Active Ingredient: Dasabuvir
Dasabuvir is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
500 - 500 mg
From 250 To 250 mg 2 time(s) per day every day for 180 day(s)
The recommended dose is 250 mg of dasabuvir twice daily (morning and evening).
Dasabuvir must not be administered as monotherapy. Dasabuvir should be used in combination with other medicinal products for the treatment of HCV.
The recommended co-administered medicinal product(s) and treatment duration for dasabuvir combination therapy are provided in the following table.
Recommended co-administered medicinal product(s) and treatment duration for dasabuvir by patient population:
| Patient population | Treatment* | Duration |
|---|---|---|
| Genotype 1b, without cirrhosis or with compensated cirrhosis | dasabuvir + ombitasvir/paritaprevir/ritonavir | 12 weeks. 8 weeks may be considered in previously untreated genotype 1binfected patients with minimal to moderate fibrosis** (GARNET study) |
| Genotype 1a, without cirrhosis | dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin* | 12 weeks |
| Genotype 1a, with compensated cirrhosis | dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin* | 24 weeks |
* Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
** When assessing severity of liver disease using non-invasive methods, a combination of blood biomarkers or the combination of liver stiffness measurement and a blood test improves accuracy and should be undertaken prior to 8 week treatment in all patients with moderate fibrosis.
In case a dose of dasabuvir is missed, the prescribed dose can be taken within 6 hours. If more than 6 hours have passed since dasabuvir is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule. Patients should be instructed not to take a double dose.
To maximise absorption, dasabuvir should be taken with food, without regard to fat and calorie content.
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