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Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum.

ABSTRACT: BACKGROUND:Concentrations of antiretrovirals in the genital tract play a key role in preexposure prophylaxis. This study aims to describe rilpivirine (Edurant) concentrations in the genital tract in pregnant and postpartum women. METHODS:International Maternal Pediatric Adolescent AIDS Clinical Trials Protocol P1026s is an ongoing, prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women that include a cohort receiving rilpivirine combination regimen. Intensive pharmacokinetics evaluations were performed at steady state during the second and third trimester, and postpartum. Plasma and directly aspirated cervicovaginal fluid (CVF) samples were collected at 4 time points around an observed dose and measured using high-performance liquid chromatography with ultraviolet detection, [plasma; lower limit of quantification (LLQ) = 10 ng/mL] or liquid chromatography-tandem mass spectrometry (CVF; LLQ = 1 ng/mL). RESULTS:A total of 24 women were included in the analysis. For all time points combined, median (interquartile range) rilpivirine concentrations were 70 ng/mL (23-121) in CVF and 92 ng/mL (49-147) in plasma. The CVF to plasma AUC(0-4) ratios were significantly higher in the second (0.90, 90% CI: 0.61 to 1.46) and third trimesters of pregnancy compared with postpartum (0.40, 90% CI: 0.19 to 0.87). Three of 189 (1.6%) plasma samples in 2 women were below the LLQ and the corresponding CVF concentrations. Seventeen additional CVF concentrations (10.6%) were below LLQ in 13 participants. No major safety concerns were noted. CONCLUSIONS:Rilpivirine concentrations were higher in the CVF during pregnancy compared with postpartum. CVF Rilpivirine is likely to achieve inhibitory concentrations effective for preventing peripartum HIV transmission.

SUBMITTER: Eke AC

PROVIDER: S-EPMC6002878 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum.

Eke Ahizechukwu C AC Chakhtoura Nahida N Kashuba Angela A Best Brookie M BM Sykes Craig C Wang Jiajia J Stek Alice M AM Smith Elizabeth E Calabrese Samantha S Capparelli Edmund V EV Mirochnick Mark M

Journal of acquired immune deficiency syndromes (1999) 20180701 3

<h4>Background</h4>Concentrations of antiretrovirals in the genital tract play a key role in preexposure prophylaxis. This study aims to describe rilpivirine (Edurant) concentrations in the genital tract in pregnant and postpartum women.<h4>Methods</h4>International Maternal Pediatric Adolescent AIDS Clinical Trials Protocol P1026s is an ongoing, prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women that include a cohort receiving rilpivirine combination regimen. In ...[more]

PMID: 29528944

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Project description:IntroductionViolence against women is a public health problem that poses serious consequences for victims and their environments. The healthcare system struggles to assess this phenomenon during prenatal and postpartum care because of pregnant and postpartum women's potential vulnerabilities. The research protocol presents the aims to evaluate the prevalence of violence, the period(s) in which it occurs, aggressors and forms it takes as well as to explore how violence against women is perceived among pregnant and postpartum women.Methods and analysisThis mixed methods study protocol uses an explanatory sequential design and is based on the establishment of meta-inferences that result from the combination of quantitative and qualitative approaches. Probabilistic sampling will be used to select the study participants: 584 women attending prenatal and/or postpartum care outpatient services at the University of Campinas Women's Hospital, Brazil. The quantitative approach will consist of four validated questionnaires, and the qualitative approach will use focus groups that serve to deepen the understanding of participants' views about the study topic. To create the focus groups, 72 study participants will be invited and divided into 6 groups (3 adolescents and 3 adults) based on age and pregnancy/postpartum condition. Descriptive analysis of sociodemographic characteristics and questionnaire results will be used to identify the prevalence and forms of violence experienced by women during the pregnancy-puerperal cycle, the relationships between women and their aggressors, and the existence of a history of violence. A bivariate and multivariate analysis will be performed to identify the association between sociodemographic factors and violence as an outcome. Qualitative data will be analysed through Grounded Theory to understand women's perceptions of the phenomenon studied.Ethics and disseminationThe research protocol was approved by the Research Ethics Committee of the University of Campinas, Brazil number CAAE: 13426819.1.0000.5404. The results will be disseminated to the health science community.

Dataset Information

Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum.

Publications

Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum.

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