Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
In resource-limited settings good early outcomes can
be achieved in children using adult fixed-dose
combination antiretroviral therapy
Daniel P. O’Briena, Delphine Sauvageotb, Rony Zachariahaand
Pierre Humbletafor Medecins Sans Frontieres
Objectives: To (a) determine early treatment outcomes and (b) assess safety in children
treated with adult fixed-dose combination (FDC) antiretroviral tablets.
Setting: Sixteen Medecins Sans Frontieres (MSF) HIV programs in eight countries in
resource-limited settings (RLS).
Methods: Analysis of routine program data gathered June 2001 to March 2005.
Results: A total of 1184 children [median age, 7 years; inter-quartile range (IQR),
4.6–9.3] were treated with antiretroviral therapy (ART) of whom 616(52%) were male.
At ART initiation, Centres for Disease Control stages N, A, B and C were 9, 14, 38 and
39%, respectively. Children were followed up for a median period of 6 months (IQR,
2–12 months). At 12 months the median CD4 percentage gain in children aged 18–59
from 85% at baseline to 11%. In those aged 60–156 months, median CD4 cell count
gainwas275 cells/ml(IQR,84-518 cells/ml),andthepercentagewithCD4 < 200 cells/
ml reduced from 51% at baseline to 11%. Treatment outcomes included; 1012 (85%)
alive and on ART, 36 (3%) deaths, 15 (1%) stopped ART, 89 (8%) lost to follow-up, and
31 (3%)with unknown outcomes. Overall probability of survival at 12 monthswas 0.87
(0.84–0.89). Side effects caused a change to alternative antiretroviral drugs in 26 (2%)
but no deaths.
generic adult FDC antiretroviral tablets. These findings strongly favour their use as an
‘interim solution’ for scaling-up ART in children; however, more appropriate pediatric
antiretroviral drugs remain urgently needed.
? 2006 Lippincott Williams & Wilkins
AIDS 2006, 20:1955–1960
Keywords: adult fixed-dose combination tablets, anti-retroviral treatment,
children, resource-limited settings
There are an estimated 2.3 million children worldwide
who are currently living with HIV, the great majority of
whom are in resource-limited settings (RLS) . An
estimated 660 000 of such children are believed to be in
urgent need of life-saving antiretroviral therapy (ART)
. Without ART, about 50% of children who are
infected with HIVat birth end up dying by their second
birthday . Although there are currently more than
1 million adults receiving ART in RLS with very good
treatment outcomes, to date, far too few children have
been started on treatment in these settings, with estimates
need of paediatric AIDS treatment receiving it .
Significant obstacles to scaling up ART in children living
in a hesitancy among health staff in starting treatment;
From theaAIDS Working Group, Medecins Sans Frontieres, and thebEpicentre, Paris, France.
Correspondence to Dr Daniel O’Brien, HIV/AIDS advisor, Medecins Sans Frontieres, Plantage Middenlaan 14, 1001 EA,
Amsterdam. The Netherlands.
Received: 27 April 2006; accepted: 4 July 2006.
ISSN 0269-9370 Q 2006 Lippincott Williams & Wilkins
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Further limitations include a possible under-reporting of
antiretroviral adverse effects due to a lack of standardized
reporting of these across the projects, and that the results
are based on a multicentric analysis comparing programs
in different contexts which may have varying operating
Although MSF has gone ahead and used adult FDCs to
administer life-saving ART to children in RLS, and the
preliminary results are very encouraging, we feel this
situation is ‘far from ideal’ and does not in anyway replace
the urgent need for adapted and affordable pediatric
formulations, including those in FDC form, to become
available. Advocacy for their urgent development is
In the meantime, our findings strongly favour the use of
adult FDC antiretroviral drugs as an ‘interim solution’ for
scaling-up ART in children, while waiting for more
appropriate pediatric antiretroviral formulations.
We would like to acknowledge the following members of
the MSF AIDS working group for their contributors to
the study concept and design, and editing of the
manuscript: Line Arnould, Suna Balkan, Laura Ciaffi,
Tom Ellman,Lisa Frigati, FelipeGarcia, VincentJanssens,
Francesca Mitjavila and Elisabeth Szumilin; and also
Laurent Ferradini from Epicentre, Paris, for his contri-
bution to the study design and data analysis.
We are also grateful to the MSF staff in the different
MSF missions in particular those in Cambodia, Kenya,
Malawi, Mozambique,Thailand, Uganda, Burkina Faso
and Zimbabwe for their work in administering ART
and for having collected data that is the basis of this
paper. We particularly thank our colleagues at the
Ministries of Health in the different countries for their
continued support, collaboration and encouragement
in the ART scale-up efforts. We thank our donors who
support HIV/AIDS care and ART in the different
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