Glecaprevir and pibrentasvir
Dosing in kidney impairment
Liver or Kidney Transplant Recipients MAVYRET is recommended for 12 weeks in patients 3 years and older who are liver or kidney transplant recipients. A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor or in genotype 3-infected patients who are PRS treatment-experienced [see Clinical Studies] .
Dosing in liver impairment
Hepatic Impairment MAVYRET is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation [see Contraindications, Warnings and Precautions, Use in Specific Populations and Clinical Pharmacology] .
| HCV Genotype | Treatment Duration | |
| No Cirrhosis | Compensated Cirrhosis (Child-Pugh A) | |
| 1, 2, 3, 4, 5, or 6 | 8 weeks | 8 weeks |
| Treatment Duration | |||
| HCV Genotype | Patients Previously Treated With a Regimen Containing: | No Cirrhosis | Compensated Cirrhosis (Child-Pugh A) |
| 1 | An NS5A inhibitor2 without prior treatment with an NS3/4A protease inhibitor (PI) | 16 weeks | 16 weeks |
| An NS3/4A PI3 without prior treatment with an NS5A inhibitor | 12 weeks | 12 weeks | |
| 1, 2, 4, 5, or 6 | PRS4 | 8 weeks | 12 weeks |
| 3 | PRS4 | 16 weeks | 16 weeks |
| Treatment-experienced patients are those who previously received treatment for the current infection. Treated with prior regimens containing ledipasvir and sofosbuvir or daclatasvir with (peg) interferon and ribavirin. Treated with prior regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg) interferon and ribavirin. PRS=Prior treatment experience with regimens containing (peg) interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor. | |||
Preparation and administration
Preparation and Administration of Oral Pellets See the MAVYRET oral pellets full Instructions for Use for details on the preparation and administration. The oral pellets should be taken together, with food, once daily. In addition, the oral pellets for the total daily dose should be sprinkled on a small amount of soft food with a low water content that will stick to a spoon and should be swallowed without chewing (e.g., peanut butter, chocolate hazelnut spread, cream cheese, thick jam, or Greek yogurt).
The entire mixture of food and oral pellets should be swallowed within 15 minutes of preparation; the oral pellets should not be crushed or chewed. Liquids or foods that would drip or slide off the spoon are not recommended as the drug may dissolve quickly and become less effective.