Hospital Pharmacy - April 2018 - 82

Hospital Pharmacy 53(2)

Table 3. Glecaprevir/Pibrentasvir Adverse Reactions (≥5% Incidence) in Treatment-Naive HCV Patients Without Cirrhosis.1

Adverse reaction
Headache
Fatigue
Nausea
Diarrhea

Glecaprevir/pibrentasvir
8 wk
(n = 157)

Glecaprevir/pibrentasvir
12 wk
(n = 233)

Daclatasvir + sofosbuvir
12 wk
(n = 115)

16%
11%
9%
7%

17%
14%
12%
3%

15%
12%
12%
3%

Note. HCV = hepatitis C virus.

Table 4. Glecaprevir/Pibrentasvir Drug Interactions.1
Concomitant drug

Effect on concentration

Antiarrhythmics
Digoxin

↑ Digoxin

Measure serum digoxin concentrations before initiating glecaprevir/pibrentasvir. Reduce
digoxin concentrations by decreasing the dose by approximately 50% or by modifying the
dosing frequency and continue monitoring.

Anticoagulants
Dabigatran etexilate

↑ Dabigatran

If glecaprevir/pibrentasvir 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.

↓ Glecaprevir
↓ Pibrentasvir

Coadministration may lead to reduced therapeutic effect of glecaprevir/pibrentasvir and is not
recommended.

↓ Glecaprevir
↓ Pibrentasvir

Coadministration is contraindicated because of potential loss of therapeutic effect.

↔ Glecaprevir
↔ Pibrentasvir

Coadministration of glecaprevir/pibrentasvir may increase the risk of ALT elevations and is
not recommended.

↓ Glecaprevir
↓ Pibrentasvir

Coadministration may lead to reduced therapeutic effect of glecaprevir/pibrentasvir and is not
recommended.

↑ Glecaprevir
↑ Pibrentasvir
↑ Glecaprevir
↑ Pibrentasvir

Coadministration is contraindicated due to increased risk of ALT elevations.

↓ Glecaprevir
↓ Pibrentasvir

Coadministration may lead to reduced therapeutic effect of glecaprevir/pibrentasvir and is not
recommended.

↑ Atorvastatin
↑ Lovastatin
↑ Simvastatin
↑ Pravastatin

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.
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 glecaprevir/pibrentasvir.
Coadministration may significantly increase the concentration of rosuvastatin. Increased statin
concentrations may increase the risk of myopathy, including rhabdomyolysis. Rosuvastatin
may be administered with glecaprevir/pibrentasvir at a dose that does not exceed 10 mg.
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.

Anticonvulsants
Carbamazepine
Antimycobacterials
Rifampin
Ethinyl estradiol-containing products
Ethinyl estradiol-containing medications
such as combined oral contraceptives
Herbal products
St. John's wort (Hypericum perforatum)
HIV antiviral agents
Atazanavir
Darunavir
Lopinavir
Ritonavir
Efavirenz
HMG-CoA reductase inhibitors
Atorvastatin
Lovastatin
Simvastatin
Pravastatin

Rosuvastatin

↑ Rosuvastatin

Fluvastatin
Pitavastatin

↑ Fluvastatin
↑ Pitavastatin

Immunosuppressants
Cyclosporine

↑ Glecaprevir
↑ Pibrentasvir

Clinical comments

Coadministration is not recommended.

Glecaprevir/pibrentasvir is not recommended for use in patients requiring stable cyclosporine
doses greater than 100 mg per day.

Note. ↑ = increased; ↓ = decreased; ↔ = no effect. ALT = alanine aminotransferase; HMG-CoA = 3-hydroxy-3-methylglutaryl coenzyme A.

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