FDA Expands Approval of AbbVie’s MAVYRET® as First and Only 8-Week Treatment for Acute Hepatitis C in Adults and Children Aged 3 and Above
AbbVie has received a significant regulatory boost for its hepatitis C treatment portfolio as the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), the company’s oral, pangenotypic direct-acting antiviral (DAA) therapy. With this approval, MAVYRET becomes the first and only DAA treatment approved to treat both acute and chronic hepatitis C virus (HCV) infections in patients as young as three years old, with or without compensated cirrhosis, using an eight-week regimen.
This expanded indication now includes the treatment of acute HCV—a condition that, if left untreated, can escalate to chronic liver disease, cirrhosis, or hepatocellular carcinoma. MAVYRET’s eight-week course demonstrated a 96% cure rate in this population, positioning it as a groundbreaking option for early intervention in hepatitis C management.
Tackling a Silent Global Epidemic
HCV is a highly infectious bloodborne virus that primarily affects the liver. It is estimated that millions globally are infected, yet many remain undiagnosed due to the often asymptomatic nature of the acute phase of infection. If left untreated, acute HCV can progress to a chronic state, triggering long-term liver complications, including fibrosis, cirrhosis, and liver cancer. In the United States alone, the cumulative medical costs associated with chronic HCV and related liver conditions are projected to reach approximately $120 billion by 2035.
“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 Dr. John Ward, Director of the Coalition for Global Hepatitis Elimination. “If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates. The public health community now has a good opportunity to cure nearly all persons and support eliminating the toll of this deadly virus. No one should die of hepatitis C.”
A Public Health Milestone: MAVYRET’s Role in Global Elimination Efforts
The FDA’s latest approval for MAVYRET aligns with international public health priorities. The World Health Organization (WHO) has called for the global elimination of HCV as a public health threat by 2030, a goal that includes reducing new infections by 90% and HCV-related deaths by 65%. However, progress toward that target has been slow. Nearly 80% of high-income countries, including the United States, are currently not on track to meet the 2030 target, with projections suggesting most will not reach elimination until after 2050 unless significant action is taken.
Global and U.S. clinical guidelines already recommend the universal treatment of individuals with HCV, regardless of whether the infection is acute or chronic. Early detection and rapid initiation of antiviral therapy are crucial to breaking the chain of transmission and preventing disease progression.
“MAVYRET has already treated over one million patients with hepatitis C worldwide,” noted Dr. Roopal Thakkar, AbbVie’s Executive Vice President of Research and Development and Chief Scientific Officer. “But we recognize that a significant unmet need remains, especially for patients with acute HCV. This label expansion, combined with public health strategies like test-and-treat models, helps advance our shared goal of HCV elimination by 2030.”
A Breakthrough Designation Backed by Strong Clinical Evidence
In recognition of its potential impact, the FDA granted Breakthrough Therapy Designation (BTD) to MAVYRET for the treatment of acute HCV infection. This designation is reserved for drugs that treat serious or life-threatening conditions and show preliminary clinical evidence of substantial improvement over available therapies.
The approval was underpinned by results from a Phase 3, multicenter, single-arm, prospective study evaluating the safety and efficacy of MAVYRET in adults with acute HCV. The study demonstrated high levels of sustained virologic response (SVR), effectively indicating that the virus was undetectable in 96% of patients following the eight-week treatment course—a critical marker of cure in HCV therapy.
Safety outcomes from the trial further bolster the confidence in MAVYRET’s use. The majority of adverse events reported during the study were mild or moderate in severity, consistent with previous safety profiles of the therapy in chronic HCV. The most common side effects included fatigue, weakness (asthenia), headache, and diarrhea, all manageable and largely transient.
Pediatric Inclusion: A Landmark in HCV Treatment Access
In addition to adult patients, the label expansion makes MAVYRET the only treatment option approved for use in children as young as three years old with acute or chronic HCV, provided they do not have cirrhosis or have only compensated cirrhosis. This pediatric inclusion is especially significant, as few therapies are available for young patients with HCV, leaving clinicians with limited tools to address early-life infection.
By enabling treatment in this vulnerable group, the expanded indication not only supports individual patient outcomes but also aligns with global goals of reducing mother-to-child transmission and preventing lifelong liver disease trajectories beginning in childhood.
Broad Implications for Public Health and Policy
This regulatory milestone arrives at a pivotal moment, as HCV cases are on the rise in the U.S., especially among populations with limited access to healthcare services, such as people who inject drugs, those experiencing homelessness, and individuals in correctional facilities. The availability of a short-duration, highly effective, and safe treatment like MAVYRET could be transformative for healthcare systems looking to implement scalable, cost-effective test-and-treat models.
With Medicaid and other public insurance programs often facing complex access and reimbursement barriers for HCV therapies, the simplified treatment duration and pediatric coverage could also support more inclusive coverage policies and broader reach. MAVYRET’s role in community-based screening and treatment programs may now become more prominent, especially as state and federal health departments ramp up efforts to curb HCV transmission.
A Step Closer to Elimination
AbbVie’s MAVYRET, already a cornerstone of HCV therapy for its pangenotypic efficacy and short treatment course, has taken a significant leap forward with this FDA label expansion. The approval reinforces the therapy’s clinical value and real-world utility in not just managing chronic HCV, but now also in intercepting the disease at the acute stage—before irreversible liver damage begins.
As healthcare systems confront the growing burden of untreated HCV and work toward WHO’s 2030 elimination targets, MAVYRET’s expanded indication stands as both a clinical and strategic asset. With the potential to simplify treatment, increase access, and improve outcomes in both adults and children, this approval represents a crucial advancement in the fight against one of the world’s most persistent infectious diseases.
