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Hospital Pharmacy 53(2)
Limitations: Results have only been reported in a meeting abstract/presentation.
Reference: Reau N, et al, 2017 (MAGELLAN-2 trial)19
Study Design: Phase 3, single-arm, open-label, multicenter study
Study Funding: AbbVie
Patients: 100 adult patients with chronic HCV genotype
1, 2, 3, 4, 5, or 6 infection without cirrhosis who were at
least 3 months post liver or renal transplant and on a stable
immunosuppressive regimen (tacrolimus, sirolimus,
everolimus, mycophenolate mofetil, azathioprine, cyclosporine, and/or mycophenolic acid). Patients were either
treatment naive or, excepting genotype 3-infected patients,
could have received treatment with interferon, peginterferon with or without ribavirin, or sofosbuvir with ribavirin with or without peginterferon. Most patients were male
(75%) and white (78%); 34% were treatment experienced;
80% had received a liver transplant, and 20% had received
a kidney transplant. Most genotypes were represented,
although the majority of patients had genotype 1 infection
(genotype 1: 57%, genotype 2: 13%, genotype 3: 24%,
genotype 4: 4%, genotype 5: 0%, and genotype 6: 2%).
Ninety-nine patients were included in the modified intention-to-treat (mITT) analysis; one patient was lost to
follow-up.
Intervention: Patients were treated with glecaprevir 300
mg/pibrentasvir 120 mg once daily for 12 weeks.
Results
Primary End Point(s)
** SVR12 was achieved in 98 of 99 patients (99%).
Secondary End Point(s)
** Posttreatment relapse occurred at posttreatment week
4 in one treatment-naive, genotype 3a-infected
patient.
** No patients experienced on-treatment virologic
failure.
Limitations: Results have only been published in a meeting abstract.
Reference: Rockstroh J, et al, 2017 (EXPEDITION-2
trial)20
Study Design: Phase 3, single-arm, open-label, multicenter study
Study Funding: AbbVie
Patients: 153 patients with chronic HCV genotype 1, 2, 3,
4, 5, or 6 infection without cirrhosis or with compensated
cirrhosis, and with HIV-1 coinfection. Enrolled patients
were HCV treatment naive or previously treated
with interferon, peginterferon with or without ribavirin, or
sofosbuvir plus ribavirin with or without peginterferon; previously treated genotype 3-infected patients were excluded.
Patients also had to be on a stable antiretroviral regimen for
at least 8 weeks prior to screening or be antiretroviral therapy naive with a CD4+ count of at least 500 cells/mm3; nine
patients were antiretroviral therapy naive. Most patients
were male (83% in patients without cirrhosis [8-week treatment group] and 94% in those with cirrhosis [12-week treatment group]), white (77% and 94%, respectively), and HCV
treatment-naive (81% and 87%, respectively); 10% had cirrhosis. Most genotypes were represented, although the
majority of patients had genotype 1 infection (genotype 1:
61% and 63%, genotype 2: 9% and 6%, genotype 3: 16%
and 25%, genotype 4: 12% and 6%, genotype 5: 0% and
0%, and genotype 6: 2% and 0%, respectively).
Intervention: Patients received glecaprevir 300 mg/
pibrentasvir 120 mg once daily for 8 weeks in patients
without cirrhosis (n=137) and for 12 weeks in patients
with compensated cirrhosis (n=16).
Results
Primary End Point(s)
** SVR12 was achieved in 150 of 153 (98%) patients
overall and in 150 of 151 (99%) patients included in
the mITT analysis. One patient lost to follow-up at
posttreatment week 12 returned at posttreatment week
24 and was found to have achieved sustained virologic response.21
Secondary End Point(s)
** Virologic failure at week 8 occurred in one HCV genotype 3-infected patient with cirrhosis, who reported
85% adherence to the treatment regimen.21
Comments: This study was conducted in Europe, Russia,
and the United States.
Limitations: Results have only been reported in a meeting
abstract/presentation.
Contraindications, Warnings, and
Precautions
Contraindications
Glecaprevir/pibrentasvir is contraindicated in patients with
severe hepatic impairment (Child-Pugh C) and in patients
receiving atazanavir or rifampin.1
The contraindications, warnings, and precautions for glecaprevir/pibrentasvir and sofosbuvir/velpatasvir are compared in Table 2.1,2
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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