Hospital Pharmacy - April 2018 - 79
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Levien and Baker
Reference: Forns X, et al, 2017 (EXPEDITION-1 trial)15
Study Design: Open-label, single-arm, multicenter, phase
3 study
Study Funding: AbbVie
Patients: 146 patients (18 years and older) with chronic
HCV infection and with compensated cirrhosis. Patients
were either treatment naive or had not responded to treatment with interferon or peginterferon with or without
ribavirin, or to treatment with sofosbuvir plus ribavirin
with or without peginterferon; all patients were NS3/4A
and NS5A inhibitor-naive. Enrolled patients were
infected with HCV genotype 1a (33%), 1b (27%), 2
(23%), 4 (11%), 5 (1%), or 6 (5%). Mean age was 60
years (range, 26 to 88 years); 62% of patients were male,
and 82% were white. The majority (75%) were treatment
naive.
Intervention: Patients received glecaprevir 300 mg/
pibrentasvir 120 mg administered orally once daily for 12
weeks.
Results
Primary End Point(s)
** SVR12 was achieved in 145 patients (99%; 95% CI,
98%-100%).
Secondary End Point(s)
** No patients experienced on-treatment virologic
failure.
** The proportion of patients with posttreatment virologic
relapse was 1%. Relapse occurred in one patient with
genotype 1a infection at posttreatment week 8. This
patient had no baseline polymorphisms or treatmentemergent substitutions in NS3; however, in NS5A,
Q30R-H58D was present at the time of failure, and
Y93N was present at baseline and at the time of failure.
Comments: EXPEDITION-1 was conducted at 40 sites in
Belgium, Canada, Germany, South Africa, Spain, and the
United States. Similar results were achieved in the phase 2
SURVEYOR-I and SURVEYOR-II studies enrolling 27
patients with HCV genotype 1 and 55 patients with HCV
genotype 3, all with compensated cirrhosis. Patients with
genotype 1 received glecaprevir 300 mg plus pibrentasvir
120 mg for 12 weeks; patients with genotype 3 received
glecaprevir 300 mg plus pibrentasvir 120 mg with or without ribavirin for 12 weeks. SVR12 was achieved in 26 of
27 patients (96%; 95% CI, 82%-99%) with genotype 1
infection, in 27 of 28 patients (96%; 95% CI, 82%-99%)
with genotype 3 treated without ribavirin, and in 27 of 27
patients (100%; 95% CI, 88%-100%) with genotype 3
treated with ribavirin.16 Part 2 of the MAGELLAN-1
phase 2 study enrolled 91 patients (18 to 70 years of age)
with HCV genotype 1 or genotype 4 infection with or
without compensated cirrhosis, and with prior virologic
failure following HCV direct-acting antiviral therapy with
NS5A and/or NS3/4A protease inhibitors. Patients were
randomized to receive 12 or 16 weeks of glecaprevir 300
mg/pibrentasvir 120 mg. SVR12 was achieved in 39 of 44
patients (89%) treated for 12 weeks and in 43 of 47 patients
(92%) treated for 16 weeks. In the subgroup of patients in
whom previous regimens with telaprevir or boceprevir
plus peginterferon-ribavirin, simeprevir plus sofosbuvir or
peginterferon-ribavirin, or multiple protease inhibitors had
failed, SVR12 was achieved at a rate of 100% (14 of 14
patients treated for 12 weeks and 13 of 13 patients treated
for 16 weeks). In the subgroup in whom previous regimens
with sofosbuvir/ledipasvir or daclatasvir plus peginterferon-ribavirin had failed, SVR12 was achieved in 14 of
16 patients (88%) treated for 12 weeks and in 17 of 18
(94%) treated for 16 weeks. In the subgroup of patients in
whom previous regimens with ombitasvir/paritaprevir/
ritonavir with or without dasabuvir, daclatasvir plus asunaprevir, or other combinations had failed, SVR12 was
achieved in 11 of 14 patients (79%) treated for 12 weeks
and in 13 of 16 (81%) treated for 16 weeks.17
Limitations: The small number of patients in some genotype groups, the limited number of treatment-experienced
patients, and the lack of an active control arm were all
limitations of the EXPEDITION-1 study.
Reference: Gane EJ, et al, 2016 (EXPEDITION-4 trial)18
Study Design: Open-label, multicenter study
Study Funding: AbbVie
Patients: 104 patients with renal impairment (estimated
glomerular filtration rate less than 30 mL/min/1.73 m2)
and HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. Patients were treatment naive or previously treated with an interferon- or
sofosbuvir-based regimen. Most patients were male
(76%) and white (62%); 42% were treatment experienced,
19% had compensated cirrhosis, and 82% were on dialysis. All genotypes were represented, although most
patients had genotype 1 infection (genotype 1: 52%, genotype 2: 16%, genotype 3: 11%, genotype 4: 19%, genotype 5 and 6: 1% each).
Intervention: Patients received glecaprevir 300 mg/
pibrentasvir 120 mg orally once daily for 12 weeks.
Results
Primary End Point(s):
** SVR12 was achieved in 102 of 104 patients (98%) in
the intention-to-treat analysis; 1 patient discontinued
treatment early, and 1 patient was lost to follow-up.
Secondary End Point(s)
** SVR4 was achieved in 103 of 104 patients (99%). The
patient not achieving SVR4 prematurely discontinued
treatment.
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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