, sofosbuvir, or any inactive components.
• ❌ Co-administration with strong P-gp or CYP3A4 inducers (rifampin, St. John's wort, carbamazepine, phenytoin).
• ❌ Pregnancy and breastfeeding.
• ❌ Pediatric patients under 18 years of age (safety and efficacy not established).
• ❌ Severe renal impairment (eGFR < 30 mL/min) without expert medical consultation.

Important drug interactions for Sofokast-Plus:

• ⚠️ Amiodarone: Co-administration is strictly contraindicated due to the risk of severe, life-threatening symptomatic bradycardia.
• ⚠️ Anticonvulsants & Antimycobacterials (rifampin, carbamazepine): Substantially reduce plasma concentrations of daclatasvir and sofosbuvir.
• ⚠️ HIV Antiretrovirals: Dose adjustment of daclatasvir may be required when co-administered with certain protease inhibitors or NNRTIs.

Sofokast-Plus is contraindicated during pregnancy and lactation. Women of childbearing potential must use effective contraception during treatment. If used in combination with ribavirin, strict contraception is mandatory for both male and female patients.

Common side effects of Sofokast-Plus (generally mild to moderate):

• 🔴 Most Common: Fatigue, headache, mild nausea, insomnia.
• 🟡 Less Common: Dizziness, decreased appetite, diarrhea, rash, pruritus, anemia (when co-administered with ribavirin).

Symptoms: Exaggerated adverse events.

Treatment: No specific antidote is available. Management consists of general supportive measures. Hemodialysis efficiently removes the main circulating metabolite of sofosbuvir, but not daclatasvir due to high protein binding.

Storage instructions for Sofokast-Plus:

• 🌡️ Temperature: Store in original packaging at temperature not exceeding 30 °C.
• ☀️ Protection: Keep protected from light and moisture.
• 👶 Safety: Keep out of reach of children.

Authenticity features of genuine Sofokast-Plus (Prazer / Aprazer):

• 🛡️ Holographic Seal: Original protective security hologram on the top flap of the outer box.
• 🔍 Tamper Seal: Protective foil seal under the cap of the plastic bottle.
• 📦 Carton Marking: Clearly printed Batch Number, Manufacturing Date, Expiry Date, and Manufacturing License Number on both the box and bottle label.