Hospital Pharmacy - April 2018 - 81
81
Levien and Baker
Table 2. Comparison of the Contraindications, Warnings, and Precautions Associated With Glecaprevir/Pibrentasvir and Sofosbuvir/
Velpatasvir.1,2
Glecaprevir/pibrentasvir
Contraindications
Coadministration of atazanavir
Coadministration of rifampin
Contraindications associated with ribavirin, when used in
conjunction with ribavirin
Severe hepatic impairment (Child-Pugh C)
Warnings and precautions
Bradycardia with concomitant use of amiodarone
Coadministration of inducers of P-glycoprotein and/or CYP
enzymes (eg, carbamazepine, efavirenz, St. John's wort)
HBV reactivation
Moderate hepatic impairment (Child-Pugh B)
Precautions associated with ribavirin, when used in
conjunction with ribavirin
X
X
Sofosbuvir/velpatasvir
Not recommended
X
X
Not recommended
X
X
X
Not recommended
X
X
Note. CYP = cytochrome P; HBV = hepatitis B virus.
Warnings and Precautions
Hepatitis B virus (HBV) reactivation has occurred in patients
coinfected with HCV and HBV who were undergoing treatment with HCV direct-acting antivirals without HBV antiviral therapy. All patients should be tested for evidence of
current or prior HBV infection before initiating treatment
with glecaprevir/pibrentasvir. HCV/HBV coinfected patients
should be monitored for hepatitis flare or HBV reactivation
during HCV treatment and during posttreatment follow-up.
HBV treatment should be initiated as clinically indicated.1
Plasma concentrations of glecaprevir and pibrentasvir
may be reduced when glecaprevir/pibrentasvir is coadministered with carbamazepine, efavirenz, and St. John's wort,
resulting in reduced therapeutic effect. The concomitant
use of these agents with glecaprevir/pibrentasvir is not
recommended.1
Glecaprevir/pibrentasvir use is not recommended in
patients with moderate hepatic impairment (Child-Pugh B).1
There are no adequate and well-controlled studies of glecaprevir/pibrentasvir in pregnant women. Glecaprevir/pibrentasvir should be used during pregnancy only if clearly needed.1
Caution should be used when administering glecaprevir/
pibrentasvir to a breastfeeding woman. No studies have been
conducted to assess the presence of glecaprevir or pibrentasvir in human milk or its effects on breastfeeding infants or
human milk production.1
Safety and effectiveness of glecaprevir/pibrentasvir have
not been established in pediatric patients.1
Adverse Reactions
The most frequently observed adverse reactions during glecaprevir/pibrentasvir clinical trials were headache (13%),
fatigue (11%), and nausea (8%).1
Table 3 includes the adverse reactions observed in treatment-naive patients without cirrhosis treated with glecaprevir/pibrentasvir for 8 or 12 weeks or daclatasvir plus
sofosbuvir for 12 weeks in a comparative trial.1
Drug Interactions
Glecaprevir and pibrentasvir are inhibitors of P-gp, breast
cancer resistance protein (BCRP), and organic anion transporting polypeptide (OATP) 1B1/3. Coadministration with
glecaprevir/pibrentasvir may increase plasma concentrations
of drugs that are substrates of P-gp, BCRP, or OATP1B1 or
OATP1B3. Glecaprevir and pibrentasvir are also weak inhibitors of CYP3A and 1A2, and of uridine glucuronosyltransferase (UGT) 1A1.1
Glecaprevir and pibrentasvir are substrates of P-gp
and/or BCRP. Glecaprevir is a substrate of OATP1B1/3.
Coadministration of glecaprevir/pibrentasvir with drugs that
inhibit P-gp, BCRP, or OATP1B1/3 may increase plasma
concentrations of glecaprevir and/or pibrentasvir.
Coadministration with drugs that induce P-gp or CYP3A
may decrease glecaprevir and pibrentasvir plasma concentrations. Carbamazepine, efavirenz, and St. John's wort, all
potent P-gp/CYP3A inducers, may significantly decrease
glecaprevir and pibrentasvir plasma concentrations, leading
to reduced therapeutic effect. Therefore, concomitant use of
these agents with glecaprevir/pibrentasvir is not recommended. Table 4 summarizes clinically important drug interactions with glecaprevir/pibrentasvir.1
Interactions are not anticipated when glecaprevir/pibrentasvir is coadministered with substrates of CYP3A, 1A2,
2C9, 2C19, or 2D6, or of UGT1A1 or UGT1A4. Clinically
significant interactions have not been observed and no dose
adjustment is required when glecaprevir/pibrentasvir is
coadministered with the following drugs: abacavir,
Table of Contents for the Digital Edition of Hospital Pharmacy - April 2018
Ed Board
TOC
HPX
Why Is Burnout a Taboo?
Stability of 2 mg/mL Adenosine Solution in Polyvinyl Chloride and Polyolefin Infusion Bags
Glecaprevir/Pibrentasvir
New Medications in the Treatement of Acute Decompensated Heart Failure
The Prescription Drug User Fee Act: Cause for Concern?
ISMP Medication Error Report Analysis
ISMP Adverse Drug Reactions
Development and Implementation of a Combined Master of Science and PGY1/PGY2 Health-System Pharmacy Administration Residency Program at a Large Community Teaching Hospital
Breadth of Statistical Training Among Pharmacy Residency Programs Across the United States
Antihypertensive Prescription Pattern and Compliance to JNC 7 and JNC 8 at Tertiary Care Government Hospital, Hyderabad, India: A Cross-sectional Retrospective Study
Changes in Pharmacy Residency Training Design Between 2012 and 2017: A Perspective of Academic Medical Centers
Incidence of Hypoglycemia in Burn Patients: A Focus for Process Improvement
Physical Compatibility of Micafungin With Sodium Bicarbonate Hydration Fluids Commonly Used With High-Dose Methotrexate Chemotherapy
Hospital Pharmacy - April 2018 - Cover1
Hospital Pharmacy - April 2018 - Cover2
Hospital Pharmacy - April 2018 - Ed Board
Hospital Pharmacy - April 2018 - TOC
Hospital Pharmacy - April 2018 - HPX
Hospital Pharmacy - April 2018 - Why Is Burnout a Taboo?
Hospital Pharmacy - April 2018 - Stability of 2 mg/mL Adenosine Solution in Polyvinyl Chloride and Polyolefin Infusion Bags
Hospital Pharmacy - April 2018 - 74
Hospital Pharmacy - April 2018 - Glecaprevir/Pibrentasvir
Hospital Pharmacy - April 2018 - 76
Hospital Pharmacy - April 2018 - 77
Hospital Pharmacy - April 2018 - 78
Hospital Pharmacy - April 2018 - 79
Hospital Pharmacy - April 2018 - 80
Hospital Pharmacy - April 2018 - 81
Hospital Pharmacy - April 2018 - 82
Hospital Pharmacy - April 2018 - 83
Hospital Pharmacy - April 2018 - 84
Hospital Pharmacy - April 2018 - New Medications in the Treatement of Acute Decompensated Heart Failure
Hospital Pharmacy - April 2018 - 86
Hospital Pharmacy - April 2018 - 87
Hospital Pharmacy - April 2018 - The Prescription Drug User Fee Act: Cause for Concern?
Hospital Pharmacy - April 2018 - 89
Hospital Pharmacy - April 2018 - ISMP Medication Error Report Analysis
Hospital Pharmacy - April 2018 - 91
Hospital Pharmacy - April 2018 - 92
Hospital Pharmacy - April 2018 - ISMP Adverse Drug Reactions
Hospital Pharmacy - April 2018 - 94
Hospital Pharmacy - April 2018 - 95
Hospital Pharmacy - April 2018 - Development and Implementation of a Combined Master of Science and PGY1/PGY2 Health-System Pharmacy Administration Residency Program at a Large Community Teaching Hospital
Hospital Pharmacy - April 2018 - 97
Hospital Pharmacy - April 2018 - 98
Hospital Pharmacy - April 2018 - 99
Hospital Pharmacy - April 2018 - 100
Hospital Pharmacy - April 2018 - Breadth of Statistical Training Among Pharmacy Residency Programs Across the United States
Hospital Pharmacy - April 2018 - 102
Hospital Pharmacy - April 2018 - 103
Hospital Pharmacy - April 2018 - 104
Hospital Pharmacy - April 2018 - 105
Hospital Pharmacy - April 2018 - 106
Hospital Pharmacy - April 2018 - Antihypertensive Prescription Pattern and Compliance to JNC 7 and JNC 8 at Tertiary Care Government Hospital, Hyderabad, India: A Cross-sectional Retrospective Study
Hospital Pharmacy - April 2018 - 108
Hospital Pharmacy - April 2018 - 109
Hospital Pharmacy - April 2018 - 110
Hospital Pharmacy - April 2018 - 111
Hospital Pharmacy - April 2018 - 112
Hospital Pharmacy - April 2018 - Changes in Pharmacy Residency Training Design Between 2012 and 2017: A Perspective of Academic Medical Centers
Hospital Pharmacy - April 2018 - 114
Hospital Pharmacy - April 2018 - 115
Hospital Pharmacy - April 2018 - 116
Hospital Pharmacy - April 2018 - 117
Hospital Pharmacy - April 2018 - 118
Hospital Pharmacy - April 2018 - 119
Hospital Pharmacy - April 2018 - 120
Hospital Pharmacy - April 2018 - Incidence of Hypoglycemia in Burn Patients: A Focus for Process Improvement
Hospital Pharmacy - April 2018 - 122
Hospital Pharmacy - April 2018 - 123
Hospital Pharmacy - April 2018 - 124
Hospital Pharmacy - April 2018 - Physical Compatibility of Micafungin With Sodium Bicarbonate Hydration Fluids Commonly Used With High-Dose Methotrexate Chemotherapy
Hospital Pharmacy - April 2018 - 126
Hospital Pharmacy - April 2018 - 127
Hospital Pharmacy - April 2018 - 128
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