The US Food and Drug Administration (FDA) has expanded the indication of the pangenotypic direct-acting antiviral (DAA) combination, glecaprevir/pibrentasvir (Mavyret®; AbbVie Inc., North Chicago, IL, USA), to include the treatment of acute hepatitis C virus (HCV) infection in adults and children aged ≥3 years, with or without compensated cirrhosis. This decision makes it the first and only therapy specifically approved for acute HCV infection.
A shift in the treatment paradigm
Previously, patients with acute HCV infection had to wait for disease progression before initiating treatment. This change allows clinicians to initiate antiviral therapy immediately after diagnosis, supporting a ‘test-and-treat’ strategy that aligns with hepatitis C elimination efforts.
“This approval offers the ability to cure patients before the infection becomes chronic and potentially causes long-term complications”
– Dr John Ward, Director of the Coalition for Global Hepatitis Elimination.¹
Clinical data supporting the expanded indication
The FDA decision is based on the results of the Phase III M20-350 trial (ClinicalTrials.gov Identifier: NCT04903626), which showed the antiviral to be a highly efficacious treatment for people with acute HCV.
The study enrolled 286 treatment-naïve adults with acute HCV infection across 70 sites globally. All patients received oral glecaprevir/pibrentasvir once daily for 8 weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the proportion of patients achieving sustained virological response 12 weeks after treatment completion (SVR12) in the intention-to-treat (ITT) population. Secondary endpoints included the proportion of patients achieving SVR12 in the modified ITT-virologic failure (mITT-VF) population, and the proportion of patients with on-treatment virologic failure or post-treatment relapse in the ITT population.¹,²
A separate Phase II/III trial (M20-054) also demonstrated efficacy in the paediatric population, leading to the inclusion of children aged ≥3 years in the approved indication.³
Both trials confirmed a favourable safety profile. Adverse events were mostly mild or moderate, with the most common being headache, fatigue, and diarrhoea. No new safety concerns were identified.²
Implications for clinical practice
For healthcare professionals, the implications are significant:
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Immediate treatment: The need to monitor patients for progression to chronic infection before initiating therapy is now obsolete. Clinicians can begin treatment as soon as acute infection is diagnosed.
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Paediatric coverage: With approval in children aged ≥3 years, this therapy bridges a critical gap in care for younger patients.
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Pangenotypic efficacy: The treatment is effective against all six major HCV genotypes, eliminating the need for genotyping before initiation.
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Simplified care pathways: Reducing the number of clinical visits can help mitigate loss to follow-up, particularly in high-risk or marginalized populations.
“Every time you set up another step in the care pathway, you risk losing a patient to follow-up. With this approval, clinicians can prescribe treatment before the patient even leaves the clinic.”
– Dr Andrew Aronsohn, American Association for the Study of Liver Diseases (AASLD).¹
References
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ContagionLive. FDA expands indication for AbbVie’s antiviral as first treatment for people with acute hepatitis C. 2025. Available at: www.contagionlive.com/view/fda-expands-indication-for-abbvie-s-antiviral-as-first-treatment-for-people-with-acute-hepatitis-c (accessed 14 June 2025).
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ClinicalTrials.gov. Study of glecaprevir/pibrentasvir in adults with acute HCV infection (M20-350). ClinicalTrials.gov Identifier: NCT04903626. Available at: https://clinicaltrials.gov/ct2/show/NCT04903626 (accessed 14 June 2025).
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BioSpace. AbbVie receives FDA approval of Mavyret® for children aged 3 years and older with HCV. 2025. Available at: www.biospace.com/article/releases/abbvie-receives-fda-approval-of-mavyret-for-pediatric-patients-aged-3-years-and-older-with-hcv/ (accessed 14 June 2025).
Editor: Katey Gabrysch
Disclosure: This article was created by the touchINFECTIOUS DISEASES team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Cite: Glecaprevir/Pibrentasvir approved for acute hepatitis C: A new era for early intervention. touchINFECTIOUS DISEASES. June 14 2025.
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