Hepatitis C Virus – BiotechReality – Information Intelligence System for Biopharma

In an important milestone for the treatment of hepatitis C, AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion of MAVYRET® (glecaprevir/pibrentasvir), its pangenotypic, oral, direct-acting antiviral (DAA) therapy. The new indication now covers adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. This milestone approval distinguishes MAVYRET as the first and only DAA therapy to be approved to cure acute HCV in a mere eight weeks, with a 96% cure rate. The approval further underscores MAVYRET's position at the forefront of the simplified, efficient treatment of hepatitis C in various patient populations and infection stages. MAVYRET has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection, The label expansion for MAVYRET, coupled with the implementation of test and treat models of care, serve as tools to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal. Roopal Thakkar A Game-Changer in Hepatitis C Care Hepatitis C (HCV) is an extremely infectious, blood-borne liver infection that tends to develop quietly. During the acute phase, within six months of illness, most patients are symptom-free. If not treated, HCV can become a chronic infection, leading to cirrhosis, fibrosis of the liver, or even hepatocellular carcinoma. Under AbbVie's estimate, the economic impact of untreated HCV in the United States alone is set to amount to nearly $120 billion in healthcare costs between now and 2035, primarily due to complications related to chronic liver disease. The broadening indication of MAVYRET follows global clinical practice guidelines, which call for universal treatment of all patients with HCV across all stages of disease. While the World Health Organization (WHO) has set HCV elimination as a goal for 2030, projected trends indicate that almost 80% of high-income nations, including the U.S., are not going to achieve the benchmark before 2050. Timely and affordable treatments such as MAVYRET are needed to address this trend and drive global elimination. The expansion of the label is a big step in the early treatment and management of acute HCV, a long-untreated segment in antiviral therapy. With a once-daily, oral treatment option now available for both acute and chronic HCV, healthcare providers have a flexible tool with which to intervene early and prevent the long-term effects of untreated infection. Source: AbbVie Last Modified:

Tag: Hepatitis C Virus

U.S. FDA Approves AbbVie’s MAVYRET® to Treat Acute Hepatitis C in Adults and Children with 96% Cure Rate

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