LediHep (Ledipasvir 90mg/sofosbuvir 400mg)

LediHep, also known as Indian Generic “Sofosbuvir 400mg/Ledipasvir 90mg” is a fixed-dose combination of LediHep and Ledipasvir indicated for the treatment of chronic hepatitis C virus (HCV). Indian Generic Sofosbuvir 400mg/Ledipasvir 90mg Its Cure rates is 94% to 99% for hepatitis C. 

LediHep is a generic prescription medicine from Zydus, which is one of the biggest pharmaceutical company in India.

LediHep Dosage:

For the treatment of chronic hepatitis C infection.

For the treatment of chronic hepatitis C virus (HCV) genotype 1 infection.

Oral dosage

Treatment-naive Adults without cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks; however, an 8-week treatment duration can be considered for those patients with a baseline hepatitis C virus RNA less than 6 million international units/mL. Recommendation includes patients coinfected with HIV.

Treatment-naive Adults with compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV.

Treatment-experienced Adults without cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV.

Treatment-experienced Adults with compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 24 weeks. Alternatively, treatment duration may be reduced to 12 weeks if ledipasvir; sofosbuvir is administered in combination with ribavirin. Ribavirin must be administered with food in 2 divided doses, and the dose is based on weight as follows: less than 75 kg give 500 mg PO twice daily; 75 kg or more give 600 mg PO twice daily. Recommendation includes patients coinfected with HIV.

Treatment-naive and experienced Adults with decompensated (Child-Pugh B or C) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with ribavirin (600 mg PO once daily) for 12 weeks. Ribavirin must be administered with food, and if tolerated, the dose may be increased as follows: if less than 75 kg give 500 mg PO twice daily; if 75 kg or more give 600 mg PO twice daily. Consider decreasing ribavirin dose for abnormal hemoglobin. Recommendation includes patients coinfected with HIV. For patients unable to take ribavirin, guidelines recommend 1 tablet PO once daily for 24 weeks.

Treatment-naive and experienced Adults who have undergone liver transplantation and are without cirrhosis or have compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with ribavirin for 12 weeks. Ribavirin must be administered with food in 2 divided doses, and the dose is based on weight as follows: less than 75 kg give 500 mg PO twice daily; 75 kg or more give 600 mg PO twice daily. Recommendation includes patients coinfected with HIV.

Treatment-naive and experienced Adults who have undergone liver transplantation and have decompensated (Child-Pugh B or C) cirrhosis†

Guidelines recommend 1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with low initial dose of ribavirin for 12 weeks as the preferred regimen. Increase ribavirin dose as tolerated.

Treatment-naive Children and Adolescents 12 to 17 years without cirrhosis or with compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV. 

Treatment-experienced Children and Adolescents 12 to 17 years without cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV. 

Treatment-experienced Children and Adolescents 12 to 17 years with compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 24 weeks. Recommendation includes patients coinfected with HIV. 

Treatment-naive Children younger than 12 years weighing at least 35 kg without cirrhosis or with compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV. 

Treatment-experienced Children younger than 12 years weighing at least 35 kg without cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV. 

Treatment-experienced Children younger than 12 years weighing at least 35 kg with compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 24 weeks. Recommendation includes patients coinfected with HIV. 

For the treatment of chronic hepatitis C virus (HCV) genotypes 5 or 6 infection.

Oral dosage

Treatment-naive and experienced Adults without cirrhosis or who have compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV.

Treatment-naive and experienced Adults with decompensated (Child-Pugh B or C) cirrhosis†

Guidelines recommend 1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with low initial dose of ribavirin for 12 weeks as a preferred regimen. Increase ribavirin dose as tolerated. For patients unable to take ribavirin, guidelines recommend 1 tablet PO once daily for 24 weeks.

Treatment-naive and experienced Adults who have undergone liver transplantation and are without cirrhosis or have compensated (Child-Pugh A) cirrhosis†

Guidelines recommend 1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with weight-based ribavirin for 12 weeks as a preferred regimen.

Treatment-naive and experienced Adults who have undergone liver transplantation and have decompensated (Child-Pugh B or C) cirrhosis†

Guidelines recommend 1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with low initial dose of ribavirin for 12 weeks as the preferred regimen. Increase ribavirin dose as tolerated.

Treatment-naive and experienced Children and Adolescents 12 to 17 years without cirrhosis or who have compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV. 

Treatment-naive and experienced Children younger than 12 years weighing at least 35 kg without cirrhosis or who have compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV. 

For the treatment of chronic hepatitis C virus (HCV) genotype 4 infection.

Oral dosage

Treatment-naive and experienced Adults without cirrhosis or who have compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV.

Treatment-naive and experienced Adults with decompensated (Child-Pugh B or C) cirrhosis†

Guidelines recommend 1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with low initial dose of ribavirin for 12 weeks as a preferred regimen. Increase ribavirin dose as tolerated. For patients unable to take ribavirin, guidelines recommend 1 tablet PO once daily for 24 weeks.

Treatment-naive and experienced Adults who have undergone liver transplantation and are without cirrhosis or have compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with ribavirin for 12 weeks. Ribavirin must be administered with food in 2 divided doses, and the dose is based on weight as follows: less than 75 kg give 500 mg PO twice daily; 75 kg or more give 600 mg PO twice daily. Recommendation includes patients coinfected with HIV.

Treatment-naive and experienced Adults who have undergone liver transplantation and have decompensated (Child-Pugh B or C) cirrhosis†

Guidelines recommend 1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with low initial dose of ribavirin for 12 weeks as the preferred regimen. Increase ribavirin dose as tolerated.

Treatment-naive and experienced Children and Adolescents 12 to 17 years without cirrhosis or who have compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV. 

Treatment-naive and experienced Children younger than 12 years weighing at least 35 kg without cirrhosis or who have compensated (Child-Pugh A) cirrhosis

1 tablet (90 mg ledipasvir; 400 mg sofosbuvir) PO once daily with or without food. The recommended duration of treatment is 12 weeks. Recommendation includes patients coinfected with HIV. 

LediHep Side Effects:

Hepatitis B virus reactivation: Before starting treatment with LediHep, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with LediHep. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking 

LediHep PI

For more Prescribing information，please ask for “FDA Prescribing Information” from our customer supporter.