[Ip-health] Child-Friendly Formulation of WHO-Recommended Treatment Now Approved by the US FDA for Children Living with HIV

Rachel Cohen rachel.cohen72 at gmail.com
Wed Jun 3 12:51:42 PDT 2015



Child-Friendly Formulation of WHO-Recommended Treatment Now Approved by the
US FDA for Children Living with HIV
The Paediatric HIV Treatment Initiative* welcomes this important step
towards closing the treatment gap for children with HIV

(Geneva, Switzerland - 3 June 2015) Infants and young children living with
HIV will finally have access to an improved formulation of an antiretroviral
(ARV) treatment, following the U.S. Food and Drug Administration's (FDA)
0TAltr.pdf> tentative approval last week of lopinavir/ritonavir (LPV/r) oral
pellets developed by the Indian generic company Cipla.

"The announcement of tentative FDA approval of the lopinavir/ritonavir oral
pellet formulation is an important step forward in increasing access to
World Health Organization-recommended antiretroviral treatment for children
under three years of age," said Ambassador Deborah L. Birx, M.D., U.S.
Global AIDS Coordinator and U.S. Special Representative for Global Health
Diplomacy.  "This supports the goals of key PEPFAR initiatives to improve
paediatric HIV/AIDS services, including the Accelerating Children's HIV/AIDS
Treatment Initiative and the Global Pediatric ARV Commitment to Action".

Until now, the only available version of this combination treatment was a
harsh-tasting syrup that required refrigeration and contained 40% alcohol.
Only a quarter of children with HIV are currently on treatment and the lack
of child-adapted formulations contributes to this unacceptable situation.

"UNITAID and its partners in the
of-children-living-with-hiv> Paediatric HIV Treatment Initiative (PHTI)*
also welcome the approval of these oral pellets, which brings us a step
nearer  to closing the shameful treatment gap for the 3.2 million children
living with HIV around the world," said Lelio Marmora, Executive Director of
UNITAID which is funding the development of paediatric formulations for HIV.

Importantly, intellectual property issues around access to future LPV/r
combinations will be reduced, thanks to a licensing agreement the
e-for-hiv-paediatric-formulations-of-lopinavir-and-ritonavir/> Medicine
Patent Pool (MPP) signed in in December 2014 with AbbVie, the patent holder
for LPV/r. "This is a crucial licence for paediatric programmes as it
benefits low- and middle-income countries where 99% of children with HIV in
the developing world live," said Greg Perry, Executive Director of the MPP.

As part of its programme to develop improved HIV medicines for children, the
Drugs for Neglected Diseases initiative(DNDi) is working with Cipla to
ensure the new pellets are registered and adopted through a large
"implementation study" that will be carried out in several sub-Saharan
African countries. In 2013,
> UNITAID gave an important grant to DNDi for its work in this area.

"Within a few weeks, the first batches of the new pellets will be shipped to
Kenya, and DNDi and our partners on the ground will quickly introduce them
along with other needed ARVs so that children can benefit immediately," said
Dr Marc Lallemant, Head of DNDi's Paediatric HIV Programme.

Last week's FDA approval is an important step towards developing what
children with HIV really need to live healthily. Supported by UNITAID, DNDi
and Cipla  aim as the next stage to develop two "4-in-1" fixed-dose
combinations of LPV/r with other key ARVs (zidovudine/lamivudine and
abacavir/lamivudine) that are recommended by the World Health Organization
(WHO). Taste-masked versions of these combinations will be even easier to
take than the new pellets and should enable large-scale expansion of access
to treatment for infants and young children with HIV.

"In 2006 only 70,000 children were receiving HIV treatment, but with the
partnership of UNITAID we've been able to work hand in hand with national
governments to put more than 760,000 children on antiretroviral therapy,"
said Dr Nandita Sugandhi, Senior Clinical Officer at the Clinton Health
Access Initiative (CHAI). "But there remain thousands of children who are
still not accessing treatment and our efforts must continue to ensure that
children living with HIV are not left behind."

* The PHTI
of-children-living-with-hiv> was created in 2014 by UNITAID, CHAI, DNDi and
the MPP to accelerate the development of priority paediatric ARVs within the
next three years, through working with drug manufacturers to develop and
supply ARVs, and to increase access by facilitating regulatory approval,
adoption, and rapid uptake in hard-hit countries as soon as drugs are


Press contact:
Ilan Moss, DNDi Communications Manager, DNDi North America
Mobile: +1-646-266-5216 E-mail:  <mailto:imoss at dndi.org> imoss at dndi.org






Rachel M. Cohen | Regional Executive Director

Drugs for Neglected Diseases initiative - North America

40 Wall Street, 24th Floor | New York, NY 10005 | USA 

T: +1 646 616 8683 | M: +1 646 824 3064 |  <mailto:rcohen at dndi.org>
rcohen at dndi.org | skype: rachelmcohen

Best Science for the Most Neglected |  <http://www.dndina.org>



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