The Food and Drug Administration (FDA) recently approved AbbVie’s Mavyret, the newest treatment for chronic hepatitis C virus infection for people without cirrhosis or with compensated cirrhosis. Mavyret (glecaprevir 100 mg and pibrentasvir 40 mg) is taken once daily (three tablets for a total daily dose of glecaprevir 300 mg and pibrentasvir 120 mg) to treat genotypes 1 through 6.

What You Need to Know about Mavyret

AbbVie’s Mavyret is one pill containing two drugs. Both are direct-acting antivirals (DAAs) which means they directly interfere with hepatitis C virus replication. One drug, glecaprevir is an HCV NS3/4A protease inhibitor. The second drug is pibrentasvir, an NS5A inhibitor.

Here is a brief summary of Mavyret:

  • Mavyret is limited to patients without cirrhosis or with compensated cirrhosis defined as Child-Pugh A.
  • The recommended dose of Mavyret for people without cirrhosis who have never been treated for hepatitis C is three pills taken daily with food for 8 weeks.
  • People without cirrhosis who have genotype 1,2,4,5, or 6 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 8 weeks.
  • People with compensated cirrhosis who have genotype 1,2,4,5, or 6 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 12 weeks.
  • People with or without cirrhosis who have genotype 3 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 16 weeks.
  • People with or without cirrhosis who have genotype 1 and prior treatment experience with regimens containing ledipasvir and sofosbuvir or daclatasvir with pegylated interferon and ribavirin are treated for 16 weeks.
  • People with or without cirrhosis who have genotype 1 and prior treatment experience with regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin are treated for 12 weeks.

Warning: The FDA gave Mavyret a boxed warning in its product label concerning the risk of hepatitis B virus reactivation among those coinfected with HBV and HCV. This warning applies to all direct-acting antiviral treatments for hepatitis C.

Drug Interactions

Mavyret should not be taken with atazanavir or rifampin. Mavyret interferes with some other drugs, most notably carbamazepine, efavirenz and St. John’s wort. Let your doctor and pharmacist know all the drugs (prescription and nonprescription) and supplements that you are taking. Other drugs may interact with Mavyret, but may still be taken as long as they are taken under medical supervision. Some examples are acid-reducing drugs, statins, certain anti-seizure medications, and some HIV and TB drugs.

Although some herbs and drugs have the potential to interact with Mavyret, this doesn’t mean you can’t take drugs that may potentially interact. It usually means that your doctor or pharmacist will advise you on how to space out the timing of your medications. To see if a medication you are taking has the potential to interact with Mavyret, see the prescribing information.

Adverse Events (Side Effects)

The majority of reported side effects were mild; headache, fatigue and nausea were the most common.

Pregnancy/breastfeeding Mavyret should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Similarly, the effects of Mavyret on infants whose mothers are breastfeeding are unknown.

How effective is Mavyret? Data from nine clinical trials reported cure rates ranging between 92 and 100 percent.

What is the cost of Mavyret? The wholesale acquisition cost is $26,400 for an 8-week course of treatment. This is substantially lower than the sticker prices of Sovaldi, Harvoni, and Epclusa. There will likely be discounts to insurance companies and state Medicaid programs as well as assistance to patients.

Will insurance cover Mavyret? My guess is that insurance companies and state Medicaid programs will welcome Mavyret, especially with its lower price. It may take a bit of time to get them up to speed. To save money and frustration, I highly recommend working with an experienced provider or a patient assistance program.