Brolund, AB

Degen, O

Ganschow, R

Ilchmann, C

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AB Brolund

C Ilchmann

R Ganschow

O Degen

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Salvage therapy with raltegravir in a 3-month-old infant

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Journal of the International AIDS Society

POSTER PRESENTATION Open Access
Salvage therapy with raltegravir in a 3-month-old
infant
AB Brolund1*, C Ilchmann2, R Ganschow1, O Degen3
From Tenth International Congress on Drug Therapy in HIV Infection
Glasgow, UK. 7-11 November 2010
Background
The integrase inhibitor raltegravir (RAL) is widely used
in adults. Only limited data are available for children
and no data for infants. We describe the case of a three-
month-old infant treated with RAL in combination with
lopinavir/r (LPV/r) and lamivudine (3TC).
Methods
The mother emigrated from Ghana several years before
and was insufficiently treated in a local hospital with
AZT, 3TC and nevirapine (NVP) with constantly high
plasma viral load (VL). At admission to the external
birth clinic her VL was 160,000 copies/ml, the CD4
count 146/ml. The infant had a gestational age of 35
weeks with a birth weight of 1940g. A high-risk chemo-
prophylaxis with AZT, 3CT and NVP was given until
the confirmation of a HIV1 infection three weeks later.
The infant was then referred to our university hospital
in an underweight state. His VL was 2.5Mio copies/ml,
the CD4 count was 37% (2110c/ml). The genotypic
resistance profile showed full resistance for all NRTIs
and NNRTIs. We started an off-label therapy including
RAL at 6mg/kg BID. The dosage was extrapolated from
smaller trials in children ≥6 years of age. RAL is only
available in 400mg tablets, so we pestled the tablet, atte-
nuated the powder and distributed the required amount
of mixture into a capsule. The content was then solved
in water and administered by the mother. We combined
RAL with LPV/r and 3CT BID which were dosed
according to paediatric recommendations and adjusted
monthly due to weight gain in closed cooperation with
the pharmacologist.
Results
The therapy was well tolerated, no clinical or laboratory
adverse events have occurred yet. The boy showed a
catch-up growth and weight gain from <3rd percentile
to >25th percentile at week 16 of therapy. In the same
period his VL decreased from 1.8Mio copies/ml to 164
copies/ml and his CD4 count increased to 39% (3357c/
ml). We performed a PK-profile and measured sufficient
drug levels of RAL and LPV/r, comparable to the lim-
ited data of PK-studies conducted in older children.
RAL Cmin: 146ng/ml, Cmax: 1960ng/ml, Tmax: 2h.
Conclusions
Due to the widely use of NNRTIs in developing coun-
tries an increasing number of mother-to-child transmis-
sions of HIV with multi resistances can be expected in
the near future. We describe a successful salvage ther-
apy including RAL in a three-month-old infant. Further
studies and investigation into the paediatric pharmacoki-
netics and application forms are warranted to confirm
our results.
Author details
1University Medical Center Hamburg Eppendorf, Department of Paediatric
Immunology, Hamburg, Germany. 2University Medical Center Hamburg
Eppendorf, Department of Medical Microbiology and Virology, Hamburg,
Germany. 3University Medical Center Hamburg Eppendorf,
Ambulanzzentrum, Infections Diseases Unit, Hamburg, Germany.
Published: 8 November 2010
doi:10.1186/1758-2652-13-S4-P157
Cite this article as: Brolund et al.: Salvage therapy with raltegravir in a
3-month-old infant. Journal of the International AIDS Society 2010 13(Suppl
4):P157.
1University Medical Center Hamburg Eppendorf, Department of Paediatric
Immunology, Hamburg, Germany
Full list of author information is available at the end of the article
Brolund et al. Journal of the International AIDS Society 2010, 13(Suppl 4):P157
http://www.jiasociety.org/content/13/S4/P157
© 2010 Brolund et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.


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Salvage therapy with raltegravir in a 3-month-old infant

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