Elise Arrivé

University of Bordeaux, Burdeos, Aquitaine, France

Are you Elise Arrivé?

Claim your profile

Publications (31)108.81 Total impact

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background Worldwide, female sex workers (FSW) represent a vulnerable population for oral diseases due to many risk factors including HIV infection and drug abuse. In sub-Saharan Africa, little is known about the burden of oral diseases and their determinants in vulnerable populations. The aim of the study was to estimate the prevalence and associated factors of oral diseases among FSW. Methods A cross sectional study was conducted among FSW who attended a dedicated non-profit clinic in Abidjan, Côte d’Ivoire from June to August 2013. Data about the presence of dental caries, periodontitis and oral-mucosal lesions were collected by a dentist during an oral examination. Behavioural information related to oral hygiene habits as well as tobacco and alcohol consumption were collected through a standardized questionnaire. Information related to HIV infection including HIV diagnosis, last known CD4 count and antiretroviral therapy were documented through a medical chart review. Logistic regression models were used to identify factors associated with oral diseases. Results A total of 249 FSW with a median age of 29 years, [Inter Quartile Range (IQR) = 23–36] and a median duration of sex work of 24 months [IQR 9–60]) were included. Current tobacco use and hazardous alcohol use were reported in 21.7 % and 19.7 % of FSW, respectively. The estimated prevalence of HIV infection was 33.7 % [95 % confidence interval (CI); 27.8 – 39.6]) and 82.1 % of HIV-infected FSW were on antiretroviral therapy . The prevalence of dental caries, periodontitis and oral-mucosal lesions were 62.3 % [95 % CI 55.5 – 67.5], 14.5 % [95 % CI 10.2 – 18.9] and 8.2 % [95 % CI 4.8 – 11.5], respectively. In multivariate analysis, periodontitis, oral-mucosal lesions and HIV infection were associated with odds ratio of 2.6 [95 % CI, 1.2–5.8]) and 50.0 [95 % CI; 6.4–384.6]. Conclusions This study showed a high prevalence of oral diseases among FSW in Abidjan. HIV infection was common and significantly associated with periodontal diseases and oral-mucosal lesions. There is a need to integrate regular screening and treatment of oral lesions into the medical follow-up of FSW along with strategies for HIV prevention. Electronic supplementary material The online version of this article (doi:10.1186/s12903-015-0129-0) contains supplementary material, which is available to authorized users.
    Full-text · Article · Dec 2015 · BMC Oral Health
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: SETTING: Drug resistance threatens tuberculosis (TB) control, particularly among human immunodeficiency virus (HIV) infected persons. OBJECTIVE: To describe practices in the prevention and management of drug-resistant TB under antiretroviral therapy (ART) programs in lower-income countries. DESIGN: We used online questionnaires to collect program-level data on 47 ART programs in Southern Africa (n=14), East Africa (n=8), West Africa (n=7), Central Africa (n=5), Latin America (n=7) and the Asia-Pacific (n=6 programs) in 2012. Patient-level data were collected on 1002 adult TB patients seen at 40 of the participating ART programs. RESULTS: Phenotypic drug susceptibility testing (DST) was available in 36 (77%) ART programs, but was only used for 22% of all TB patients. Molecular DST was available in 33 (70%) programs and was used in 23% of all TB patients. Twenty ART programs (43%) provided directly observed therapy (DOT) during the entire course of treatment, 16 (34%) during the intensive phase only, and 11(23%) did not follow DOT. Fourteen (30%) ART programs reported no access to second-line anti-tuberculosis regimens; 18 (38%) reported TB drug shortages. CONCLUSIONS: Capacity to diagnose and treat drug-resistant TB was limited across ART programs in lower-income countries. DOT was not always implemented and drug supplies were regularly interrupted, which may contribute to the global emergence of drug resistance.
    Full-text · Article · Nov 2014 · The International Journal of Tuberculosis and Lung Disease
  • [Show abstract] [Hide abstract]
    ABSTRACT: Aims: The aims were to describe emtricitabine (FTC) pharmacokinetics in a large population of pregnant women during the different trimesters of pregnancy, and to explain FTC pharmacokinetic variability during pregnancy. Methods: FTC plasma concentrations were measured in 103 non-pregnant and 83 pregnant women, including women in the different trimesters of pregnancy and on the day of delivery. A total of 457 plasma concentrations were available for analysis. A population pharmacokinetic model was developed with Monolix 4.1.3. Results: FTC pharmacokinetics was best described by a two compartment model. The effect of creatinine clearance on apparent elimination clearance (CL/F) was significant. CL/F in pregnant women was significantly higher compared with non-pregnant women (geometric mean 24.1 vs 20.5 l h(-1) , P < 0.001), reflecting a modified renal function. FTC daily exposures (AUC) during pregnancy were lower than AUC in non-pregnant women, regardless of the trimester of pregnancy. FTC AUC geometric means were 8.38 mg l(-1 ) h in the second trimester of pregnancy, 8.16 mg l(-1 ) h in the third trimester of pregnancy, 8.30 mg l(-1 ) h on the day of delivery and 9.77 mg l(-1 ) h in non-pregnant women. FTC concentrations 24 h after administration were lower in pregnant women compared with non-pregnant women (0.054 vs. 0.079 mg l(-1) , P < 0.001) but still above the inhibitory concentration 50%. Conclusions: FTC CL/F was increased by 18% during pregnancy, reflecting a modified renal function with 50% increase in estimated glomerular filtration rate. However, the impact of this modified renal function on FTC pharmacokinetics was not sufficiently large to consider dose adjustments during pregnancy.
    No preview · Article · Jul 2014 · British Journal of Clinical Pharmacology
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: We describe the association between age at antiretroviral therapy (ART) initiation and 24-month CD4 cell response in West African HIV-infected children. All HIV-infected children from the IeDEA paediatric West African cohort, initiating ART, with at least two CD4 cell count measurements, including one at ART initiation (baseline) were included. CD4 cell gain on ART was estimated using a multivariable linear mixed model adjusted for baseline variables: age, CD4 cell count, sex, first-line ART regimen. Kaplan-Meier survival curves and a Cox proportional hazards regression model compared immune recovery for age within 24 months post-ART. Of the 4808 children initiated on ART, 3014 were enrolled at a median age of 5.6 years; 61.2% were immunodeficient. After 12 months, children at least 4 years at baseline had significantly lower CD4 cell gains compared with children less than 2 years, the reference group (P < 0.001). However, by 24 months, we observed higher CD4 cell gain in children who initiated ART between 3 and 4 years compared with those less than 2 years (P < 0.001). The 24-month CD4 cell gain was also strongest in immunodeficient children at baseline. Among these children, 75% reached immune recovery: 12-month rates were significantly highest in all those aged 2-5 years at ART initiation compared with those less than 2 years. Beyond 12 months on ART, immune recovery was significantly lower in children initiated more than 5 years (adjusted hazard ratio: 0.69, 95% confidence interval: 0.56-0.86). These results suggest that both the initiation of ART at the earliest age less than 5 years and before any severe immunodeficiency is needed for improving 24-month immune recovery on ART.
    Full-text · Article · May 2014 · AIDS (London, England)
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To estimate the prevalence of oral mucosal diseases and dental caries among HIV-infected children receiving antiretroviral treatment (ART) in West Africa and to identify the factors associated with the prevalence of oral mucosal lesions. Multicentre cross-sectional survey in five paediatric HIV clinics in Côte d'Ivoire, Mali and Sénégal. A standardised examination was performed by trained dentists on a random sample of HIV-infected children aged 5-15 years receiving ART. The prevalence of oral and dental lesions and mean number of decayed, missing/extracted and filled teeth (DMFdefT) in temporary and permanent dentition were estimated with their 95% confidence interval (95% CI). We used logistic regression to explore the association between children's characteristics and the prevalence of oral mucosal lesions, expressed as prevalence odds ratio (POR). The median age of the 420 children (47% females) enrolled was 10.4 years [interquartile range (IQR) = 8.3-12.6]. The median duration on ART was 4.6 years (IQR = 2.6-6.2); 84 (20.0%) had CD4 count<350 cells/mm(3) . A total of 35 children (8.3%; 95% CI: 6.1-11.1) exhibited 42 oral mucosal lesions (24 were candidiasis); 86.0% (95% CI = 82.6-89.3) of children had DMFdefT ≥ 1. The presence of oral mucosal lesions was independently associated with CD4 count < 350 cells/mm(3) (POR = 2.96, 95% CI = 1.06-4.36) and poor oral hygiene (POR = 2.69, 95% CI = 1.07-6.76). Oral mucosal lesions still occur in HIV-infected African children despite ART, but rarely. However, dental caries were common and severe in this population, reflecting the need to include oral health in the comprehensive care of HIV.
    Full-text · Article · Jan 2014 · Tropical Medicine & International Health
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA.Methods/design: The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group.The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the Geriatric Oral Health Assessment Index) will also be compared between the two groups. Evidence-based management of potential aggravating factors in subjects with active RA could be of clinical importance, yet there are few randomized controlled trials on the effect of periodontal treatment on the clinical parameters of RA. The ESPERA trial is designed to determine if non-surgical periodontal treatment could improve clinical outcomes in patients with active RA, and the quality of life of these patients.Trial registration: The ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06.
    Full-text · Article · Aug 2013 · Trials
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Introduction We studied the frequency of documentation of disclosure of HIV status in medical charts and its correlates among HIV-infected adolescents in 2009, in Abidjan, Côte d'Ivoire. Methods The PRADO-CI is a cross-sectional study aimed at studying HIV-infected adolescents’ social, psychological, and behavioural difficulties and their determinants in Abidjan, Côte d'Ivoire. In this study, we present specific analyses on disclosure. All HIV-infected adolescents aged 13–21 years and followed at least once in 2009 in two urban HIV-care centres in Abidjan (Cepref and Yopougon Teaching Hospital) were enrolled in the study. Standardized data were extracted from medical records to document if there was notification of disclosure of HIV status in the medical record. Frequency of notification of HIV disclosure was estimated with its 95% confidence interval (CI) and correlates were analyzed using logistic regression. Results In 2009, 229 adolescents were included: 126 (55%) males; 93% on antiretroviral therapy (ART), 61% on cotrimoxazole prophylaxis. Their median age was 15 years at the time of the study. Among the 193 patients for whom information on HIV status disclosure was documented (84%), only 63 (32.6%; 95% CI=26.0–39.3%) were informed of their status. The proportion of adolescents informed increased significantly with age: 19% for 13–15 years, 33% for 16–18 years and 86% for 19–21 years (p <0.0001). Adolescents on ART tended to be more likely to be informed of their HIV status (34.5%) than those not treated (13.3%) (p=0.11). Those on cotrimoxazole were significantly more likely to be informed (39.6%) than those not (21.9%) (p=0.01). Disclosure was significantly higher in adolescents with a history of ART regimen change (p=0.003) and in those followed in the Cepref (48.4%) compared to the Yopougon Teaching Hospital (24.8%), (p=0.001). In multivariate analyses, disclosed HIV status was significantly higher in those followed-up in the Cepref compared to the other centre: adjusted odds ratio (aOR)=3.5 (95% CI: 1.1–10.9), and among older adolescents compared to those aged 13–15 years: [16–18 years] aOR=4.2 (95% CI: 1.5–11.5) and [>18 years]: aOR=22.1 (95% CI: 5.2–93.5). Conclusions HIV disclosure rate was low among Ivoirian HIV adolescents and was site- and age-dependent. There is a need for practical interventions to support HIV disclosure to adolescents which provides age-appropriate information about the disease.
    Full-text · Article · Jun 2013 · Journal of the International AIDS Society
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: We assessed the effect of HIV status disclosure on retention in care from initiation of antiretroviral therapy (ART) among HIV-infected children aged 10 years or more in Cote d'Ivoire, Mali and Sénégal. Multi-centre cohort study within five paediatric clinics participating in the IeDEA West Africa collaboration. HIV-infected patients were included in this study if they met the following inclusion criteria: aged 10-21 years while on ART; having initiated ART ≥ 200 days before the closure date of the clinic database; followed ≥ 15 days from ART initiation in clinics with ≥ 10 adolescents enrolled. Routine follow-up data were merged with those collected through a standardized ad hoc questionnaire on awareness of HIV status. Probability of retention (no death or loss-to-follow-up) was estimated with Kaplan-Meier method. Cox proportional hazard model with date of ART initiation as origin and a delayed entry at date of 10th birthday was used to identify factors associated with death or loss-to-follow-up. 650 adolescents were available for this analysis. Characteristics at ART initiation were: median age of 10.4 years; median CD4 count of 224 cells/mm³ (47% with severe immunosuppression), 48% CDC stage C/WHO stage 3/4. The median follow-up on ART after the age of 10 was 23.3 months; 187 adolescents (28.8%) knew their HIV status. The overall probability of retention at 36 months after ART initiation was 74.6% (95% confidence interval [CI]: 70.5-79.0) and was higher for those disclosed compared to those not: adjusted hazard ratio for the risk of being death or loss-to-follow-up = 0.23 (95% CI: 0.13-0.39). About 2/3 of HIV-infected adolescents on ART were not aware of their HIV status in these ART clinics in West Africa but disclosed HIV status improved retention in care. The disclosure process should be thus systematically encouraged and organized in adolescent populations.
    Full-text · Article · Mar 2012 · PLoS ONE
  • [Show abstract] [Hide abstract]
    ABSTRACT: Oral condition could be associated with cognitive impairment, but this is not yet well documented. We therefore hypothesized that people with poor oral condition would be more at risk to develop dementia. The objective of this study thus was to describe the oral condition of French community-dwelling elderly persons and to assess its relationship with the occurrence of dementia. Oral examination was conducted on a sample of individuals aged 66-80 years followed-up prospectively for screening of dementia over 15 years in Gironde, France. Univariate and multivariate analyses of the risk of dementia were performed using a Cox proportional hazard model with delayed entry. Data from 405 individuals were analyzed; 45.4% men; median age at baseline: 70 years [interquartile range (IQR): 68-75]. The median number of decayed, missing, and filled teeth was 18 (IQR: 13-24) and was higher in women (median: 20 versus 17, P = 0.004) and in persons with lower school level (median: 21 versus 17, P = 0.003). Among 348 persons with sextant eligible for periodontal assessment, 2/3 required periodontal care: 5.2% had bleeding observed, 44.8% calculus, 17.8% 4-5 mm pockets, and 2.9%≥ 6 mm pockets. The incidence of dementia during a median follow-up of 10 years (IQR: 6.5-13.7) was 19 per 1000 person-years. The adjusted hazard ratio for a number of missing teeth ≥ 11 (median) on the risk of dementia was 1.13 (95% confidence interval, CI = [0.60-2.12]) in people with higher education (n = 312) and 0.30 (CI = 0.11-0.79) in persons with lower school level (n = 93) (P for modification effect = 0.0002). Having eleven or more missing teeth seemed to be associated with a lower risk of dementia in people with lower education possibly owing to the suppression of source of chronic inflammation.
    No preview · Article · Nov 2011 · Community Dentistry And Oral Epidemiology
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background With 2.1 million HIV-infected children in 2008 in the world, especially in sub-Saharan Africa, the paediatric HIV/AIDS care remains an important public health challenge and is principally based on cotrimoxazole prophylaxis and antiretroviral treatments. This paper aims to review the effectiveness of cotrimoxole prophylaxis and antiretroviral treatment in HIV-infected children in Africa, specifically mortality and treatment outcomes. Methods In two times, we searched the online databases PubMed™ and Scopus™ for articles and abstracts published in English and French between January 2004 and November 2009, with the following terms : « HIV » and « Africa » and [“paediatric” or “children” or “child”] and [“mortality” or “survival”] and [“cotrimoxazole” or “prophylaxis”] at the first time, « HIV » and « Africa » and [“paediatric” or “children” or “child”] and [“mortality” or “survival”] and [“antiretroviral”] and [“treatment” or “therapy”] at the second time. Longitudinal studies on HIV-infected children under cotrimoxazole prophylaxis or antiretroviral treatment were selected when survival outcomes were reported. Results The probability of death was significantly reduced by 43% where children received cotrimoxazole prophylaxis compared to placebo. Compared to the survival without treatment, the benefit of antiretroviral therapy on HIV-infected children survival was evident in all publications but early mortality was observed within the six first months of antiretroviral treatment. Over fifty percent of deaths occurred in this period. Severe malnutrition, anaemia and lower CD4% were identified as mortality predicting factors in both children received cotrimoxazole prophylaxis or treated by antiretroviral therapy. Discussion Better knowledge of determinants of early mortality for these children are important to optimized their survival and improve their quality of care and life. Finally, the beneficial effect of cotrimoxazole prophylaxis when associated with antiretroviral treatment has not been reported and need to be exploring in detail for more information.
    Full-text · Article · Jul 2011 · La Presse Médicale
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Our objective was to investigate neonatal emtricitabine (FTC) plasma and intracellular pharmacokinetics. The study was designed as a phase I/II prospective trial in two sequential steps evaluating the combination of tenofovir disoproxil fumarate (TDF) and FTC for the prevention of mother-to-child-transmission (PMTCT) of HIV. HIV-1-infected pregnant women received two tablets of TDF (300 mg) and FTC (200 mg) at onset of labor and then one tablet daily for 7 days postpartum. Based on the data obtained in the first part of the Tenofovir/Emtricitabine in Africa and Asia (TEmAA) Study, single doses of 2 mg/kg of FTC and 13 mg/kg of TDF were given to the neonates within 12 h after birth. A total of 540 FTC plasma concentrations and 44 active intracellular phosphorylated metabolite FTC-TP concentrations were taken from the 36 enrolled women and their neonates. Concentrations were measured by the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and analyzed by a population approach. The proposed dose obtained by simulations based on plasma drug concentrations was confirmed. However, median FTC-TP exposures were, respectively, 5.9 and 6.8 times higher in the fetus and the neonate than in the adult. High FTC-TP concentrations were observed in the four children who had serious adverse events (SAEs), but the link between FTC-TP concentrations and SAEs in children was not formally identified. The exposure to the active form of FTC was high in neonates despite plasma drug concentrations equivalent to those in adults. Our results are similar to those obtained with zidovudine or lamivudine.
    Full-text · Article · Apr 2011 · Antimicrobial Agents and Chemotherapy
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The objective of this study was to investigate for the first time tenofovir (TFV) pharmacokinetics in plasma and peripheral blood mononuclear cells (PBMCs) of the neonate. HIV-1-infected pregnant women received two tablets of tenofovir disoproxil fumarate (TDF; 300 mg) and emtricitabine (FTC; 200 mg) at onset of labor and then one tablet daily for 7 days postpartum. A single dose of 13 mg/kg of body weight of TDF was administered to 36 neonates within 12 h of life after the HIV-1-infected mothers had been administered two tablets of TDF-emtricitabine at delivery. A total of 626 samples collected within the 2 days after the drug administration were measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and analyzed by a population approach. In the neonate, the median TFV plasma area under the curve and minimal and maximal concentrations, respectively, were 3.73 mg/liter · h and 0.076 and 0.29 mg/liter. In PBMCs, TFV concentrations were detectable in all fetuses, whereas tenofovir diphosphate (TFV-DP) was quantifiable in only two fetuses, suggesting a lag in appearance of TFV-DP. The median TFV-DP neonatal concentration was 146 fmol/10⁶ cells (interquartile range [IQR], 53 to 430 fmol/10⁶ cells); two neonates had very high TFV-DP concentrations (1,530 and 2963 fmol/10⁶ cells). The 13-mg/kg TDF dose given to neonates produced plasma TFV and intracellular active TFV-DP concentrations similar to those in adults. This dose should be given immediately after birth to reduce the delay before the active compound TFV-DP appears in cells.
    Full-text · Article · Apr 2011 · Antimicrobial Agents and Chemotherapy
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: With 2.1 million HIV-infected children in 2008 in the world, especially in sub-Saharan Africa, the paediatric HIV/AIDS care remains an important public health challenge and is principally based on cotrimoxazole prophylaxis and antiretroviral treatments. This paper aims to review the effectiveness of cotrimoxole prophylaxis and antiretroviral treatment in HIV-infected children in Africa, specifically mortality and treatment outcomes. In two times, we searched the online databases PubMed™ and Scopus™ for articles and abstracts published in English and French between January 2004 and November 2009, with the following terms : « HIV » and « Africa » and ["paediatric" or "children" or "child"] and ["mortality" or "survival"] and ["cotrimoxazole" or "prophylaxis"] at the first time, « HIV » and « Africa » and ["paediatric" or "children" or "child"] and ["mortality" or "survival"] and ["antiretroviral"] and ["treatment" or "therapy"] at the second time. Longitudinal studies on HIV-infected children under cotrimoxazole prophylaxis or antiretroviral treatment were selected when survival outcomes were reported. The probability of death was significantly reduced by 43% where children received cotrimoxazole prophylaxis compared to placebo. Compared to the survival without treatment, the benefit of antiretroviral therapy on HIV-infected children survival was evident in all publications but early mortality was observed within the six first months of antiretroviral treatment. Over fifty percent of deaths occurred in this period. Severe malnutrition, anaemia and lower CD4% were identified as mortality predicting factors in both children received cotrimoxazole prophylaxis or treated by antiretroviral therapy. Better knowledge of determinants of early mortality for these children are important to optimized their survival and improve their quality of care and life. Finally, the beneficial effect of cotrimoxazole prophylaxis when associated with antiretroviral treatment has not been reported and need to be exploring in detail for more information.
    Full-text · Article · Feb 2011 · La Presse Médicale
  • Elise Arrivé

    No preview · Article · Jan 2011
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The aim was to evaluate emtricitabine (FTC) and tenofovir (TFV) neonatal ingestion through breast milk. Median TFV and FTC breast milk doses represented 0.03% and 2%, respectively, of the proposed oral infant doses. Neonatal simulated plasma concentrations were extremely low for TFV but between the half-maximal inhibitory concentration and the adult minimal expected concentration for FTC. The rare children who will acquire HIV despite TDF-FTC therapy will need to be monitored for viral resistance acquisition.
    Full-text · Article · Dec 2010 · Antimicrobial Agents and Chemotherapy
  • [Show abstract] [Hide abstract]
    ABSTRACT: OBJECTIVE: Viral resistance occurs with a high frequency after single-dose nevirapine. We aimed to evaluate the tolerance and resistance profiles of a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) given to HIV-1-infected delivering women and their newborns. DESIGN: An open-label phase I/II trial in Cambodia, Cote d'Ivoire and South Africa. METHODS: HIV-1-infected pregnant women received zidovudine from the enrollment until the beginning of labor, when single-dose nevirapine and two tablets of TDF/FTC were given. One daily tablet of TDF/FTC was then administered for 7 days postpartum. All infants received single-dose nevirapine with single-dose TDF (13 mg/kg) and single-dose FTC (2 mg/kg) and 1 week of zidovudine. Mothers and infants were followed for 2 months. Serious adverse events, kinetic of maternal plasma HIV-1 RNA, pediatric HIV infection and genotypic resistance and viral subtype were assessed. RESULTS: Thirty-six HIV-1-infected pregnant women were enrolled: median age 28 years (interquartile range: 26-31 years), median CD4 cell count 462 cells/mul (interquartile range: 376-632) and median HIV-1 RNA 3.7 log10 copies/ml (interquartile range: 2.95-4.11). Two infants had clinical serious adverse events, including one who died (neonatal sepsis). One transient grade 3 neutropenia and two grade 3/4 hyperbilirubinemia were also reported in neonates. One HIV pediatric in-utero infection was diagnosed (2.8%; 95% confidence interval 0-15.4%). Genotypic viral resistance to nevirapine was detected in one mother out of 34 (2.9%) at one month postpartum, but was also detectable at enrollment. CONCLUSION: The combination of TDF/FTC to delivering women and their neonates appears well tolerated and to minimize the occurrence of nevirapine viral resistance.
    No preview · Article · Oct 2010 · AIDS (London, England)
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The aim of the present study was to describe the nevirapine (NVP) pharmacokinetics (PK) in pregnant women and their neonates and to evaluate the transplacental drug transfer and administration scheme for the prevention of mother-to-child transmission. Thirty-eight HIV-1-infected pregnant women were administered one tablet of NVP (200 mg) and two tablets of tenofovir-emtricitabine (Truvada) at the initiation of labor. Children were given NVP syrup (2 mg/kg of body weight) as a single dose (sdNVP) on the first day of life. By pair, NVP concentrations were measured in 11 maternal, 1 cord blood, and 2 neonatal plasma samples and analyzed by a population approach. A one-compartment model was used for mothers and neonates; the absorption rate constants for mothers and neonates were 0.95 h(-1) (intersubject variability, 111%) and 0.39 h(-1), respectively; the apparent elimination clearances were 1.42 liter·h(-1) (intersubject variability, 22%) and 0.035 liter·h(-1), respectively; and apparent volumes of distribution were 87.3 liters (intersubject variability, 25%) and 5.65 liters, respectively. An effect compartment was linked to maternal circulation by mother-to-cord and cord-to-mother rate constants of 1.10 h(-1) and 1.43 h(-1), respectively. Placental transfer, expressed as the fetal-to-maternal area under the curve ratio, was 75%. Neonates had a very long half-lives (110 h) compared to adults. In the 38 mothers, the simulated median individual predicted time during which the NVP concentration remained above the half-maximal inhibitory concentration (IC(50)) was 13.2 days (range, 12 to 19.2 days). Thus, the administration of tenofovir-emtricitabine for at least 3 weeks after delivery should be considered to prevent the emergence of resistant viruses. The neonate must receive sdNVP immediately after birth when the infant is born less than 30 min after maternal drug intake to keep NVP concentrations above the IC(50).
    Full-text · Article · Oct 2010 · Antimicrobial Agents and Chemotherapy
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Prevention of mother-to-child transmission (MTCT) of human immunodeficiency virus type 1 (HIV-1) remains a challenge in most resource-limited settings, particularly in Africa. Single-dose and short-course antiretroviral (ARV) regimens are only partially effective and have failed to achieve wide coverage despite their apparent simplicity. More potent ARV combinations are restricted to pregnant women who need treatment for themselves and are also infrequently used. Furthermore, postnatal transmission via breast-feeding is a serious additional threat. Modifications of infant feeding practices aim to reduce HIV-1 transmission through breast milk; replacement feeding is neither affordable nor safe for the majority of African women, and early breast-feeding cessation (eg, prior to 6 months of life) requires substantial care and nutritional counseling to be practiced safely. The recent roll out of ARV treatment has changed the paradigm of prevention of MTCT. To date, postnatal ARV interventions that have been evaluated target either maternal ARV treatment to selected breast-feeding women, with good efficacy, or single-drug postexposure prophylaxis for short periods of time to their neonates, with a partial efficacy and at the expense of acquisition of drug-related viral resistance. We hypothesize that a viable solution to eliminate pediatric AIDS lies in the universal provision of fully suppressive ARV regimens to all HIV-1-infected women through pregnancy, delivery, and the entire breast-feeding period. On the basis of available evidence, we suggest translating into practice the recently available evidence on this matter without any further delay.
    Full-text · Article · Nov 2009 · Clinical Infectious Diseases
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis. The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups. The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies. Current Controlled Trials ISRCTN15334496.
    Full-text · Article · Sep 2009 · Trials
  • [Show abstract] [Hide abstract]
    ABSTRACT: OBJECTIVE: Viral resistance occurs with high frequency after single-dose nevirapine. We aimed to evaluate the safety and resistance profiles of a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) in HIV-1-infected pregnant women and their newborns. DESIGN: An open-label phase I/II trial in Cote d'Ivoire, Cambodia and South Africa. METHODS: Women received antenatal zidovudine, intrapartum single-dose nevirapine and two tablets of TDF/FTC and one daily tablet of TDF/FTC during the 7 days postpartum. Their infants received single-dose nevirapine and zidovudine for 1 week. Serious adverse events (SAEs), kinetic of maternal plasma HIV-1 RNA viral load, genotypic resistance at 28 days postpartum and paediatric HIV-1 infection at 3, 28 and 45 days of life were assessed. RESULTS: Thirty-eight HIV-1-infected pregnant women were enrolled (19 in Abidjan, 12 in Phnom Penh and seven in Soweto) with a median CD4 cell count of 450 cells/microl and median viral load of 4.08 log10 copies/ml. Women received TDF/FTC 4.9 h in median before delivery. Biological SAEs occurred in nine women. Among 39 live births, nine infants had clinical SAEs, including four deaths, and two developed severe anaemia. These SAEs were not likely to be related to TDF/FTC. Maternal viral load decreased by a median of 0.90 log10 copies/ml at 2 days postpartum and returned to baseline value at 28 days. No intrapartum HIV transmission was reported. No genotypic resistance mutation to zidovudine, nevirapine, FTC or TDF was detected. CONCLUSION: The TDF/FTC combination was well tolerated in delivering women and exposed newborns. Nevirapine viral resistance appears to have been avoided by the intrapartum and 7-day postpartum TDF/FTC regimen.
    No preview · Article · Apr 2009 · AIDS (London, England)