By
Dennis Peprah, GNA
Sunyani, Dec. 3, GNA
– The Indian pharmaceutical company, Cipla has announced their commitment to
price the ground-breaking new product Quadrimune, a “4 in 1” treatment for
young children with HIV at below a US Dollar a day.
Quadrimune is
currently under review by the US Food and Drug Administration (FDA) for use in
children between three and 25 kg bodyweight.
This pleasant
tasting, heat-stable fixed-dose combination of four antiretrovirals (ARVs) for
infants and young children with HIV was developed in partnership by Cipla and
the not-for-profit Drugs for Neglected Diseases initiative (DNDi) with
financial support from Unitaid and other donors.
If it receives
tentative approval by the FDA in 2020, the 4-in-1 will represent a major
improvement in the treatment of HIV in very young children and will replace
older, bitter-tasting medicines, medicines requiring refrigeration, or regimens
that are no longer recommended by the World Health Organization (WHO).
‘Cipla is happy that
over the past 20 years it has contributed to making adult antiretroviral drugs
available at affordable prices for patients throughout the developing world, in
particular Africa, and has pioneered the development of paediatric fixed-dose
combinations of ARVs for children,’ says Dr Yusuf K Hamied, Chairman of Cipla.
‘Over the years, the
treatment of children with HIV has been neglected. In order to ensure faster
access, particularly in sub-Saharan Africa, our product Quadrimune, once
approved, will be offered for less than one dollar a day for children, he said
in a statement copied to the Ghana News Agency (GNA).
“Children living
with HIV have been neglected for too long, with the recommended treatment for
years consisting of bitter-tasting syrup with 40 per cent alcohol content,’
said Dr Bernard Pécoul, Executive Director of DNDi.
Mothers were often
forced to bury the syrup in the sand to keep it cool, because it required
refrigeration. The new Quadrimune is pleasant-tasting, heat-stable and
easy-to-use. We will finally have a treatment designed specifically for infants
and young children, who are at the highest risk of dying if they do not receive
treatment.’
It is estimated that
1.8 million children are living with HIV, almost 90 per cent of whom live in
sub-Saharan Africa. Only an estimated 54 per cent of these children have access
to HIV treatment and over 300 children still die from the disease every day.
Inappropriate, suboptimal treatment options have contributed to low treatment
coverage.
Quadrimune contains
the WHO-recommended ARVs abacavir, lamivudine, lopinavir and ritonavir, in the
form of granules filled in capsules.
If approved, parents
and caretakers will be able to administer the drugs to children by sprinkling
the granules with soft food, water, or milk. The 4-in-1 does not require
refrigeration and is easy to administer to infants and children of different
weights and ages.
Cipla will provide
Quadrimune at an ex-factory cost of US$ 15 per pack of 120 capsules, giving a
price of $1 per day ($360 per year) for children in the medium weight bracket
of 10 to 13.9 kg, with prices lower, at 50 US cents per day for younger
children and infants.
“This optimal
child-adapted all-in-one ARV regimen, that meets WHO recommendations, will be a
game-changer for millions of infants and young children,” Unitaid Executive
Director Lelio Marmora said.
“Unitaid is proud to
have supported from day one the development of this new 4-in-1 treatment that
is safe and effective, adapted and palatable, easy-to-use and with no
requirement for refrigeration. Once adopted, this innovative formulation will
enable great advances in the treatment of the youngest kids.”
Since 2013, WHO has
recommended regimens that include a class of ARVs called protease inhibitors,
which includes lopinavir/ritonavir (LPV/r), for infants and young children.
Cipla and DNDi
worked closely to develop Quadrimune, testing over 30 formulations of abacavir,
lamivudine, and LPV/r, ensuring good taste-masking and selecting one which met
the standards required for enable regulatory submission.
The 4-in-1 could be
the first of several new treatment options for young children with HIV that are
now on the horizon.
DNDi is a
not-for-profit research and development organization working to deliver new
treatments for neglected diseases – notably leishmaniasis, sleeping sickness,
Chagas disease, specific filarial infections and mycetoma – as well as
treatments for neglected patients, particularly those living with paediatric
HIV and hepatitis C.
Since its inception
in 2003, DNDi and its partners have already delivered eight innovative
treatments to improve the quality of life and health of patients.
Unitaid also brings
the power of new medical discoveries to the people who most need them and helps
set the stage for large-scale introduction of new health products by
collaborating with governments and partners such as PEPFAR, the Global Fund and
WHO.
It invests in new
ways to prevent, diagnose and treat diseases including HIV/AIDS, hepatitis C,
tuberculosis and malaria more quickly, affordably and effectively.
GNA
