- MAVIRET can now be used as an 8-week, once-daily paediatric
granule formulation option in treatment-naïve, without cirrhosis or
with compensated cirrhosis, chronic Hepatitis C (HCV) paediatric
patients aged 3 to <12 years with genotype (GT)1-6, weighing at
least 12kg to less than 45kg
- Health Canada's decision
makes MAVIRET the first pan-genotypic treatment option for
treatment-naïve, compensated cirrhotic, chronic HCV patients as
young as 3 years of age and weighing 12kg or more
- This approval is supported by 98.4 per cent cure* rate
across this group of patients who received the approved
paediatric granule formulation
MONTREAL, June 22, 2022 /CNW/ - AbbVie (NYSE: ABBV)
announced today that Health Canada has approved a change in the
marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to
include its use for the treatment in paediatric patients 3 to 12
years old, weighing at least 12kg to less than 45kg.1
MAVIRET is now approved as an 8-week, pan-genotypic (GT1-6)
treatment for treatment-naïve, chronic HCV patients, without
cirrhosis or with compensated cirrhosis in adults and children aged
3 years and older.1**
"There is an estimated 250,000 people living in Canada with chronic hepatitis C including
young children who I have witnessed first-hand at SickKids in need
of treatment options," said Dr. Simon
Ling, MBChB, MRCP(UK), Division of Gastroenterology,
Hepatology and Nutrition, SickKids Toronto. "The approval of
MAVIRET® as a paediatric indication is a necessary step that will
add a beneficial therapeutic option to treat HCV infection in
children."
The label extension is supported by data from the phase 2/3,
non-randomized, open-label, multicenter DORA Part 2 study
evaluating the safety and efficacy of weight-based dosing of
glecaprevir/pibrentasvir (G/P) granules for 8, 12 or 16 weeks in 80
children aged 3 years to less than 12 years with chronic HCV
infection.1 Patients received a paediatric formulation
of glecaprevir (GLE)/pibrentasvir (PIB), comprised of film-coated
granules of GLE and PIB, in a sachet mixed together in a small
amount of soft food for once-daily oral administration. The mixture
of food and granules should be swallowed immediately; the granules
should not be crushed or chewed.1
"With Canada's commitment to
eliminating viral hepatitis as a public health threat by 2030, the
approval of MAVIRET® for paediatric patients is a positive
advancement in reaching our goals," said Jennifer van Gennip, Executive Director, Action
Hepatitis Canada. "Now with access to treatment of viral hepatitis
amongst children, one more barrier to elimination is removed."
In DORA Part 2, the overall SVR12 rate for the subjects who
received the final recommended dose was 98.4% (61/62 )1.
No subject taking the final recommended dose experienced virologic
failure1. The adverse reactions observed in patients 3
less than 12 years of age were consistent with those observed in
clinical trials of MAVIRET in adults with the exception of vomiting
(occurring at approximately 8%), rash, and abdominal pain upper
(each occurring at approximately 4%) which were observed more
frequently than in adults.1
"MAVIRET has had a significant impact on the lives of people
affected by chronic HCV, and we are pleased that pediatric patients
are now also able to benefit from this treatment option," said
Tracey Ramsay, Vice-president and
General Manager, AbbVie Canada. "We are committed to helping
achieve the World Health Organization's 2030 goal of HCV
elimination and we believe Health Canada's expanded approval for
MAVIRET will help Canadians to get one step closer."
About the DORA part 2
Study2
The efficacy, safety and pharmacokinetics of G/P in children 3
years to less than 18 years old was demonstrated in an open-label
study which was comprised of two parts, DORA Part 13 and
Part 22.
DORA Part 2 evaluated the safety and efficacy of weight-based
dosing of G/P granules for 8, 12 or 16 weeks in 80 children aged 3
years to less than 12 years. 18 subjects received the initial lower
dose, and 62 subjects received the final recommended dose. The
median age was 7 years (range: 3 to 11); 73% had HCV genotype 1, 3%
had genotype 2, 23% had HCV genotype 3, 3% had HCV genotype 4; 55%
were female; 4% were Black; 97.5% were HCV TN; 2.5% were
treatment-experienced to interferon; 1% had HIV-coinfection; none
had cirrhosis; the mean weight was 25 kg (range: 13 to 44). In DORA
Part 2, the overall SVR12 rate for the subjects who received the
final recommended dose was 98.4% (61/62). No subject taking the
final recommended dose experienced virologic failure. One
9-year-old child with HCV GT3b infection, who had received the
initial lower dose, experienced virologic failure. The child
had K30R and V31M at baseline and treatment-emergent Y93H at
relapse in NS5A; baseline or treatment-emergent substitutions were
not detected in NS3. The pattern of adverse reactions observed was
comparable with that observed in clinical studies of G/P
film-coated tablets in adolescents and adults.
About MAVIRET™
(glecaprevir/pibrentasvir)1,2
MAVIRET® is approved by Health Canada for the treatment of
chronic hepatitis C virus (HCV) infection in adults and children 3
years and older across all major genotypes (GT1-6). MAVIRET is a
pan-genotypic, once-daily, ribavirin-free treatment that combines
glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir
(40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.
The new paediatric formulation consists of MAVIRET coated granules
in sachet. Each sachet contains 50mg of glecaprevir and 20mg of
pibrentasvir. The recommended dosage in number of sachets is based
on body weight for children1.
MAVIRET is an 8-week, pan-genotypic option for patients without
cirrhosis and who are new to treatment**. MAVIRET is
also approved as a treatment for patients with specific treatment
challenges, including those with compensated cirrhosis across all
major genotypes, and those who previously had limited treatment
options, such as patients with severe chronic kidney1
disease (CKD). MAVIRET is a pan-genotypic treatment approved
for use in patients across all stages of CKD.
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ:
ENTA) for HCV protease inhibitors and regimens that include
protease inhibitors.
MAVIRET is contraindicated in patients with severe hepatic
impairment (Child-Pugh C) and is not recommended in patients with
moderate hepatic impairment (Child-Pugh B).1
For important safety information, please consult the MAVIRET
Product Monograph at www.abbvie.ca.
About Hepatitis C
An estimated 250,000 people in Canada are living with chronic hepatitis C but
as many as 40% are not aware that they have it.4 Left
undiagnosed and untreated, chronic hepatitis C can lead to
cirrhosis, liver cancer or liver failure. Currently,
hepatitis C is the leading indication for liver transplant
in Canada.5 AbbVie supports a range of efforts
to help elevate and prioritize HCV elimination because we know
achieving the shared goal of elimination by 2030 will take more
than medicine. It will take transparent and collaborative
partnerships with all stakeholders – industry, healthcare
providers, healthcare systems, patient groups and their support
networks. Joint efforts and maximizing the time we have left will
enable us to reach this goal.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about
AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on
Twitter, on Instagram or find us on LinkedIn.
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_____________________
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*
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Patients who achieve
a sustained virologic response at 12 weeks post treatment (SVR12)
are considered cured of hepatitis C.
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**
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The recommended
duration of MAVIRET is 12 weeks in liver or kidney transplant
recipients with or without cirrhosis.
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|
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1
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AbbVie Canada. Maviret
Product Monograph. Retrieved
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/MAVIRET_PM_EN.pdf.
April 2022.
|
2
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Jonas MM et al.
Pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir
in children with chronic hepatitis C virus: part 2 of the DORA
study. J Hepatol (2021)
|
3
|
Jonas, MM et al.
Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir
in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA
Study. J Hepatol (2020)
|
4
|
Canadian Network on
Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination
efforts in
Canada. https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf
Accessed April 2022.
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5
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Canadian Liver
Foundation. How you advocate.
https://www.liver.ca/how-you-help/advocate/ Accessed April
2022.
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SOURCE AbbVie Canada