Dataset Information

Outcomes in a cohort of women who discontinued maternal triple-antiretroviral regimens initially used to prevent mother-to-child transmission during pregnancy and breastfeeding--Kenya, 2003-2009.

ABSTRACT: BACKGROUND:In 2012, the World Health Organization (WHO) amended their 2010 guidelines for women receiving limited duration, triple-antiretroviral drug regimens during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV (tARV-PMTCT) (Option B) to include the option to continue lifelong combination antiretroviral therapy (cART) (Option B+). We evaluated clinical and CD4 outcomes in women who had received antiretrovirals for prevention of mother-to-child transmission and then discontinued antiretrovirals 6-months postpartum. METHODS AND FINDINGS:The Kisumu Breastfeeding Study, 2003-2009, was a prospective, non-randomized, open-label clinical trial of tARV-PMTCT in ARV-naïve, Kenyan women. Women received tARV-PMTCT from 34 weeks' gestation until 6-months postpartum when women were instructed to discontinue breastfeeding. Women with CD4 count (CD4) <250cells/mm3 or WHO stage III/IV prior to 6-months postpartum continued cART indefinitely. We estimated the change in CD4 after discontinuing tARV-PMTCT and the adjusted relative risk [aRR] for factors associated with declines in maternal CD4. We compared maternal and infant outcomes following weaning-when tARV-PMTCT discontinued-by maternal ARV status through 24-months postpartum. Compared with women who continued cART, discontinuing antiretrovirals was associated with infant HIV transmission and death (10.1% vs. 2.4%; P?=?0.03). Among women who discontinued antiretrovirals, CD4<500 cells/mm3 at either initiation (21.8% vs. 1.5%; P?=?0.002; aRR: 9.8; 95%-confidence interval [CI]: 2.4-40.6) or discontinuation (36.9% vs. 8.3%; P<0.0001; aRR: 4.4; 95%-CI: 1.9-5.0) were each associated with increased risk of women requiring cART for their own health within 6 months after discontinuing. CONCLUSIONS:Considering the serious health risks to the woman's infant and the brief reprieve from cART gained by stopping, every country should evaluate the need for and feasibility to implement WHO Option B+ for PMTCT. Evaluating CD4 at antiretroviral initiation or 6-months postpartum can identify pregnant women who would most benefit from continuing cART in settings unable to implement WHO Option B+.

SUBMITTER: Minniear TD

PROVIDER: S-EPMC3986059 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Outcomes in a cohort of women who discontinued maternal triple-antiretroviral regimens initially used to prevent mother-to-child transmission during pregnancy and breastfeeding--Kenya, 2003-2009.

Minniear Timothy D TD Girde Sonali S Angira Frank F Mills Lisa A LA Zeh Clement C Peters Philip J PJ Masaba Rose R Lando Richard R Thomas Timothy K TK Taylor Allan W AW

PloS one 20140414 4

<h4>Background</h4>In 2012, the World Health Organization (WHO) amended their 2010 guidelines for women receiving limited duration, triple-antiretroviral drug regimens during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV (tARV-PMTCT) (Option B) to include the option to continue lifelong combination antiretroviral therapy (cART) (Option B+). We evaluated clinical and CD4 outcomes in women who had received antiretrovirals for prevention of mother-to-child transm ...[more]

PMID: 24733021

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Project description:BACKGROUND: Effective strategies are needed for the prevention of mother-to-child HIV transmission (PMTCT) in resource-limited settings. The Kisumu Breastfeeding Study was a single-arm open label trial conducted between July 2003 and February 2009. The overall aim was to investigate whether a maternal triple-antiretroviral regimen that was designed to maximally suppress viral load in late pregnancy and the first 6 mo of lactation was a safe, well-tolerated, and effective PMTCT intervention. METHODS AND FINDINGS: HIV-infected pregnant women took zidovudine, lamivudine, and either nevirapine or nelfinavir from 34-36 weeks' gestation to 6 mo post partum. Infants received single-dose nevirapine at birth. Women were advised to breastfeed exclusively and wean rapidly just before 6 mo. Using Kaplan-Meier methods we estimated HIV-transmission and death rates from delivery to 24 mo. We compared HIV-transmission rates among subgroups defined by maternal risk factors, including baseline CD4 cell count and viral load. Among 487 live-born, singleton, or first-born infants, cumulative HIV-transmission rates at birth, 6 weeks, and 6, 12, and 24 mo were 2.5%, 4.2%, 5.0%, 5.7%, and 7.0%, respectively. The 24-mo HIV-transmission rates stratified by baseline maternal CD4 cell count <500 and ?500 cells/mm(3) were 8.4% (95% confidence interval [CI] 5.8%-12.0%) and 4.1% (1.8%-8.8%), respectively (p?=?0.06); the corresponding rates stratified by baseline maternal viral load <10,000 and ?10,000 copies/ml were 3.0% (1.1%-7.8%) and 8.7% (6.1%-12.3%), respectively (p?=?0.01). None of the 12 maternal and 51 infant deaths (including two second-born infants) were attributed to antiretrovirals. The cumulative HIV-transmission or death rate at 24 mo was 15.7% (95% CI 12.7%-19.4%). CONCLUSIONS: This trial shows that a maternal triple-antiretroviral regimen from late pregnancy through 6 months of breastfeeding for PMTCT is safe and feasible in a resource-limited setting. These findings are consistent with those from other trials using maternal triple-antiretroviral regimens during breastfeeding in comparable settings.

Project description:BackgroundThe safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants.MethodsWithin 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth.ResultsA total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan-Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intrapartum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P=0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P=0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P=0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P<0.001 for both comparisons with the other groups).ConclusionsIn neonates whose mothers did not receive ART during pregnancy, prophylaxis with a two- or three-drug ART regimen is superior to zidovudine alone for the prevention of intrapartum HIV transmission; the two-drug regimen has less toxicity than the three-drug regimen. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD] and others; ClinicalTrials.gov number, NCT00099359.).

Project description:Breast milk is considered the ideal infant nutrition, and medical organizations encourage breastfeeding worldwide. Moreover, breastfeeding is often perceived as a natural and spontaneous socio-biological process and one of the fundamental roles of new mothers. While breastfeeding is beneficial, little scientific consideration has been given to its potential psychological challenges. Here, we investigate the phenomenon of breastfeeding pain in mothers and its association with maternal and infant behavioral regulation. During the postpartum weeks, the mother-infant dyad can be considered one allostatic unit directed at infant regulation and development. We hypothesize that pain comprises an allostatic challenge for mothers and will thus impair the capacity for dyadic regulation. To test this, we recruited 71 mothers with varying levels of breastfeeding pain and videotaped them with their infants (2-35 weeks old) during spontaneous face-to-face interactions. We quantified the individual differences in dyadic regulation by behaviorally coding the second-by-second affective expressions for each mother and infant throughout their interactions. We tested the extent to which breastfeeding pain alters affect regulation during mother-infant interactions. We discovered that mothers with severe breastfeeding pain express less affective expressions and less infant-directed gaze during interactive moments of engagement and play than mothers with no or moderate pain. Moreover, infants of mothers experiencing pain during breastfeeding express less affective expressions and more mother-directed gaze while interacting with their mothers than infants of mothers who are not in pain. This demonstrates that the allostatic challenge of maternal pain interferes with the behavioral regulation of both mothers and infants. Since the mother-infant dyad is a codependent allostatic unit, the allostatic challenges of one partner can impact the dyad and thus potentially impact child development, bonding, and mother and infant well-being. The challenges of breastfeeding should be considered in addition to the nutritional advances.

Project description:BackgroundCyclosporine is widely used for immunosuppressive treatment of various systematic and local autoimmune diseases. Breastfeeding is conventionally contraindicated when treating with cyclosporine due to its excretion into breast milk, which may cause immune suppression of exposed infants and affect infants` growth. A few cases have tested cyclosporine levels in random breast milk samples and concluded the infants exposed to safe cyclosporine levels during breastfeeding. Since infants do not maintain a fixed feeding schedule, we monitored cyclosporine levels in breast milk at different times of the day to assess the safety of breast milk for infants throughout the day.Case presentationA 32-year-old dichorionic twin-pregnancy woman had nephrotic syndrome with renal biopsy confirmed type V lupus nephritis for over five years. She was treated only with prednisone 10 mg a day before pregnancy and during early pregnancy. Cyclosporine was added in her regimen from 22 weeks gestation and was adjusted to 225 mg a day from 28 weeks gestation. After parturition, she partially breastfed her twin infants while being treated with cyclosporine 3 mg/kg a day as well as prednisone and hydroxychloroquine sulfate. The cyclosporine level in maternal blood was determined, and several breast milk samples were collected for consecutive 48 h beginning on the ninth day after parturition. The concentration of cyclosporine in breast milk was measured and ranged from 0.443 to 5.307 mcg/L. Both infants grew and developed normally at the three-month follow-up, with no adverse effects observed. The study was conducted at West China Second University Hospital of Sichuan University, started in September 2021, with the consent of the participant and the approval of the ethics committee.ConclusionIn this case, cyclosporine levels in breast milk were low at all times of the day. The growth and development of both infants were normal at three months postpartum. Thus, breastfeeding may still be an option for mothers with nephrotic syndrome who are treated with cyclosporine.

Dataset Information

Outcomes in a cohort of women who discontinued maternal triple-antiretroviral regimens initially used to prevent mother-to-child transmission during pregnancy and breastfeeding--Kenya, 2003-2009.

Publications

Outcomes in a cohort of women who discontinued maternal triple-antiretroviral regimens initially used to prevent mother-to-child transmission during pregnancy and breastfeeding--Kenya, 2003-2009.

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