Page 334 - SAHCS HIVMed Journal Vol 20 No 1 2019
P. 334

Page 3 of 7  Original Research


              TABLE 2: Maternal antiretroviral therapy, infant prophylaxis and feeding regimens recommended by the South African national prevention of mother-to-child transmission
              programme of 2010 for human immunodeficiency virus-positive women during pregnancy and after delivery and their human immunodeficiency virus-exposed infants.
              Variable                                                      PMTCT programme
                                                2010 (1st edition) 19                   2010 (2nd edition) 22
              Maternal ART regimen
              CD4 > 350 cells/mm 3              Dual therapy†                           Dual therapy†
              CD4 ≤ 350 cells/mm  or stage 3 or 4 HIV  Lifelong cART‡                   Lifelong cART‡
                         3
              Infant prophylaxis
              EFF                               NVP for 6 weeks                         NVP for 6 weeks
              Breastfeeding without maternal lifelong cART  NVP until 1 week post-cessation of breastfeeding  NVP until 1 week post-cessation of breastfeeding
              Breastfeeding with maternal lifelong cART  NVP for 6 weeks                NVP for 6 weeks
              Infant feeding regimens           EFF if the AFASS criteria are met       Exclusive breastfeeding for all infants
                                                Exclusive breastfeeding if AFASS criteria are not met
              AFASS, acceptable, feasible, affordable, safe, sustainable; AZT, azidothymidine; cART, combination antiretroviral therapy; EFF, exclusive formula feeding; FTC, emtricitabine; NVP, nevirapine; TDF,
              tenofovir.
              †, Dual therapy: AZT from 14 weeks gestation, followed by three-hourly AZT and single dose NVP during labour, with a single dose of TDF and FTC after delivery (ART discontinued after delivery).
              ‡, Lifelong cART: TDF + lamivudine/FTC + NVP/efavirenz (continued after delivery).

              Exclusion criteria

              Infants were excluded if death occurred before 4 weeks of   690 infants
              age, azidothymidine (AZT) was used as PMTCT, feeds were    ≤ 1500 g at birth
              exclusively DBM or EFF, no HIV-PCR result was available at
              4–6 weeks of age, admission to the neonatal unit occurred                  Exclusions based on no HIV-exposure:
              after 72 h of life, HIV was deemed to have been acquired                    - 404 infants: not HIV-exposed
              in  utero  and clinical  records  were  missing  or incomplete              - 67 infants: HIV-exposure not documented
              (Figure 1).
                                                                       219 HIV-exposed infants
                                                                         ≤ 1500 g at birth
              Background                                                                 Protocol exclusions:
                                                                                          - 54 infants: no HIV-PCR by 4–6 weeks
              Infant feeding regimens                                                     - 39 infants: demised < 4 weeks of age†
                                                                                          - 20 infants: received AZT
              Although free tins of formula were provided for HIV-exposed                 - 13 infants: file incomplete or not traced
              infants  who  complied  with  the  acceptable,  feasible,                   - 10 infants: received exclusive DBM / EFF
              affordable, safe and sustainable (AFASS) feeding criteria,                  - 2 infants: transferred in a•er 72 h
                                                             21
                                                                                          - 1 infant: in utero HIV transmission
              breastfeeding was officially adopted in August 2011 (Tshwane   Study populaon of
              Declaration) as the feeding regimen of choice for all infants,   80 infants  39 infant deaths < 4 weeks of age:†
              including those who were HIV-exposed as breast milk was                   - Median weight 800 g (range: 450–1400 g)
                                              25
              shown to be safe in these infants provided they received                    - 15 infants weighed < 750 g
                                                                                          - 14 infants weighed 750–999 g
                    26
              PMTCT  (Table 2).                                                          - Median gestaon 28 weeks
                                                                                           (range 24–34 weeks)
              Maternal antiretroviral therapy regimens                                   - Timing of death
                                                                                             - 25 infants died < 72 h of life
              The National PMTCT programme of 2010 used the maternal                      - 7 infants died between 72 h and 7 days
              CD4 count and HIV staging to determine maternal antenatal                     of life
                                                                                          - 7 infants died > 7 days of life
              and postnatal ART regimens 19,22,27  (Table 2).                            - HIV variables
                                                                                          - Infant HIV-PCR done on 9/39
                                                                                            (all negave)
              Exposure of infants to maternal antenatal antiretroviral                    - Maternal CD4 done on 28/39 with
              therapy                                                                       median of 301 cells/mm (range: 11–977)
                                                                                                        3
              Duration of exposure to maternal antenatal ART (lifelong cART               - 26/39 mothers received antenatal ART
              or dual therapy) was defined, for the purpose of this study, as   AZT, azidothymidine; DBM, donor breast milk; EFF, exclusive formula feeding; GA, gestational
              optimal (≥ 4 weeks), suboptimal (< 4 weeks) or no ART.  age; PCR, polymerase chain reaction; HIV, human immunodeficiency virus.
                                                                    FIGURE 1: Flow chart detailing exclusions.
              Infant prophylaxis                                    Continuous data were expressed as medians and ranges and
              All infants were initiated on NVP after delivery, which was   categorical data as frequencies and percentages. Cumulative
              continued for at least 6 weeks. A weight-based dosing regimen,
              as recommended by the World Health Organization,  was   incidence and 95% confidence intervals were determined using
                                                         28
              adopted for infants weighing < 1800 g: 2 mg/kg daily for the   Poisson regression.
              first 2 weeks of life and 4 mg/kg thereafter. 29
                                                                    Ethical consideration
              Data analysis                                         The study protocol was approved by the Ethics Committee of

              Statistical analysis was performed using Stata statistical software   the Faculty of Health Sciences of the University of Pretoria,
              2017 (Release 15.1, StataCorp LLC, College Station, US).    South Africa (Ethics approval number 351/2013).


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