The approval makes Mavyret the first and only oral eight-week direct-acting antiviral therapy for people with Acute Hepatitis C Virus.
Shares of AbbVie (ABBV) traded over 1% higher on Wednesday after the company announced that the U.S. Food and Drug Administration (FDA) approved an expanded treatment scope for its drug Mavyret.
Mavyret is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without damage to the liver or with early stages of liver scarring where the organ is still functioning well.
The approval makes Mavyret the first and only oral eight-week direct-acting antiviral therapy for people with Acute Hepatitis C Virus, the company said.
HCV is a blood-borne disease affecting the liver. While people recently infected may not have symptoms, it can lead to liver-related complications if left untreated.
The United States is expected to incur $120 billion in total medical costs over the next 10 years through 2035, linked to chronic liver disease and other related conditions caused by untreated HCV, AbbVie said.
The expanded treatment scope of Mavyret was supported by positive data from a late-stage study evaluating the safety and efficacy of the drug’s eight-week treatment in adults with acute HCV infection.
The majority of adverse events identified in the treatment were only mildly or moderately severe, the company said. Commonly identified adverse events included fatigue, asthenia, headache, and diarrhea.
Mavyret brought in $306 million in net revenue for AbbVie in the first quarter of 2025, including $142 million from within the U.S. However, this marked a 12.3% decrease in revenue generated by the drug in the corresponding quarter of 2024.
On Stocktwits, retail sentiment around AbbVie stayed within ‘bearish’ territory over the past 24 hours, coupled with ‘low’ message volume.

ABBV stock is up by over 7% this year and has risen about 14% over the past 12 months.
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