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Generic name |
glecaprevir-pibrentasvir |
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Strength & form |
100 mg/40 mg tablet |
Special Authority criteria |
|
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For the treatment of treatment-naïve or treatment-experienced1 patients 3 years of age or older with chronic hepatitis C (CHC) genotype (GT) 1, 2, 3, 4, 5 or 6 infection, who meet all the following criteria: OR For the treatment of direct-acting antivirals (DAA)-experienced2 adult patients with CHC genotype 1 infection, who meet all the following criteria:
AND
AND
AND
AND
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Treatment regimens for genotype 1, 2, 3, 4, 5 or 6 CHC patients 3 years of age and older with: |
Approval period |
---|---|
Genotype 1, 2, 3, 4, 5, and 6 treatment-naïve with no cirrhosis or with compensated cirrhosis6 |
8 weeks |
Genotype 1, 2, 3, 4, 5, or 6 (non-GT3) treatment-experienced1 with no cirrhosis |
|
Genotype 1, 2, 3, 4, 5, or 6 (non-GT3) treatment-experienced1 with compensated cirrhosis6 |
12 weeks |
Genotype 3 treatment-experienced1 with no cirrhosis or with compensated cirrhosis6 |
16 weeks |
Treatment regimens for genotype 1 DAA-experienced2 CHC adults patients with: |
Approval period |
---|---|
Genotype 1 NS3/4A protease inhibitor-experienced, but NS5A inhibitor-naïve, with no cirrhosis or with compensated cirrhosis6 |
12 weeks |
Genotype 1 NS5A inhibitor treatment-experienced, but NS3/4A inhibitor inhibitor-naïve, with no cirrhosis or compensated cirrhosis6 |
16 weeks |