Ledipasvir + sofosbuvir

Generic name
Ledipasvir + sofosbuvir
Brand name
ATC Code
J05AP51
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Ledipasvir + sofosbuvir

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Exposure to ledipasvir, sofosbuvir and GS-331007 ( important metabolite of sofosbovir) in childrenn of children aged 3 years and above is similar to exposure in adults

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Chronic hepatitis C
  • Oral
    • ≥ 3 years and ≥ 35 kg

      • ledipasvir 90 mg and sofosbuvir 400 mg once daily in a single dose.

      • Duration of treatment:

        CHC genotypes 1, 4, 5 or 6:
        Patients without cirrhosis: 12 weeks. In previously untreated patients with HCV genotype 1, a duration of treatment of 8 weeks can be considered.
        Patients with compensated cirrhosis: 24 weeks. In combination with ribavirin: 12 weeks
        Patients after liver transplants: 12 weeks in combination with ribavirin. If ribavirin is not tolerated or cannot be considered: patients without cirrhosis: ledipasvir + sofosbuvir 12 weeks; patients with cirrhosis: ledipasvir + sofosbuvir 24 weeks.
        Patients with decompensated cirrhosis, regardless of the transplantation status: 12 weeks in combination with ribavirin or 24 weeks without ribavirin.

        CHC genotype 3
        Patients with compensated cirrhosis and/or patients in whom earlier treatment has failed: 24 weeks in combination with ribavirin

    • ≥ 3 years and 17 up to 35 kg

      • ledipasvir 45 mg and sofosbuvir 200 mg once daily in a single dose.

      • Duration of treatment:

        CHC genotypes 1, 4, 5 or 6:
        Patients without cirrhosis: 12 weeks. In previously untreated patients with HCV genotype 1, a duration of treatment of 8 weeks can be considered.
        Patients with compensated cirrhosis: 24 weeks. In combination with ribavirin: 12 weeks
        Patients after liver transplants: 12 weeks in combination with ribavirin. If ribavirin is not tolerated or cannot be considered: patients without cirrhosis: ledipasvir + sofosbuvir 12 weeks; patients with cirrhosis: ledipasvir + sofosbuvir 24 weeks.
        Patients with decompensated cirrhosis, regardless of the transplantation status: 12 weeks in combination with ribavirin or 24 weeks without ribavirin.

        CHC genotype 3
        Patients with compensated cirrhosis and/or patients in whom earlier treatment has failed: 24 weeks in combination with ribavirin

    • ≥ 3 years and < 17 kg

      • ledipasvir 33,75 mg and sofosbuvir 150 mg once daily in a single dose.

      • Duration of treatment:

        CHC genotypes 1, 4, 5 or 6:
        Patients without cirrhosis: 12 weeks. In previously untreated patients with HCV genotype 1, a duration of treatment of 8 weeks can be considered.
        Patients with compensated cirrhosis: 24 weeks. In combination with ribavirin: 12 weeks
        Patients after liver transplants: 12 weeks in combination with ribavirin. If ribavirin is not tolerated or cannot be considered: patients without cirrhosis: ledipasvir + sofosbuvir 12 weeks; patients with cirrhosis: ledipasvir + sofosbuvir 24 weeks.
        Patients with decompensated cirrhosis, regardless of the transplantation status: 12 weeks in combination with ribavirin or 24 weeks without ribavirin.

        CHC genotype 3
        Patients with compensated cirrhosis and/or patients in whom earlier treatment has failed: 24 weeks in combination with ribavirin

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Side effects in children aged 12-18 years are the same as in adults.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

DIRECT ACTING ANTIVIRALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB12
J05AB06
J05AB16
J05AB04
J05AB11
J05AB14
Phosphonic acid derivatives
J05AD01
Protease inhibitors
J05AE08
J05AE10
J05AE07
J05AE02
J05AE04
J05AE03
J05AE01
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF06
J05AF02
J05AF09
J05AF10
J05AF05
J05AF04
J05AF07
J05AF13
J05AF13
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG06
J05AG03
J05AG04
J05AG01
J05AG05
Neuraminidase inhibitors
J05AH02
J05AH01
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Other antivirals
J05AX28
J05AX12
J05AX07
J05AX09
J05AX08
J05AX24
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Integrase inhibitors
J05AJ04
Antivirals for treatment of HCV infections
J05AP54
J05AP57
J05AP08
J05AP55

Reference

  1. Gilead Sciences International Ltd., SmPC Harvoni (EU/1/14/958) Rev 21, 29-07-2020, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose