FDA Approves New Hepatitis C Treatment Mavyret for All Genotypes

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The U.S. FDA approved Hepatitis C treatment Mavyret, for all genotypes, for patients without cirrhosis and those with compensated cirrhosis as well as patients with genotype 1 who have been previously treated with an HCV NS5A inhibitor or NS3/4A protease inhibitor but not both and for patients with severe kidney disease, including those on dialysis.

 

Mavyret is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor. Mavyret is taken without ribavirin. Mavyret is made by AbbVie and U.S. FDA approved on August 3, 2017.

 

Prior to Treatment:

All patients should be tested for evidence of current or prior Hepatitis B (HBV) core antibody (anti-HBc) before treatment with Mavyret.

 

Dosage and Duration:

Mavyret is a fixed-dose combination tablet containing glecaprevir 100 mg and pibrentasvir 40 mg. No ribavirin required. The recommended oral dosage of Mavyret is three tablets taken once daily with food.

 

For all genotypes: 1, 2, 3, 4, 5, 6 patients without any treatment experience and no cirrhosis, treatment is for 8 weeks. Patients without any treatment experience with compensated cirrhosis, treatment is for 12 weeks.

 

For genotype 1 patients who have been previously treated with an NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor, and no cirrhosis, recommended treatment is for 16 weeks.

 

For genotype 1 patients who have been previously treated with an NS3/4A PI 2 and with an NS5A inhibitor, with no cirrhosis and patients with compensated cirrhosis, treatment is for 12 weeks.

 

For all genotypes 1, 2, 4, 5, or 6 patients who have been previously treated with an PRS 3 with no cirrhosis, treatment is for 8 weeks and for patients with compensated cirrhosis, treatment is for 12 weeks. For patients with genotype 3 with no cirrhosis, treatment is for 16 weeks and patients with compensated cirrhosis, treatment is for 16 weeks.

 

For all genotype patients with chronic kidney disease recommended treatment is for 12 weeks.

 

Side Effects:

The most common side effects reported in clinical trials were headache, fatigue, nausea and some with diarrhea.

 

Cure Rate:

Clinical trials report cure rates from 92% to 100% with the average cure of 98%.

 

Drug Interactions:

It is very important to tell your physician and pharmacist any medical conditions you have and all medications, vitamins and supplements or herbs you take prior to taking Mavyret.

 

Mavyret should not be taken with atazanavir, or rifampin. Mavyret also interferes with other drugs, especially carbamazepine, efavirenz, and St. John’s wort.

 

It is important to note that additional drug to drug interactions may occur. To get a complete listing of drug interactions, see prescribing information list provided by Mavyret.

 

Warning:  

Mavyret is not recommended for children and is not recommended for patients with decompensated cirrhosis (severe hepatic impairment Child-Pugh C).

 

It has been reported that patients who are co-infected with Hepatitis B and C or patients who have had Hepatitis B in the past, could be at risk for hepatitis B reactivation. Hep B has been reported in HCV/HBV coinfected patients who were taking or had taken treatment with the Hep C direct acting antiviral and not receiving treatment for Hep B.

 

Prior to taking Mavyret, make sure your physician tests you for Hepatitis B antibodies and report any prior history of Hepatitis B or treatment for Hep B. Some cases have resulted in serious hepatitis reactivation, liver failure, and death.

 

Be sure to report pregnancy or breast feeding to your physician prior to taking Mavyret.

 

For full product information see Mavyret.com. For co-pay assistance or patient assistance program for Mavyret call: 1-877-628-9738 to learn more.

 

Do you have a question or comment about Hepatitis C treatment? We’d love to hear from you.

 

Share your comments below.

 

To view this post or other resources, see our home page at, Life Beyond Hep C.

 

Related Posts:

 

FDA Approves New Hepatitis C Treatment Vosevi for all genotypes

 

 

 

 

 

FDA Approves Hepatitis C Treatment Breakthrough for Children

 

 

 

 

 

10 Proactive Steps for Your Hep C Battle Plan

 

 

 

 

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2 Responses to FDA Approves New Hepatitis C Treatment Mavyret for All Genotypes

  1. Richard s. August 16, 2017 at 7:58 am #

    Dear Connie, I have a question. I was exposed in 1970 to a blood transfusion which gave me hepatitis c, of which I have been cured, but I also must have been exposed to hepatitis b since I have the antibodies . I never developed hepatitis b. Would Mavyret counterindicated for me? Praise the Lord Jesus Christ that we have this medicine. Only through His grace are we blessed. God bless all the hep c warriors with good health. It is a beautiful day at the ocean, even though it is only 6 am here in California. My prayers are that within the next few years there will no longer be any more cases of hep c. His bondservant, Richard .

    • Connie M August 16, 2017 at 11:51 am #

      Hi Richard,
      Since you were treated with a different Hepatitis C treatment, your treatment did not pose a problem with re-activation of hep B, even though you have the antibodies. Mavyret and some of the brand new treatments do have this unfortunately so patients would need to tested and closely monitored if they have the Hep B anitbodies.
      This is not to say this treatment would definitely cause Hep B to become active, but there is a chance since it was reported in the clinical trials. But your treatment was different and if there was a problem with yours becoming reactive, you would have seen it by now, plus your liver panel blood work would have picked up on it. So you’re fine.

      But all Hep C treatments are improving greatly. Even Mavyret as well as some of the new ones don’t include Ribavirin and work on all genotypes, which is fantastic. It’s so great to see treatment options in as little as 8 weeks. In some clinical trials they are working on treatments for 4 and 6 weeks and for those in different stages.

      Hope this info helps. Thanks for sharing today.
      Blessings my friend,
      Connie

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