Triple-Antiretroviral Prophylaxis to Prevent Mother-To-Child HIV
Transmission through Breastfeeding—The Kisumu Breastfeeding Study, Kenya:
A Clinical Trial
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/mm3 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.
Trial registration:
ClinicalTrials.gov NCT00146380
: Please see later in the article for the Editors' Summary
Vyšlo v časopise:
Triple-Antiretroviral Prophylaxis to Prevent Mother-To-Child HIV
Transmission through Breastfeeding—The Kisumu Breastfeeding Study, Kenya:
A Clinical Trial. PLoS Med 8(3): e32767. doi:10.1371/journal.pmed.1001015
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1001015
Souhrn
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/mm3 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.
Trial registration:
ClinicalTrials.gov NCT00146380
: Please see later in the article for the Editors' Summary
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