Brand Name: Mavyret
Generic Name: glecaprevir and pibrentasvir
What is Mavyret, and what is it used for?
Mavyret is a fixed-dose combination tablet containing glecaprevir and pibrentasvir for oral administration. Glecaprevir is a HCV NS3/4A PI, and pibrentasvir is a HCV NS5A inhibitor.
Mavyret is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
Mavyret is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.
What are the side effects of Mavyret?
Risk of hepatitis B virus reactivation in patients coinfected with HCV and HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Mavyret. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy.
Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Common side effects of Mavyret include:
What is the dosage of Mavyret?
Mavyret is a fixed-dose combination product containing glecaprevir 100 mg and pibrentasvir 40 mg in each tablet.
The recommended oral dosage of Mavyret is 3 tablets taken at the same time once daily with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).
Liver Or Kidney Transplant Recipients
- Mavyret is recommended for 12 weeks in adult and pediatric patients 12 years and older or weighing at least 45 kg who are liver or kidney transplant recipients.
- A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor or in genotype 3-infected patients who are PRS treatment-experienced.
- Mavyret is not recommended in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C).
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What drugs interact with Mavyret?
Mechanisms For The Potential Effect Of Mavyret On Other Drugs
- Glecaprevir and pibrentasvir are inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide (OATP) 1B1/3. Coadministration with Mavyret may increase plasma concentration of drugs that are substrates of P-gp, BCRP, OATP1B1 or OATP1B3. Glecaprevir and pibrentasvir are weak inhibitors of cytochrome P450 (CYP) 3A, CYP1A2, and uridine glucuronosyltransferase (UGT) 1A1.
- Fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment, including treatment with Mavyret. If Mavyret is coadministered with warfarin, close monitoring of INR values is recommended during treatment and post-treatment follow-up.
Mechanisms for The Potential Effect Of Other Drugs On Mavyret
- Glecaprevir and pibrentasvir are substrates of P-gp and/or BCRP. Glecaprevir is a substrate of OATP1B1/3. Coadministration of Mavyret with drugs that inhibit hepatic P-gp, BCRP, or OATP1B1/3 may increase the plasma concentrations of glecaprevir and/or pibrentasvir.
- Coadministration of Mavyret with drugs that induce P-gp/CYP3A may decrease glecaprevir and pibrentasvir plasma concentrations.
- Carbamazepine, phenytoin, efavirenz, and St. John’s wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of Mavyret. The use of these agents with Mavyret is not recommended.
Table 5: Potentially Significant Drug Interactions Identified in Drug Interaction Studies
|Concomitant Drug Class: Drug Name||Effect on Concentration||Clinical Comments|
|Digoxin||↑ digoxin||Measure serum digoxin concentrations before initiating Mavyret. Reduce digoxin concentrations by decreasing the dose by approximately 50% or by modifying the dosing frequency and continue monitoring.|
|Dabigatran etexilate||↑dabigatran||If Mavyret and dabigatran etexilate are coadministered, refer to the dabigatran etexilate prescribing information for dabigatran etexilate dose modifications in combination with P-gp inhibitors in the setting of renal impairment.|
|Coadministration may lead to reduced therapeutic effect of Mavyret and is not recommended.|
|Coadministration is contraindicated because of potential loss of therapeutic effect .|
|Ethinyl Estradiol-Containing Products:|
|Ethinyl estradiol-containing medications such as combined oral contraceptives||↔ glecaprevir
|Coadministration of Mavyret may increase the risk of ALT elevations and is not recommended.|
|St. John’s wort (hypericum perforatum)||↓ glecaprevir
|Coadministration may lead to reduced therapeutic effect of Mavyret and is not recommended.|
|Coadministration is contraindicated due to increased risk of ALT elevations.|
|Darunavir Lopinavir Ritonavir||↑ glecaprevir
|Coadministration is not recommended.|
|Coadministration may lead to reduced therapeutic effect of Mavyret and is not recommended.|
|HMG-CoA Reductase Inhibitors:|
|Atorvastatin Lovastatin Simvastatin||↑ atorvastatin
|Coadministration may increase the concentration of atorvastatin, lovastatin, and simvastatin. Increased statin concentrations may increase the risk of myopathy, including rhabdomyolysis. Coadministration with these statins is not recommended.|
|Pravastatin||↑ pravastatin||Coadministration may increase the concentration of pravastatin. Increased statin concentrations may increase the risk of myopathy, including rhabdomyolysis. Reduce pravastatin dose by 50% when coadministered with Mavyret.|
|Rosuvastatin||↑ rosuvastatin||Coadministration may significantly increase the concentration of rosuvastatin. Increased statin concentrations may increase the risk of myopathy, including rhabdomyolysis. Rosuvastatin may be administered with Mavyret at a dose that does not exceed 10 mg.|
|Fluvastatin Pitavastatin||↑ fluvastatin
|Coadministration may increase the concentrations of fluvastatin and pitavastatin. Increased statin concentrations may increase the risk of myopathy, including rhabdomyolysis. Use the lowest approved dose of fluvastatin or pitavastatin. If higher doses are needed, use the lowest necessary statin dose based on a risk/benefit assessment.|
|Mavyret is not recommended for use in patients requiring stable cyclosporine doses > 100 mg per day.|
|↑= increase; ↓= decrease; ↔ = no effect|
Drugs with No Observed Clinically Significant Interactions with Mavyret
No dose adjustment is required when Mavyret is coadministered with the following medications:
Is Mavyret safe to take while pregnant or breastfeeding?
- No adequate human data are available to establish whether or not Mavyret poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse developmental effects were observed when the components of Mavyret were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose of Mavyret.
- No definitive conclusions regarding potential developmental effects of glecaprevir could be made in rabbits, since the highest achieved glecaprevir exposure in this species was only 7% (0.07 times) of the human exposure at the recommended dose.
- There were no effects with either compound in rodent pre/post-natal developmental studies in which maternal systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 47 and 74 times, respectively, the exposure in humans at the recommended dose.
- It is not known whether the components of Mavyret are excreted in human breast milk, affect human milk production, or have effects on the breastfed infant. When administered to lactating rodents, the components of Mavyret were present in milk, without effect on growth and development observed in the nursing pups.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Mavyret and any potential adverse effects on the breastfed child from Mavyret or from the underlying maternal condition.
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Mavyret (glecaprevir and pibrentasvir) treats chronic Hepatitis C (Hep C) caused by a half dozen different types of the hep C virus. Side effects include headache, fatigue, nausea, diarrhea, and others. People who take Mavyret also run a risk of reactivating any latent Hepatitis B infection they may be carrying. Consult your doctor if pregnant or breastfeeding.
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Related Disease Conditions
Hepatitis (Viral Hepatitis A, B, C, D, E, G)
Hepatitis is most often viral, due to infection with one of the hepatitis viruses (A, B, C, D, E, F (not confirmed), and G) or another virus (such as those that cause infectious mononucleosis, cytomegalovirus disease). The main nonviral causes of hepatitis are alcohol and drugs. Many patients infected with hepatitis A, B, and C have few or no symptoms of illness. For those who do develop symptoms of viral hepatitis, the most common are flu-like symptoms including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, and aching in the abdomen. Treatment of viral hepatitis is dependent on the type of hepatitis.
How Long Can a Person Live After Being Diagnosed With Hepatitis C (Hep C)?
Hepatitis C is a virus that causes inflammation of the liver. The impact of hepatitis C on lifespan is dependent on how the disease progresses and the effectiveness of timely treatment.
What’s Worse, Hepatitis A, B, or C?
Because there is no vaccination available against hepatitis C, hepatitis C is often considered worse than hepatitis A or B.
Hepatitis C (HCV, Hep C)
Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
Is Hepatitis Contagious?
Hepatitis means "inflammation of the liver," and there are several different types of such as A, B, C, D, and E. Some types of hepatitis are contagious and some types are not. Hepatitis symptoms vary upon the type of disease; however, the following symptoms may develop in someone with hepatitis: fatigue, nausea and vomiting, abdominal pain and discomfort, jaundice (yellowing of the skin and whites of the eyes), and loss of appetite. Treatment for hepatitis depends upon the cause. Some types of hepatitis have a vaccine to prevent spread of disease such as hepatitis A and B.
Is Hepatitis B Contagious?
Hepatitis B is a type of liver infection. Hepatitis B is spread through person-to-person contact or through personal items like razors, toothbrushes, etc. Symptoms of hepatitis B include fever, yellowish skin (jaundice), dark urine, fatigue, nausea, and vomiting. There is no drug to cure hepatitis B; however, there is a hepatitis B vaccine available.
Hepatitis A and B Vaccinations
Hepatitis A and hepatitis B are the two most commnon viruses that infect the liver. Hepatitis A and Hepatitis B can be prevented and treated with immunizations (vaccinations) such as Havrix, Vaqta, Twinrix, Comvax, Pediarix, and hepatitis b immune globulin (HBIG).
Hepatitis B (HBV, Hep B)
The hepatitis B virus (HBV, hep B) is a unique, coated DNA virus belonging to the Hepadnaviridae family of viruses. The course of the virus is determined primarily by the age at which the infection is acquired and the interaction between the virus and the body's immune system. Successful treatment is associated with a reduction in liver injury and fibrosis (scarring), a decreased likelihood of developing cirrhosis and its complications, including liver cancer, and a prolonged survival.
Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by people sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Hepatitis C Cure (Symptoms, Transmission, Treatments, and Cost)
Hepatitis is inflammation of the liver. There are a variety of toxins, diseases, illicit drugs, medications, bacterial and viral infections, and heavy alcohol use can case inflammation of the liver. Hepatitis C viral infection (HCV) is one type of hepatitis. According to the CDC, in 2014 there were an estimated 30,500 cases of acute hepatitis C infections in the US. An estimated 2.7-3.9 million people in the US have chronic hepatitis C. The virus is spread from person-to-person via blood-to-blood contact. Symptoms of HCV infection include joint pain, jaundice, dark urine, nausea, fatigue, fever, loss of appetites, clay colored stool. Hepatitis C can be cured with medications in most people. There is no vaccine against the hepatitis C virus.
Can Alcoholic Hepatitis Be Cured?
Liver damage from mild alcoholic hepatitis can usually be cured by complete abstinence from alcohol and lifestyle changes. Learn about symptoms, treatment, and survival rates.
Is Hepatitis A Contagious?
Hepatitis means inflammation of the liver. Hepatitis A is one type of hepatitis. Hepatitis is transmitted through person to person contact, contaminated ice, vegetables, fruits, and untreated water. Hepatitis A can be prevented by the hepatitis A vaccine. Symptoms of hepatitis A may include nausea and/or vomiting, fever, loss of appetite, abdominal pain, dark urine, clay-colored stools, jaundice (yellowish color to skin and/or eyes, or joint pain.
What Causes Hepatitis?
Hepatitis is inflammation of the liver. It can occur due to a variety of factors, but the most common cause is a virus infection. The types of hepatitis are hepatitis A, B, C, D, and E. Hepatitis can be acute (short-term) or chronic (long-term) and can have fatal complications. Early diagnosis, treatment and lifestyle modification can slow or inhibit the progression of the disease and reduce complications.
Can Alcoholic Hepatitis Be Reversed?
While mild alcoholic hepatitis may be reversed, once it reaches the stage of liver cirrhosis, it is irreversible. After diagnosis, abstaining from alcohol can improve your lifespan.
Hepatitis E Viral Infection
Hepatitis E (hep E) is a type of hepatitis viral infection that includes hepatitis A, B, C, D, F, which is caused by the hepatitis E virus. Usually, you get (transmitted) hepatitis E from eating or drinking dirty or contaminated water. Hepatitis E can be very serious, especially if a woman is pregnant. Up to ¼ of women who are pregnant with the hep E virus can die from the infection. The signs and symptoms of hepatitis E infection are nausea and vomiting, brown or dark urine, stool changes jaundice (yellow eyes and skin), pain in the right side of the abdomen, dark or brown urine, and light-colored stool. Some people with hep E don’t have any symptoms so they don’t know that they are contagious. It takes about 6 weeks to recover from hep E. A person who has any type of hepatitis, including hepatitis E, should not drink any alcohol. Hep E complications are rare, but when they do occur they include severe (“fulminant”) hepatitis, liver failure, and death. Currently, no specific drugs or treatments are available for hepatitis E. Moreover, the only hepatitis E vaccine currently is available in China. Avoid alcohol, keep hydrated, and getting rest are home remedies for hepatitis E. Talk to your doctor before taking any over-the-counter (medications), especially those containing acetaminophen (Tylenol and others). Usually, the prognosis and life expectancy for hepatitis E after recovery is good. Most people do not have long term liver problems from the infection.
How Long Can You Live With Hepatitis A?
Acute illness of hepatitis A typically subsides within two months; however, it may last for up to six months in more severe cases.
What Is HCV Positive? Symptoms and Causes
HCV positive (reactive) is an interpretation of the results of the HCV antibody test that may mean the following.
Hepatitis Vaccines for Hepatitis B and C
Hepatitis is a family of viruses that infect the liver. There are vaccines for hepatitis A and B infections, but not for hepatitis C.
Is Hepatitis B HBV Curable?
While there is no permanent cure for hepatitis B, 90 percent of adults infected with the virus ultimately recover from their symptoms within a few months.
Is HBV the Same as Hepatitis B?
Hepatitis B is caused by HBV, or the hepatitis B virus. Learn about transmission, diagnosis, phases of infection, and treatment options.
What Happens If You Have Hepatitis?
Hepatitis is a term used to describe inflammation or swelling of the liver. Chronic liver infection and inflammation could damage the liver parenchyma (tissue) and lead to complications.
Treatment & Diagnosis
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