AbbVie’s Maviret demonstrated a 96% sustained cure rate for acute hepatitis C in clinical testing, yet its practical impact hinges on overcoming obstacles beyond its proven effectiveness. The medication, combining glecaprevir and pibrentasvir, received FDA clearance for acute infections in June 2025 and EU authorization in June 2026, where it is marketed as MaviRET.
A Phase 3 trial confirmed that 96.2% of participants achieved a sustained virologic response at 12 weeks, with no treatment failures or relapses. Originally approved for chronic hepatitis C in 2017, the expanded indication now allows for earlier intervention before the disease becomes chronic. Ivan Gentile, an infectious disease specialist at the University of Naples Federico II, noted that treatment delays raise transmission risks and reduce patient engagement. His analysis shows that prompt intervention could disrupt the cycle of reinfection, especially among high-risk groups.
The trial included 18% of participants with two or more prior hepatitis C infections, some experiencing up to six episodes. Reinfection rates among people with recent drug use reach 5.9 per 100 person-years, compared to 1.27 in the general population. Gentile argued that retreatment protocols must be paired with harm-reduction measures, such as sterile injection equipment and substance-use disorder support. Without these complementary strategies, even effective treatments risk being undermined by ongoing exposure.
However, the trial’s participant demographics revealed critical gaps. Only 14.3% of participants were classified as people who currently or recently injected drugs. Nearly half of the participants had HIV, but all were receiving antiretroviral therapy, meaning they were connected to the healthcare system. This limits the applicability of the results to populations with limited medical access. Gentile called for additional studies to track diagnosis-to-treatment intervals, completion rates, and reinfection patterns in harder-to-reach groups.
For people with recent drug use, hepatitis C reinfection remains a persistent challenge. A systematic review of 36 studies covering 6,311 person-years found reinfection rates nearly five times higher than in the general population. Gentile emphasized that treatment alone cannot address the root causes of reinfection. Instead, integrated prevention services, including regular testing and rapid retreatment, are essential. “Repeated treatment must therefore be integrated into a broader prevention strategy, including harm-reduction services, access to sterile injecting equipment, treatment for substance-use disorders when appropriate, sexual-health interventions, regular HCV RNA testing and rapid retreatment following reinfection,” he stated.
The expanded approval of MaviRET in the EU aligns with global elimination targets. The Coalition for Global Hepatitis Elimination has highlighted that early intervention can prevent chronic disease progression, which affects 69,000 Americans annually, a figure that has doubled since the mid-2010s. Despite the availability of curable therapies since the 1990s, reinfection rates persist, particularly among those with ongoing risk behaviors.
