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Mavyret
glecaprevir/ pibrentasvir
Black Box Warnings .
Hepatitis B Reactivation
test all pts for currrent or prior HBV infection before starting tx; reported in HCV/HBV co-infected pts on or those who completed HCV direct-acting antiviral tx who were not on anti-HBV tx, incl. cases resulting in fulminant hepatitis, hepatic failure, and death; screen all pts for HBV infection before initial tx; monitor for hepatitis flare or s/sx HBV reactivation during tx and after D/C; initiate anti-HBV tx if needed
Adult Dosing .
Dosage forms: TAB: 100 mg/40 mg; PELLET: 50 mg/20 mg per pkt
chronic hepatitis C infection, genotypes 1-6
- [tx-naive pts]
- Dose: 300 mg/120 mg PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts]
- Dose: 300 mg/120 mg PO qd x16wk; Info: give w/ sofosbuvir, ribavirin if tx failure w/ glecaprevir/pibrentasvir or sofosbuvir-based regimen; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
acute hepatitis C infection, genotypes 1-6
- [tx-naive pts]
- Dose: 300 mg/120 mg PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts]
- Dose: 300 mg/120 mg PO qd x16wk; Info: give w/ sofosbuvir, ribavirin if tx failure w/ glecaprevir/pibrentasvir or sofosbuvir-based regimen; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
renal dosing
- [see below]
- renal impairment: no adjustment
- HD: no adjustment; no supplement; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C: contraindicated
Peds Dosing .
- Dosage forms: TAB: 100 mg/40 mg; PELLET: 50 mg/20 mg per pkt
chronic hepatitis C infection, genotypes 1-6
- [tx-naive pts, 3-11 yo, <20 kg]
- Dose: 150 mg/60 mg pellets PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-naive pts, 3-11 yo, 20-29 kg]
- Dose: 200 mg/80 mg pellets PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-naive pts, 3-11 yo, 30-44 kg]
- Dose: 250 mg/100 mg pellets PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-naive pts, 3-11 yo, >45 kg]
- Dose: 300 mg/120 mg PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-naive pts, 12 yo and older]
- Dose: 300 mg/120 mg PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 3-11 yo, <20 kg]
- Dose: 150 mg/60 mg pellets PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 3-11 yo, 20-29 kg]
- Dose: 200 mg/80 mg pellets PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 3-11 yo, 30-44 kg]
- Dose: 250 mg/100 mg pellets PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 3-11 yo, >45 kg]
- Dose: 300 mg/120 mg PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 12 yo and older]
- Dose: 300 mg/120 mg PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
acute hepatitis C infection, genotypes 1-6
- [tx-naive pts, 3-11 yo, <20 kg]
- Dose: 150 mg/60 mg pellets PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-naive pts, 3-11 yo, 20-29 kg]
- Dose: 200 mg/80 mg pellets PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-naive pts, 3-11 yo, 30-44 kg]
- Dose: 250 mg/100 mg pellets PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-naive pts, 3-11 yo, >45 kg]
- Dose: 300 mg/120 mg PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-naive pts, 12 yo and older]
- Dose: 300 mg/120 mg PO qd x8wk; Info: refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 3-11 yo, <20 kg]
- Dose: 150 mg/60 mg pellets PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 3-11 yo, 20-29 kg]
- Dose: 200 mg/80 mg pellets PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 3-11 yo, 30-44 kg]
- Dose: 250 mg/100 mg pellets PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 3-11 yo, >45 kg]
- Dose: 300 mg/120 mg PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
- [tx-experienced pts, 12 yo and older]
- Dose: 300 mg/120 mg PO qd x8wk, x12wk, or x16wk; Info: duration depends on genotype subtype, cirrhosis status, transplant status, prior tx; may give w/ sofosbuvir, ribavirin; refer to AASLD/IDSA hepatitis C guidelines; give w/ food; do not chew pellets
renal dosing
- [see below]
- renal impairment: no adjustment
- HD: no adjustment; no supplement; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C: contraindicated
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment, Child-Pugh Class B-C
- hepatic decompensation hx
- avoid: breastfeeding (pts w/ cracked nipple or bleeding nipple)
- caution: HBV carriers
- caution: HCV infection and HBV infection, concurrent
- caution: hepatic decompensation risk
- caution: hepatocellular carcinoma
- caution: alcohol abuse
- caution: immunosuppressed pts
- caution: diabetes mellitus
Drug Interactions .
Overview
glecaprevir
direct-acting antiviral
- CYP3A4 substrate
- BCRP substrate
- OATP1B1 substrate
- OATP1B3 substrate
- P-gp substrate
- CYP1A2 inhibitor, weak
- CYP3A4 inhibitor, weak
- BCRP inhibitor
- OATP1B1 inhibitor, moderate
- OATP1B3 inhibitor, moderate
- P-gp inhibitor, strong
- caution advised w/ narrow therapeutic index drugs extensively metabolized in the liver; viral eradication may improve hepatic metabolic function, decr. levels, efficacy of concomitant drugs
- monitor glucose w/ drugs used for diabetes tx; viral eradication may change hepatic function, alter blood glucose control resulting in serious symptomatic hypoglycemia
pibrentasvir
direct-acting antiviral
- BCRP substrate
- P-gp substrate
- CYP1A2 inhibitor, weak
- CYP3A4 inhibitor, weak
- BCRP inhibitor
- OATP1B1 inhibitor, moderate
- OATP1B3 inhibitor, moderate
- P-gp inhibitor, strong
- caution advised w/ narrow therapeutic index drugs extensively metabolized in the liver; viral eradication may improve hepatic metabolic function, decr. levels, efficacy of concomitant drugs
- monitor glucose w/ drugs used for diabetes tx; viral eradication may change hepatic function, alter blood glucose control resulting in serious symptomatic hypoglycemia
Contraindicated
- atazanavir
- cisapride
- colchicine
- elagolix
- eliglustat
- fezolinetant
- grazoprevir
- rifampin
Avoid/Use Alternative
- alpelisib
- alprazolam
- apalutamide
- apixaban
- atorvastatin
- atrasentan
- bosentan
- brincidofovir
- butalbital
- carbamazepine
- cenobamate
- cladribine oral
- codeine
- cyclosporine
- dabigatran
- dabrafenib
- darunavir
- doxorubicin
- efavirenz
- encorafenib
- ensartinib
- enzalutamide
- ethinyl estradiol (contraceptive)
- etravirine
- fedratinib
- fexinidazole
- fosphenytoin
- futibatinib
- hydrocodone
- ivosidenib
- lefamulin
- lenacapavir
- lopinavir/ritonavir
- lorlatinib
- lovastatin
- lumacaftor/ivacaftor
- mavacamten
- meperidine
- methadone
- mitapivat
- mitotane
- modafinil
- nafcillin
- neratinib
- nevirapine
- oxycodone
- pacritinib
- pazopanib
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimozide
- pralsetinib
- primidone
- propafenone
- relugolix
- repotrectinib
- resmetirom
- rifabutin
- rifapentine
- ritonavir
- rivaroxaban
- silodosin
- simvastatin
- sirolimus
- sirolimus albumin-bound
- sotorasib
- St. John's wort
- tepotinib
- tizanidine
- topotecan
- venetoclax
- voxilaprevir
- zavegepant
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- afatinib
- alfentanil
- aminophylline
- amiodarone
- atogepant
- avanafil
- avapritinib
- avatrombopag
- bendamustine
- brigatinib
- caffeine citrate
- capivasertib
- carvedilol
- ceritinib
- clozapine
- daunorubicin
- digoxin
- diltiazem
- disopyramide
- docetaxel
- dofetilide
- domperidone
- edoxaban
- eluxadoline
- enfortumab vedotin
- entrectinib
- erdafitinib
- erythromycin
- etoposide
- everolimus
- felodipine
- fentanyl
- finerenone
- flibanserin
- fluvastatin
- gepirone
- gilteritinib
- glyburide
- ibrutinib
- idelalisib
- imatinib
- infigratinib
- irinotecan
- ivabradine
- ixabepilone
- lapatinib
- lemborexant
- levoketoconazole
- lomitapide
- lonafarnib
- loperamide
- lumateperone
- lurasidone
- lurbinectedin
- mavorixafor
- methotrexate
- midazolam
- mitoxantrone
- mobocertinib
- momelotinib
- morphine
- nateglinide
- nifedipine
- nimodipine
- nintedanib
- nisoldipine
- oliceridine
- paclitaxel
- pemigatinib
- pitavastatin
- posaconazole
- pravastatin
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- ranolazine
- red yeast rice
- repaglinide
- ribociclib
- rimegepant
- riociguat
- romidepsin
- rosuvastatin
- selpercatinib
- selumetinib
- sufentanil
- tacrolimus
- tadalafil
- talazoparib
- temsirolimus
- theophylline
- tolvaptan
- triazolam
- ubrogepant
- vardenafil
- vimseltinib
- vinblastine
- vincristine
- vinorelbine
- warfarin
- zanubrutinib
Caution Advised
- abrocitinib
- adagrasib
- aliskiren
- alosetron
- armodafinil
- artemether/lumefantrine
- asciminib
- azithromycin
- belumosudil
- belzutifan
- bempedoic acid
- berotralstat
- bexarotene
- bisoprolol
- canagliflozin
- cannabidiol
- capmatinib
- captopril
- cariprazine
- ceftobiprole
- cimetidine
- clarithromycin
- clobazam
- clopidogrel
- cobicistat
- cobimetinib
- conivaptan
- cyclophosphamide
- danicopan
- danshen
- daridorexant
- darolutamide
- deflazacort
- dexamethasone
- dicloxacillin
- dihydroergotamine
- diosmin
- dronedarone
- echinacea
- elacestrant
- elafibranor
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eltrombopag
- enasidenib
- eplerenone
- ergotamine
- eslicarbazepine acetate
- febuxostat
- felbamate
- fluvoxamine
- fosamprenavir
- fostamatinib
- fostemsavir
- garlic
- gemfibrozil
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- indomethacin
- irbesartan
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ketoconazole
- larotrectinib
- lasmiditan
- lazertinib
- ledipasvir
- leflunomide
- leniolisib
- letermovir
- levacetylleucine
- maraviroc
- maribavir
- meropenem
- methylergonovine
- midostaurin
- mifepristone
- milk thistle
- mirabegron
- naldemedine
- naproxen
- nefazodone
- nelfinavir
- odevixibat
- olutasidenib
- omaveloxolone
- osimertinib
- oteseconazole
- oxcarbazepine
- palovarotene
- paroxetine
- perampanel
- pioglitazone
- pirfenidone
- pirtobrutinib
- ponatinib
- prednisone
- pretomanid
- quercetin
- regorafenib
- rifaximin
- roflumilast
- roflumilast topical
- rolapitant
- rucaparib
- rufinamide
- sacubitril
- sarecycline
- sarilumab
- seladelpar
- sirolimus topical
- somatropin
- sorafenib
- sotagliflozin
- sparsentan
- stiripentol
- sulfasalazine
- suvorexant
- suzetrigine
- tafamidis
- tazemetostat
- tecovirimat
- tedizolid phosphate
- telmisartan
- telotristat ethyl
- teriflunomide
- tezacaftor/ivacaftor
- ticagrelor
- tipranavir
- tocilizumab
- topiramate
- tovorafenib
- trazodone
- trimethoprim
- trofinetide
- tucatinib
- turmeric
- uridine triacetate
- vaborbactam
- vadadustat
- valbenazine
- vamorolone
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vemurafenib
- verapamil
- voclosporin
- vorasidenib
- xanomeline
- zonisamide
Adverse Reactions .
Serious Reactions
- HBV reactivation
- hepatic decompensation
- hepatic failure
- angioedema
Common Reactions
- headache
- fatigue
- pruritus
- nausea
- vomiting (peds pts)
- asthenia
- diarrhea
- rash (peds pts)
- abdominal pain (peds pts)
- bilirubin elevated
Safety/Monitoring .
Monitoring Parameters
CBC, hepatitis B serology incl. HBsAg, LFTs, pregnancy test at baseline; Cr at baseline, 4wk after tx start, then if clinically indicated; s/sx of hepatic impairment during tx if pre-existing hepatic decompensation risk; s/sx of hepatitis or HBV reactivation during tx and after D/C if current or prior HBV infection
Pregnancy/Lactation .
Pregnancy
Clinical Summary
glecaprevir: weigh risk/benefit during pregnancy, consider delaying pregnancy until treatment completed; no human data available; no known risk of fetal harm based on animal data at up to 53x recommended human dose
pibrentasvir: weigh risk/benefit during pregnancy, consider delaying pregnancy until treatment completed; no human data available; no known risk of fetal harm based on animal data at up to 1.5x and 51x recommended human dose
Lactation
Clinical Summary
glecaprevir: avoid breastfeeding if nipples cracked or bleeding, otherwise may use while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
pibrentasvir: avoid breastfeeding if nipples cracked or bleeding, otherwise may use while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for glecaprevir: liver partially; CYP450: CYP3A4 substrate (partial); for pibrentasvir: none; CYP450: none
Excretion: for glecaprevir: feces 92.1%, urine 0.7%; Half-life: 6h; for pibrentasvir: feces 96.6%; Half-life: 13h
Subclass: Hepatitis C (HCV)
Mechanism of Action
glecaprevir binds to active site of HCV protease (direct-acting antiviral); pibrentasvir inhibits non-structural protein 5A (NS5A), limiting viral replication (direct-acting antiviral)
Formulary .
No Formulary Selected
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