Hepcee
Generic Name
Sofosbuvir + Daclatasvir
Manufacturer
Generic Pharmaceuticals Inc.
Country
Bangladesh
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Description
Overview of the medicine
Hepcee is a combination of Sofosbuvir and Daclatasvir, two direct-acting antiviral agents, used for the treatment of chronic Hepatitis C virus (HCV) infection in adults.
Uses & Indications
Dosage
Adults
One tablet orally once daily for 12 or 24 weeks, depending on HCV genotype, prior treatment experience, and presence of cirrhosis.
Elderly
No specific dose adjustment required for elderly patients.
Renal_impairment
Dose adjustment or monitoring may be required in severe renal impairment (eGFR < 30 mL/min) or end-stage renal disease. Consult guidelines.
How to Take
Take orally once daily, with or without food. Swallow the tablet whole; do not chew or crush.
Mechanism of Action
Sofosbuvir inhibits HCV RNA-dependent RNA polymerase (NS5B), preventing viral replication. Daclatasvir inhibits HCV NS5A protein, which is essential for viral replication and assembly.
Pharmacokinetics
Onset
Rapid antiviral effect.
Excretion
Primarily via urine and feces for both components.
Half life
Sofosbuvir (active metabolite): ~0.5 hours (parent prodrug), ~18-19 hours (active metabolite). Daclatasvir: ~12-15 hours.
Absorption
Both Sofosbuvir and Daclatasvir are rapidly absorbed after oral administration. Sofosbuvir is a prodrug and is metabolized to its active nucleoside analog.
Metabolism
Sofosbuvir is metabolized primarily in the liver by hydrolysis to its active metabolite GS-331007. Daclatasvir is primarily metabolized by CYP3A.
Side Effects
Contraindications
- Hypersensitivity to Sofosbuvir, Daclatasvir, or any component of the formulation.
- Co-administration with strong P-gp inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) due to potential reduction in drug efficacy.
Drug Interactions
Digoxin
Increased digoxin levels, monitor digoxin concentrations.
Amiodarone
Increased risk of severe symptomatic bradycardia. Co-administration is not recommended.
Statins (e.g., Rosuvastatin)
Increased exposure of statins, adjust statin dose.
Acid-reducing agents (PPIs, H2-blockers, antacids)
May decrease absorption of Daclatasvir; separate administration times or avoid co-administration for some agents.
Strong P-gp Inducers (e.g., Rifampin, Carbamazepine)
Significantly decrease plasma levels of Sofosbuvir and Daclatasvir, leading to reduced efficacy. Contraindicated.
Storage
Store below 30°C in a dry place, away from direct sunlight. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, monitoring for adverse effects and supportive treatment are recommended. Hemodialysis can remove the main circulating metabolite of Sofosbuvir but not Daclatasvir.
Pregnancy & Lactation
Pregnancy Category B for Sofosbuvir. For Daclatasvir, animal studies show adverse effects. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Sofosbuvir or Daclatasvir are excreted in human milk; caution should be exercised. If co-administered with Ribavirin, Ribavirin is contraindicated in pregnancy.
Side Effects
Contraindications
- Hypersensitivity to Sofosbuvir, Daclatasvir, or any component of the formulation.
- Co-administration with strong P-gp inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) due to potential reduction in drug efficacy.
Drug Interactions
Digoxin
Increased digoxin levels, monitor digoxin concentrations.
Amiodarone
Increased risk of severe symptomatic bradycardia. Co-administration is not recommended.
Statins (e.g., Rosuvastatin)
Increased exposure of statins, adjust statin dose.
Acid-reducing agents (PPIs, H2-blockers, antacids)
May decrease absorption of Daclatasvir; separate administration times or avoid co-administration for some agents.
Strong P-gp Inducers (e.g., Rifampin, Carbamazepine)
Significantly decrease plasma levels of Sofosbuvir and Daclatasvir, leading to reduced efficacy. Contraindicated.
Storage
Store below 30°C in a dry place, away from direct sunlight. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, monitoring for adverse effects and supportive treatment are recommended. Hemodialysis can remove the main circulating metabolite of Sofosbuvir but not Daclatasvir.
Pregnancy & Lactation
Pregnancy Category B for Sofosbuvir. For Daclatasvir, animal studies show adverse effects. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Sofosbuvir or Daclatasvir are excreted in human milk; caution should be exercised. If co-administered with Ribavirin, Ribavirin is contraindicated in pregnancy.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months
Availability
Globally, widely available in many countries including Bangladesh
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patents expired or nearing expiration for generic manufacturers
WHO Essential Medicine
YesClinical Trials
Clinical trials have demonstrated high sustained virologic response (SVR) rates (over 90%) across various HCV genotypes, indicating high efficacy in clearing the virus.
Lab Monitoring
- Baseline and periodic monitoring of HCV RNA levels
- Liver function tests (ALT, AST, bilirubin)
- Renal function (eGFR)
- Cardiac monitoring for patients on amiodarone
Doctor Notes
- Emphasize patient adherence to the full treatment course.
- Thoroughly review concomitant medications for potential drug interactions, especially with amiodarone or strong P-gp inducers.
- Monitor liver and renal function as clinically indicated.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop treatment early, even if you feel better.
- Report any severe side effects or unusual symptoms immediately to your doctor.
- Do not take any other medications without consulting your doctor.
Missed Dose Advice
If a dose is missed and it is within 18 hours of the scheduled time, take it as soon as possible. If more than 18 hours have passed, skip the missed dose and take the next dose at the regularly scheduled time. Do not take a double dose.
Driving Precautions
This medicine may cause dizziness, fatigue, or visual disturbances. Exercise caution when driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Avoid alcohol consumption.
- Maintain a healthy diet and lifestyle.
- Avoid sharing needles or personal items that could transmit the virus.
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International brand names for this medicine. Click a brand to search for detailed information.
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