WHO, UNAIDS and UNICEF modify recommendations for cotrimoxazole
prophylaxis in children
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Joint WHO/UNAIDS/UNICEF statement on use of cotrimoxazole as
prophylaxis in HIV exposed and HIV infected children
Statement on use of cotrimoxazole prophylaxis
22 November 2004 - - WHO, UNAIDS and UNICEF, guided by recent
evidence, have agreed to modify as an interim the current recom-
mendations (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 recom-
mendations for cotrimoxazole for adults and children. Cotrimoxa-
zole remains important even with increasing access to ART, as it
use can improve survival independently of specific HIV treat-
ment. 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 interven-
tion 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 in-
fection 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 infec-
tions, 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 moth-
ers) 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 re-
quired to be taken as follows:
. HIV exposed children - until HIV infection has been defini-
tively 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 cotrimoxa-
zole continues to provide protection after immune restoration is
achieved.
Under what circumstances should cotrimoxazole be discontinued:
. Occurrence of severe cutaneous reactions such as Stevens John-
son syndrome, renal and/or hepatic insufficiency or severe hema-
tological toxicity.
. In an HIV exposed child ONLY once HIV infection has confi-
dently been excluded;
- For a non-breastfeeding child <18 months of age this is by
negative DNA or RNA virological HIV testing,
- For a breastfed HIV exposed child < 18months - negative vi-
rological testing is only reliable if conducted 6 weeks after
cessation of breastfeeding,
- For a breastfed HIV-exposed child >18 months - negative HIV
antibody testing 3 months after stopping breastfeeding,
- In an HIV-infected child:
- 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 be-
fore a full 6 months of successful adherence to ARV therapy, and
then only when clinical evidence of immune restoration is pre-
sent. Continuing cotrimoxazole may continue to provide benefit
even once child has clinically improved.
- 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 prophy-
laxis 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 provid-
ers responsible for HIV care of the child.
. Providers should ensure regular sustained supply of high qual-
ity 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 accu-
rately estimating programme needs and extra budgetary alloca-
tion.
. 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 antiret-
roviral therapy.
Policy and programme information
. National AIDS treatment, care and support policies and strate-
gies 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 comprehen-
sive 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 chil-
dren. Cotrimoxazole prophylaxis is an essential health interven-
tion that needs to be included in child health services (includ-
ing 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 chil-
dren 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 confirma-
tion of HIV infection status.
. National monitoring of antimicrobial resistance of pneumonia,
dysentery and malaria in children is recommended because cotri-
moxazole 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 Liv-
ing With HIV/Aids In Africa, accessible at:
http://www.unaids.org/EN/other/functionalities/Search.asp
2. Co-trimoxazole as prophylaxis against opportunistic infec-
tions as HIV-infected Zambian children (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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