Glecaprevir/pibrentasvir was a "highly efficacious treatment for people with acute HCV," with 96.2% of patients analyzed having sustained virological response 12 weeks post-treatment.
FDA expands glecaprevir/pibrentasvir indication for acute hepatitis C down to 3 years of age | Image credit: Contemporary Pediatrics
The FDA has approved an expanded indication for AbbVie's glecaprevir/pibrentasvir (Mavyret) to include patients aged 3 years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. According to a press release from AbbVie, glecaprevir/pibrentasvir is the first and only oral, 8-week pangenotypic treatment option approved for people with HCV. With the expansion, providers can now treat patients immediately at the time of diagnosis.1
The infectious, blood-borne disease impacts the liver, and those who have been recently infected, or those with acute HCV, may not display symptoms. Untreated, HCV could lead to liver-related complications such as liver cancer or cirrhosis.
According to updated clinical guidance, published in Pathogens in February 2024, though children represent a small proportion of those infected with HCV, many have chronic HCV infection, posing an increased risk of complications "including cirrhosis, portal hypertension, hepatic decompensation with hepatic encephalopathy, and hepatocellular carcinoma in adulthood," according to guideline authors Chaowapong Jarasvaraparn, Christopher Hartley, and Wikrom Karnsakul.2
"The physical, emotional, and economic burden of a curable condition like hepatitis C is far too great in the United States and around the world," said John Ward, MD, director, Coalition for Global Hepatitis Elimination, in a statement. "If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates to chronic disease and eventually cirrhosis or liver cancer. The public health community now has a good opportunity to cure nearly all persons to support eliminating the toll of this deadly virus. No one should die of hepatitis C."1
The extended label was supported by data from a phase 3, 8-week, multicenter, single-arm, and prospective trial (M20-350; NCT04903626) evaluating the safety and efficacy of glecaprevir/pibrentasvir in patients with HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection from 70 locations across the world. Patients received oral tablets of glecaprevir/pibrentasvir once daily for 8 weeks, then followed up for 12 weeks after treatment ended. The percentage of patients with sustained virological response 12 weeks post-treatment was the primary endpoint of the study in the intention-to-treat population.
According to AbbVie, results demonstrated glecaprevir/pibrentasvir was a "highly efficacious treatment for people with acute HCV," with 96.2% of patients analyzed having sustained virological response 12 weeks post-treatment (95% CI, 93.2-97.8)., according to study results posted to ClinicalTrials.gov.3 The majority of adverse events were reported to be mild or moderate, with a majority of reported adverts events being headache, fatigue, asthenia, and diarrhea.1
"[Glecaprevir/pibrentasvir] has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection," said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie, in the expanded approval announcement. "The label expansion for [glecaprevir/pibrentasvir] coupled with the implementation of test and treat models of care, serve as tools to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal."1
References:
1. US FDA approves expanded indication for AbbVie's Mavyret (glecaprevir/pibrentasvir) as first and only treatment for people with acute hepatitis C virus. AbbVie. Press release. June 11, 2025. Accessed June 12, 2025. https://news.abbvie.com/2025-06-11-U-S-FDA-Approves-Expanded-Indication-for-AbbVies-MAVYRET-R-Glecaprevir-Pibrentasvir-as-First-and-Only-Treatment-for-People-with-Acute-Hepatitis-C-Virus
2. Jarasvaraparn C, Hartley C, Karnsakul W. Updated Clinical Guidelines on the Management of Hepatitis C Infection in Children. Pathogens. 2024 Feb 16;13(2):180. doi: 10.3390/pathogens13020180. PMID: 38392918; PMCID: PMC10891648.
3. Study to evaluate adverse events and change in disease activity in adult and adolescent participants with acute hepatitis c virus (hcv) infection on treatment with oral tablets of glecaprevir (gle)/pibrentasvir (pib). ClinicalTrials.gov. Updated April 6, 2025. Accessed June 12, 2025.
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