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

Interactions
PK
Renal impairment
References

Glecaprevir + Pibrentasvir

Generic name
Glecaprevir + Pibrentasvir
Brand name
ATC Code
J05AP57

Pharmacokinetics in children

No information is present at this moment.

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

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Available formulations

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Dosages

Chronic hepatitis C
  • Oral
    • Granules
      • 3 years up to 18 years and 12 up to 20 kg
        [1]

        • 150 mg / 60 mg glecaprevir / pibrentasvir per day in 1 dose

        • Duration of treatment:
          • Children without prior HCV treatment:
            • All genotypes, with or without cirrhosis: 8 weeks
          • Children with prior HCV treatment:
            • Genotype 1,2,4,5,6:
              • Without cirrhosis: 8 weeks
              • With cirrhosis: 12 weeks
            • Genotype 3:
              • With and without cirrhosis: 16 weeks
      • 3 years up to 18 years and 20 up to 30 kg
        [1]

        • 200 mg / 80 mg glecaprevir / pibrentasvir per day in 1 dose 

        • Duration of treatment:
          • Children without prior HCV treatment:
            • All genotypes, with or without cirrhosis: 8 weeks
          • Children with prior HCV treatment:
            • Genotype 1,2,4,5,6:
              • Without cirrhosis: 8 weeks
              • With cirrhosis: 12 weeks
            • Genotype 3:
              • With and without cirrhosis: 16 weeks
      • 3 years up to 18 years and 30 up to 45 kg
        [1]

        • 250 mg / 100 mg glecaprevir / pibrentasvir per day in 1 dose 

        • Duration of treatment:
          • Children without prior HCV treatment:
            • All genotypes, with or without cirrhosis: 8 weeks
          • Children with prior HCV treatment:
            • Genotype 1,2,4,5,6:
              • Without cirrhosis: 8 weeks
              • With cirrhosis: 12 weeks
            • Genotype 3:
              • With and without cirrhosis: 16 weeks
    • Tablet
      • 3 years up to 18 years and ≥ 45 kg
        [1]

        • 300 mg / 120 mg glecaprevir / pibrentasvir per day in 1 dose 

        • Duration of treatment:
          • Children without prior HCV treatment:
            • All genotypes, with or without cirrhosis: 8 weeks
          • Children with prior HCV treatment:
            • Genotype 1,2,4,5,6:
              • Without cirrhosis: 8 weeks
              • With cirrhosis: 12 weeks
            • Genotype 3:
              • With and without cirrhosis: 16 weeks

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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.

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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

The safety profile in children aged 12-18 years is similar to that in adults. Diarrhea, nausea, and vomiting were slightly more frequent in pediatric patient 3-12 years of age compared with adolescents (adverse reactions: 3.8% versus 0%, 3.8% versus 0%, and 7.5% versus 2.1%, respectively).

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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 in children

The granules should be sprinkled over a small amount of soft food, with low water content, that sticks to a spoon and can be swallowed without chewing (for example, peanut butter, hazelnut spread, soft cheese/cream cheese, thick jam or Greek yogurt).

(alternatively, add to dedicated administration section)

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Interactions

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

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Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB04
J05AB11
J05AB14
Protease inhibitors
J05AE10
J05AE03
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10
J05AF05
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG01
Neuraminidase inhibitors
J05AH02
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR10
Other antivirals
J05AX12
J05AX08
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR10
Antivirals for treatment of HCV infections
J05AP08
J05AP55

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Reference

  1. AbbVie Deutschland GmbH & Co. KG, SmPC Maviret (EU/1/17/1213/001) Rev 14, 01-09-2021, www.ema.europa.eu

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Changes

Changes