Detailed instructions for patient use of Epclusa, a drug for treating hepatitis C

Common name: Sofosbuvir/Velpatasvir (Sofosbuvir/Velpatasvir)

Trade name:Jisandai (Bingtongsha)（Epclusa）

Dosage form: oral tablet

Specifications: Each tablet contains 400 mgsofosbuvir and 100 mgvelpatasvir

1. Indications

Epclusa(Epclusa) is suitable for the treatment of adults and pediatric patients 12 years old and above (weight at least 30 kg) of chronic hepatitis C virus (HCV) infection, including all 6 genotypes (GT 1-6). It can be used in patients without cirrhosis or with compensated cirrhosis; for patients with decompensated cirrhosis, it should be used in combination with ribavirin.

2. Mechanism of action

Gisanda (Bingtonsa) is a combination drug consisting of sofosbuvir and velpatasvir:

Sofosbuvir: is an NS5Bnucleotide polymerase inhibitor that blocks the elongation of the HCV RNA chain by binding to the viral RNApolymerase and inhibits viral replication.

Velpatasvir: is an NS5A inhibitor that inhibits the replication of viral RNA and the assembly of virus particles by binding to the viral NS5A protein.

3. Pharmacology

1. Absorption:Gesanda (Bingtonsa) is well absorbed after oral administration, and the maximum plasma concentration (Cmax) of sofosbuvir and velpatasvir is reached within approximately 2-4 hours after taking the drug.

2. Distribution: Sofosbuvir and velpatasvir are widely distributed in the body, and the binding rate of velpatasvir to plasma proteins exceeds99%.

3. Metabolism: Sofosbuvir is metabolized in the liver through hydrolysis and oxidation to form active metabolitesGS-461203. Velpatasvir is primarily excreted unchanged in the feces.

4. Excretion: The active metabolites of sofosbuvir are mainly excreted through the kidneys, while velpatasvir is mainly excreted through bile.

4. Dosage and usage

1. Adult dosage: Take one tablet (400 mgsofosbuvir and 100 mgvelpatasvir) once daily for 12 weeks.

2. Patients with decompensated cirrhosis: It is recommended that G3 (Bingtonsa) be used in combination with ribavirin, and the treatment cycle is still 12 weeks.

3. Children’s dosage: Children aged 12 years and above or weighing at least 30 kg, the dosage is the same as for adults.

5. Side Effects

1. Common side effects: headache, fatigue, nausea, diarrhea, insomnia, etc., are usually mild to moderate and can be well tolerated by most patients.

2. Serious side effects: May include allergic reactions, bradycardia and other adverse reactions related to drug ingredients. If serious side effects occur, you should stop taking the drug immediately and seek medical treatment.

6. Warnings and Precautions

1. Risk of bradycardia: Combined use with amiodarone (Amiodarone) may cause severe bradycardia. It is recommended to evaluate cardiac function before starting treatment.

2. Liver function monitoring: For patients with cirrhosis, liver function should be closely monitored during treatment.

3. Pregnancy and lactation: Use during pregnancy Jisandai (Bingtonsha) may cause harm to the fetus. Breastfeeding women should use it with caution after weighing the pros and cons.

7. Contraindications

1. Contraindicated in patients allergic to sofosbuvir, velpatasvir or any component of this drug.

2. It is forbidden to use concurrently with potentP-gp inducers (such as rifampicin, St. John's wort).

8. Drug interactions

1. P-gpinducing agents: Simultaneous use may reduce the efficacy of G3 (protonsa). Simultaneous use with potent P-gpinducing agents (such as rifampicin, St. John's wort) should be avoided.

2. Proton pump inhibitors: When combined with proton pump inhibitors (such as omeprazole), the absorption of velpatasvir may be reduced. It is recommended to use proton pump inhibitors 2 hours before or 4 hours after the use of Protonsa.

9. Medication for Special Populations

1. Elderly people: There is no need to adjust the dose according to age, but attention should be paid to changes in liver and kidney function.

2. Patients with renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Caution should be evaluated before use in patients with severe renal insufficiency or those receiving dialysis.

3. Patients with hepatic impairment: No dose adjustment is required in patients without cirrhosis or compensated cirrhosis. Patients with decompensated cirrhosis should be coadministered with ribavirin and monitored closely.

4. Children and Adolescents: Adult doses may be used in children 12 years and older or weighing at least 30 kg.

The above are the detailed instructions for the use ofEpclusa(Epclusa). Patients should read the instructions carefully before use and conduct treatment under the guidance of a doctor to ensure the safety and efficacy of the medication.