AbbVie Receives U.S. FDA Approval of MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 Weeks
3.4 million in the U.S. are infected with chronic hep c1See below for Important Safety Information.
Use and Important Safety Information
MAVYRET™ (glecaprevir and pibrentasvir) tablets are a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
IMPORTANT SAFETY INFORMATION
What is the most important information to know about MAVYRET?
MAVYRET must not be taken if people:
- Have certain liver problems
- Are taking the medicines:
- atazanavir (Evotaz®, Reyataz®)
- rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®)
What should people tell a doctor before taking MAVYRET?
- If they have ever had hepatitis B virus infection, liver problems other than hep C infection, or any other medical conditions.
- If they are pregnant or plan to become pregnant, or if they are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm a person’s unborn baby or pass into breast milk. A doctor should be consulted about the best way to feed a baby if taking MAVYRET.
About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause people to have too much or not enough MAVYRET or other medicines in their body. This may affect the way MAVYRET or other medicines work, or may cause side effects.
- A new medicine must not be started without telling a doctor. A doctor will provide instruction on whether it is safe to take MAVYRET with other medicines.
What are the common side effects of MAVYRET?
- The most common side effects of MAVYRET are headache and tiredness.
These are not all of the possible side effects of MAVYRET. A doctor should be notified if there is any side effect that is bothersome or that does not go away.
This is the most important information to know about MAVYRET. For more information, people should talk to a doctor or healthcare provider.
People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including the Patient Information.
If people cannot afford their medication, they should contact www.pparx.org for assistance.
1. Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61(1):77-87 (and supplementary appendix)