• Mavyret is a fixed-dose combination medication containing glecaprevir and pibrentasvir that may be used to treat hepatitis C infection (HCV). Glecaprevir is an NS3/4A protease inhibitor and pibrentasvir is an NS5A inhibitor.
• Glecaprevir inhibits an enzyme called HCV NS3/4A protease, which is necessary for the cleavage of the HCV-encoded polyprotein into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins which is essential for viral replication.
• Pibrentasvir inhibits an RNA-dependent polymerase called HCV NS5A, which is also needed by the virus to replicate itself. The ingredients in Mavyret initially greatly reduce and then completely stop the production of new copies of the hepatitis C virus.
• Mavyret belongs to the class of medicines known as hepatitis C antivirals. It may also be called a combination antiviral agent.

• May be used to treat all chronic hepatitis C virus (HCV) genotypes (1-6) in adult and pediatric patients 12 years and older. Patients should weigh at least 99 pounds (45 kg).
• May be used to treat people without cirrhosis or with compensated cirrhosis (Child-Pugh A).
• Can be given to people with HCV genotype 1 infection, who have previously been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
• Cures hepatitis in most people. The success rate for curing hepatitis C ranges from 95 to 99%.
• Dosage regimens are the same for people with or without concomitant HIV.
• Duration of treatment depends on liver function, previous treatments, and other medical conditions. For treatment-naive patients, the recommended length of treatment is 8 weeks. For those who have previously received HCV treatment, the duration of treatment can range from 8 to 16 weeks. For liver or kidney transplant recipients Mavyret is recommended for 12 weeks.
• Available as oral tablets or oral pellets.
• The usual dosage for adults is 3 tablets once a day with food.
• Oral pellets in packets are recommended for children weighing less than 45 kg. Each packet contains glecaprevir 50 mg and pibrentasvir 20 mg. The recommended dosage in children aged 3 to less than 12 years of age is based on weight. For example, for children weighing 20kg to less than 30kg, the recommended dosage is four 50 mg/20 mg packets of oral pellets once daily.
• Cure rates for HCV range from 92% to 100%.
• Well tolerated.
• Price is competitive compared to other approved oral HCV treatments and may be the lowest-cost option. People with commercial insurance may be able to lower their copay cost to as little as $5 by requesting the Mavyret Savings Copay Card from AbbVie.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Headache, nausea, diarrhea, itch, and fatigue are the most common side effects of Mavyret. Most side effects are of mild to moderate severity and only 2% of people discontinued Mavyret due to side effects.
• Do not use in patients with moderate to severe liver impairment (Child-Pugh B or C) or any history of prior hepatic decompensation (acute decline in liver function in patients with cirrhosis). Cases of hepatic decompensation/failure, some of which have been fatal have been reported in NS3/4A protease-inhibitor regimens, including Mavyret.
• The list price of Mavyret for a 4-week supply is $13,200 or $26,400 per 8-week treatment course, according to AbbVie, the manufacturer. However, a patient's out-of-pocket cost may be significantly less based on their public or private insurance coverage and copay. AbbVie’s Patient Assistance Plan may also lower the costs based on eligibility.
• Usually considered a specialty medication, and may require access through a specialty pharmacy.
• Reactivation of the hepatitis B virus has been reported in people who have a current or prior hepatitis B virus (HBV) infection before initiating treatment with Mavyret. In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death.
• Mavyret may lower blood sugar levels, elevate bilirubin levels (to at least 2 times the upper limit of normal), and affect INR levels or drug concentrations of medications with a narrow therapeutic index. Monitor.
• No dosage adjustment is needed when given with buprenorphine/naloxone or methadone to people with opioid use disorder.
• No dosage adjustment is needed in mild, moderate, or severe renal impairment including those on dialysis.
• It is not known how Mavyret affects a developing fetus. Women should refrain from becoming pregnant while taking Mavyret. Women should also not breastfeed while taking Mavyret.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Mavyret is best taken at the same time every day. Take all three doses at once with food.
• If your child has been prescribed oral pellets, give them all together, with food, once daily. Sprinkle them on a small amount of soft food with a low water content that will stick to a spoon and should be swallowed without chewing (such as peanut butter, chocolate hazelnut spread, cream cheese, thick jam, or Greek yogurt). This mixture of food and oral pellets should be swallowed within 15 minutes of preparation. Do not crush or chew the oral pellets.
• Follow your physician's advice with regards to the dosage of Mavyret and do not miss or skip doses. If you miss a dose and it has been less than 18 hours since you should have taken Mavyret, then take the missed dose. If it has been more than 18 hours, do not take the missed dose just go back to taking your dose at the usual time. Do not stop taking Mavyret without talking to your doctor first.
• Take Mavyret for the duration that is recommended by your physician.
• Seek urgent medical attention if you develop a very slow heartbeat, feel faint or unwell, or experience symptoms such as dizziness or lightheadedness, weakness, excessive tiredness, shortness of breath, chest pains, confusion, or memory problems. Also see your doctor if you develop other worrying symptoms such as dark urine, abdominal pain, vomiting blood, yellowing of the skin or eyes, or you bleed or bruise more often than normal.
• Alcohol may increase the risk of side effects with Mavyret, such as nausea, diarrhea, fatigue, and headache. Alcohol itself can also cause liver inflammation and liver scarring (cirrhosis). Drinking alcohol while taking Mavyret may increase the risk of cirrhosis, liver failure, or liver cancer. This is why clinicians typically suggest that all patients with HCV avoid alcohol use. However, one drink now and then is unlikely to affect the outcome of treatment.
• Before you start taking Mavyret your doctor will test you for hepatitis B virus (HBV) infection. This is because treating HCV may reactivate an underlying hepatitis B infection (HBV). Any underlying HBV infection should be treated before Mavyret is started.
• Tell your doctor if you take any other medications or supplements, including those purchased from a supermarket or health store. Some medications, such as amiodarone, should not be taken with Mavyret.
• There is limited data as to the effects of Mavyret on a developing fetus. If you are taking Mavyret you should use adequate contraception to ensure you do not become pregnant. If you do become pregnant while taking Mavyret, see your doctor immediately. The effects of Mavyret on a breastfeeding infant are also not known. While you are taking Mavyret to treat hepatitis C, you should take steps to ensure you do not pass HCV to others. This includes not sharing needles and practicing safe sex.
• If you have a history of liver disease or any other medical conditions such as HIV, be sure to tell your healthcare provider.

• The success rate for curing hepatitis C with Mavyret ranges from 95 to 99%.
• Liver cirrhosis seems to make it harder to clear the hepatitis infection so if you have cirrhosis you may need to have a longer treatment of 12 weeks.
• Success rates vary depending on whether a patient has cirrhosis or not and the duration of treatment. In summary success rates for genotype (GT) 1 are 98-99%, GT2 98-100%, GT3 93-100%, GT4 93-100%, GT5 95-100%, GT6 92-100%.
• In a biochemical assay, glecaprevir inhibited the proteolytic activity of recombinant NS3/4A enzymes from clinical isolates of HCV genotypes 1a, 1b, 2a, 2b, 3a, 4a, 5a, and 6a with IC50 values ranging from 3.5 to 11.3 nM.

Medicines that interact with Mavyret may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Mavyret. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Mavyret include:

• anticonvulsants, such as carbamazepine, phenytoin or phenobarbital
• antimicrobials, such as rifabutin or rifampin (contraindicated)
• atazanavir (contraindicated)
• dabigatran
• digoxin
• cyclosporine
• HIV medications, such as darunavir, efavirenz, lopinavir, tenofovir, tipranavir, or ritonovir
• HMG-CoA reductase inhibitors such as atorvastatin, pravastatin, simvastatin, or rosuvastatin
• inducers of P-glycoprotein such as carbamazepine, dexamethasone, doxorubicin, nefazodone, phenobarbital, phenytoin, prazosin, rifampicin, St. John's wort, tenofovir, tipranavir, trazodone, and vinblastine
• drugs that are substrates of breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, and OATP2B1, such as benzylpenicillin, hormones, and statins
• oral contraceptives that contain ethinylestradiol (may increase the risk of ALT elevations)
• proton pump inhibitors (such as omeprazole)
• St. John's Wort.

Carbamazepine, efavirenz, and St John's Wort can significantly reduce Mavyret concentrations and are not recommended.

Mavyret has been associated with changes in blood glucose control in people with diabetes resulting in serious symptomatic hypoglycemia (low blood sugar levels). The dosage of some diabetes medications may need to be reduced.

Mavyret is a weak inhibitor of cytochrome P450 CYP3A, CYP1A2, and uridine glucuronosyltransferase.

Frequent monitoring of certain relevant laboratory parameters may be necessary, such as the International Normalized Ratio (INR) in people taking warfarin, blood glucose levels in those with diabetes, or drug concentrations of concomitant medications with a narrow therapeutic index, such as immunosuppressants. Dosage adjustments of other medications may be necessary.

Note that this list is not all-inclusive and includes only common medications that may interact with Mavyret. Refer to the prescribing information for Mavyret for a complete list of interactions.