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FDA Approves Mavyret (G/P, glecaprevir and pibrentasvir) for Pediatric HCV Treatment 3 Years & Older
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On June 10, 2021, the Food and Drug Administration (FDA) approved the use of glecaprevir and pibrentasvir ("G/P") or MAVYRET®, for the treatment of HCV in pediatric patients 3 years and older without cirrhosis or with compensated cirrhosis. With this pediatric approval MAVYRET® provides oral pellet formulation option for patients 3 years to less than 12 years old.
Providing an opportunity to cure this small yet critical group of patients is directly in line with AbbVie's goal to take on the world's toughest health challenges and the brand's strategic imperative to expand MAVYRET's clinical profile to key populations.
This expansion supported by the DORA Part 2 trial to include pediatric patients was granted priority review by the FDA. DORA Part 2 was a phase 2/3, open-label trial, investigating G/P in pediatric subjects 3 years to less than 12 years without cirrhosis who received G/P for 8, 12, or 16 weeks. Treatment duration was chosen to match approved adult durations based on HCV genotype and prior treatment experience. Key efficacy data demonstrated overall SVR12 rate was 98.4% (n=61/62) with no virologic failures with no virologic failures. One subject did not achieve SVR12 after discontinuing treatment due to an adverse reaction. The adverse reactions observed in subjects 3 years to less than 12 years of age were consistent with those observed in clinical trials of G/P in adults with the exception of vomiting (occurring at 8%), rash, and abdominal pain upper (each occurring at 4%) which were observed more frequently in pediatric subjects less than 12 years of age compared to adults.
Click here to view the US prescribing information characterizing the safety and efficacy information supporting approval by the FDA.
For immediate questions, please feel free to contact AbbVie Global Medical Information (GMI) at 1-800-633-9110 or via the GMI Website .
Important Safety Information: G/P is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation and in patients who are taking atazanavir or rifampin. Additionally, as with all direct acting antiviral (DAA) products, there is a boxed warning for G/P regarding the risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV. HBV reactivation has been reported in HCV/HBV coinfected patients who underwent DAA therapy, and some cases have resulted in fulminant hepatitis, hepatic failure, and death.
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