Hospital Pharmacy - April 2018 - 78

78

Hospital Pharmacy 53(2)
CI, 92%-98%) treated with glecaprevir/pibrentasvir for
8 weeks. The 8-week glecaprevir/pibrentasvir regimen
was noninferior to the 12-week regimen with the same
agents. The 12-week glecaprevir/pibrentasvir regimen
was noninferior to the 12-week sofosbuvir plus daclatasvir regimen, which is a guideline-recommended
therapy for genotype 3 infection without cirrhosis.

Secondary End Point(s)
** Posttreatment virologic relapse occurred in 1% of
patients in each of the 12-week treatment arms and in
3% in the 8-week treatment arm.
** Nonvirologic failure occurred in 7 patients treated
with glecaprevir/pibrentasvir for 12 weeks, in 3
patients treated with sofosbuvir plus daclatasvir for 12
weeks, and in 2 patients treated with glecaprevir/
pibrentasvir for 8 weeks.
Comments: The study was conducted in Australia,
Canada, France, New Zealand, the United Kingdom, and
the United States.
Limitations: Results have only been presented in a meeting abstract.
Drug: Glecaprevir/Pibrentasvir
Reference: Zeuzem S, et al, 2016 (ENDURANCE-1 trial)9
Study Design: Phase 3, randomized, open-label, multicenter study
Study Funding: AbbVie
Patients: 703 patients with chronic HCV genotype 1 without cirrhosis and with or without HIV-1 coinfection.
Enrolled patients were treatment naive or previously
treated with interferon or peginterferon with or without
ribavirin, or with sofosbuvir plus ribavirin with or without
peginterferon. Approximately half of the patients were
male (49%) and the majority were white (84%); 62% were
treatment naive; and 42% were infected with genotype 1a;.
Only 5% were coinfected with HIV-1. Among HCV treatment-experienced patients, 99% had received an interferon-based regimen, and the remaining 1% had received
a sofosbuvir-based regimen. Patients with HIV and
patients previously treated with sofosbuvir were excluded
from the analysis of the primary end points.
Intervention: Patients received glecaprevir 300 mg/
pibrentasvir 120 mg orally once daily for either 8 weeks
or 12 weeks.

Results
Primary End Point(s)
** SVR12 was achieved in 331 of 332 patients (99.7%)
in the 12-week treatment arm.
** SVR12 was achieved in 332 of 335 patients (99.1%)
in the 8-week treatment arm; this result was noninferior to the SVR12 rate in the 12-week treatment arm.

Secondary End Point(s)
** SVR12 in patients with HIV-1 coinfection was
achieved in 15 of 15 patients (100%) treated for 8
weeks and in 18 of 18 patients (100%) treated for 12
weeks.
** SVR12 was achieved in the 3 patients with prior
sofosbuvir treatment experience.
** On-treatment virologic failure occurred at day 29 in 1
patient with genotype 1a infection in the 8-week treatment arm.
** Posttreatment relapse was not observed in any patient.
Comments: In part 1 of the similar MAGELLAN-1
study, which enrolled 50 patients 18 to 70 years of age
with HCV genotype 1 infection without cirrhosis but with
prior virologic failure or relapse following HCV directacting antiviral therapy, SVR12 was achieved in 6 of 6
patients (100%; 95% CI, 61%-100%) treated with glecaprevir 200 mg/pibrentasvir 80 mg, in 21 of 22 (95%; 95%
CI, 78%-99%) treated with glecaprevir 300 mg/pibrentasvir 120 mg plus ribavirin, and in 19 of 22 (86%; 95% CI,
67%-95%) treated with glecaprevir 300 mg/pibrentasvir
120 mg for 12 weeks.10 The phase 2 SURVEYOR-I and
SURVEYOR-II studies enrolled a total of 449 patients 18
to 70 years of age with HCV genotypes 1, 2, 3, 4, 5, or 6
without cirrhosis who were either treatment naive or had
previously been treated with peginterferon-ribavirin. In
these 2 dose-ranging studies using 8- and 12-week treatment periods, SVR12 was achieved in 92% to 100% of
patients.11 In a subsequent part 4 to the SURVEYOR-II
study in patients treated with glecaprevir 300 mg/pibrentasvir 120 mg once daily for 8 weeks, sustained virologic
response at posttreatment week 4 (SVR4) was achieved in
141 of 145 (97%) patients with genotype 2 infection, in
45 of 46 (98%) with genotype 4 infection, in 2 of 2 (100%)
with genotype 5 infection, and in 10 of 10 (100%) with
genotype 6 infection.12 In a similar study (ENDURANCE-4)
including 121 treatment-naive or treatment-experienced
(interferon- or sofosbuvir-based regimen) patients with
chronic HCV infection genotype 4, 5, or 6 treated with
glecaprevir 300 mg/pibrentasvir 120 mg once daily for 12
weeks, SVR12 was achieved in 120 of 121 patients (99%;
treatment failure occurred in one patient who discontinued treatment on day 12).13
Limitations: ENDURANCE-1 was a large study comparing 8-week and 12-week treatment durations in
patients infected with HCV genotype 1, but numbers of
patients with HIV coinfection or experience with sofosbuvir therapy were insufficient to draw any conclusions for
those groups. Results have only been reported in a meeting abstract/presentation. As a postmarketing requirement, AbbVie will conduct an additional study evaluating
the efficacy of glecaprevir/pibrentasvir in HCV genotype
1-infected patients previously treated with an NS5A
inhibitor plus sofosbuvir.14



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
Hospital Pharmacy - April 2018 - Cover3
Hospital Pharmacy - April 2018 - Cover4
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2020
https://www.nxtbook.com/nxtbooks/sage/psychologicalscience_demo
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2020
https://www.nxtbook.com/nxtbooks/sage/fai_202009
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_august2020
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2020
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2020
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_february2020
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2019
https://www.nxtbook.com/nxtbooks/sage/fai_201909
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_july2019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2019
https://www.nxtbook.com/nxtbooks/sage/canadianpharmacistsjournal_05062019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2019
https://www.nxtbook.com/nxtbooks/sage/sri_supplement_201903
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_february2019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2018
https://www.nxtbook.com/nxtbooks/sage/tec_20180810
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2018
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_julyaugust2018
https://www.nxtbook.com/nxtbooks/sage/fai_201807
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2018
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2018
https://www.nxtbook.com/nxtbooks/sage/sri_supplement_201803
https://www.nxtbook.com/nxtbooks/sage/slas_discovery_201712
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_february2018
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_november2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_september2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_julyaugust2017
https://www.nxtbook.com/nxtbooks/sage/fai_supplement_201709
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_may2017
https://www.nxtbook.com/nxtbooks/sage/fai_201706
https://www.nxtbook.com/nxtbooks/sage/fai_201607
https://www.nxtbookmedia.com