Stopping the control arm in response to the DSMB: mother's choice of HIV prophylaxis during breastfeeding in the BAN Study.
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ABSTRACT:
SUBMITTER: Chavula C
PROVIDER: S-EPMC3253884 | biostudies-literature | 2012 Jan
REPOSITORIES: biostudies-literature
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Stopping the control arm in response to the DSMB: mother's choice of HIV prophylaxis during breastfeeding in the BAN Study.
Chavula Charity C Long Dustin D Mzembe Enalla E Kayira Dumbani D Chasela Charles C Hudgens Michael G MG Hosseinipour Mina M King Caroline C CC Ellington Sascha S Chigwenembe Margret M Jamieson Denise J DJ van der Horst Charles C
Contemporary clinical trials 20111025 1
The Data and Safety Monitoring Board (DSMB) for the Breastfeeding, Antiretrovirals, and Nutrition study, a clinical trial aimed to prevent postnatal HIV transmission, recommended halting randomization to the enhanced standard-of-care (control) arm. The 67 mother-infant pairs on the control arm and less than 21 weeks postpartum at the time of the DSMB recommendation were read a script informing them of the DSMB decision and offering them the maternal or infant antiretroviral interventions for the ...[more]
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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.
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Project description:IntroductionAntiretroviral pre-exposure prophylaxis (PrEP) for the prevention of HIV acquisition is cost-effective when delivered to those at substantial risk. Despite a high incidence of HIV infection among pregnant and breastfeeding women in sub-Saharan Africa (SSA), a theoretical increased risk of preterm birth on PrEP could outweigh the HIV prevention benefit.MethodsWe developed a decision analytic model to evaluate a strategy of daily oral PrEP during pregnancy and breastfeeding in SSA. We approached the analysis from a health care system perspective across a lifetime time horizon. Model inputs were derived from existing literature and local sources. The incremental cost-effectiveness ratio (ICER) of PrEP versus no PrEP was calculated in 2015 U.S. dollars per disability-adjusted life year (DALY) averted. We evaluated the effect of uncertainty in baseline estimates through one-way and probabilistic sensitivity analyses.ResultsPrEP administered to pregnant and breastfeeding women in SSA was cost-effective. In a base case of 10,000 women, the administration of PrEP averted 381 HIV infections but resulted in 779 more preterm births. PrEP was more costly per person ($450 versus $117), but resulted in fewer disability-adjusted life years (DALYs) (3.15 versus 3.49). The incremental cost-effectiveness ratio of $965/DALY averted was below the recommended regional threshold for cost-effectiveness of $6462/DALY. Probabilistic sensitivity analyses demonstrated robustness of the model.ConclusionsProviding PrEP to pregnant and breastfeeding women in SSA is likely cost-effective, although more data are needed about adherence and safety. For populations at high risk of HIV acquisition, PrEP may be considered as part of a broader combination HIV prevention strategy.
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Project description:BackgroundWe aimed to systematically review the health preference literature using discrete choice experiments (DCEs), an attribute-based stated preference method, to investigate patient preferences for HIV pre-exposure prophylaxis (PrEP).MethodsA search in PubMed, Scopus, CINAHL, and Embase was conducted on July 1, 2021, and updated on November 3, 2021. We used two concepts to create our search strategy: (1) discrete choice experiments/conjoint analysis/best-worst scaling, and (2) HIV PrEP.The study is registered in PROSPERO (CRD42021267026).FindingsIn total, 1060 studies were identified, and 18 were included in the analysis. Various attributes were examined, including dosing regimen, type of PrEP products, side effects, other side benefits, cost, effectiveness, dispensing venue, and additional support services. Dosing frequency, cost, the effectiveness of PrEP, dispensing venue, and side effects were the most common attributes examined in DCEs. Despite significant heterogeneity in preferences across subpopulations, overall, the most important attributes were cost (28%, 5/18), effectiveness (28%, 5/18) followed by dosing frequency (17%, 3/18).InterpretationNotably, in studies where all of these three attributes were examined, some individuals would trade effectiveness for cost or vice versa. Ensuring PrEP is low cost or free, widely disseminating information of its effectiveness and advancements in reducing dosing frequency could accelerate the uptake of PrEP for those who would benefit from PrEP the most.FundingNone.
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