An estimated 69,000 Americans acquired hepatitis C in 2023, roughly double the mid-2010s rate, even though the disease has been curable with an eight- to 12-week course of oral antivirals for more than a decade. AbbVie’s Maviret became the first of those antivirals cleared for acute infection in June 2025, with a 96% cure rate in trial.
The European Union followed suit, approving Maviret for acute hepatitis C infections in June 2026. The drug, a combination of glecaprevir and pibrentasvir, has proven its effectiveness in combating the virus.
Treatment Efficacy
Months after both approvals, it is now clear that the treatment is not reaching all the patients most susceptible to recurrent infections. John Ward, director of the Coalition for Global Hepatitis Elimination, said in an AbbVie press release, “If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates to chronic disease.”
Hepatitis C treatments date back to 1991, when the FDA approved an alpha interferon injection with a mere 10% viral eradication rate. Since then, treatment efficacy has improved dramatically, nearly tenfold.
Clinical Trial Results
AbbVie’s Maviret demonstrated remarkable results in its Phase 3 trial, achieving a 96.2% sustained virologic response rate at 12 weeks in the intention-to-treat group. The modified intention-to-treat group, excluding non-virologic failures, saw a 100% response rate, with no on-treatment virologic failures or post-treatment relapses.
Maviret received EU approval for chronic HCV in 2017, followed by FDA approval shortly after. The FDA expanded its approval to include acute HCV last year, with the EU following suit in June 2026.
Real-World Implications
“Before the acute indication, patients could be required to wait for confirmation of chronicity, even though current clinical guidelines support treatment as soon as acute infection is diagnosed. That delay can add unnecessary visits, create administrative barriers and, most importantly, increase the risk that patients disengage from care,” Ivan Gentile, an infectious disease specialist at the University of Naples Federico II and co-author of the trial results, said in an email.
In the Phase 3 trial for acute HCV, about 18% of participants were treating their second or subsequent infection. Nearly 40% of these had two or more prior infections, with two participants having six prior infections.
Among those with recurrent infections, Maviret was the most common previous treatment. Gentile stated, “The study found that a history of prior HCV infection did not appear to affect the [SVR]. Moreover, no virologic failures were observed in the study, including among participants who had previously received [Maviret] for an earlier infection.”
A systematic review of 36 studies covering 6,311 person-years found an overall reinfection rate of 5.9 per 100 person-years among people with recent drug use. Comparatively, general reinfection rates for HCV are approximately 1.27 per 100 person-years.
“Antiviral treatment does not modify the underlying exposure,” Gentile said. “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.”
“Reinfection should not be seen as a reason to delay or even withhold therapy, but as a signal that treatment and prevention services need to be delivered together. From an elimination perspective, people with repeated infections may actually be among those for whom rapid treatment has the greatest potential individual and public-health value,” he added.
Limitations and Next Steps
“This study provides strong evidence of antiviral efficacy, but it does not fully answer the question of effectiveness in populations that are least engaged in care,” Gentile said. Only 14.3% of participants in the Phase 3 trial were classified as people who currently or recently injected drugs.
Almost 50% of the participants had HIV, but all of them were receiving antiretroviral therapy, meaning they were connected to the healthcare system. These factors may have contributed to the trial’s low dropout rate and could limit how well the results generalize to people who aren’t regularly engaged in care, Gentile said.
“The acute indication provides a valuable tool in this context because it removes one practical barrier: clinicians no longer need to wait for confirmation of chronicity or rely on off-label prescribing before initiating treatment,” he said.
Leave a Reply