On November 13th, Chicago-based AbbVie, a research-based global biopharmaceutical company, released new findings on its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRET™ (glecaprevir/pibrentasvir).
The data released is excellent news for treatment-naïve patients suffering from compensated cirrhosis.
After 8 weeks of taking Mavyret, results from the Phase 3 EXPEDITION-8 study were really encouraging: 100 percent of genotype 1, 2, 4, 5 and 6 patients presented a sustained virologic response 12 weeks after the treatment, according to the protocol analysis.
Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
The results were presented on November 13th in San Francisco, California, at The Liver Meeting® 2018, organized by the American Association for the Study of Liver Diseases (AASLD).
Background on hepatitis C in the US
Hepatitis C is an infection of the liver caused by the hepatitis C virus (HCV). In the United States, this infection is one of the leading causes of chronic liver disease. The Centers for Disease Control (CDC) estimate that between 2.7 and 3.9 million people are infected with chronic HCV.
There are at least six distinct genotypes (strains) of the disease. About three-quarters of Americans have genotype 1. According to the U.S. Centers for Disease Control and Prevention, 3.9 million people in the United States have chronic HCV, so it is no wonder that, over the past several years, some direct-acting antivirals have been approved for treatment. With this new result, Mavyret seems ready to wipe out the competition.
When was Mavyret approved and who is it for?
When giving its approval in August 2017, the FDA said at least 92 percent of the people who took the drug had no HCV detected in the blood 12 weeks after completing the first round of treatment. Prior to this approval, Mavyret was evaluated in clinical studies on approximately 2,300 adults with all six genotypes.
Mavyret is recommended for treating patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection, without cirrhosis and with compensated cirrhosis (Child-Pugh A). Patients who were previously treated with either an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both, can also take Mavyret.
The daily dose to be taken consists of 3 tablets; treatment for most patients only requires an 8-week duration, shorter than any other treatment options currently available on the market.
The drug shouldn’t be taken by people with severe liver scarring (cirrhosis), or by those who are treated with atazanavir and firampin. People who also have hepatitis B virus, must be closely monitored if they are treated with Mavyret.
What does the recent study prove about the drug and how will it influence patients?
Since other treatments usually take 12 weeks to complete, taking 8 weeks of Mavyret is a better option, especially with this new data showing 100 percent cure rates.
“Current guidelines recommend a 12-week pan-genotypic regimen for people who have hepatitis C, are treatment-naïve and have compensated cirrhosis,” said Robert S. Brown, Jr., M.D., the Gladys and Roland Harriman professor of medicine, Weill Cornell Medical College. “We are interested in investigating shorter treatment options, which may simplify care for patients with compensated cirrhosis while providing high cure rates.”
The ongoing Phase 3b EXPEDITION-8 study is meant to prove how safe is it to take Mavyret and whether it really works for treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6).1 Cohort one of the study refers to patients with genotype 1, 2, 4, 5, 6 chronic HCV-infected patients, while cohort two includes genotype 3 (GT3) chronic HCV-infected patients.
“MAVYRET is already having a significant impact on people living with HCV. However, there are still groups of patients who may benefit from a shorter treatment option,” said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. “We continue to investigate and understand the value of an 8-week treatment regimen for patients, something we recognize as an important step towards HCV elimination.”
Results are more than encouraging: no patients stopped taking the drug due to adverse reactions, and no virologic failures have been reported in cohort one of the study. Registered adverse events (>5%) were pruritus (9.6%), fatigue (8.6%), headache (8.2%) and nausea (6.4%).
Great news for AbbVie
The shorter treatment period, only eight weeks of therapy in the majority of treatment-naïve, non-cirrhotic patients regardless of HCV genotype (GT1–6), gives Mavyret a very good vantage point over Gilead’s Harvoni (8–12 weeks of treatment for most GT1 and GT4 patients) and Epclusa (12 weeks of treatment for GT2–3 patients).
In addition, AbbVie chose an aggressive pricing strategy for Mavyret in the US, which allows the company to rapidly seize a share in an increasingly competitive marketplace.
So far, efforts have paid off; AbbVie’s second quarter earnings, announced on July 27th showed a strong performance for its hepatitis C virus (HCV) portfolio—$953M in Q2 and over $1.8B for H1 2018.
About MAVYRET™ (glecaprevir/pibrentasvir)
MAVYRET™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets, taken with food.
MAVYRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment-the majority of people living with HCV. MAVYRET is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.