AbbVie’s antiviral Maviret achieved a 96% cure rate in a Phase 3 trial for acute hepatitis C, leading to U.S. approval in June 2025 and a European Union extension in June 2026.
Trial results confirm high efficacy
No on-treatment virologic failures or post-treatment relapses were observed.
Since the first FDA-approved interferon injection in 1991, which cleared roughly 10% of patients, antiviral therapy effectiveness has risen dramatically, making hepatitis C a largely curable disease.
The efficacy has increased by nearly an order of magnitude since then. The Phase 3 trial that evaluated AbbVie’s Maviret, a direct-acting antiviral that targets HCV, showed a sustained virologic response rate (SVR) of 96.2% at 12 weeks in the intention-to-treat population and 100% in the modified intention-to-treat population excluding non-virologic failures, with no on-treatment virologic failures or post-treatment relapses.
According to John Ward, director of the Coalition for Global Hepatitis Elimination, treating patients with hepatitis C early on with effective therapies can essentially cure all patients before the disease progresses to a chronic state, as stated in an AbbVie press release.
Regulatory milestones and practical impact
The medication received chronic-infection approval in the EU in 2017, followed six days later by the FDA. A label expansion later added acute infection to both regions, removing the need to confirm chronicity before prescribing.
Ivan Gentile, an infectious-disease specialist, noted in an email that prior to the approval of treatments for acute hepatitis C, patients often had to wait for confirmation that the disease had become chronic, despite clinical guidelines recommending treatment as soon as the infection is detected.
Delaying treatment can lead to unnecessary medical visits, create bureaucratic hurdles, and most critically, increase the likelihood that patients will disengage from their care, potentially allowing the disease to spread further and hindering efforts to eliminate hepatitis C.
Read Also: AI agents help manage data surge in trials
Reinfection risk and high-risk groups
About 18% of trial participants had experienced at least one prior hepatitis C infection, and nearly 40% of those had two or more episodes. Two individuals entered the study after six previous infections.
Gentile noted that prior infection did not diminish SVR rates, and no virologic failures occurred even among those previously treated with the same regimen, indicating the drug’s robustness against repeat exposure.
A recent study found that among patients with recurrent hepatitis C infections, the most common previous treatment was AbbVie’s Maviret, and that neither prior infections nor previous exposure to the same treatment regimen appeared to compromise the effectiveness of the treatment for the current episode.
A review of 36 studies, covering a total of 6,311 person-years of follow-up, found that the overall rate of reinfection among individuals with recent drug use was 5.9 per 100 person-years, significantly higher than the general reinfection rate of 1.27 per 100 person-years for hepatitis C.
Limitations and future research needs
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.
The trial enrolled only 14.3% of participants who currently or recently injected drugs, and nearly half were people living with HIV who were already on antiretroviral therapy, suggesting strong linkage to care.
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.
