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Ledipasvir and Sofosbuvir Tablets

Overview
Ledipasvir-sofosbuvir tablets are antiviral drugs, which are a combination of ledipasvir and sofosbuvir. Ledipasvir is an inhibitor of HCV NS5A protein. Sofosbuvir is an inhibitor of HCV NS5B RNA-dependent RNA polymerase.

What are the conditions for use?
It is used to treat chronic hepatitis C virus (HCV) infection in adults and adolescents aged 12 to <18 years.

How to take?
It can be taken on an empty stomach or with food.

Sit or stand and swallow the whole tablet with 200ml of warm water. Do not chew or crush the film-coated tablet.

How much to take? (Take as directed by a doctor or as follows)
For adults and adolescents aged 12-18 years, the recommended dose of this product is one tablet once a day.

It is suitable for the recommended duration of treatment for adults and adolescents (12-18 years) with HCV genotype 1, 2, 4, 5 or 6 HCV mono-infection and HCV/HIV-1 co-infection.

Adults and adolescents 12 years or older with HCV genotype 1, 4, 5, or 6:

[Patients without cirrhosis]

Take 12 weeks of Ledipasvir-Sofosbuvir. For patients with genotype 1 infection who have not been treated previously, consider 8 weeks of Ledipasvir-Sofosbuvir.

[Patients with compensated cirrhosis]

Take 12 weeks of Ledipasvir-Sofosbuvir plus ribavirin A, or 24 weeks of Ledipasvir-Sofosbuvir without ribavirin. For patients who are considered to be at low risk of clinical disease progression and have options for subsequent retreatment, consider 12 weeks of Ledipasvir-Sofosbuvir without ribavirin.

[Patients without cirrhosis or after liver transplantation with compensated cirrhosis]

Take 12 weeks of Ledipasvir-Sofosbuvir plus ribavirin A. For patients who are not suitable for or cannot tolerate ribavirin, consider 12 weeks (patients without cirrhosis) or 24 weeks (patients with cirrhosis) of Ledipasvir-Sofosbuvir Tablets (without ribavirin).

[Patients with decompensated cirrhosis (regardless of transplant status)]

Take 12 weeks of Ledipasvir-Sofosbuvir Tablets + Ribavirin B. For patients who are not suitable for or cannot tolerate ribavirin, consider 24 weeks of Ledipasvir-Sofosbuvir Tablets (without ribavirin).

Adults and adolescents 12 years or older with genotype 3 HCV:

[Patients with compensated cirrhosis and/or previous treatment failure]

Take 24 weeks of Ledipasvir-Sofosbuvir Tablets + Ribavirin A.

Adult patients with genotype 2 HCV:

Take 12 weeks of Ledipasvir-Sofosbuvir Tablets.

A Adults: Weight-based ribavirin (<75kg=1,000 mg, ≥75kg=1,200 mg), divided into two doses to be taken orally with food. Adolescents: For ribavirin dosing recommendations, see the following ribavirin dosing regimens recommended for adolescent patients aged 12 to <18 years.

B For ribavirin dosing recommendations for patients with decompensated cirrhosis, see below.

Ribavirin dosing recommendations for patients with decompensated cirrhosis when administered in combination with Ledipasvir Sofosbuvir Tablets:

[Patients with Child-Pugh-Turcotte (CPT) B cirrhosis before transplantation]

For patients weighing <75kg, the dose is 1000mg/day; for patients weighing ≥75kg, the dose is 1200mg/day.

[Pre-transplant CPT C cirrhosis; post-transplant CPT B or C cirrhosis]

The starting dose is 600 mg, and if well tolerated, the dose can be increased to a maximum of 1000/1200 mg (1000 mg for patients weighing <75 kg; 1200 mg for patients weighing ≥75 kg). If the starting dose is poorly tolerated, the dose should be reduced based on hemoglobin levels as clinically indicated.

If a more normalized ribavirin dose (by weight and renal function) cannot be achieved for tolerability reasons, 24 weeks of ledipasvir/sofosbuvir + ribavirin should be considered to minimize the risk of relapse.

The following ribavirin dosing regimen is recommended for adolescent patients 12 to <18 years of age when given in combination with ledipasvir-sofosbuvir tablets, where the ribavirin dose is given twice daily with food:

[Weight <47 kg]: The dose used is 15 mg/kg/day.

【Weight 47-49kg】: The dosage is 600mg/day.

【Weight 50-65kg】: The dosage is 800mg/day.

【Weight 66-74kg】: The dosage is 1000mg/day.

【Weight> or =75kg】: The dosage is 1200mg/day.

Guidelines for adjusting the dose of ribavirin in adults when used with Ledipasvir-Sofosbuvir tablets:

【Hemoglobin level in patients without heart disease】

If <10g/dL, the dose of ribavirin should be reduced to 600mg/day. If <8.5g/dL, ribavirin should be discontinued.

【Hemoglobin level in patients with a stable history of heart disease】

If <10g/dL, the dose of ribavirin should be reduced to 600mg/day, and the hemoglobin decrease should be ≥2g/dL during any 4-week treatment period. If <8.5g/dL, ribavirin should be discontinued, and levels remain <12g/dL despite dose reduction during 4 weeks of treatment.

After ribavirin is discontinued due to laboratory abnormalities or clinical abnormalities, an attempt can be made to restart ribavirin at 600 mg per day and further increase the dose to 800 mg per day. However, it is not recommended to increase ribavirin to the originally assigned dose (1000mg-1200mg per day).

If vomiting occurs within 5 hours of taking the drug, a second tablet should be taken. If vomiting occurs more than 5 hours after taking the drug, no second dose is required.

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