Page 375 - SAHCS HIVMed Journal Vol 20 No 1 2019

Page 2 of 8 Original Research

However, administering ART in a neonate and young infant including those exposed to HIV. 29,30,31,32,33,34,35,36 Vision was
is not easy with potential drug resistance because of assessed clinically during testing and through the ability to
25
under-dosing, or neurotoxicity because of overdosing. The track small cake decorations (‘hundreds and thousands’ test),
long-term outcomes of very early exposure to ART are still which implies visual acuity of 6/24 or better. 37
unknown. It is therefore imperative that neurodevelopmental
testing be undertaken after early ART initiation. Our aim Statistical analysis was performed using Stata release 11
was to determine the neurodevelopmental outcomes of (StataCorp, College Station, TX) and Statistica 13 (software.
perinatally HIV-infected children after initiating ART within dell.com. Dell Inc. 2015). For descriptive statistics, mean and
the first 3 weeks of life. s.d. were reported for normally distributed data and median
and interquartile range (IQR) for skewed data. Guided by
Research methods and design distribution of the data, Spearman and Pearson correlations
were used to explore correlation between various parameters
We report early data from a prospective descriptive study
conducted in the Family Centre for Research with Ubuntu and neurodevelopmental outcomes. For calculating age at VL
(FAM-CRU) in Tygerberg Hospital, Cape Town, South Africa, suppression, those who had not yet achieved VL suppression
with recruitment from the Médecins Sans Frontières service in were assigned a date 2 days after the GMDS. Regression
Khayelitsha and elsewhere in the public sector. Antiretroviral analysis explored the contribution of five predictors of GMDS
therapy was started as soon as HIV infection was confirmed. scores: birth weight, ART start age, baseline VL, baseline
HIV diagnosis was made by quantitative HIV-1 viral load CD4% and age at first VL suppression.
(VL) testing and confirmed by a qualitative HIV-1 RNA PCR.
Indeterminate samples were repeated until HIV diagnosis Descriptive data and GMDS scores were also compared to
confirmation. 26,27 Inclusion criteria were the following: birth those from the early treatment arms on Children with HIV
weight > 2000 g, commencing ART < 6 weeks of age and no Early antiRetroviral treatment (CHER) trial participating in
infant cytomegalovirus (CMV) infection. Mothers or legal a neurodevelopmental sub-study who received early ART
guardians were consented in person in their language of from a median of age of 7.7 weeks and were assessed by the
choice according to Good Clinical Practice standards. same investigators at 11 months of age. 10

Participants were seen as frequently as needed until stable, Ethical considerations
monthly for 3 months and then 3 monthly. Visits included a
medical examination, growth monitoring, adverse event Mothers or legal guardians were consented in person in their
assessment and social work support where needed. At each language of choice according to Good Clinical Practice
visit, a pharmacist calculated the percentage adherence for standards. The Stellenbosch University Health Research
each drug from returned ART containers and an adherence Ethics Committee approved the study (No.: M14/07/029).
counsellor established reasons for over or under-dosing with
the parent or caregiver, offered advice on problems identified Results
and reviewed measuring techniques. HIV viral load was Of 29 children studied, 23 (79%) were female. Mean birth
performed at baseline, 3, 6 and 12 months. Undetectable VLs weight was 3002 ± 501 g and gestation was 37.9 ± 2.3 weeks.
were reported as < 100 or < 40 copies/mL depending on the HIV+ diagnosis was made by 48 h of birth in 7 (24%) and
blood volume available for testing. CD4 cell counts were within 7 days of birth in 17 (59%) infants. Median [IQR] age
done at 3, 6 and 12 months. Antiretroviral therapy comprised for starting ART was 6.0 [3–10] days (range 0–21) from birth.
Zidovudine, Lamivudine and Nevirapine, with Lopinavir/
Ritonavir replacing Nevirapine after 2 weeks of age or Twenty-three achieved VL suppression at median [IQR] 19.1
gestational age of 42 weeks. Once weight exceeded 3 kg and [14.7–35.9] weeks of age (range 2–53) (Table 1).
gestational age was above 44 weeks, Abacavir replaced
Zidovudine. Participants also received co-trimoxazole from 6 The GMDS was performed at a mean of 11.5 ± 0.8 months
weeks of age. (range 10.2–13.1) and scores are described in Table 2. Mean
GMDS quotients were in the average range and within 1 s.d.
The Griffiths mental development scales (GMDS) (0–2 years) of the standardised scores. The locomotor subscale had the
were conducted by the same developmental paediatrician lowest mean quotient. No children were suspected of
28
(B.L.) at 10–12 months of age. The GMDS assesses five having hearing or vision problems.
subscales: locomotor, personal–social, hearing-and-language,
eye–hand coordination and performance (visual–motor Clinical status at the time of GMDS is described in Table 3. One
abilities). A global score, the General Griffiths, is also child had progressed to WHO stage II HIV disease (persistent
calculated. Raw scores are converted into quotients, derived oral candida), and two to stage III (chronic suppurative otitis
from norms of healthy British children, with a mean of 100 media and pulmonary tuberculosis). Nine children (31%) had
and standard deviation (s.d.) of 16. While the GMDS is detectable VL at the time of GMDS testing, six (21%) had
neither standardised nor validated in South Africa, it is not yet achieved viral suppression and three had previously
the most widely used developmental assessment tool, is suppressed (one at 27 weeks and two at 19 weeks of
considered culturally fair and is used to assess young children age), but rebounded to log 5.44 (273 328 copies/mL),

http://www.sajhivmed.org.za 368 Open Access