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Efficacy and safety of tenofovir in preventing mother-to-infant transmission of hepatitis B virus: a meta-analysis based on 6 studies from China and 3 studies from other countries.
Li, W, Jia, L, Zhao, X, Wu, X, Tang, H
BMC gastroenterology. 2018;(1):121
Abstract
BACKGROUND The vertical transmission of HBV from mothers to their infants at birth or in early infancy has a significant role in the endemicity of HBV infection. Tenofovir is one of the most potent anti-HBV agents with a high genetic barrier to resistance. The study is to evaluate the efficacy of tenofovir in preventing perinatal HBV transmission, as well as monitoring safety for mothers and infants. METHODS PubMed, Embase, Web of Science, and CNKI (National Knowledge Infrastructure, China) database were systematically reviewed for studies that compared the efficacy and safety of tenofovir with other treatments. Pooled estimates were expressed with weight mean difference (WMD) with 95% confidence intervals (95% CIs) and risk ratio (RR) with 95% CIs. RESULTS Nine studies involving 1046 pregnant patients met the inclusion criteria and were included in this meta-analysis. Compared with other treatments, tenofovir significantly reduced maternal HBV DNA levels (WMD = 2.33 log10 IU/mL, 95% CI: 1.01, 3.64; P < 0.001), infant HBsAg positivity rate (RR = 0.25, 95% CI: 0.16, 0.38; P < 0.001), infant HBeAg positivity rate (RR = 0.26, 95% CI: 0.14, 0.48; P < 0.001), infant HBV DNA positivity rate (RR = 0.15, 95% CI: 0.07, 0.31; P < 0.001), and immunoprophylaxis failure rate (RR = 0.31, 95% CI: 0.13, 0.73; P = 0.008). Moreover, maternal and infant safety profiles, including ALT, CK, and Cr were comparable between tenofovir and other treatment groups. CONCLUSION Based on the current evidence, our study suggested that tenofovir significantly reduced the rate of vertical transmission of HBV, as well as the HBV DNA levels in HBV-infected mothers. Moreover, tenofovir was safe and tolerable for both mothers and their infants.
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Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomized, Open-Label, Clinical Trial.
Flynn, PM, Taha, TE, Cababasay, M, Fowler, MG, Mofenson, LM, Owor, M, Fiscus, S, Stranix-Chibanda, L, Coutsoudis, A, Gnanashanmugam, D, et al
Journal of acquired immune deficiency syndromes (1999). 2018;(4):383-392
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Abstract
BACKGROUND No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period. SETTING Fourteen sites in Sub-Saharan Africa and India. METHODS A randomized, open-label strategy trial was conducted in HIV-1-infected women with CD4 counts ≥350 cells/mm (or ≥country-specific ART threshold if higher) and their breastfeeding HIV-1-uninfected newborns. Randomization at 6-14 days postpartum was to mART or infant nevirapine (iNVP) prophylaxis continued until 18 months after delivery or breastfeeding cessation, infant HIV-1 infection, or toxicity, whichever occurred first. The primary efficacy outcome was confirmed infant HIV-1 infection. Efficacy analyses included all randomized mother-infant pairs except those with infant HIV-1 infection at entry. RESULTS Between June 2011 and October 2014, 2431 mother-infant pairs were enrolled; 97% of women were World Health Organization Clinical Stage I, median screening CD4 count 686 cells/mm. Median infant gestational age/birth weight was 39 weeks/2.9 kilograms. Seven of 1219 (0.57%) and 7 of 1211 (0.58%) analyzed infants in the mART and iNVP arms, respectively, were HIV-infected (hazard ratio 1.0, 96% repeated confidence interval 0.3-3.1); infant HIV-free survival was high (97.1%, mART and 97.7%, iNVP, at 24 months). There were no significant differences between arms in median time to breastfeeding cessation (16 months) or incidence of severe, life-threatening, or fatal adverse events for mothers or infants (14 and 42 per 100 person-years, respectively). CONCLUSIONS Both mART and iNVP prophylaxis strategies were safe and associated with very low breastfeeding HIV-1 transmission and high infant HIV-1-free survival at 24 months.
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Knowledge, attitude and practice of infant feeding in the first 6 months among HIV-positive mothers at the Queen Mamohato Memorial hospital clinics, Maseru, Lesotho.
Olorunfemi, SO, Dudley, L
African journal of primary health care & family medicine. 2018;(1):e1-e12
Abstract
BACKGROUND The balance between the risks of transmission of human immunodeficiency virus (HIV) through breastfeeding and its life-saving benefits complicates decisions about infant feeding among HIV-positive mothers in the first 6 months. OBJECTIVE The aim of this study was to assess the knowledge, attitude and practice of infant feeding among HIV-positive mothers attending the prevention of mother-to-child transmission services in Maseru, Lesotho.Method and setting: This observational cross-sectional study was done by collecting data from HIV-positive mothers attending the filter clinics of Queen Mamohato Memorial hospital in Maseru, Lesotho. HIV-positive mothers with infants below the age of 6 months attending the clinics at the time of the study were interviewed using a standardised questionnaire. We described the sociodemographic profile of the mothers, the information and education received on prevention of mother-to-child transmission (PMTCT) infant feeding options, the mothers' knowledge, attitudes and practices of infant feeding, and assessed risk factors for improved knowledge, attitudes and practices. RESULTS The majority (96%) of the 191 HIV-positive mothers who participated in the survey knew about the PMTCT programme and related breastfeeding services. Most of the participants chose to breastfeed (89%), while only 8% formula-fed their infants. Knowledge received during the PMTCT programme was significantly associated with the decision to exclusively breastfeed their infants. Earlier infant feeding counselling and education was associated with more exclusively breastfeeding as compared to late infant feeding counselling (p < 0.001). CONCLUSION The study found that HIV-positive mothers attending health clinics in Maseru, Lesotho, had high knowledge, and appropriate attitudes and practices with respect to infant feeding; and that early counselling and education improved infant feeding methods among these mothers.
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Does saline enema during the first stage of labour reduce the incidence of Clostridium difficile colonization in neonates? A randomized controlled trial.
Nada, AM, Mohsen, RA, Hassan, YM, Sabry, A, Soliman, NS
The Journal of hospital infection. 2018;(3):356-359
Abstract
BACKGROUND Maternal rectal enemas may reduce neonatal bacterial exposure during labour, which may reduce the risk of neonatal colonization with Clostridium difficile. The aim of this study was to determine the effectiveness of a saline enema during the first stage of labour in reducing neonatal colonization with C. difficile. METHODS This study was conducted at Cairo University Hospital, Egypt from January 2016 to July 2016. Asymptomatic mothers with uncomplicated vaginal delivery and their neonates without diarrhoea were included. The study group underwent saline enema, and the control group had no intervention. Stool samples were collected from neonates one week after delivery. The primary outcome was the detection of C. difficile in stool culture and direct detection of C. difficile Toxin A and Toxin B by enzyme-linked immunosorbent assay. FINDINGS The two groups were comparable (P>0.05) in terms of age, gravidity, parity, body mass index and gestational age. C. difficile was detected in 13.54% and 37.63% of stool cultures from the enema group and the control group, respectively (P<0.001). Direct detection of Toxins A and B was positive in 22.92% of cases in the enema group and 53.76% of cases in the control group (P<0.001). CONCLUSION This study suggests that a saline enema for the mother during the first stage of labour may be useful in reducing the risk of neonatal gut colonization by C. difficile.
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Does U=U for breastfeeding mothers and infants? Breastfeeding by mothers on effective treatment for HIV infection in high-income settings.
Waitt, C, Low, N, Van de Perre, P, Lyons, F, Loutfy, M, Aebi-Popp, K
The lancet. HIV. 2018;(9):e531-e536
Abstract
Can the campaign Undetectable=Untransmittable (U=U), established for the sexual transmission of HIV, be applied to the transmission of HIV through breastfeeding? European AIDS Clinical Society and, to some extent, American guidelines now state that mothers with HIV who wish to breastfeed should be supported, with increased clinical and virological monitoring. This Viewpoint summarises existing evidence on transmission of HIV through breastfeeding, differences in HIV dynamics and viral load between breastmilk and plasma, and the effects of antiretroviral therapy on infants. At present, insufficient evidence exists to make clear recommendations for the required frequency of clinical and virological monitoring for mother and infant in a breastfeeding relationship or for the action to be taken in the event of viral rebound. We propose a roadmap for collaborative research to provide the missing evidence required to enable mothers who wish to breastfeed to make a fully informed choice.
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Integration of postpartum healthcare services for HIV-infected women and their infants in South Africa: A randomised controlled trial.
Myer, L, Phillips, TK, Zerbe, A, Brittain, K, Lesosky, M, Hsiao, NY, Remien, RH, Mellins, CA, McIntyre, JA, Abrams, EJ
PLoS medicine. 2018;(3):e1002547
Abstract
BACKGROUND As the number of HIV-infected women initiating lifelong antiretroviral therapy (ART) during pregnancy increases globally, concerns have emerged regarding low levels of retention in HIV services and suboptimal adherence to ART during the postpartum period. We examined the impact of integrating postpartum ART for HIV+ mothers alongside infant follow-up within maternal and child health (MCH) services in Cape Town, South Africa. METHODS AND FINDINGS We conducted a randomised trial among HIV+ postpartum women aged ≥18 years who initiated ART during pregnancy in the local antenatal care clinic and were breastfeeding when screened before 6 weeks postpartum. We compared an integrated postnatal service among mothers and their infants (the MCH-ART intervention) to the local standard of care (control)-immediate postnatal referral of HIV+ women on ART to general adult ART services and their infants to separate routine infant follow-up. Evaluation data were collected through medical records and trial measurement visits scheduled and located separately from healthcare services involved in either arm. The primary trial outcome was a composite endpoint of women's retention in ART care and viral suppression (VS) (viral load < 50 copies/ml) at 12 months postpartum; secondary outcomes included duration of any and exclusive breastfeeding, mother-to-child HIV transmission, and infant mortality. Between 5 June 2013 and 10 December 2014, a total of 471 mother-infant pairs were enrolled and randomised (mean age, 28.6 years; 18% nulliparous; 57% newly diagnosed with HIV in pregnancy; median duration of ART use at randomisation, 18 weeks). Among 411 women (87%) with primary endpoint data available, 77% of women (n = 155) randomised to the MCH-ART intervention achieved the primary composite outcome of retention in ART services with VS at 12 months postpartum, compared to 56% of women (n = 117) randomised to the control arm (absolute risk difference, 0.21; 95% CI: 0.12-0.30; p < 0.001). The findings for improved retention in care and VS among women in the MCH-ART intervention arm were consistent across subgroups of participants according to demographic and clinical characteristics. The median durations of any breastfeeding and exclusive breastfeeding were longer in women randomised to the intervention versus control arm (6.9 versus 3.0 months, p = 0.006, and 3.0 versus 1.4 months, p < 0.001, respectively). For the infants, overall HIV-free survival through 12 months of age was 97%: mother-to-child HIV transmission was 1.2% overall (n = 4 and n = 1 transmissions in the intervention and control arms, respectively), and infant mortality was 1.9% (n = 6 and n = 3 deaths in the intervention and control arms, respectively), and these outcomes were similar by trial arm. Interpretation of these findings should be qualified by the location of this study in a single urban area as well as the self-reported nature of breastfeeding outcomes. CONCLUSIONS In this study, we found that integrating ART services into the MCH platform during the postnatal period was a simple and effective intervention, and this should be considered for improving maternal and child outcomes in the context of HIV. TRIAL REGISTRATION ClinicalTrials.gov NCT01933477.
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Male partner involvement on initiation and sustainment of exclusive breastfeeding among HIV-infected post-partum women: Study protocol for a randomized controlled trial.
Ihekuna, D, Rosenburg, N, Menson, WNA, Gbadamosi, SO, Olawepo, JO, Chike-Okoli, A, Cross, C, Onoka, C, Ezeanolue, EE
Maternal & child nutrition. 2018;(2):e12545
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Exclusive Breastfeeding (EBF) among human immunodeficiency virus (HIV)-infected mothers is known to be associated with a sustained and significant reduction in HIV transmission and has the potential to reduce infant and under-five mortality. Research shows that EBF is not common in many HIV-endemic, resource-limited settings despite recommendations by the World Health Organization. Although evidence abounds that male partner involvement increases HIV testing and uptake and retention of prevention of mother-to-child transmission interventions, few studies have evaluated the impact of male partners' involvement and decision-making on initiation, maintenance, and sustainment of EBF. We propose a comparative effectiveness trial of Men's Club as intervention group compared to the control group on initiation and sustainment of EBF. Men's Club will provide male partners of HIV-infected pregnant women one 5-hr interactive educational intervention to increase knowledge on EBF and explore barriers and facilitators of EBF and support. Additionally, participating male partners in the Men's Club as intervention group will receive weekly text message reminders during the first 6-week post-natal period to improve initiation and sustainment of EBF. Participants in the Men's Club as control group will receive only educational pamphlets. Primary outcomes are the differences in the rates of initiation and sustainment of EBF at 6 months between the two groups. Secondary outcomes are differences in male partner knowledge of infant feeding options and the intent to support EBF in the two groups. Understanding the role and impact of male partners on the EBF decision-making process will inform the development of effective and sustainable evidence-based interventions to support the initiation and sustainment of EBF.
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Ebola Infection in Pregnancy: A Global Perspective and Lessons Learned.
Haddad, LB, Horton, J, Ribner, BS, Jamieson, DJ
Clinical obstetrics and gynecology. 2018;(1):186-196
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The 2014 to 2016 Ebola outbreak, primarily based in 3 West African countries, had far-reaching global effects. Importantly, the crisis highlighted large gaps in reproductive health services in affected countries and inadequate health care system preparedness for obstetrical patients in the setting of highly contagious infectious diseases. We aim to review Ebola virus effects with a focus on the obstetrical implications in the context of this recent Ebola outbreak, discuss the lessons learned following this outbreak and propose current measures specific to obstetrics that should be considered in preparation for the next concerning emergent infectious disease.
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Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women.
Brites, C, Nóbrega, I, Luz, E, Travassos, AG, Lorenzo, C, Netto, EM
HIV clinical trials. 2018;(3):94-100
Abstract
Background Late-presenting pregnant women pose a challenge in the prevention of HIV-1 mother-to-child-transmission. We compared the safety and efficacy of raltegravir and lopinavir/ritonavir for this population. Methods We did a single-center, pilot, open-label, randomized trial in Brazil (N = 44). We randomly allocated late-presenting HIV-infected pregnant women (older than 18 years with a plasma HIV-1 RNA >1000 copies/mL) to receive raltegravir 400 mg twice a day or lopinavir/ritonavir 400/100 mg twice a day plus zidovudine and lamivudine (1:1). The primary endpoint was virological suppression at delivery (HIV-1 RNA <50 copies per mL), in all patients who received at least one dose of study drugs (modified intention-to-treat analysis). Missing information was treated as failure. We assessed safety in all patients. Results We enrolled and randomly assigned treatment to 33 patients (17 in raltegravir group) between June 2015 and June 2017. The study was interrupted by the IRB because a significant difference between arms was detected in an interim analysis. All patients completed follow up at delivery. At delivery, virological suppression was achieved by 13/17 (76.5%) of patients in raltegravir group, versus 4/16 (25.0%) in lopinavir/ritonavir group (RR 3.1, 95% CI: 1.3-7.4). Patients in raltegravir group had significantly higher proportion of virological suppression at 2, 4, and 6 weeks than lopinavir/ritonavir group. Adverse events were most of mild intensity, but patients in lopinavir/ritonavir group had significantly more gastrointestinal adverse events. There was neither discontinuation nor deaths in this trial. Conclusion Raltegravir might be a first-line option for treatment of HIV-infected late-presenting pregnant women.
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Impact of Timing of Antiretroviral Treatment and Birth Weight on Mother-to-Child Human Immunodeficiency Virus Transmission: Findings From an 18-Month Prospective Cohort of a Nationally Representative Sample of Mother-Infant Pairs During the Transition From Option A to Option B+ in Zimbabwe.
Dinh, TH, Mushavi, A, Shiraishi, RW, Tippett Barr, B, Balachandra, S, Shambira, G, Nyakura, J, Zinyowera, S, Tshimanga, M, Mugurungi, O, et al
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2018;(4):576-585
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BACKGROUND Preventing mother-to-child transmission of human immunodeficiency virus transmission (MTCT) depends on early initiation of antiretroviral therapy (ART). We report the 18-month MTCT risk during the transition from Option A to Option B+ in Zimbabwe, and assess whether ART preconception could eliminate MTCT in breastfeeding populations. METHODS In 2013, we consecutively recruited a nationally representative sample of 6051 infants aged 4-12 weeks and their mothers from 151 immunization clinics using a multistage stratified cluster sampling method. We identified 1172 human immunodeficiency virus (HIV)-exposed infants and evaluated them at baseline and every 3 months until the child became HIV-infected, died, or reached age 18 months. RESULTS The cumulative MTCT risk through 18 months postdelivery was 7.0%. Of the HIV-infected mothers, 35.3% started ART preconception, 28.9% during pregnancy, and 9.7% after delivery, and 16.0% received zidovudine during pregnancy. Compared to mothers without antiretroviral drug use, MTCT among those starting ART preconception and during pregnancy was lower by 88% (adjusted hazard ratio [aHR], 0.12; 95% confidence interval [CI], .06-.24) and 75% (aHR, 0.25; 95% CI, .14-.45), respectively. HIV-exposed infants with birth weight <2.5 kg (low birth weight) were 2.6-fold more likely to acquire HIV infection compared to those with birth weight ≥2.5 kg (aHR, 2.57; 95% CI, 1.44-4.59). Controlling for other factors, breastfeeding was not significantly associated with MTCT. CONCLUSIONS ART preconception has the highest impact on reducing MTCT, indicating that HIV-infected, reproductive-age women should be prioritized in "treat-all" strategies. HIV-infected mothers without ART use should be identified at the first immunization visit and treatment initiated to reduce postdelivery MTCT. MTCT risk is higher in mothers with low-birth-weight deliveries.