[e-med] L'OMS, l'ONUSIDA et l'UNICEF recommendent la prophylaxis par le cotrimoxazole chez l'enfant

["remed" <remed@remed.org>]

L'OMS, l'ONUSIDA et l'UNICEF recommendent la prophylaxis par le
cotrimoxazole chez l'enfant

[voir aussi ci-dessous le communiqué en fin de message qui n'est pas encore
traduit en français.CB]

Santé. Selon un essai mené en Zambie, le cotrimoxazole réduit quasiment de
moitié la mortalité.
L'antibiotique qui s'attaque au sida
http://www.liberation.fr/page.php?Article=255533
Par Sandrine CABUT
samedi 20 novembre 2004 (Liberation - 06:00)

c'est peut-être, enfin, une lueur d'espoir pour les centaines d'enfants qui
meurent chaque jour du sida, faute d'accès aux antirétroviraux. Une étude
menée en Zambie et publiée dans The Lancet daté d'aujourd'hui montre qu'un
antibiotique de faible coût, le cotrimoxazole, peut réduire quasiment de
moitié la mortalité des enfants atteints par le virus. Les résultats de cet
essai contre placebo ont été si impressionnants qu'il a été interrompu
prématurément, afin que tous les participants puissent recevoir
l'antibiotique. L'Unicef et l'Organisation mondiale de la santé (OMS) ont
appelé à une prescription systématique du cotrimoxazole chez les enfants
séropositifs des pays en voie de développement. Pour l'instant, ce
traitement n'est recommandé que lorsque le taux de CD4 (qui traduit
l'évolution de la maladie) est inférieur à 15 %.

Impact. S'il est officialisé rapidement, le nouveau protocole pourrait avoir
un impact de santé public considérable : sur les 38 millions de personnes
vivant avec le VIH dans le monde, plus de deux millions sont des mineurs de
moins de 15 ans, selon les données d'Onusida. Et en 2003, le sida a tué près
de 500 000 enfants, soit plus de 1 300 par jour. L'étude publiée dans The
Lancet a été coordonnée par l'équipe britannique du Dr Gibb, du département
des essais cliniques internationaux. Elle a inclu 541 enfants âgés de 1 à 14
ans, à différents stades d'évolution de l'infection par le VIH. La moitié a
été traitée par du cotrimoxazole, un antibiotique (associant deux molécules)
utilisé de longue date pour lutter contre les infections opportunistes,
telle la pneumocystose. Les autres ont reçu un placebo. Après dix-neuf mois
de suivi, 112 des 269 enfants sous placebo étaient morts ­ soit 42 %, contre
28 % dans le groupe cotrimoxazole. Au total, le risque de mortalité a chuté
de 43 % sous cotrimoxazole ; et celui d'hospitalisation de 23 %.

Résistance. Les succès ont été constatés quels que soient l'âge et le taux
de lymphocytes. Un résultat d'autant plus remarquable que la Zambie connaît
un fort taux de résistance à cet antibiotique. «Le mécanisme d'action du
cotrimoxazole dans cette étude n'est pas entièrement clair, reconnaissent
les chercheurs. Bien qu'il y ait, semble-t-il, une baisse de la mortalité
par infection pulmonaire dans le groupe cotrimoxazole, cela ne paraît pas
lié à un effet sur des pneumonies à pneumocystis, puisqu'aucun cas n'a été
confirmé.»

Outre ce champignon, l'antibiotique agit aussi sur des bactéries et des
parasites, dont le paludisme. Selon New Scientist, le coût d'un traitement
annuel par cotrimoxazole serait de l'ordre de 7 à 12 dollars par enfant. Un
budget négligeable par rapport à celui des antirétroviraux : 200 à 300
dollars pour les moins onéreux. Mais qui ne doit pas faire oublier que c'est
un choix par défaut. Le cotrimoxazole, «percée majeure», selon l'Unicef, est
bien moins efficace sur la mortalité que les antirétroviraux.

******************

(see web versions at http://www.who.int/3by5/en/)

22 November 2004: WHO, UNAIDS and UNICEF, guided by recent evidence, have
agreed to modify as an interim the current recommendations(1) for
cotrimoxazole prophylaxis in children. This is based upon recent trial data
from Zambia (2).
These data and other new evidence will be reviewed in early 2005 by an
expert committee convened to revise and update the recommendations for
cotrimoxazole for adults and children.
Cotrimoxazole remains important even with increasing access to ART, as it
use can improve survival independently of specific HIV treatment. Current
recommendations suggest it should be used before children require ARVs
because it may even postpone the time at which ART needs to be started.


Prophylactic dosing with cotrimoxazole for HIV infected children with any
sign or symptoms suggestive of HIV is a key intervention that should be
offered as part of a basic package of care to reduce morbidity and
mortality.

Cotrimoxazole prophylaxis is also a crucial potentially life saving
intervention that should be given to all HIV exposed children born to
HIV-infected mothers, in settings where HIV infection status cannot be
reliably confirmed in the first 18 months of life.


Cotrimoxazole is a widely available antibiotic that is available in syrup
and solid formulations at low-cost in most settings, including resource
limited settings. It is highly effective for the treatment and prevention of
Pneumocystis pneumonia. In HIV infected children it also offers protection
against other infections, this remains important even with increasing access
to ARV treatment.

Greater advocacy for the use of cotrimoxazole prophylaxis in children is
urgently required.


Who should get cotrimoxazole:

*	All HIV exposed children (children born to HIV infected mothers)
from 4-6 weeks  of age (whether or not part of a prevention of
mother-to-child transmission [PMTCT] programme)
*	Any child identified as HIV-infected with any clinical signs or
symptoms suggestive of HIV, regardless of age or CD4 count.

How long should cotrimoxazole be given:
Cotrimoxazole is required to be taken as follows:
*	HIV exposed children - until HIV infection has been definitively
ruled out  AND the mother is no longer breastfeeding
*	HIV infected children - indefinitely where ARV treatment is not yet
available.
*	Where ARV treatment is being given- cotrimoxazole can be stopped
only once clinical or immunological indicators confirm restoration of the
immune system for 6 months or more (also see below). With current evidence
it is not yet clear if cotrimoxazole continues to provide protection after
immune restoration is achieved.
Under what circumstances should cotrimoxazole be discontinued:
*	Occurrence of severe cutaneous reactions such as Stevens Johnson
syndrome, renal and/or hepatic insufficiency or severe hematological
toxicity.
*	In an HIV exposed child ONLY once HIV infection has confidently been
excluded;
o	For a non- breastfeeding child <18 months of age this is by
negative DNA or RNA virological HIV testing
o	For a breastfed HIV exposed child < 18months - negative virological
testing is only reliable if conducted 6 weeks after cessation of
breastfeeding,
o	For a breastfed HIV-exposed child >18 months - negative HIV antibody
testing 3 months after stopping breastfeeding
*	In an HIV- infected child:
o	If the child is on ARV therapy, cotrimoxazole can be stopped ONLY
when evidence of immune restoration has occurred. This can be assumed where
the child is over 18 months of age and CD4% >15 at two measurements, at
least 3 to 6 months apart. If a CD4 count is not available, cotrimoxazole
should not be stopped before a full 6 months of successful adherence to ARV
therapy, and then only when clinical evidence of immune restoration is
present. Continuing cotrimoxazole may continue to provide benefit even once
child has  clinically improved.
o	If ARV therapy is not available it should not be discontinued

What doses of cotrimoxazole should be used?
*	Syrup use is recommended in very young children up to 10-12 kg
*	Recommended dosages of 6-8 mg/kg once daily should be used.
*	Once tablets can be taken, half of a standard adult tablet crushed
may be used for children up to 10kg, one whole tablet for 10-25kg, two
single strength or one double strength for over 25kg (a usual single
strength tablet provides Sulfamethoxazole 400 mg and trimethoprim 80 mg).
*	Use weight band dosages rather than body surface area doses
*	If the child is allergic to cotrimoxazole, dapsone is the best
alternative

What follow- up is required?

*	Assessment of tolerance and adherence: Cotrimoxazole prophylaxis
should be a routine part of care of HIV infected children, and be assessed
at all regular clinic visits or follow-up visits by health workers and/or
other members of multidisciplinary care teams.

Initial clinic follow-up in children is suggested monthly, and then every
three months, if cotrimoxazole is well tolerated.

Other operational issues
Drug supplies
*	Cotrimoxazole should be prescribed by the health care providers
responsible for HIV care of the child.
*	Providers should ensure regular sustained supply of high quality
cotrimoxazole, and ensure the child has enough supply until after the next
scheduled appointment for regular monitoring or ARV related care. This
should ensure doses are not missed.
*	Governments need to ensure an uninterrupted drug supply for both
treatment and prophylaxis is available. This requires accurately estimating
programme needs and extra budgetary allocation.
*	Existing drug distribution systems should be used for supply
*	Private sector including industry and other medical insurance plans,
should be encouraged to provide  prophylaxis to families and include
provision for children

Patient information
Patients need to be clear that while cotrimoxazole does not cure HIV,
regular dosing is essential for protection of children from infections that
are more common or more likely to occur in HIV infection. Cotrimoxazole does
not replace the need for antiretroviral therapy.
Policy and programme information
It is recommended that:
*	National AIDS treatment, care and support policies and strategies
include provision of cotrimoxazole prophylaxis
*	National ARV treatment  guidelines, PMTCT guidelines, and clinical
care guidelines include cotrimoxazole prophylaxis for HIV exposed and HIV
infected children
*	Health providers at all levels are sensitized and trained to provide
cotrimoxazole prophylaxis to all HIV-exposed and HIV -infected children
*	Countries should supply the cotrimoxazole for children free of
charge or at subsidized rates where possible
Monitoring and evaluation
In order to monitor progress towards the delivery of comprehensive AIDS
treatment, care and support, National programmes should assess the extent to
which the range of HIV related care services are being implemented and set
clear targets for children. Cotrimoxazole prophylaxis is an essential health
intervention that needs to be included in child health services (including
IMCI), PMTCT services, TB services and HIV ART treatment services (facility
based and community based).  Monitoring of progress towards achieving this
should include:
*	Monitoring the provision of cotrimoxazole prophylaxis to children
and adolescents within existing care services (including, paediatric HIV
care, home based care and IMCI).
*	Documenting the proportion of HIV-exposed infants in PMTCT programs
who receive cotrimoxazole interventions until confirmation of HIV infection
status.

*	National monitoring of antimicrobial resistance of pneumonia,
dysentery and malaria in children is recommended because cotrimoxazole is
widely used for other clinical indications.
References
1. Provisional WHO/Unaids Secretariat Recommendations Unaids On The Use Of
Cotrimoxazole Prophylaxis In Adults And Children Living With
HIV/Aids In Africa, accessible at:
http://www.unaids.org/EN/other/functionalities/Search.asp
2. Co-trimoxazole as prophylaxis against opportunistic infections as
HIV-infected Zambian children (CHAP): a chap a double-blind randomized
placebo-controlled trial.  Chintu C, GJ Bhat,  AS Walker, V Mulenga, F
Sinyinza, L Farrelly, Kagangson,  A Zumla, Gillespie, A Nunn, D M Gibb
Lancet 2004;364: 1865-71



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