Page 366 - SAHCS HIVMed Journal Vol 20 No 1 2019
P. 366

Page 5 of 12  Original Research


              Maternal demographics                                 Antiretroviral therapy during pregnancy

              Table 1 provides a summary of maternal characteristics,   Table 3 describes the in-utero antiretroviral exposures
              stratified by HIV status. Of the 27 maternal deaths reported   during the course of pregnancy. 3932 infants were exposed to
              during the study period, 12 (44.4%) died prior to childbirth.   ART during pregnancy (96.8% of HIV-exposed infants). Twin
              Only 2 of the remaining 15 (13.3%) maternal deaths were   births and births exposed to more than one ART regimen
              captured by the surveillance team during the reporting year   during pregnancy were excluded from the risk analysis.
              due to restricted access to these medical records at the time of   Uncertain timing of exposures due to the uncertainty of the
              data collection.                                      temporal  ordering  of  LMP  and  ART  initiation  resulted  in
                                                                    almost a third (30.4%) of all singleton births being excluded
              Most of the 10  417 women (10  293, 98.8%) had a known     from analysis  (1105 of 3632). Of the remaining  births,  380
              HIV status, of whom 4013 (38.5%) were HIV-positive. The   (10.4%) were exposed from conception, and 653 (18.0%)
              HIV-positive women had 4063 babies (live or stillborn). HIV-  initiated treatment some time during the first trimester. In 56
              infected women tended to be older than HIV-uninfected   cases, ART exposure was classified as having occurred prior
              women; teenage pregnancies in the HIV-uninfected group   to pregnancy based only on self-reported timing in the
              were  5  times  more  common  than  the  HIV-infected  cohort   absence of a reported LMP.
              (9.9% vs. 1.8%). Self-reported use  of alcohol,  tobacco and
              illicit substances was higher among HIV-infected women.  Congenital malformations at birth among
                                                                    HIV-exposed birth outcomes
              Only 195 women (1.9%) did not seek any antenatal care
              before delivery. More than two-thirds (70.5%) of the cohort   HIV infection in the mothers was reported in 11 of the 37
              had four or more antenatal visits. However, almost half   (29.7%) included CM cases (Table 2), all of whom received
                                                                    ART at some time during pregnancy as described in Table 4.
              (43.1%)  first  sought  care  after  20  weeks  of gestation.  The
              prevalence of previous ABOs was reported for multigravidae   Five of these infants were exposed to ART continuously from
              (n = 6316) with only six women (0.1%) reporting previously   conception throughout T1. One of these had a regimen
              giving birth to infants with CMs.                     change to TDF/FTC/EFV during the second trimester of
                                                                    pregnancy; two were initiated on ART at some time during
              HIV prevalence increased with age, reaching 58.3%     the first trimester, and four were initiated during the second
              (640/1106) in women over 35 years of age. The prevalence in   trimester.
              multigravidae (49.2%) was more than twice that in
              primigravid women (21.9%). Women who reported being   In addition to the 2 neural tube defects reported among
              currently employed had a higher prevalence of HIV than   infants  of  the  women  on ART,  a  case  of  anencephaly  was
              unemployed women. Both TB and syphilis were more      reported in an HIV-unexposed infant.
              commonly reported in HIV-infected women.
                                                                    Risk analyses
              Birth outcomes                                        The numbers in Table 3 may not directly match with those in
              Among the birth outcomes reflected in Table 2, 10 197 were   Tables 5 and 6 because cases with missing values for the
              live births, 275 (2.6%) pregnancy losses, 85 (0.8%) NND, 852   outcomes concerned were excluded from the denominators
              (8.1%) SGA and 56 (0.5%) new-borns with CMs detected   in Tables 5 and 6.
              at  birth (Supplementary  Table 1). Thirty-seven of the CMs
              were eligible for inclusion in the teratogenicity analysis   There was no significant difference in risk of CM in births
              (Analysis A), of which 11 (29.7%) occurred in women on ART   exposed to  ART during the first trimester compared to
              during pregnancy (described in Table 4). The other 19 CMs   HIV-unexposed births and HIV-exposed births only
              were excluded from the analysis based on Holmes’s criteria   exposed to  ART beyond T1 (2.11 [95% CI 0.65–6.92;
              noted earlier. Extra two CMs were excluded from the risk   p = 0.214]; Table 5).
              analysis as they occurred among women whose  ART
              exposure time was uncertain or who switched ART regimens   The first-trimester exposure to the EFV-based treatment (0.87
              during critical or uncertain times.                   [95% CI 0.12–6.40]) was not associated with an increased risk
                                                                    compared to births not exposed to ART in the first trimester.
              Of the 3632 ART-exposed singleton births, the vast majority   However, there was a higher risk of CMs in births with pre-
              of births (3391, 93.4%) reported being on the recommended   pregnancy initiation of NVP-based ART (9.28 [95% CI 2.27–
              first-line adult ART regimen, TDF-FTC-EFV. There were only   37.94; p = 0.002]) compared to births not exposed to ART in
              96 singleton births (2.6%) exposed to NVP-based regimens   the first trimester. Similar findings were obtained when a
              during pregnancy, at least 58 (60.4%) of whom were already   sensitivity analysis was conducted including cases with first-
              on  treatment  before  pregnancy.  In  total,  there  were  3465   trimester ART initiation.
              (95.4%) births exposed to an EFV-based  ART regimen, of
              which 306 (8.8%) were initiated before the pregnancy and an   After adjusting for age category, parity and education,
              additional 641 (18.5%) were initiated during the first trimester.  ART and EFV-based ART initiation regardless of the timing

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