Breast Feeding Women on Art Cannot Transmit Hiv to Their Babies Ncbi
AIDS. Author manuscript; bachelor in PMC 2012 Mar nineteen.
Published in terminal edited course every bit:
PMCID: PMC3305463
HALMS: HALMS399402
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Breastfeeding with maternal antiretroviral therapy or formula feeding to foreclose HIV postnatal mother-to-kid manual in Rwanda
Cécile-Alexandra Peltier
1INT 108, ESTHER Phase 2 Project Lux-Development, Kingali,RW
Gilles-François Ndayisaba
1INT 108, ESTHER Phase 2 Project Lux-Evolution, Kingali,RW
Philippe Lepage
twoHôpital Universitaire des Enfants Reine Fabiola Université Libre de Bruxelles, BE
Johan Van Griensven
1INT 108, ESTHER Stage two Projection Lux-Development, Kingali,RW
Valériane Leroy
3Centre épidémiologie et biostatistique INSERM : U897, Université Victor Segalen - Bordeaux II, FR
Christine Omes
oneINT 108, ESTHER Stage 2 Project Lux-Development, Kingali,RW
Patrick-C Ndimubanzi
oneINT 108, ESTHER Phase 2 Project Lux-Evolution, Kingali,RW
Olivier Courteille
fourDepartment of infectious diseases CHU Luxembourg, FR
Abstract
Objective
To assess the ix-month HIV-costless survival of children with 2 strategies to prevent HIV mother-to-child transmission.
Design
Non-randomized interventional cohort study.
Setting
Four public wellness centers in Rwanda.
Participants
Between May 2005 and January 2007, all consenting HIV-infected meaning women were included.
Intervention
Women could choose the mode of feeding for their babe: breastfeeding (BF) with maternal highly active antiretroviral therapy (HAART) for six months or formula feeding (FF). All received HAART from 28 weeks of gestation. 9-month cumulative probabilities of HIV transmission and HIV-gratis survival were determined using the Kaplan-Meier method, and compared using the log-rank test. Determinants were analyzed using a Cox model assay.
Results
Of the 532 kickoff-live born infants, 227 (43%) were BF and 305 (57%) were FF. Overall, 7 (1.3%) children were HIV-infected of whom half-dozen were infected in utero. But 1 child in the BF group became infected between calendar month three and month vii, corresponding to a 9-month cumulative risk of postnatal infection of 0.v% (95% CI 0.ane–3.4%; P=0.24) with BF. 9-month cumulative mortality was 3.3% (95% CI 1.six–6.9%) in the BF arm group and 5.vii% (95% CI three.six–9.2%) for the FF group (P=0.20). HIV-free survival past ix months was 95% (95% CI 91–97%) in the BF grouping and 94% (95% CI 91–96%) for the FF group (P=0.66), with no significant deviation in the adjusted analysis (adjusted gamble ratio for BF: 1.two (95% CI 0.v–ii.9%).
Conclusions
Maternal HAART while BF could be a promising culling strategy in resource-limited countries.
Keywords: Adult, Antiretroviral Therapy, Highly Active, methods, Chest Feeding, Cohort Studies, Female, HIV Infections, drug therapy, epidemiology, manual, HIV-one, Humans, Baby, Babe Formula, administration & dosage, Infant, Newborn, Infectious Disease Transmission, Vertical, prevention & control, Post-Exposure Prophylaxis, methods, Pregnancy, Pregnancy Complications, Infectious, drug therapy, epidemiology, Rwanda, epidemiology, Survival Analysis
Keywords: Africa, PMTCT, HIV, antiretroviral, breastfeeding, formula feeding, postnatal manual
INTRODUCTION
In adult countries, comprehensive prevention of mother-to-child transmission(PMTCT) programs that utilize antiretroviral treatment(ART) prophylaxis and alternatives to breastfeeding(BF), have been shown to be very effective, resulting in overall HIV perinatal manual rates of less than 2%[1]. Similarly, low rates of perinatal transmission take been demonstrated in PMTCT programs in low-income countries[2–4]. Nevertheless, when BF is employed, peculiarly for extended periods and mixed with formula feeding(FF), subsequent manual through BF clearly reduces the long-term efficacy of these prophylactic regimens[five–8]. Sectional breastfeeding(EBF) with early on cessation[9] and FF are ii conceivable alternatives to prevent postnatal HIV transmission[iv]. Several studies from low-income countries have reported postnatal transmission rates of less than ii% using alternatives to BF without a higher overall bloodshed rate[two, 10]. However, in operational settings, these alternatives have shown a worrying increase in overall mortality amidst FF children, probably due to the lack of access to clean water, incorrect dilution of formula, and inadequate admission to formula or postnatal follow-upward[11–12]. As a issue, electric current Globe Health Arrangement(WHO) guidelines recommended EBF with early weaning if replacement feeding is acceptable, viable, affordable, sustainable and safe [13]. Unfortunately, there are still concerns: EBF cannot completely avoid HIV transmission, but early weaning may lead to an increased morbidity in children[12]. With the increased access to ARV in Africa, two other approaches could exist conceivable also: giving safety antiretroviral treatment to breastfed children born to HIV positive mothers[14–16] or to provide maternal highly active antiretroviral treatment(HAART) while BF[2, 17–18]. Although several studies provide indirect evidence for the efficacy of this latter intervention[19–21], well-designed studies evaluating the efficacy of this strategy in poor countries are almost non-existent or on-going. No single study has formally compared maternal BF with HAART to FF within the same accomplice in resource-express countries.
Therefore, we implemented an interventional cohort study to appraise these ii interventions to prevent postnatal MTCT of HIV-i in Rwanda: BF combined with maternal HAART for a maximum elapsing of six months versus sectional FF. The purpose of this paper is to report the efficacy of these interventions based on HIV-1 manual, mortality and HIV-free survival until 9 months of historic period.
METHODS
Study Pattern and Setting
This was a not-randomized, interventional cohort written report, named "AMATA", which ways "milk" in the local language (Kinyarwanda). It was conducted at 4 government-run wellness facilities: one rural wellness centre (70 km from Kigali, the uppercase city), one semi-rural wellness middle (fifteen km from Kigali) and two urban sites in Kigali. Each of these four sites had antenatal intendance services with PMTCT programs in place, providing admission to treatment for HIV infection. Routine HIV testing and HAART are provided free of charge in Rwanda.
Study population
Between May 2005 and January 2007, all HIV-infected pregnant women entering the PMTCT programs in these iv centres were invited to participate in the study from 28 weeks of gestation. The women were counselled about the take chances of higher morbidity with FF and the risk of HIV through BF during 2 data prenatal sessions; those consenting to participate were given the pick of infant feeding mode at inclusion, prior to delivery.
Interventions
All enrolled women received HAART from 28 weeks of gestation irrespective of the study group. In line with the Rwandan national protocol, pregnant women with CD4 jail cell count <350 cells/μL and/or WHO clinical phase 4 were considered eligible for lifelong HAART, consisting (in 2005) of combined therapy with stavudine(D4T), lamivudine(3TC) and nevirapine(NVP). For the rest (WHO clinical stage i, ii, three and CD4 cell count >350/μL), a rubber HAART regimen containing zidovudine(AZT), 3TC and efavirenz(EFV) was started. EFV was chosen to avert the hepatotoxicity due to NVP for women having high CD4 cell counts[22]. AZT was preferred over D4T in condom HAART given its well documented efficacy in PMTCT.
After inclusion, those choosing FF had specific education sessions with the counsellors on safe preparation of formula, which was provided costless of charge until six months of age. These women were too informed that they would be given an injection of five mg oestradiol just after delivery, to assist suppressing the breast milk production. In the BF group, women were counselled to exclusively breastfeed until six months and then to perform rapid weaning. A supplement of "sosoma" (mixture of soya, sorghum and maize) was given during the weaning menstruum for one month and was also given to the FF grouping. All food supplementation was stopped at 7 months unless severe malnutrition (weight-for-age below the fifth percentile) was diagnosed, after excluding underlying medical problems. Nosotros used the Centers for Disease Control and Prevention curves[23], every bit the 2006 international WHO curves[24] were non available at the starting time of the study. After nativity, prophylactic HAART was stopped for the non lifelong eligible women that had opted for FF unless they became eligible for HAART in between. For BF women, prophylactic HAART was given until seven months of age (until one month after weaning) to protect infants against the hazard of postnatal transmission associated with mixed feeding if precipitous weaning was not washed. In each case, a courage of AZT and 3TC was given for vii days after stopping NVP/EFV, to reduce the risk of resistance[25].
Following WHO recommendations, all newborn infants exposed to HIV received NVP two mg/kg at nascency and AZT 4 mg/kg twice-daily for seven days. At six weeks of historic period, cotrimoxazole was given to all infants until ix months of age and continued after for those infected[22].
Follow-upwards procedures
Follow-upward of mother-infant pairs was done by the AMATA squad, consisting of physicians, nurses and counsellors. Female parent-infant pairs were examined clinically at birth (within 48 hours) and follow-upwardly visits were scheduled at fifteen days, six weeks and three, six, seven and nine months post-partum. At each visit, adherence to HAART (pill count and questionnaires) and the feeding method were assessed by maternal interview and clinical examination and women were counselled accordingly. Breast health and feeding techniques were evaluated at each visit. If a breast-fed baby had received any liquids or solids fifty-fifty once (with the exception of drugs), they were then considered to have received "mixed feeding", using the WHO definitions[26]. In case of problematic or bereft BF, the demand to add additional feeding was discussed and mixed feeding was an acceptable choice. All women were counselled near family unit planning; those on an EFV-containing regimen were given three-monthly progesterone injections.
All care was provided for free, and transportation costs were reimbursed past the projection. CD4 prison cell count and HIV-RNA plasma viral load(VL) of all women were measured at inclusion, at delivery (less than 48 hours subsequently having given nascence) and at six months postpartum.
CD4 cell count was done using a FACSCalibur instrument (BD Bioscience, Becton, Dickinson and company, United states). VL tests were done with the Real-time polymerase chain reaction(PCR) testing on COBAS TaqMan® 48 Analyzer (Roche, Switzerland).
The HIV condition of the infant was established with a HIV-1 DNA PCR assay using the Amplicor technique (version 1.5, Roche Molecular Systems, Pleasanton, CA).
Diagnosis of HIV infection in children
HIV Deoxyribonucleic acid PCR tests were performed in children at birth, at six weeks, three months, seven and 9 months of age. Infants were defined as having been infected in utero if the HIV-i DNA PCR was positive within 48 hours of life and confirmed to be positive in the side by side test. Transmission was considered to have occurred peripartum if a negative result at birth was followed past a positive consequence at six weeks of age. The blood exam done at day fifteen was stored and performed merely in case of different results between birth and six weeks PCR tests. Children with a positive HIV Deoxyribonucleic acid PCR later solar day 15 were considered infected through breast milk if claret samples from nascence and day 15 were negative. Every positive HIV exam for children was confirmed by a second positive exam before a final diagnosis of HIV infection was accustomed.
Mortality and morbidity data were obtained through hospital inpatient and outpatient records or past interview of the family member at each scheduled visits.
Primary Outcome Measures
Three main outcomes were measured at nine months of age among the liveborn children:
-
Cumulative incidence of mother-to-kid HIV transmission (peri-natal and postnatal)
-
Cumulative babe bloodshed.
-
Cumulative incidence of HIV-free survival: HIV infection or expiry whichever came start.
Statistical Assay
Every first-born liveborn child was included in the analysis in an intent-to-feed analysis, BF+HAART or FF. The allocation to a feeding grouping was based on the feeding option chosen before delivery. All newborns that died before 48 hours of life linked to anoxia and prematurity before whatever feeding were non included in the analysis, to exclude deaths unrelated to the feeding choice. The Pupil t-test, Wilcoxon rank-sum test, χ2 test and Fisher'south exact test were used to decide differences in ways, medians values and proportions betwixt groups. Cumulative probability of events in the first nine months of life was calculated using Kaplan-Meier estimates with 95% Confidence Intervals(CI). This was advisable since intervals betwixt tests were less than three months[27]. Comparisons were made using the log-rank test. Infants who were lost to follow-up(LTFU) before reaching study stop points were recorded at the date of their last HIV test available. LTFU was defined as having missed planned appointments after having been actively sought at domicile. The timing of conquering of infection was estimated to accept occurred midway between the dates of the last negative and the offset positive test. Determinants for nine-month HIV-free survival were explored using a Cox model adjusted on the following variables : infant feeding modalities, and co-variants: maternal CD4 count at delivery, time on HAART prior to delivery, access to clean water, level of the female parent's didactics, mode of delivery and birth weight and sex activity of the infant. VL at commitment was not included, since data were missing for 18% of women. Data were entered and stored using Access TM software, information analysis was done with Epi Info TM(version 3.iii.2), SPSS TM(version 16) and Stata TM(Version 9).
Sample size
The main judgement criterion was HIV-free survival, expected to exist 95% overall at nine-months of age. To exist able to detect a seven.v% difference in HIV-free survival (a abiding Hour of 0.38) with a power of 80%[28], 205 patients needed to exist included in each grouping. Assuasive for 10% LTFU, we decided to include at to the lowest degree 225 pregnant women in each group.
Ethics
The written report was designed and conducted in collaboration with the Rwandan Ministry building of Wellness. The National Upstanding Committee of Rwanda, having an international registration, approved the written report with annual evaluation of the study progress reports and re-evaluation of the protocol. An informed consent has been obtained for all patients included in this accomplice.
RESULTS
Report population
From May 2005 to January 2007, 562 HIV-positive pregnant women were included in the study, of whom 240(42.vii%) preferred BF nether HAART and 322(57.three%) women chose FF. Eleven(2.0%) women were LTFU prior to delivery, and 551 infants were born during the study, of whom 11 were twins (2d born excluded) and 14(2.five%) were stillborns. Overall, five(ane.0%) newborns died within 48 h of life (four were premature, and one infant died on the second day of a neonatal infection that was clinically present at the time of nascence; the mother had fever during expulsion). None of these five deaths were related to feeding exposure and were excluded from farther analysis. Therefore 532 mothers-infant pairs were included in this analysis (Figure 1).
Amata cohort profile. Rwanda, 2005–2007
Commitment characteristics of these women and infants are summarized in Tabular array 1. Women choosing BF were slightly younger, had higher CD4 prison cell count and were less likely to exist eligible for lifelong HAART than women choosing FF. They had also less access to clean water. VL at commitment was like in both groups but 95(17.8%) VL were missing at commitment due to laboratory technical problems. Women in the FF were too more likely to have started life-long Art prior to inclusion in the study. Overall, 256(48.ane%) women were on HAART for life after inclusion.
Tabular array 1
Baseline and commitment characteristics of HIV infected mothers and their liveborn infants past babe-feeding group: formula feeding(FF) or breastfeeding(BF) with maternal HAART; AMATA cohort, Rwanda, 2005–2007
| Overall N= 532 | F F N= 305 | BF + HAART North= 227 | P value | ||||
|---|---|---|---|---|---|---|---|
| | |||||||
| N | % | N | % | North | % | ||
| Maternal age | 532 | 305 | 227 | ||||
| Median (years) | 29 | 29 | 28 | 0.000 | |||
| Interquartile range | 25–33 | 26–34 | 24–32 | ||||
| WHO clinical stage (North) | 532 | 305 | 227 | ||||
| i & 2 | 470 | 88.iii% | 266 | 87.2% | 204 | 89.nine% | 0.345 |
| 3 & 4 | 62 | 11.7% | 39 | 12.8% | 23 | ten.1% | |
| Maternal CD4 cell count (N) | 471 | 274 | 197 | ||||
| Hateful (/mm3) | 461 | 434 | 498 | 0.005 | |||
| Interquartile range (/mm3) | 279–592 | 241–545 | 326–659 | ||||
| Delivery maternal VL copies | 431 | 247 | 184 | ||||
| <xl copies/ml | 221 | 51.iii% | 126 | 51.0% | 94 | 51.6% | 0.898 |
| <g copies/ml | 385 | 89.three% | 225 | 91.1% | 160 | 86.9% | 0.168 |
| Duration of HAART (N) | 523 | 300 | 223 | ||||
| Mean (weeks) | nineteen.5 | 21.8 | 16.4 | 0.766 | |||
| Interquartile range (weeks) | 7–14 | 6–15 | 8–13 | ||||
| Eligible for HAART (N) | 256 | 48.1% | 164 | 53.8% | 92 | ||
| Started at enrolment | 78 | 14.7% | 42 | 13.8% | 36 | 15.9% | 0.007 |
| Started before enrolment | 178 | 33.5% | 122 | 40.0% | 56 | 24.7% | |
| Educational level (N) | 518 | 301 | 217 | ||||
| None/Primary | 461 | 89.0% | 267 | 88.7% | 194 | 89.four% | 0.802 |
| Secondary/University | 57 | eleven.0% | 34 | xi.3% | 23 | x.6% | |
| Water type/source (N) | 518 | 301 | 217 | ||||
| Piped indoor | 61 | eleven.viii% | 39 | thirteen.0% | 22 | 10.i% | 0.043 |
| Public tap | 363 | 70.1% | 219 | 72.8% | 144 | 66.four% | |
| Source water | 85 | 16.4% | twoscore | 13.3% | 45 | 20.7% | |
| River/Stagnant water | 9 | 1.7% | iii | i.0% | half-dozen | 2.8.% | |
| Electricity at dwelling (N) | 520 | 302 | 218 | ||||
| Yep | 117 | 22.five% | 74 | 24.5% | 43 | 19.7% | 0.197 |
| Place of delivery (N) | 532 | 305 | 227 | ||||
| Wellness facilities | 485 | 91.2% | 275 | ninety.2% | 210 | 92.5% | 0.345 |
| Abode | 47 | 8.viii% | 30 | 9.eight% | 17 | seven.5% | |
| Mode of delivery (North) | 532 | 305 | 227 | ||||
| Caesarian section | 86 | 16.ii% | 47 | fifteen.4% | 39 | 17.0% | 0.583 |
| Gestational age ( N) | 532 | 305 | 227 | ||||
| Mean (weeks) | 39.7 | 39.five | 39.eight | 0.032 | |||
| Interquartile range (Weeks) | 39–41 | 39–41 | 39–41 | ||||
| Infant Birth Weight (Northward) | 532 | 305 | 227 | ||||
| Mean (kg) | three.one | iii.ane | 3.1 | 0.281 | |||
| Interquartile range (kg) | two.eight–iii.4 | 2.8–3.4 | ii.8–3.4 | ||||
| <two.5 kg | two.6 | 2.0 | vi | 0.038 | |||
| Infant sex (N) | 532 | 305 | 227 | ||||
| Female | 262 | 49.2% | 152 | 49.eight% | 111 | 48.ix% | 0.830 |
Tolerance of and adherence to the interventions
No mother interrupted her HAART treatment, although 11(two.1%) required drug substitution due to toxicity, one during pregnancy and ten after commitment. Of all these side effects, 7 were due to AZT-related anaemia, and ii were due to D4T-related lipodystrophy. In addition, 1 adult female interrupted EFV treatment due to a severe low and ane example of rash due to NVP was observed. No HIV-related deaths were reported. Adherence to exclusive BF was very good (94.ii%). None of the infants of the 13 women who practiced mixed feeding were infected.
Outcomes
Overall, seven children were infected with HIV-i of which six in utero (3 in each baby feeding group). Only one child in the BF group became infected between month 3 and calendar month seven and no child acquired HIV infection between birth and ix months in the FF group. In the BF group, the cumulative probability of HIV-one transmission at six weeks and 9 months was 1.3% (95%CI 0.iv–iv.one%) and 1.eight% (95%CI 0.seven–four.viii%), respectively. In the FF group, these cumulative probabilities were similar at six weeks and 9 months estimated to be one% (95%CI: 0.iii–three.0%). Over the get-go ix months, the probability of HIV-1 transmission was not statistically dissimilar between both groups (log-rank examination, P=0.43). The ane infant who acquired HIV infection in the BF grouping represented a cumulative risk of postnatal infection of 0.5% (95%CI 0.ane–three.iv%; P=0.24) at nine months of life. Although the infecting BF mother was receiving HAART, she had been suffering from gastritis with severe vomiting from four months post-partum. This, in combination with prolonged fasting for religious reasons, fabricated her adherence and drug assimilation questionable. Finally, while hospitalized for severe vomiting, she all of a sudden ceased BF at five months. Her plasma VL result at vi months postpartum showed a VL of 1600 copies/ml.
Overall, by 9 months of age, 7(3.1%) children had died in the BF group and seventeen(five.6%) in the FF group. For the 22 infants who died before ix months of age and were HIV-negative at birth, a negative PCR event was bachelor for all of them past 3 months prior to decease. The nine-month cumulative probability of expiry for the BF grouping was iii.three% (95%CI 1.6–half dozen.9%) and 5.7% (95%CI 3.6–9.ii%) for the FF group, with no statistically significant difference (log-rank test, P=0.20).
Amongst the 532 exposed liveborn children, 29 were HIV-1 infected or expressionless at 9 month of age. Equally shown in figure 2, the nine-month cumulative HIV-free survival was 95% (95%CI 91–97%) in the BF grouping and 94% (95%CI 91–96%) in the FF group (log-rank test, P=0.66).
Kaplan Meier HIV-gratis survival in infants in the formula and breastfed with maternal HAART group. AMATA cohort, Rwanda, 2005–2007
Afterward aligning for potential confounders in the adjusted analysis, no pregnant difference in HIV-free survival was seen between the 2 intervention groups, with an adapted Hr of 1.2 (95%CI 0.5–2.9%) for BF versus FF (Table 2). The only statistically significant factors retained were maternal CD4 cell count below 350/μL and birth weight beneath two.5 kg. If LTFU was considered as dead/infected in a sensitivity analysis, an adjusted HR of 1.nine (95%CI 0.9–4.0%) for BF compared to FF was found (data not shown).
Tabular array 2
Multivariate Cox model analysis to assess the correlates of HIV infection or death within the first 9 months of life in, Rwanda, 2005–2007 (N=465)a
| Hourb | P | Adjusted Hrb | P | |
|---|---|---|---|---|
| Babe feeding group | ||||
| Formula feeding (FF) | ane | 1 | ||
| Breastfeeding (BF) | i.0 (0.4–2.3) | 0.99 | ane.2 (0.five–1.9) | 0.68 |
| Baseline CD4 count at enrolment | ||||
| > 350 cells/μL | 1 | 1 | ||
| ≤ 350 cells/μL | 2.half dozen (i.1.vi.0) | 0.03 | 2.7 (one.i–half-dozen.iv) | 0.02 |
| Time on HAART prior to delivery | ||||
| > 2 months | one | 1 | ||
| ≤ 2 months | i.4 (0.vi–three.2) | 0.45 | 1.iii (0.5–iii.0) | 0.55 |
| Access to running water | ||||
| Yes | 1 | one | ||
| No | ii.9 (0.4–21.7) | 0.xxx | ii.4 (0.3–18.8) | 0.39 |
| Instruction | ||||
| Post master | ane | i | ||
| None/Chief | 2.4 (0.vii–8.1) | 0.16 | 2.2 (0.half dozen–7.6) | 0.22 |
| Caesarian section | ||||
| Yes | 1 | one | ||
| No | four.0 (0.5–30.0) | 0.17 | 3.8 (0.v–28.6) | 0.19 |
| Infant sex | ||||
| Female | 1 | one | ||
| Male | 2.0 (0.viii–5.0) | 0.12 | ii.3 (0.nine–five.7) | 0.08 |
| Infant birth weight | ||||
| > 2.five kg | 1 | ane | ||
| ≤ two.5 kg | iii.2 (one.two–8.6) | 0.02 | 3.3 (1.one–9.4) | 0.03 |
DISCUSSION
This is the start study reporting the field efficacy of two concomitant PMTCT interventions to reduce postnatal transmission of HIV. Whereas FF has been the recommended choice in developed countries, this intervention is not feasible for many African women and carries a higher risk of morbidity and mortality in resource-limited settings that needs to be balanced against its benefits in preventing postnatal transmission. With the antiretroviral era in Africa since 2004, providing HAART to women while BF is another believable choice, offering a culturally appropriate alternative. In our study, following a backbone of maternal HAART co-ordinate to 2006 WHO criteria[25], both postnatal approaches were institute to be safe and effective, with similar nine-calendar month HIV-costless survival of about 95%. The overall nine-calendar month manual rate was about 1.3%, one of the lowest MTCT rate ever reported from low-income countries[29] and similar to those reported from industrialized countries. We attribute this stiff effect to the combination of starting HAART prior to delivery, antiretroviral prophylaxis to the newborn and continued HAART for six months while BF.
In a meta-assay, the risk of HIV transmission by EBF was estimated around 0.vii% per child-calendar month of BF follow-up[vi]. In other contempo African studies, the lowest reported rates of transmission with EBF by three–six months have varied between 1.3 % and 5.6%[ii–3, 30–31]. Although these studies are difficult to compare directly, our postnatal transmission charge per unit for women BF under HAART would propose a significant reduction in postnatal transmission. We establish only 1 other published report (DREAM Program), assessing the efficacy of BF combined with maternal HAART to reduce postnatal transmission (boosted 0.8% postnatal transmission in the BF group with HAART), but without a FF comparison group at the same period of time[2].
The results with FF were also encouraging, showing an overall mortality lower than in infants born to HIV-uninfected mothers in Rwanda[32]. The total mortality of children followed in the AMATA trial was 4.7% at 9 months, without statistically pregnant differences betwixt the BF and FF groups. This is in dissimilarity with some studies that take shown an overall increased mortality in FF infants and we propose that this is considering both studies (DREAM and AMATA) were strongly focused on patients' counseling, education, and adept quality of care and adaptation of the feeding option to the mother's choice. These data as well confirm the importance of postnatal follow-up for exposed children, very oft neglected when PCR-testing is non available, resulting in express access to intendance and information.
We chose a cohort pattern instead of a randomized clinical trial to avoid the upstanding problems associated with a fixed allocation of the infant feeding practices[33]. In addition, this design helped to assess the mother'south option of feeding method with FF with a close follow-upwardly and education for the preparation of milk. We believe this was a key gene in encouraging good adherence[34]. To be able to offering women a culturally adequate method of feeding, that matched HIV manual rates using FF, resulted in very important public health implications.
This written report had several limitations. Offset, while adjusting for the cohort pattern our findings remained essentially unchanged in multivariate analysis, rest confounding may still be possible. Second, these outcomes were obtained within a specific study enquiry setting with high quality of care and follow-upwardly. Consequently, these findings could not be generalized to the country level. Third, even though the overall tolerance of HAART was very skillful in this report, toxicity of HAART could be problematic in settings with fewer resources for follow-up.
Finally, this study did not accept the power to detect pocket-size differences in postnatal HIV-ane infection or bloodshed betwixt the 2 approaches.
There are some public health caveats, as well. In most low-income countries, access to HAART services is however limited and particularly challenging for pregnant women during the last trimester of pregnancy. Even if attainable everywhere, cost implications of dissemination of this PMTCT model will have to be considered in each state. There is also the potential of an increased take a chance of infection with resistant viruses for those newborns infected while breastfed from mothers taking HAART[35]. This issue may become less problematic now since, based on a contempo pediatric study, WHO currently recommends to care for all young HIV infected children with protease inhibitors in example of recent exposure to NVP[36–37].
Several relevant questions remain to exist addressed. How will mixed feeding affect the postnatal transmission charge per unit, even if HAART is taken? If HAART does protect against transmission during mixed feeding, then could HAART be continued for longer periods (due east.g. up to ane yr) or during all the BF menses? It also remains to be seen whether sufficient levels of adherence to prophylactic HAART tin can be achieved to avoid emergence of drug-resistance, especially when HAART is given for a longer period.
At that place may be several alternatives to replacement feedings such as diluted, boiled cow'due south milk or heated expressed breast milk[38] that might be more easily implemented in remote places where provision of HAART or FF can exist problematic.
We conclude that BF when combined with maternal HAART can be associated with a minimal hazard of postnatal transmission, like to the FF one in our accomplice, and with HIV transmission rates as low every bit those in high-income countries. A key implication of this report is that women can be offered a choice in baby feeding options, both of which could be safe and effective, given regular postnatal follow-up and counseling. This information would be useful in guiding recommendations on the safest and all-time infant feeding modalities according to the dissimilar African contexts combined with the full spectrum of antiretroviral strategies, including Art for those in need.
Acknowledgments
We thank all families of children enrolled in the study. Nosotros appreciated the abiding collaboration of Ministry of health of Rwanda. Nosotros give thanks Joseph Viankandondera for his communication and for sharing with usa his valuable feel in PMTCT clinical trials in Rwanda. We also thank Tony Reid for reviewing the manuscript in detail.
Funding: This study was funded past the ministry building of foreign affairs of Grand-Duché of Luxembourg (Lux-Evolution, projects RWA 021, INT 107, INT108 ESTHER Phase 2 Grand duchy of luxembourg)
Footnotes
Contributed by
Contributors: Cécile Alexandra Peltier (CAP), Gilles François Ndayisaba (GFN), Philippe Lepage (PL), Johan van Griensven (JvG), Valériane Leroy (VL), Christine Omes (CO), Patrick Cyaga Ndimubanzi (PCN), Olivier Courteille (OC), Vic Arendt (VA).
Contributed by
Role of contributors: VA, CO and CAP designed and conceived the written report; GFN, PCN, OC, CO and CAP implemented the report. JvG and GFN analyzed the data; VL, PL, CAP, JvG wrote the paper, OC coordinated laboratory collection and quality of analysis, PCN and GFN coordinated information drove and conceived the database, VL, PL and VA too checked the methodology and results of statistical assay. All authors read and approved the final version of the report.
Conflict of involvement: None
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