Mavyret Labeling Updated With Dosing for Liver, Kidney Transplant Patients
The Food and Drug Administration (FDA) has approved updates to the Mavyret (glecaprevir, pibrentasvir; AbbVie) labeling to include new data from the M14-730 HCV/HIV-1 co-infection study, and from the M13-596 liver and renal transplant study.
Mavyret consists of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor. It is currently indicated to treat adults with chronic HCV genotype 1, 2, 3, 4, 5, or 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A). It is also indicated to treat adults with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
The Dosage and Administration section has been revised to state that Mavyret is recommended for 12 weeks in liver or kidney transplant recipients. A 16-week treatment duration is recommended for genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor (PI) or in genotype 3-infected patients who are PRS treatment-experienced; PRS is defined as prior treatment experience with regimens containing peginterferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor.
The Adverse Reactions section was updated to include safety data for HCV/HIV-1 co-infected patients and those with liver or kidney transplant. Findings from the open-label EXPEDITION-2 (N=153) study and ENDURANCE-1 (N=33) study of HCV/HIV-1 co-infected patients showed similar safety profiles to that observed in HCV mono-infected patients. Fatigue, nausea, and headache were the most common adverse reactions seen among the Mavyret arm in EXPEDITION-2.
Safety data from the MAGELLAN-2 (N=100) study among post-liver or -kidney transplant patients with genotypes 1, 2, 3, 4, or 6 chronic HCV infection without cirrhosis showed a similar safety profile to Phase 2/3 studies of patients without a history of transplantation. Headache, fatigue, nausea, and pruritus were the most common adverse reactions seen in the Mavyret arm.
Similarly, the Clinical Studies sections were updated to include findings from the EXPEDITION-2 and MAGELLAN-2 studies. In the EXPEDITION-2 study, HCV/HIV-1 co-infected patients who were HCV treatment-naive or treatment-experienced to combinations of peginterferon, ribavirin, and/or sofosbuvir received Mavyret for 8 weeks (if no cirrhosis) or 12 weeks (if compensated cirrhosis). The SVR12 rate in the co-infected patients was 98% (N=150).
In the single-arm, open-label MAGELLAN-2 study, post-transplant patients who were HCV treatment-naive or treatment-experienced to combinations of peginterferon, ribavirin, and/or sofosbuvir received Mavyret for 12 weeks. The overall SVR12 rate in post-transplant patients was 98% (N=98).
Mavyret is available as 100mg/40mg strength tablets.
For more information call (800) 633-9110 or visit Mavyret.com.