Detailed instructions for the third generation of Ji

1. Indications

吉三代(sofosbuvir and velpatasvir)issofosbuvir (a hepatitis C virus(HCV)nucleotide analogNS5Bpolymerase inhibitor) and velpatasvir (aHCV A fixed-dose combination of NS5Ainhibitors) for the treatment of patients with Hepatitis C virus (HCV)genotype1, pan>2, 3, 4, 5 or 6infection:

(1)No cirrhosis or compensated cirrhosis

(2)Decompensated cirrhosis in combination with ribavirin.

2. Dosage and usage

Recommended dosage for adults:One tablet (400 mgsofosbuvir and 100mgvelpatasvir) taken orally once daily with or without food.

Recommended dosage for pediatric patients 3 years of age and older:Recommended dosage is based on body weight.

For pediatric patients under 6 years old, please take Jisandai oral granules with food.

Should be prepared and taken according to the instructions for useJisandaioral pellets.

For treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or compensated cirrhosis (Child-Pugh A), the recommended regimen is Jisandai once a day for 12 weeks.

If used concomitantly with ribavirin, follow ribavirin dosage and dose adjustment recommendations.

Three. Dosage form and strength

Tablets:Sofosbuvir400mg, verapamil100mg; 200mgsofosbuvir and 50mgvelpatasvir.

Oral pellets: 200mg sofosbuvir and 50mg velpatasvir; 150mg pan>sofosbuvir and 37.5mgvelpatasvir.

Four. Contraindications

For patients who are contraindicated with ribavirin, the combination regimen of G3-G3 and ribavirin is contraindicated.

Five. Warnings and Precautions

1.Risk of hepatitis B virus reactivation:Test all patients for evidence of current or past HBV infection before initiating hepatitis C virus treatment. Monitor HCV/HBV/HBV co-infected patients for HBV reactivation and hepatitis recurrence during HCV treatment and post-treatment follow-up. Initiate appropriate management of HBV-infected patients as clinically indicated.

2.Bradycardia when used concomitantly with amiodarone:Severe symptomatic bradycardia may occur in patients taking amiodarone, especially in patients who are concurrently taking β blockers, or in patients with underlying cardiac comorbidities and / or advanced liver disease. It is not recommended to use amiodarone and GISANDAI at the same time. Cardiac monitoring is recommended for patients with no other feasible treatment options.

6. adverse reactions

1.In adult and pediatric subjects 6 years old and above who received Jisandatreatment for 12 weeks. The most common adverse reactions observed were headache and fatigue.

2.The most common adverse reactions observed in pediatric subjects 6 years old( occurred at a rate greater than or equal to 10%, 1< /span>Grade or2Grade) is a problem with vomiting and product use(Spitting up medication).

3.Most common adverse reactions observed after 12 weeks of treatment with epafloxacin and ribavirin in adults with decompensated cirrhosis(The incidence is greater than or equal to 10%, all grades ) are fatigue, anemia, nausea, headache, insomnia and diarrhea.

7. drug interactions

1.P-gpInducers and /or moderate to strong CYP inducers(such as rifampicin, St. John's wort, carbamazepine):may reduce the concentration of sofosbuvir and / or velpatasvir. EPCLUSA is not recommended for use with P-gp inducers and / or moderate to strong CYP inducers.

2.Read full prescribing information before use to learn about potential drug interactions.

3.Clearment with direct-acting antiviralsHCV infection may result in changes in liver function that may affect the safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose may be required))And adjust the dosage of certain concomitant medications.

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