Cotrimoxazole for all HIV-exposed/infected infants and children. WHO/UNAIDS

[Guest guest]

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 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 s

syndrome, renal and/or hepatic insufficiency or severe hematological

toxicity.

In an HIV exposed child ONLY once HIV infection has confidently 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

virological 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 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.

- 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

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 , V Mulenga, F

Sinyinza, L Farrelly, Kagangson, A Zumla, Gillespie, A Nunn, D M Gibb

Lancet 2004;364: 1865-71

http://www.who.int/3by5/mediacentre/news32/en/print.html

http://www.who.int/3by5/mediacentre/en/Cotrimstatement.pdf