Mavyret - Interactions Glecaprevir and Pibrentasvir
This section below outlines the advice given to doctors and pharmacists when prescribing and dispensing Mavyret
Drug Interactions
- Carbamazepine, efavirenz, and St. John’s wort may decrease concentrations of glecaprevir and pibrentasvir. Coadministration of carbamazepine, efavirenz containing regimens, and St. John’s wort with MAVYRET is not recommended. (5.3)
- Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. (7.3)
- Medication- Assisted Treatment (MAT) for Opioid Use Disorder. (7.4)
- Consult the full prescribing information prior to and during treatment for potential drug interactions. (4, 7, 12.3)
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.
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 [see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )].
established & other potential drug interactions
Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact the safe and effective use of concomitant medications. For example, altered blood glucose control resulting in serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. Management of hypoglycemia in these cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.
Frequent monitoring of relevant laboratory parameters (e.g. International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as CYP P450 substrates with a narrow therapeutic index (e.g. certain immunosuppressants) is recommended to ensure safe and effective use. Dose adjustments of concomitant medications may be necessary.
Table 5 provides the effect of MAVYRET on concentrations of coadministered drugs and the effect of coadministered drugs on glecaprevir and pibrentasvir [see Contraindications ( 4 ) , Warnings and Precautions ( 5.3 ) , and Clinical Pharmacology ( 12.3 ) ].
| Concomitant Drug Class: Drug Name |
Effect on Concentration |
Clinical Comments |
| Antiarrhythmics: | ||
| 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. |
| Anticoagulants: | ||
| 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. |
| Anticonvulsants: | ||
| Carbamazepine | ↓ glecaprevir ↓ pibrentasvir |
Coadministration may lead to reduced therapeutic effect of MAVYRET and is not recommended. |
| Antimycobacterials: | ||
| Rifampin | ↓ glecaprevir ↓ pibrentasvir |
Coadministration is contraindicated because of potential loss of therapeutic effect [see Contraindications ( 4 ) ]. |
| Ethinyl Estradiol-Containing Products: | ||
| Ethinyl estradiol-containing medications such as combined oral contraceptives |
↔ glecaprevir ↔ pibrentasvir |
Coadministration of MAVYRET may increase the risk of ALT elevations and is not recommended. |
| Herbal Products: | ||
| St. John’s wort (hypericum perforatum) |
↓ glecaprevir ↓ pibrentasvir |
Coadministration may lead to reduced therapeutic effect of MAVYRET and is not recommended. |
| HIV-Antiviral Agents: | ||
| Atazanavir | ↑ glecaprevir ↑ pibrentasvir |
Coadministration is contraindicated due to increased risk of ALT elevations [see Contraindications ( 4 ) ]. |
| Darunavir Lopinavir Ritonavir |
↑ glecaprevir ↑ pibrentasvir |
Coadministration is not recommended. |
| Efavirenz | ↓ glecaprevir ↓ pibrentasvir |
Coadministration may lead to reduced therapeutic effect of MAVYRET and is not recommended. |
| HMG-CoA Reductase Inhibitors: | ||
| Atorvastatin Lovastatin Simvastatin |
↑ atorvastatin ↑ lovastatin ↑ simvastatin |
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 ↑ pitavastatin |
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. |
| Immunosuppressants: | ||
| Cyclosporine | ↑ glecaprevir ↑ pibrentasvir |
MAVYRET is not recommended for use in patients requiring stable cyclosporine doses > 100 mg per day. |
| See Clinical Pharmacology, Tables 8 and 9 . ↑= increase; ↓= decrease; ↔ = no effect |
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medication-assisted treatment (mat) for opioid use disorder
No buprenorphine/naloxone or methadone dosage adjustment is required when used concomitantly with MAVYRET. There is insufficient information to make a recommendation regarding the concomitant use of naltrexone with MAVYRET.
drugs with no observed clinically significant interactions with mavyret
No dose adjustment is required when MAVYRET is coadministered with the following medications: abacavir, amlodipine, caffeine, dextromethorphan, dolutegravir, elvitegravir/cobicistat, emtricitabine, felodipine, lamivudine, lamotrigine, losartan, midazolam, norethindrone or other progestin-only contraceptives, omeprazole, raltegravir, rilpivirine, sofosbuvir, tacrolimus, tenofovir alafenamide, tenofovir disoproxil fumarate, tolbutamide, and valsartan.
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