An exploration of anaemia in low birth weight infants exposed to perinatal zidovudine at the neonatal unit in King Edward VIII Hospital.

M. Med. University of KwaZulu-Natal, Durban 2013.Large clinical trials beginning with the PACTG-076 trial and other trials across Europe and America have showed that perinatal exposure to Zidovudine (AZT) results in haematological side effects in the neonate, mainly anaemia, which are clinically insignificant and reversible. There is however limited data in sub-Saharan Africa on the impact of intrauterine exposure to AZT on neonates, particularly low birth weight neonates, at the height of the HIV/PMTCT era. The aim of the study was to evaluate the prevalence and clinical significance of anaemia among low birth weight neonates, in a diverse South African setting. This observational descriptive study looked at medical records of HIV-exposed, low-birth weight neonates (less than 2500g) admitted to the neonatal unit at King Edward VIII Hospital from May 2008 to February 2010, who have had intrauterine exposure to AZT. A total of 95 neonatal birth and medical records were analysed. The total prevalence of anaemia was 47%. The neonates were placed into categories according to gestational age. The prevalence of anaemia was 16.7% and the mean Hb was 17g/dL in the 26-28 week gestational age category, prevalence of anaemia was 37% and mean Hb was 16g/dL in the 29-31 week category, and the prevalence of anaemia was 54.8% with a mean of 17g/dL in the over 31 week gestational age category. The minimum haemoglobin was 11.0g/dL and maximum haemoglobin was 24g/dL. The mean haemoglobin in the neonates exposed to more than 28 days of Zidovudine was lower than the mean Hb in neonates exposed to less than 28 days in the 29-31week and over 31 week gestational age categories. The haematological side effects of anaemia in neonates resulting from AZT exposure inutero were found to be prevalent but of a mild and clinically insignificant nature in keeping with existing international and continental studies. The severity of anaemia in low birth weight/ pre-term neonates appears to be the same as in term neonates of normal birth weight depicted in these studies. The presence of neonatal anaemia at birth has been shown to be related to the duration of exposure to intrauterine AZT in one of the three age groups. There were no identified issues that would warrant amending current recommendations for the routine use of AZT for the prevention of mother-child HIV transmission however these findings require further research involving larger numbers and follow up of neonates in order to adequately analyse current PMTCT guidelines

The multi-country PROMOTE HIV antiretroviral treatment observational cohort in Sub-Saharan Africa: objectives, design, and baseline findings.

CAPRISA, 2018.Abstract available in pdf

Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant.

BACKGROUND: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the coronavirus disease 2019 (Covid-19) pandemic. In a phase 1-2 trial involving healthy adults, the NVX-CoV2373 nanoparticle vaccine had an acceptable safety profile and was associated with strong neutralizing-antibody and antigen-specific polyfunctional CD4+ T-cell responses. Evaluation of vaccine efficacy was needed in a setting of ongoing SARS-CoV-2 transmission. METHODS: In this phase 2a-b trial in South Africa, we randomly assigned human immunodeficiency virus (HIV)-negative adults between the ages of 18 and 84 years or medically stable HIV-positive participants between the ages of 18 and 64 years in a 1:1 ratio to receive two doses of either the NVX-CoV2373 vaccine (5 μg of recombinant spike protein with 50 μg of Matrix-M1 adjuvant) or placebo. The primary end points were safety and vaccine efficacy against laboratory-confirmed symptomatic Covid-19 at 7 days or more after the second dose among participants without previous SARS-CoV-2 infection. RESULTS: Of 6324 participants who underwent screening, 4387 received at least one injection of vaccine or placebo. Approximately 30% of the participants were seropositive for SARS-CoV-2 at baseline. Among 2684 baseline seronegative participants (94% HIV-negative and 6% HIV-positive), predominantly mild-to-moderate Covid-19 developed in 15 participants in the vaccine group and in 29 in the placebo group (vaccine efficacy, 49.4%; 95% confidence interval [CI], 6.1 to 72.8). Vaccine efficacy among HIV-negative participants was 60.1% (95% CI, 19.9 to 80.1). Of 41 sequenced isolates, 38 (92.7%) were the B.1.351 variant. Post hoc vaccine efficacy against B.1.351 was 51.0% (95% CI, -0.6 to 76.2) among the HIV-negative participants. Preliminary local and systemic reactogenicity events were more common in the vaccine group; serious adverse events were rare in both groups. CONCLUSIONS: The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, with higher vaccine efficacy observed among HIV-negative participants. Most infections were caused by the B.1.351 variant. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT04533399.)

Perceptions of women enrolled in a cardiovascular disease screening and prevention in HIV study

Background: The ISCHeMiA (integration of cardiovascular disease screening and prevention in the human immunodeficiency virus [HIV] management plan for women of reproductive age) study is an ongoing, 3-year, prospective, quasi-experimental study comparing usual care to a primary health care intervention plan guided by the World Health Organization Package of Essential Non-Communicable (WHO-PEN) disease interventions. Sixty eight percent of women were overweight or obese at baseline in the ISCHeMiA study, many of whom reported nonadherence to interventions at 6 months post enrolment. This study explores the perceptions of women living with HIV (WHIV) towards their participation in the ISCHeMiA study to understand the barriers and facilitators to lifestyle modification interventions for cardiovascular disease (CVD) risk prevention.Methods: A qualitative enquiry using semistructured interviews was conducted with 30 overweight WHIV at one year post-enrolment in the WHO-PEN intervention arm of the ISCHeMiA study. Data were transcribed verbatim following the interviews and analysed using conventional content analysis.Results: Four major themes emerged from the data, namely perceived body image, benefits barriers and recommendations to improve adherence to WHO-PEN lifestyle modification management.Conclusion: Women in the ISCHeMiA study believed that HIV associated stigma hindered access to care. Financial limitations and the lack of social support posed barriers to adherence to programme participation. They were further challenged by poor body image perception. Participants believed that such interventions offered them hope and feelings of improved well-being. Women recommended that lifestyle modification interventions such as those studied in the ISCHeMiA study should include partners and family to improve adherence through social support.

Factors associated with unsuppressed viremia in women living with HIV on lifelong ART in the multi-country US-PEPFAR PROMOTE study: A cross-sectional analysis.

BackgroundDespite recent efforts to scale-up lifelong combination antiretroviral therapy (cART) in sub-Saharan Africa, high rates of unsuppressed viremia persist among cART users, and many countries in the region fall short of the UNAIDS 2020 target to have 90% virally suppressed. We sought to determine the factors associated with unsuppressed viremia (defined for the purpose of this study as >200 copies/ml) among sub-Saharan African women on lifelong cART.MethodsThis cross-sectional analysis was based on baseline data of the PROMOTE longitudinal cohort study at 8 sites in Uganda, Malawi, Zimbabwe and South Africa. The study enrolled 1987 women living with HIV who initiated lifelong cART at least 1-5 years ago. Socio-demographic, clinical, and cART adherence data were collected. We used multivariable Poisson regression with robust variance to identify factors associated with unsuppressed viremia.ResultsAt enrolment, 1947/1987 (98%) women reported taking cART. Of these, HIV-1 remained detectable in 293/1934 (15%), while 216/1934 (11.2%) were considered unsuppressed (>200 copies/ml). The following factors were associated with an increased risk of unsuppressed viremia: not having household electricity (adjusted prevalence risk ratio (aPRR) 1.74, 95% confidence interval (CI) 1.28-2.36, pConclusionSocioeconomic barriers such as poverty, and individual barriers like not being married, young age, and self-reported missed doses are key predictors of unsuppressed viremia. Targeted interventions are needed to improve cART adherence among women living with HIV with this risk factor profile

Unintended pregnancy and contraception use among African women living with HIV: Baseline analysis of the multi-country US PEPFAR PROMOTE cohort.

BackgroundAbout 90% of unintended pregnancies are attributed to non-use of effective contraception-tubal ligation, or reversible effective contraception (REC) including injectables, oral pills, intra-uterine contraceptive device (IUCD), and implant. We assessed the prevalence of unintended pregnancy and factors associated with using RECs, and Long-Acting-Reversible-Contraceptives (LARCs)-implants and IUCDs, among women living with HIV (WLHIV) receiving antiretroviral therapy (ART).MethodsWe conducted cross-sectional analyses of the US-PEPFAR PROMOTE study WLHIV on ART at enrollment. Separate outcome (REC and LARC) modified-Poisson regression models were used to estimate prevalence risk ratio (PRR) and corresponding 95% confidence interval (CI).ResultsOf 1,987 enrolled WLHIV, 990 (49.8%) reported their last/current pregnancy was unintended; 1,027/1,254 (81.9%) non-pregnant women with a potential to become pregnant reported current use of effective contraception including 215/1,254 (17.1%) LARC users. Compared to Zimbabwe, REC rates were similar in South Africa, aPRR = 0.97 (95% CI: 0.90-1.04), p = 0.355, lower in Malawi, aPRR = 0.84 (95% CI: 0.78-0.91), pConclusionsUnintended pregnancy was common while use of effective contraception methods particularly LARCs was low among these African WLHIV. HIV viral load, education, sexual-activity, fertility desires, and economic independence are pertinent individual-level factors integral to the multi-level barriers to utilization of effective contraception among African WLHIV. National programs should prioritize strategies for effective integration of HIV and reproductive health care in the respective African countries

PROMOTE study enrollment and contraceptive use reported by women with available data at baseline.

PROMOTE—Promoting Maternal and Infant Survival Everywhere; Child-bearing potential refers to women who had no biological preclusion to becoming pregnant; Of the 1,254 women with available contraception data at baseline, every woman reported currently using at least one method to prevent getting pregnant. Contraceptive data was not available for 549 (30.4%) women who were enrolled before the relevant reproductive health questions were added to the baseline questionnaire.</p

Factors associated with use of contraceptive methods (REC/ LARC) reported at PROMOTE study entry.

Factors associated with use of contraceptive methods (REC/ LARC) reported at PROMOTE study entry.</p

Study population characteristics at study enrolment among women with pregnancy potential, by reversible effective contraception (REC) use.

Study population characteristics at study enrolment among women with pregnancy potential, by reversible effective contraception (REC) use.</p