The US Food and Drug Administration (FDA) approved the hepatitis C virus (HCV) treatment Mavyret (glecaprevir, pibrentasvir), granting biopharmaceutical firm AbbVie Breakthrough Therapy Designation and Priority Review for the treatment of GT1 HCV patients not cured with prior direct-acting antiviral therapy. Clinical trials of the drug demonstrated an overall cure rate of 98 percent in patients who received the recommended duration of treatment.
Mavyret is an 8-week pan-genotypic treatment for patients without cirrhosis and who are new to treatment. It is a once-daily, ribavirin-free treatment suitable for adults with all major genotypes (GT1-6) of HCV. AbbVie's drug is a combination of two new direct-acting antivirals: the NS3/4A protease inhibitor glecaprevir, and the NS5A inhibitor pibrentasvir. These anti-virals target and inhibit the proteins necessary for the replication of the hepatitis C virus.
The drug was designed to cure all the major genotypes of the disease and offer treatment options to patients with specific challenges, such as chronic kidney disease or those who do not respond to treatment with either NS5A inhibitors or NS3/4A protease inhibitor direct-acting anti-virals. Drugs currently used to treat patients with HCV include Harvoni (ledipasvir, sofosbuvir), Epclusa (sofosbuvir, velpatasvir) and Rebetol (ribavirin).
An estimated 3.4 million Americans have chronic HCV infection, according to figures from the Ipsos Healthcare HCV Monitor 2017. Data from the Centers for Disease Control and Prevention (CDC) suggest levels of new hepatitis C infections in the US nearly tripled over the last five years, reaching a 15-year high. AbbVie estimates up to 95 percent of patients with HCV will be eligible for treatment with Mavyret.
Fred Poordad, MD, vice-president of academic and clinical affairs at the Texas Liver Institute and professor of medicine at the University of Texas Health, San Antonio, commented: "The clinical trial program for Mavyret resulted in high cure rates across a range of patient populations… This approval helps achieve physicians' goals of delivering effective options for a broad range of patients."
Clinical trials of Mavyret involved approximately 2,300 patients with HCV genotypes 1-6, all without cirrhosis or with mild cirrhosis. The results showed between 92 and 100 percent of patients who received the treatment for between eight and 12 weeks showed no signs of the virus in their blood after 12 weeks.
Who can take Mavyret?
Mavyret is indicated for treating adult patients with chronic HCV genotypes 1-6 without cirrhosis or with compensated cirrhosis.
Who should not take Mavyret?
- Patients with certain liver problems.
- Patients taking: atazanavir (branded drugs include Evotaz and Reyataz), or rifampin (Rifadin, Rifamate, Rifater, Rimactane)
What should you tell healthcare providers before starting a course of Mavyret?
- Inform doctors of any history of hepatitis B virus infection. Mavyret carries the risk of reactivating the hepatitis B virus, which may cause serious liver problems, including liver failure and even death. Doctors will monitor patients at risk of hepatitis B reactivation, both during and after treatment with Mavyret.
- Doctors should also be made aware if patients are pregnant or have plans to become pregnant.
- Always inform doctors of any other medications you take before taking a new prescription medication. This includes supplements and over-the-counter drugs, as well as prescription medicines.
What are the common side effects of Mavyret?
Headaches, fatigue, and nausea, although other side effects are possible. Patients with concerns about side effects or who experience other bothersome side effects or those that do not abate over time are advised to notify their healthcare provider.
For more information on Mavyret visit the link below.
http://www.rxabbvie.com/pdf/mavyret_pi.pdf