Abstract Book Vol. 1 [International Conference on AIDS (16th: 2006: Toronto, Canada)]

TUPEO342
WHO and UNICEF infant feeding policy for
HIV-positive women - how feasible is it?
R.M. Bland', M.L. Newell', N.C. Rollins2, A. Coutsoudis2, H.M.
Coovadia2. 'Africa Centre for Health and Population Studies, University of
KwaZulu Natal, Somkhele, South Africa, 2University of KwaZulu Natal, Durban,
South Africa
Background: WHO/UNICEF guidelines state that HIV-positive women should
give replacement feeds (RF) if they are acceptable, feasible, affordable,
sustainable and safe. If not, exclusive breastfeeding (EBF) is recommended
for the first few months. Whether this is attainable in populations is less clear.
In 1999 EBF rates in the study population were 6% at 16 weeks. We present
data on exclusive breastfeeding practices from an ongoing prospective study
examining EBF and postnatal HIV transmission.
Methods: HIV-infected and uninfected women were counselled, antenatally,
on infant feeding as per WHO recommendations. Women choosing EBF were
supported at home by trained lay breastfeeding counsellors, with no previous
health background: 4 antenatal visits and at least fortnightly visits for 6
months postnatally. Daily feeding practices, recorded at weekly intervals, were
documented by a separate field worker to reduce bias.
Results: Of 1377 positive women, 1136 (82%) initiated EBF, 109 (8%) RF, 35
(3%) started mixed feeding and for 97 (7%) there was no information about
feeding practices in week one. Median maternal age was 25.1 (15.1 - 45.8);
67% had access to clean water; 10.6% had a CD4 count <200 cells; median
birthweight was 3100g. Compared to women initiating EBF, women initiating
RF were more likely to be the main income provider (p<0.01) and to have a
CD4 cell count below 200 cells per ml (p<0.001). 52% of those who started
EBF continued for 5 months or more. The median duration of EBF was 144 days
(range 1 - 180). Of the 205 women who initiated EBF and subsequently either
moved, withdrew or were lost to follow-up, 80% were still EBF at the time of
last contact.
Conclusions: Compared to our pilot, this programme achieved high rates of
sustained EBF according to a strict WHO definition. Well-trained lay counsellors
offer an effective alternative to over-stretched medical and nursing staff.
TUPEO343
Injectable sustained release nevirapine, designed to
be co-administered in programs of accelerated DPT
immunization, for the prevention of mother-to-child
HIV transmission associated with breast feeding
T. Smith', J.L. Sullivan2, M. Neely', R. Jelliffe4, F. Phus, N. Elfess, C. De Melo',
R. Bencomos, L. Battaglias, K. Arunraj', M. Baums. 'Auritec Pharmaceuticals,
Pasadena, CA, United States, 2University of Massachusetts, Pediatrics,
Worcester, MA, United States, 3University of Southern California, Pediatrics,
Los Angeles, CA, United States, 4University of Southern California, Medicine,
Los Angeles, CA, United States, sOak Crest Institute of Science, Pasadena, CA,
United States
Background: HIV transmission through breast feeding remains a serious
problem.. HPTN 046 will assess daily oral nevirapine administration for 6 months
and early weaning. We have developed an injectable platform technology in
order to reduce dosing frequency. DPT immunizations are routinely given from
6 weeks of age in the developing world.
Methods: nevirapine was formulated into a polymer based sustained
release injectable; in vitro release was determined using a modified USP
type 2 apparatus and in vivo pharmacokinetics and safety were studied after
subcutaneous administration in rats.

100
Sso
70
so
40
l 20
10.

Nevirspine In Vitro iolution
44a

Tuesday
15 August
Poster
Exhibition

U

5 T10 1s5
Time (deml

20 2s 30o

[in vivo PK]
Using known elimination half lives for rats (2.5 hr) and humans, (40 hr) we can
model predicted plasma levels in infants
Nevirapine infant Model

10
a 1
0.1
0.01

10 15 20 25 30
Time in days

[Infant model]
Conclusions: A sustained release monthly injection could be piggy-backed
onto existing accelerated DPT immunization programs for breast feeding infants
in developing countries and could maintain protective nevirapine levels until
weaning. Such a system might be more feasible than daily oral delivery in a
context of limited resources.
TUPEO344
Infant feeding counselling for HIV-infected women:
appropriateness of choice and practice
R.M. Bland', N.C. Rollins', M.L. Newell', A. Coutsoudis2,
H.M. Coovadia2. 1Africa Centre for Health and Population Studies, University of
KwaZulu Natal, Somkhele, South Africa, 'University of KwaZulu Natal, Durban,
South Africa

Resul
polyvir
In vitr

ts: Formulations were developed by coating nevirapine particles with Background: Do infant feeding choices by HIV-positive women, as
nyl alcohol and polylactic acid polymers. recommended by WHO, match resources available to them at home? We present
o studies showed a half life of dissolution of ca. 7 days. feeding intentions and practices of women from an ongoing prospective study.
Methods: Pregnant women were counselled on infant feeding options and
supported in their choice postnatally by lay counsellors. Feeding intentions
Plasma NevirapineLevels in Rats after SC Injetion were compared against 4 resources that facilitate safe, feasible and sustainable
00 replacement feeding (RF): clean water, fridge, fuel, regular maternal income.
Results: The antenatal feeding intentions of 1253 positive women were: EBF
rat I(exclusive breastfeeding) 73%; RF 9%; undecided 18%. 3% of all women had
30 r access to all 4 resources; of whom 23% chose RF. Of those choosing RF, 8%
had access to 4 resources; 39% to 3; 35% to 2; 16% to 1; and 2% to 0.
Significantly more of those intending to EBF than RF adhered to their intention
10.postnatally in week 1 (EBF 78%; RF 42%; p<0.001). The number of antenatal
feeding counselling visits significantly influenced adherence: compared to the
4 maximum visits, those visited 1 (AOR 10.4; 95% CI 7.73 - 14.03); 2 (AOR
2.04; 95% CI 1.35 - 3.09); or 3 times (AOR 1.74; 95% CI 1.11 - 2.74) were
more likely to change their feeding option postnatally. Of 1238 negative women,
1021 (82%) intended to EBF; 21 (2%) to RF; and 193 (16%) were undecided.
75% intending to EBF adhered to this in week 1. 11 babies of negative women
0,(1%) received no breast milk in week one.
0 5 10 15 20 25 Conclusions: Most women did not have the 4 resources considered necessary
Time days for RF, but chose appropriately to EBF. Adherence to intention was higher in
those who chose to EBF than RF. 'Spillover' to negative women appears minimal,
ro release] despite provision of free formula in the area. Lay HIV counsellors are able to
provide quality infant feeding counselling according to international guidelines.

[In vit

In vivo testing in rats revealed no serious local or systemic safety issues.
Pharmacokinetic testing showed sustained release over 28 days. In vitro-in
vivo correlation will be discussed.

XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1