Hospital Pharmacy - April 2018 - 76
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Hospital Pharmacy 53(2)
Table 1. Comparison of Indications for Pangenotypic, Fixed-Dose Combination Products.1,2,3
Indication
Glecaprevir/
Pibrentasvir (Mavyret)
Sofosbuvir/
Velpatasvir (Epclusa)
Xa
X
Chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection
without cirrhosis or with compensated cirrhosis
Chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection
with decompensated cirrhosis in combination with
ribavirin
HCV genotype 1, 2, 3, 4, 5, or 6 infection without
cirrhosis or with compensated cirrhosis in patients
previously treated with interferon, peginterferon,
ribavirin, and/or sofosbuvir, but not with an NS3/4A
protease inhibitor or NS5A inhibitor
HCV genotype 1 infection without cirrhosis or with
compensated cirrhosis in patients previously treated
with an HCV NS5A inhibitor or NS3/4A protease
inhibitor, but not both
HCV genotype 1, 2, 3, 4, 5, or 6 infection without
cirrhosis or with compensated cirrhosis in patients
previously treated with peginterferon alfa-ribavirin
with or without an NS3/4A protease inhibitor
HCV genotype 1, 2, 3, 4, 5, or 6 infection with
decompensated cirrhosis in combination with
ribavirin in patients previously treated with
peginterferon alfa-ribavirin with or without an
NS3/4A protease inhibitor
HCV genotype 1, 2, 3, 4, 5, or 6 infection without
cirrhosis or with compensated cirrhosis in patients
previously treated with an HCV NS5A inhibitor
HCV genotype 1a or 3 infection without cirrhosis or
with compensated cirrhosis and previously treated
with sofosbuvir without an NS5A inhibitor
Sofosbuvir/Velpatasvir/
Voxilaprevir (Vosevi)
X
b
X
b
b
X
X
Note. NS3/4A protease inhibitors: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, and voxilaprevir. NS5A inhibitors: daclatasvir,
elbasvir, ledipasvir, ombitasvir, pibrentasvir, and velpatasvir. HCV = hepatitis C virus; FDA = Food and Drug Administration.
a
X = FDA-approved use.
b
Use evaluated in clinical trials.
noncirrhotic HCV-infected subjects, the peak concentration
of glecaprevir was reduced by 51% relative to healthy subjects, but overall exposure was not altered. Peak concentration of pibrentasvir was reduced by 63% and overall exposure
was 34% lower relative to healthy subjects.1
Glecaprevir and pibrentasvir are both highly plasma protein bound (97.5% and greater than 99%, respectively).1
The elimination half-life of glecaprevir is 6 hours, while
that of pibrentasvir is 13 hours. Both are primarily eliminated via the biliary-fecal route, with greater than 90% of the
dose excreted in the feces. Metabolism via cytochrome P450
(CYP-450) 3A is a secondary means of elimination for glecaprevir. Less than 1% of the dose of either component is
excreted in the urine.1 Glecaprevir has been shown to dosedependently increase pibrentasvir exposure, while pibrentasvir does not significantly alter glecaprevir exposure.5
Glecaprevir and pibrentasvir area under the curve values
were increased up to 56% in non-HCV-infected subjects
with mild, moderate, severe, or end-stage renal impairment
not on dialysis compared with subjects with normal renal
function. Exposure to both agents was also similar with and
without dialysis in dialysis-dependent non-HCV-infected
subjects. In HCV-infected subjects with end-stage renal disease (with or without dialysis), glecaprevir exposure was
86% higher and pibrentasvir exposure was 54% higher than
in subjects with normal renal function. No dose adjustment is
necessary in patients with mild, moderate, or severe renal
impairment, including those on dialysis.1
In HCV-infected patients with mild hepatic impairment
(Child-Pugh A) and compensated cirrhosis, glecaprevir exposure
was increased approximately 2-fold while pibrentasvir exposure
was similar to that of noncirrhotic HCV-infected subjects. In
non-HCV-infected subjects with moderate hepatic impairment
(Child-Pugh B), glecaprevir exposure was 100% higher than in
subjects with normal hepatic function, while pibrentasvir exposure was 26% higher. In patients with severe hepatic impairment
(Child-Pugh C), glecaprevir exposure was 11-fold higher than in
subjects with normal hepatic function, while pibrentasvir exposure was 114% higher. No dose adjustment is necessary in
patients with mild hepatic impairment. Use is not recommended
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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