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The FDA has approved updates to the labeling for hepatitis C virus (HCV) drug glecaprevir and pibrentasvir (Mavyret) to include new data from 2 clinical studies.
The FDA has approved updates to the labeling for hepatitis C virus (HCV) drug glecaprevir and pibrentasvir (Mavyret) to include new data from 2 clinical studies, according to a press release.
Labeling revisions include updates to the dosing recommendations, as well as safety and efficacy outcomes data from the HCV/HIV-1 coinfection study (M14-730) and from the liver and renal transplant study (M13-596).
The Dosage and Administration section was updated to include dosing recommendations for 12 weeks in liver or kidney transplant recipients and a 16-week treatment duration in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor or in genotype (GT) 3-infected patients who are pegylated interferon, ribavirin, and sofosbuvir (PRS) treatment-experienced.
Additionally, the Adverse Reactions and Clinical Studies sections were updated to include safety and efficacy data from the trials for HCV/HIV-1 coinfected individuals and patients with liver or kidney transplant.
The updated labeling includes data for:
Updated safety information includes the following key data:
Eighty-one percent of patients with liver or kidney transplant treated with glecaprevir and pibrentasvir had adverse reactions of mild severity and 2% experienced a serious adverse reaction.
Additionally, labeling was updated to reflect the following clinical trial efficacy outcomes data:
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