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[e-drug] DNDi & Cipla - Paediatric 4-in-1 ARVs to Fulfil New WHO Guidelines

E-DRUG: DNDi & Cipla - Paediatric 4-in-1 ARVs to Fulfil New WHO Guidelines


DNDi & Cipla Advance Development of Paediatric 4-in-1 ARVs to
Fulfill New WHO Guidelines

Immediate, Expanded, and Improved Treatments Needed for Infants and
Toddlers with HIV*

The World Health Organization’s new HIV treatment guidelines, released
today at the 2013 International AIDS Society (IAS) Conference, include new
antiretroviral (ARV) therapy (ART) recommendations for HIV-infected
children, and will mean that more children will be on better treatments.
The Drugs for Neglected Diseases *initiative* (DND*i*) applauds the new
guidelines and, with Cipla Ltd. and other partners, is expediting the
development of urgently needed 4-in-1 ARVs adapted for babies and toddlers
with HIV, to be delivered by 2015.

The new 2013 WHO Consolidated Guidelines on the Use of Antiretroviral Drugs
for Treating and Preventing HIV Infection were released today at the 7th IAS
Conference on HIV Pathogenesis, Treatment and Prevention. The updated
guidelines call for immediate ART for all HIV-infected children under five
years of age, regardless of clinical or immunological status, which will
greatly broaden the paediatric HIV patient population on treatment and thus
increase demand. Importantly, the guidelines also recommend the use of
potent protease inhibitor-based first-line ARV regimens, ideally in a
fixed-dose combination (FDC), for all children under three years old.

'The new international guidelines call for getting many more young kids
with HIV on the best treatment - with no delay’, said Dr Bernard
Pécoul, Executive Director of DND. ‘‘We are reassured that the
pediatric ARV formulation we are striving to deliver to babies and toddlers
with HIV is completely aligned with the WHO’s new recommendations.’*

Welcoming the new international HIV guidelines, Dr Jaideep A Gogtay, Chief
Medical Officer of Cipla said, ‘Cipla reinforces its commitment towards
HIV and AIDS and will continue to develop novel and child-friendly formulations
to ensure wider access of ARV drugs to HIV-infected children.’

** **
An estimated 3.3 million children (<15 years old) live with HIV/AIDS, but
only 28% of those in need of treatment are receiving it, compared with 54%
of adults. Without treatment, half of all HIV-positive children will die
before the age of two, and 80% will die before they turn five years old.****

DNDi entered the field of paediatric HIV in 2011 due to the critical
unmet need of an appropriate ARV formulation for infants and young
children. Current formulations of protease inhibitors for children too
young to swallow tablets are in an alcohol-based liquid form. These
formulations taste terrible, are difficult to store and transport, and
require refrigeration, which is a hindrance in many developing countries.
Additionally, administering the correct dose of medicine is challenging
since it involves measuring precise amounts of various liquid formulations,
which risks errors in dosing. Undesirable interactions with drugs for
tuberculosis, the most common co-infection with HIV, pose further

To fulfill the need for better paediatric formulations, DNDi is
partnering with the Indian drug manufacturer Cipla Ltd. to develop two
4-in-1 ARV FDCs designed specifically for children under three years of
age, or until they are able to swallow tablets. This new formulation
comprises tiny granules, which fit into a capsule that can be opened to
spread the medicine onto soft food or be mixed with milk. The ARVs are
‘taste-masked’, require no refrigeration, and are easy to dose according to
the child’s weight.

‘Since its creation in 2006, UNITAID has been addressing paediatric HIV by
creating the market for child-friendly antiretroviral treatments as
previously there was no incentive for pharmaceutical companies to invest in
developing these medicines and so none existed’, said Philippe
Douste-Blazy, Chair of the Board of UNITAID. ‘The international community
must continue to commit to developing the best possible treatments to avoid
childhood HIV becoming a neglected disease. UNITAID’s investment in this
project with DNDi is already a vital contribution.’

** **
The two ‘4-in-1’ combinations contain lopinavir/ritonavir + zidovudine +
lamivudine (LPV/r/AZT/3TC) and lopinavir/ritonavir + abacavir + lamivudine
(LPV/r/ABC/3TC), respectively. An additional formulation of ritonavir
granules is being developed for babies and young children who require
treatment for both HIV and tuberculosis. The goal is to make these new FDCs
available by 2015, by working closely with health professionals in the
field and research organizations in the most affected countries.

‘We are racing against the clock to ensure rapid delivery of a new 4-in-1
ARV medicine for young children,’ said Dr Marc Lallemant, Head of DNDi’s
Paediatric HIV Programme. ‘Yet getting from the recommendations to
actual implementation and treatment access will require the full support of
donors, international and national regulatory authorities, national HIV
programmes, civil society, and people living with HIV themselves to make
this a reality for HIV-infected children.’

** **
DNDi’s paediatric HIV drug development programme is supported financially
by UNITAID, the French Development Agency (AFD), and Médecins Sans
Frontières/Doctors Without Borders (MSF).

About Paediatric HIV/AIDS*
According to UNAIDS (2011), an estimated 3.3 million children under the age
of 15 years are living with HIV/AIDS, 3.1 million of whom (94%) live in
sub-Saharan Africa. Each day, more than 900 children are newly infected
with HIV and 600 die from AIDS-related complications. Only 355,000
HIV-positive children have access to antiretroviral therapy (ART),
representing just 28% of those in urgent clinical need. Without treatment,
one-third of children born with HIV will die before their first birthday,
50% will die before they turn two, and 80% will die before they are five
years old.

About the Drugs for Neglected Diseases initiative (DNDi)
DNDi is a not-for-profit research and development organization working
to deliver new treatments for neglected diseases, in particular human
African trypanosomiasis, Chagas disease, leishmaniasis, filaria, and
paediatric HIV. DNDi was established in 2003 by Médecins Sans
Frontières/Doctors Without Borders (MSF), Oswaldo Cruz Foundation of
Brazil, Indian Council for Medical Research, Kenya Medical Research
Institute, Ministry of Health of Malaysia, and Institut Pasteur of France.
The WHO Special Programme for Research and Training in Tropical Diseases
(WHO-TDR) serves as a permanent observer. Since 2003, DNDi has delivered
six treatments for neglected patients: two fixed-dose drug combinations for
malaria (ASAQ and ASMQ); nifurtimox-eflornithine combination therapy (NECT)
for late-stage sleeping sickness; sodium stibogluconate and paromomycin
(SSG&PM) combination therapy for visceral leishmaniasis in Africa; a set of
combination therapies for visceral leishmaniasis in Asia; and a paediatric
formulation of benznidazole for Chagas disease.

About Cipla
Cipla laid the foundation for the Indian pharmaceutical industry in 1935,
with the vision to make India self-reliant in healthcare. Over the years,
Cipla has emerged as one of the most respected names not just in India but
worldwide. Its state-of-the-art R&D centre has given the country and the
world many firsts. This includes the revolutionary AIDS cocktail for less
than a dollar a day. The company has over 34 manufacturing facilities
across India, and manufactures 2,000+ products in 65 therapeutic
categories. With a turnover of over US $ 1.5 billion, Cipla serves doctors
and patients in over 170 countries. It has earned a name for maintaining
one global standard across all its products and services. Cipla continues
to support, improve and save millions of lives with its high-quality drugs
and innovative devices.

Media contacts (on site at IAS):
Peng Lin Wong: Tel: +60 12 425 5020 / email: plwong@dndi.org
Oliver Yun: Tel: +1-646-266-5216 / email: oyun@dndi.org****

Rachel M. Cohen
Regional Executive Director
Drugs for Neglected Diseases *initiative* (DNDi), North America
40 Wall Street, 24th Floor, New York, NY 10005
Mob: +1.646.824.3064
Office: +1.646.616.8683
Email: rcohen@dndi.org

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