FDA Updates Hepatitis C Drug Labeling to Include New Clinical Data

Article

The revised labeling for glecaprevir and pibrentasvir (Mavyret) includes data from clinical trials on the safety and efficacy of the treatment for HIV-1 coinfected patients and liver and kidney transplant recipients.

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:

  • Adverse reactions in HCV/HIV-1 coinfected individuals.
  • Adverse reactions in individuals with liver or kidney transplant.
  • Treatment-naïve or PRS treatment-experienced adults with HCV/HIV-1 coinfection without cirrhosis or with compensated cirrhosis.
  • Treatment naïve or PRS treatment-experienced adults with liver or kidney transplant without cirrhosis.

Updated safety information includes the following key data:

  • Adverse reactions assessed in patients with HIV-1 coinfection from treatment for 8 or 12 weeks included fatigue (10%), nausea (8%), and headache (5%).
  • The overall safety profile in patients with HIV-1 coinfection was similar to that observed in HCV mono-infected individuals.
  • In liver or kidney transplant recipients, the overall safety profile was similar to that observed in individuals in the phase 2 and 3 studies without a history of transplantation.
  • The most common adverse reactions in patients with liver or kidney transplant observed after receiving treatment for 12 weeks were headache (17%), fatigue (16%), nausea (8%), and pruritis (7%).
  • 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:

  • The EXPEDITION-2 study assessed efficacy in 153 HCV/HIV-1 coinfected patients, including those who were HCV treatment-naïve or treatment experienced to combinations of pegylated interferon, ribavirin, and/or sofosbuvir, with the exception of GT3-infected individuals who were all treatment naïve.
  • In EXPIDITON-2, the SVR12 rate in HCV/HIV-1 coinfected patients was 98% (150/153). One patient experienced on-treatment virologic failure and no patients relapsed.
  • MAGELLAN-2 evaluated 100 post-liver or -kidney transplant HCV GT 1, 2, 3, 4, or 6 infected patients without cirrhosis who received treatment for 12 weeks, including HCV treatment-naïve or treatment-experienced to combinations of pegylated interferon, ribavirin, and/or sofosbuvir with the exception of GT3-infected patients who were all treatment-naïve.
  • In MAGELLAN-2, the overall SVR12 rate in post-transplant patients was 98% (98/100). There was 1 relapse and no on-treatment virologic failures.

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