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[PMID]: 27774794 [Au] Autor: Seay JS; Mandigo M; Kish J; Menard J; Marsh S; Kobetz E [Ad] Endereço: a Miller School of Medicine , University of Miami , Miami , FL , USA. [Ti] Título: Intravaginal practices are associated with greater odds of high-risk HPV infection in Haitian women. [So] Source: Ethn Health;22(3):257-265, 2017 Jun. [Is] ISSN: 1465-3419 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: OBJECTIVE: Haitian women have the highest incidence of cervical cancer within the Western hemisphere. Intravaginal hygiene practices have been linked with human papilloma virus (HPV) infection and cervical dysplasia. These practices, known as 'twalet deba' in Haitian Creole, are common among Haitian women and are performed with various natural and synthetic agents. As part of a community-based participatory research initiative aimed at reducing cervical cancer disparities in rural Haiti, we explored the use of intravaginal agents and their associations with high-risk HPV infection. DESIGN: Community Health Workers recruited 416 women for cervical self-sampling from two neighborhoods within Thomonde, Haiti. Participants were interviewed regarding intravaginal hygiene practices and completed a cervical self-sampling procedure. Cervical samples were analyzed for the presence of high-risk HPV infection. Associations between each intravaginal agent and high-risk HPV infection were examined via univariate logistic regression analyses, as well as via multivariate analyses controlling for sociodemographic factors and concurrent agent use. RESULTS: Nearly all women (97.1%) performed twalet deba, using a variety of herbal and commercially produced intravaginal agents. Approximately 11% of the participants tested positive for high-risk HPV. Pigeon pea and lime juice were the only agents found to be associated with high-risk HPV in the univariate analyses, with women who used these agents being approximately twice as likely to have high-risk HPV as those who did not. Only pigeon pea remained significantly associated with high-risk HPV after controlling for sociodemographic factors and concurrent agent use. CONCLUSION: Two agents, pigeon pea and lime juice, may contribute to risk for HPV infection in this population. Results suggest that in addition to cervical cancer screening interventions, future preventive initiatives should focus on minimizing risk by advocating for the use of less-toxic twalet deba alternatives. [Mh] Termos MeSH primário: Conhecimentos, Atitudes e Prática em Saúde/etnologia Higiene Infecções por Papillomavirus/etnologia Ducha Vaginal/efeitos adversos [Mh] Termos MeSH secundário: Administração Intravaginal Adulto Compostos de Alúmen/administração & dosagem Cajanus Citrus aurantiifolia Pesquisa Participativa Baseada na Comunidade Feminino Sucos de Frutas e Vegetais Haiti/epidemiologia Seres Humanos Infecções por Papillomavirus/epidemiologia Infecções por Papillomavirus/virologia Preparações de Plantas/administração & dosagem Permanganato de Potássio/administração & dosagem Fatores de Risco Sabões/administração & dosagem Ducha Vaginal/métodos Saúde da Mulher/etnologia [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Alum Compounds); 0 (Plant Preparations); 0 (Soaps); 00OT1QX5U4 (Potassium Permanganate); 34S289N54E (aluminum sulfate) [Em] Mês de entrada: 1803 [Cu] Atualização por classe: 180301 [Lr] Data última revisão: 180301 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 161025 [St] Status: MEDLINE [do] DOI: 10.1080/13557858.2016.1246423

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[PMID]: 29260226 [Au] Autor: Saccone G; Maruotti GM; Giudicepietro A; Martinelli P; Italian Preterm Birth Prevention (IPP) Working Group [Ad] Endereço: Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy. [Ti] Título: Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial. [So] Source: JAMA;318(23):2317-2324, 2017 12 19. [Is] ISSN: 1538-3598 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: Importance: Spontaneous preterm birth is a major cause of perinatal morbidity and mortality. It is unclear if a cervical pessary can reduce the risk of spontaneous preterm delivery. Objective: To test whether in asymptomatic women with singleton pregnancies and no prior spontaneous preterm birth but with short cervical length on transvaginal ultrasound, use of a cervical pessary would reduce the rate of spontaneous preterm birth at less than 34 weeks of gestation. Design, Setting, and Participants: Parallel-group, nonblinded, randomized clinical trial conducted from March 1, 2016, to May 25, 2017, at a single center in Italy. Asymptomatic women with singleton gestations, no previous spontaneous preterm births, and cervical lengths of 25 mm or less at 18 weeks 0 days to 23 weeks 6 days of gestation were eligible. Interventions: Patients were randomized 1:1 to receive either cervical pessary (n = 150) or no pessary (n = 150). The pessary was removed between 37 weeks 0 days and 37 weeks 6 days of gestation or earlier if clinically indicated. The control group received standard care. For cervical length of 20 mm or shorter, women in both groups were prescribed vaginal progesterone, 200 mg/d, until 36 weeks 6 days of gestation. No bed rest or activity restriction was recommended. Main Outcomes and Measures: The primary end point was spontaneous preterm birth at less than 34 weeks of gestation. Secondary outcomes were adverse events. Results: Among 300 women who were randomized (mean age, 29 [SD, 6.3] years; mean gestational age, 22 [SD, 1.3] weeks), 100% completed the trial. The primary end point occurred in 11 women (7.3%) in the pessary group and 23 women (15.3%) in the control group (between-group difference, -8.0% [95% CI, -15.7% to -0.4]; relative risk, 0.48 [95% CI, 0.24-0.95]). During follow-up, the pessary group had a higher rate of increased or new vaginal discharge (86.7% vs 46.0%; between-group difference, +40.7% [95% CI, +30.1%-+50.3%]; relative risk, 1.88 [95% CI, 1.57-2.27]). Conclusions and Relevance: Among women without prior spontaneous preterm birth who had asymptomatic singleton pregnancies and short transvaginal cervical length, use of a cervical pessary, compared with no pessary use, resulted in a lower rate of spontaneous preterm birth at less than 34 weeks of gestation. The results of this single-center, nonblinded study among selected pregnant women require confirmation in multicenter clinical trials. Trial Registration: clinicaltrials.gov Identifier: NCT02716909. [Mh] Termos MeSH primário: Colo do Útero/anatomia & histologia Pessários Nascimento Prematuro/prevenção & controle [Mh] Termos MeSH secundário: Administração Intravaginal Adulto Medida do Comprimento Cervical Terapia Combinada Feminino Seres Humanos Estimativa de Kaplan-Meier Gravidez Progesterona/uso terapêutico Progestinas/uso terapêutico [Pt] Tipo de publicação: JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Progestins); 4G7DS2Q64Y (Progesterone) [Em] Mês de entrada: 1801 [Cu] Atualização por classe: 180228 [Lr] Data última revisão: 180228 [Sb] Subgrupo de revista: AIM; IM [Da] Data de entrada para processamento: 171221 [Cl] Clinical Trial: ClinicalTrial [St] Status: MEDLINE [do] DOI: 10.1001/jama.2017.18956

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[PMID]: 28746164 [Au] Autor: Husnik MJ; Brown ER; Marzinke M; Livant E; Palanee-Phillips T; Hendrix CW; Matovu Kiweewa F; Nair G; Soto-Torres LE; Schwartz K; Hillier SL; Baeten JM; MTN-020 ASPIRE Study Team [Ad] Endereço: *Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA; †University of Washington, Seattle, WA; ‡Johns Hopkins University School of Medicine, Baltimore, MD; §Magee-Womens Research Institute & Foundation, University of Pittsburgh Medical Center, Pittsburgh, PA; ‖Wits Reproductive Health and HIV Institute, University of Witwatersrand, Hillbrow Health Precinct, Johannesburg, South Africa; ¶Makerere University-John Hopkins University Research Collaboration, Kampala, Uganda; #Center for AIDS Programme of Research in South Africa, Durban, South Africa; **Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health Rockville, MD; ††FHI 360, Durham, NC; and ‡‡Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA. [Ti] Título: Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial. [So] Source: J Acquir Immune Defic Syndr;76(3):330-337, 2017 11 01. [Is] ISSN: 1944-7884 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: BACKGROUND: Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. METHODS: During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. RESULTS: An upward trend in adherence was observed (P < 0.0001); the proportion of samples from subjects in the active arm with dapivirine >95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. CONCLUSIONS: Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention. [Mh] Termos MeSH primário: Fármacos Anti-HIV/uso terapêutico Infecções por HIV/prevenção & controle HIV-1 Adesão à Medicação/estatística & dados numéricos Pirimidinas/uso terapêutico [Mh] Termos MeSH secundário: Administração Intravaginal Adulto Fármacos Anti-HIV/sangue Estudos de Viabilidade Feminino Seres Humanos Monitorização Fisiológica/métodos Profilaxia Pré-Exposição Pirimidinas/sangue Adulto Jovem [Pt] Tipo de publicação: CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (Pyrimidines); TCN4MG2VXS (Dapivirine) [Em] Mês de entrada: 1710 [Cu] Atualização por classe: 180223 [Lr] Data última revisão: 180223 [Sb] Subgrupo de revista: IM; X [Da] Data de entrada para processamento: 170727 [St] Status: MEDLINE [do] DOI: 10.1097/QAI.0000000000001503

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[PMID]: 29215514 [Au] Autor: Al-Ibraheemi Z; Brustman L; Bimson BE; Porat N; Rosenn B [Ad] Endereço: Department of Obstetrics and Gynecology, Mount Sinai West Hospital, New York, New York. [Ti] Título: Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial. [So] Source: Obstet Gynecol;131(1):23-29, 2018 Jan. [Is] ISSN: 1873-233X [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: OBJECTIVE: To test the hypothesis that cervical ripening using a combination of misoprostol and a transcervical Foley bulb leads to delivery within a shorter time compared with misoprostol alone. METHODS: This randomized controlled trial was offered to women admitted for cervical ripening. Inclusion criteria were gestational age 37 weeks or greater with intact membranes, singleton fetus, cephalic presentation, and Bishop score 6 or less. Exclusion criteria included, among others, prior uterine surgery, ruptured membranes, and any contraindication to vaginal delivery. Patients were randomized to cervical ripening using misoprostol and a transcervical Foley bulb simultaneously or misoprostol alone. Primary outcome was time from placement of the misoprostol to delivery. Secondary outcomes included time to active phase, time from active phase to delivery, cesarean delivery rate, uterine tachysystole, estimated blood loss, chorioamnionitis, cord pH, 5-minute Apgar score, and neonatal intensive care unit admission. Sample size calculation revealed that 94 participants were required in each group to detect a 3-hour difference with 80% power and α error of 0.05. Intention-to-treat analysis was performed. RESULTS: From September 2015 to July 2016, a total of 200 patients were randomized, 100 to each group. There were no differences between groups with respect to parity, body mass index, gestational age, Bishop score, birth weight, or indication for induction. Time to delivery was significantly shorter in the combined misoprostol-transcervical Foley group: 15.0 (11.0-21.8) hours (median [interquartile range]) vs 19.0 (14.0-27.3) hours in the misoprostol-only group (P=.001). This time difference remained significant after subanalysis by parity or after excluding cesarean deliveries. There was no difference between groups with respect to the rate or indication for cesarean delivery, estimated blood loss, rate of tachysystole, chorioamnionitis, or neonatal outcomes. CONCLUSION: Cervical ripening using misoprostol in combination with a transcervical Foley bulb is an effective method to shorten the course of labor compared with misoprostol alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02566005. [Mh] Termos MeSH primário: Maturidade Cervical/efeitos dos fármacos Misoprostol/administração & dosagem Ocitócicos/administração & dosagem Resultado da Gravidez Cateterismo Urinário [Mh] Termos MeSH secundário: Administração Intravaginal Adulto Terapia Combinada Feminino Idade Gestacional Seres Humanos Gravidez Estudos Prospectivos Medição de Risco Estatísticas não Paramétricas Adulto Jovem [Pt] Tipo de publicação: COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Oxytocics); 0E43V0BB57 (Misoprostol) [Em] Mês de entrada: 1801 [Cu] Atualização por classe: 180207 [Lr] Data última revisão: 180207 [Sb] Subgrupo de revista: AIM; IM [Da] Data de entrada para processamento: 171208 [Cl] Clinical Trial: ClinicalTrial [St] Status: MEDLINE [do] DOI: 10.1097/AOG.0000000000002403

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[PMID]: 29283540 [Au] Autor: Herring MS; Hodgden JD [Ti] Título: In non-pregnant patients over the age of 18 with symptomatic bacterial vaginosis, does the addition of oral or vaginal probiotics compared to standard antibiotic use alone, decrease time to recurrence? [So] Source: J Okla State Med Assoc;109(10):485-6, 2016 Oct. [Is] ISSN: 0030-1876 [Cp] País de publicação: United States [La] Idioma: eng [Mh] Termos MeSH primário: Antibacterianos/uso terapêutico Probióticos/administração & dosagem Vaginose Bacteriana/tratamento farmacológico [Mh] Termos MeSH secundário: Administração Intravaginal Administração Oral Quimioterapia Combinada Feminino Seres Humanos Probióticos/uso terapêutico Recidiva [Pt] Tipo de publicação: JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW [Nm] Nome de substância: 0 (Anti-Bacterial Agents) [Em] Mês de entrada: 1801 [Cu] Atualização por classe: 180123 [Lr] Data última revisão: 180123 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 171229 [St] Status: MEDLINE

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[PMID]: 27771115 [Au] Autor: Abel JM; Bishop BE; Thomas JM; Ellersieck MR; Poock SE; Smith MF; Patterson DJ [Ad] Endereço: Division of Animal Sciences, University of Missouri, Columbia, Missouri, USA; College of Veterinary Medicine, University of Missouri, Columbia, Missouri, USA. [Ti] Título: Comparing strategies to synchronize estrus before fixed-time artificial insemination in primiparous 2-year-old beef cows. [So] Source: Theriogenology;87:306-315, 2017 Jan 01. [Is] ISSN: 1879-3231 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: Two experiments evaluated controlled internal drug release (CIDR)-based protocols to synchronize estrus in primiparous 2-year-old beef cows. In each experiment, treatments were balanced according to body condition score and days postpartum. Experiment 1 compared the 14-day CIDR-PG (14-d) and 7-day CO-Synch + CIDR (7-d) protocols on the basis of estrous response, pregnancy rates after fixed-time artificial insemination (FTAI), and final pregnancy rate. Cows assigned to 14-d (n = 355) received a CIDR insert on Day 0 with removal on Day 14. Cows assigned to 7-d (n = 349) received gonadotropin releasing hormone (GnRH) and a CIDR insert on Day 23. On Day 30, CIDRs were removed from 7-d cows, and PGF was administered to all cows in each treatment. On Day 33, GnRH was administered concurrent with FTAI at 66 and 72 hours after PGF for 7-d and 14-d treated cows, respectively. Estrous response before FTAI was higher for 7-d compared with 14-d cows (74% vs. 43%, respectively; P < 0.0001); however, pregnancy rates resulting from FTAI were similar (14-d 63%; 7-d 64%; P = 0.52). Ovarian follicular dynamics and serum estradiol-17ß concentrations were evaluated among a subset of cows assigned to each protocol. Dominant follicle diameter was smaller at PGF (P = 0.04) and FTAI (P = 0.002) among 14-d cows compared with 7-d cows; however, estradiol-17ß at PGF (P = 0.06) and FTAI (P = 0.001) was greater for 14-d versus 7-d treated cows. Experiment 2 compared estrous response and pregnancy rates in 2-year-old beef cows after FTAI- or split-time artificial insemination (STAI) following synchronization of estrus with the 14-day protocol. Cows assigned to FTAI (n = 266) were inseminated at a fixed time concurrent with GnRH at 72 hours after PGF regardless of estrus expression, whereas cows assigned to STAI (n = 257) were inseminated based on estrus expression as determined by activation of an estrus detection aid. Cows assigned to STAI that exhibited estrus by 72 hours were inseminated; however, AI was delayed until 24 hours after GnRH (96 hours after PGF ) for nonestrous cows. Total estrous response was increased for STAI- versus FTAI-treated cows (STAI 64%; FTAI 42%; P < 0.0001); pregnancy rates resulting from AI were similar (STAI 55%; FTAI 56%; P = 0.60). In summary, the 14-day CIDR-PG and 7-day CO-Synch + CIDR protocols can be used effectively to synchronize estrus before FTAI in primiparous 2-year-old beef cows. Although expression of estrus was increased using STAI in conjunction with the 14-day protocol, this approach did not increase pregnancy rates compared with FTAI. [Mh] Termos MeSH primário: Bovinos Sincronização do Estro/métodos Inseminação Artificial/veterinária [Mh] Termos MeSH secundário: Administração Intravaginal Animais Dinoprosta/administração & dosagem Dinoprosta/farmacologia Esquema de Medicação Estradiol/sangue Feminino Folículo Ovariano/diagnóstico por imagem Folículo Ovariano/efeitos dos fármacos Paridade Gravidez Progesterona/administração & dosagem Progesterona/farmacologia [Pt] Tipo de publicação: JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 4G7DS2Q64Y (Progesterone); 4TI98Z838E (Estradiol); B7IN85G1HY (Dinoprost) [Em] Mês de entrada: 1704 [Cu] Atualização por classe: 171201 [Lr] Data última revisão: 171201 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 161025 [St] Status: MEDLINE

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[PMID]: 28068860 [Au] Autor: Sinkey RG; Garcia MR; Odibo AO [Ad] Endereço: a Department of Obstetrics and Gynecology , University of South Florida Morsani College of Medicine , Tampa , FL , USA. [Ti] Título: Does adjunctive use of progesterone in women with cerclage improve prevention of preterm birth? [So] Source: J Matern Fetal Neonatal Med;31(2):202-208, 2018 Jan. [Is] ISSN: 1476-4954 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: OBJECTIVE: To evaluate outcomes among pregnancies with cerclage as compared to cerclage and adjunctive progesterone. METHODS: A retrospective cohort study was performed from 1 October 2011-30 June 2015 including women with a singleton gestation with vaginal cerclage. Exclusion criteria included multiple gestations, simultaneous 17-alpha hydroxyprogesterone caproate (17-OHPC) and vaginal progesterone (vag-p) use, and patients lost to follow-up. Primary outcome was prevention of preterm birth less than 35 (PTB <35) weeks gestational age (GA). RESULTS: One hundred thirty-six patients met inclusion criteria; 73 women had cerclage only, 53 had cerclage and 17-OHPC, 10 had cerclage and vag-p. GA at cerclage placement was similar across groups (p = 0.068). There was a difference in prevention of PTB <35 weeks GA among groups (p = 0.035) with a trend toward earlier delivery among patients with cerclage and vag-p. Rates of PTB <35 weeks in the cerclage (29%) and cerclage and 17-OHPC groups (34%) were similar (p = 0.533). The odds ratio for risk of PTB <35 weeks among women with cerclage and vag-p as compared to all other patients was 5.21 (95%CI: 1.3-21.2). CONCLUSION: The combination of cerclage with intramuscular progesterone resulted in similar PTB prevention as compared to cerclage alone. There may be an association between cerclage, vaginal progesterone and higher rates of PTB which may be attributed to characteristics of the group rather than the therapies studied. [Mh] Termos MeSH primário: Cerclagem Cervical Resultado da Gravidez/epidemiologia Nascimento Prematuro/tratamento farmacológico Nascimento Prematuro/prevenção & controle Progesterona/uso terapêutico Progestinas/uso terapêutico [Mh] Termos MeSH secundário: Administração Intravaginal Adulto Feminino Seres Humanos Recém-Nascido Estimativa de Kaplan-Meier Gravidez Progesterona/administração & dosagem Progestinas/administração & dosagem Estudos Retrospectivos Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Progestins); 4G7DS2Q64Y (Progesterone) [Em] Mês de entrada: 1711 [Cu] Atualização por classe: 171128 [Lr] Data última revisão: 171128 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170111 [St] Status: MEDLINE [do] DOI: 10.1080/14767058.2017.1280019

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[PMID]: 28982161 [Au] Autor: Smith JM; Moss JA; Srinivasan P; Butkyavichene I; Gunawardana M; Fanter R; Miller CS; Sanchez D; Yang F; Ellis S; Zhang J; Marzinke MA; Hendrix CW; Kapoor A; Baum MM [Ad] Endereço: Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America. [Ti] Título: Novel multipurpose pod-intravaginal ring for the prevention of HIV, HSV, and unintended pregnancy: Pharmacokinetic evaluation in a macaque model. [So] Source: PLoS One;12(10):e0185946, 2017. [Is] ISSN: 1932-6203 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: Globally, women bear an uneven burden for sexual HIV acquisition. Results from two clinical trials evaluating intravaginal rings (IVRs) delivering the antiretroviral agent dapivirine have shown that protection from HIV infection can be achieved with this modality, but high adherence is essential. Multipurpose prevention technologies (MPTs) can potentially increase product adherence by offering protection against multiple vaginally transmitted infections and unintended pregnancy. Here we describe a coitally independent, long-acting pod-IVR MPT that could potentially prevent HIV and HSV infection as well as unintended pregnancy. The pharmacokinetics of MPT pod-IVRs delivering tenofovir alafenamide hemifumarate (TAF2) to prevent HIV, acyclovir (ACV) to prevent HSV, and etonogestrel (ENG) in combination with ethinyl estradiol (EE), FDA-approved hormonal contraceptives, were evaluated in pigtailed macaques (N = 6) over 35 days. Pod IVRs were exchanged at 14 days with the only modification being lower ENG release rates in the second IVR. Plasma progesterone was monitored weekly to determine the effect of ENG/EE on menstrual cycle. The mean in vivo release rates (mg d-1) for the two formulations over 30 days ranged as follows: TAF2 0.35-0.40; ACV 0.56-0.70; EE 0.03-0.08; ENG (high releasing) 0.63; and ENG (low releasing) 0.05. Mean peak progesterone levels were 4.4 ± 1.8 ng mL-1 prior to IVR insertion and 0.075 ± 0.064 ng mL-1 for 5 weeks after insertion, suggesting that systemic EE/ENG levels were sufficient to suppress menstruation. The TAF2 and ACV release rates and resulting vaginal tissue drug concentrations (medians: TFV, 2.4 ng mg-1; ACV, 0.2 ng mg-1) may be sufficient to protect against HIV and HSV infection, respectively. This proof of principle study demonstrates that MPT-pod IVRs could serve as a potent biomedical prevention tool to protect women's sexual and reproductive health and may increase adherence to HIV PrEP even among younger high-risk populations. [Mh] Termos MeSH primário: Antivirais/administração & dosagem Dispositivos Anticoncepcionais Femininos Infecções por HIV/prevenção & controle Herpes Genital/prevenção & controle Gravidez não Planejada [Mh] Termos MeSH secundário: Administração Intravaginal Animais Antivirais/farmacocinética Feminino Seres Humanos Macaca nemestrina Gravidez [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Antiviral Agents) [Em] Mês de entrada: 1710 [Cu] Atualização por classe: 171031 [Lr] Data última revisão: 171031 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 171006 [St] Status: MEDLINE [do] DOI: 10.1371/journal.pone.0185946

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[PMID]: 28961280 [Au] Autor: Chuchuen O; Maher JR; Henderson MH; Desoto M; Rohan LC; Wax A; Katz DF [Ad] Endereço: Department of Biotechnology, Faculty of Technology, Khon Kaen University, Khon Kaen, Thailand. [Ti] Título: Label-free analysis of tenofovir delivery to vaginal tissue using co-registered confocal Raman spectroscopy and optical coherence tomography. [So] Source: PLoS One;12(9):e0185633, 2017. [Is] ISSN: 1932-6203 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: Vaginally applied microbicide products offer a female-controlled strategy for preventing sexual transmission of HIV. Microbicide transport processes are central to their functioning, and there is a clear need for a better understanding of them. To contribute to that end, we developed an assay to analyze mass transport rates of microbicide molecules within the epithelial and stromal layers of polarized vaginal mucosal tissue during contact with a gel vehicle. The assay utilizes a new diffusion chamber mounted in a custom instrument that combines confocal Raman spectroscopy and optical coherence tomography. This measures depth-resolved microbicide concentration distributions within epithelium and stroma. Data for a tenofovir gel were fitted with a compartmental diffusion model to obtain fundamental transport properties: the molecular diffusion and partition coefficients in different compartments. Diffusion coefficients in epithelium and stroma were computed to be 6.10 ± 2.12 x 10-8 and 4.52 ± 1.86 x 10-7 cm2/sec, respectively. The partition coefficients between epithelium and gel and between stroma and epithelium were found to be 0.53 ± 0.15 and 1.17 ± 0.16, respectively. These drug transport parameters are salient in governing the drug delivery performance of different drug and gel vehicle systems. They can be used to contrast drugs and vehicles during product design, development and screening. They are critical inputs to deterministic transport models that predict the gels' pharmacokinetic performance, which can guide improved design of products and optimization of their dosing regimens. [Mh] Termos MeSH primário: Fármacos Anti-HIV/administração & dosagem Análise Espectral Raman/métodos Tomografia de Coerência Óptica/métodos [Mh] Termos MeSH secundário: Administração Intravaginal Animais Calibragem Seres Humanos Técnicas In Vitro Membrana Mucosa Suínos Tenofovir/administração & dosagem [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Anti-HIV Agents); 99YXE507IL (Tenofovir) [Em] Mês de entrada: 1711 [Cu] Atualização por classe: 171103 [Lr] Data última revisão: 171103 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170930 [St] Status: MEDLINE [do] DOI: 10.1371/journal.pone.0185633

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[PMID]: 28949973 [Au] Autor: Crowther CA; Ashwood P; McPhee AJ; Flenady V; Tran T; Dodd JM; Robinson JS; PROGRESS Study Group [Ad] Endereço: Liggins Institute, University of Auckland, Auckland, New Zealand. [Ti] Título: Vaginal progesterone pessaries for pregnant women with a previous preterm birth to prevent neonatal respiratory distress syndrome (the PROGRESS Study): A multicentre, randomised, placebo-controlled trial. [So] Source: PLoS Med;14(9):e1002390, 2017 Sep. [Is] ISSN: 1549-1676 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: BACKGROUND: Neonatal respiratory distress syndrome, as a consequence of preterm birth, is a major cause of early mortality and morbidity. The withdrawal of progesterone, either actual or functional, is thought to be an antecedent to the onset of labour. There remains limited information on clinically relevant health outcomes as to whether vaginal progesterone may be of benefit for pregnant women with a history of a previous preterm birth, who are at high risk of a recurrence. Our primary aim was to assess whether the use of vaginal progesterone pessaries in women with a history of previous spontaneous preterm birth reduced the risk and severity of respiratory distress syndrome in their infants, with secondary aims of examining the effects on other neonatal morbidities and maternal health and assessing the adverse effects of treatment. METHODS: Women with a live singleton or twin pregnancy between 18 to <24 weeks' gestation and a history of prior preterm birth at less than 37 weeks' gestation in the preceding pregnancy, where labour occurred spontaneously or in association with cervical incompetence or following preterm prelabour rupture of the membranes, were eligible. Women were recruited from 39 Australian, New Zealand, and Canadian maternity hospitals and assigned by randomisation to vaginal progesterone pessaries (equivalent to 100 mg vaginal progesterone) (n = 398) or placebo (n = 389). Participants and investigators were masked to the treatment allocation. The primary outcome was respiratory distress syndrome and severity. Secondary outcomes were other respiratory morbidities; other adverse neonatal outcomes; adverse outcomes for the woman, especially related to preterm birth; and side effects of progesterone treatment. Data were analysed for all the 787 women (100%) randomised and their 799 infants. FINDINGS: Most women used their allocated study treatment (740 women, 94.0%), with median use similar for both study groups (51.0 days, interquartile range [IQR] 28.0-69.0, in the progesterone group versus 52.0 days, IQR 27.0-76.0, in the placebo group). The incidence of respiratory distress syndrome was similar in both study groups-10.5% (42/402) in the progesterone group and 10.6% (41/388) in the placebo group (adjusted relative risk [RR] 0.98, 95% confidence interval [CI] 0.64-1.49, p = 0.912)-as was the severity of any neonatal respiratory disease (adjusted treatment effect 1.02, 95% CI 0.69-1.53, p = 0.905). No differences were seen between study groups for other respiratory morbidities and adverse infant outcomes, including serious infant composite outcome (155/406 [38.2%] in the progesterone group and 152/393 [38.7%] in the placebo group, adjusted RR 0.98, 95% CI 0.82-1.17, p = 0.798). The proportion of infants born before 37 weeks' gestation was similar in both study groups (148/406 [36.5%] in the progesterone group and 146/393 [37.2%] in the placebo group, adjusted RR 0.97, 95% CI 0.81-1.17, p = 0.765). A similar proportion of women in both study groups had maternal morbidities, especially those related to preterm birth, or experienced side effects of treatment. In 9.9% (39/394) of the women in the progesterone group and 7.3% (28/382) of the women in the placebo group, treatment was stopped because of side effects (adjusted RR 1.35, 95% CI 0.85-2.15, p = 0.204). The main limitation of the study was that almost 9% of the women did not start the medication or forgot to use it 3 or more times a week. CONCLUSIONS: Our results do not support the use of vaginal progesterone pessaries in women with a history of a previous spontaneous preterm birth to reduce the risk of neonatal respiratory distress syndrome or other neonatal and maternal morbidities related to preterm birth. Individual participant data meta-analysis of the relevant trials may identify specific women for whom vaginal progesterone might be of benefit. TRIAL REGISTRATION: Current Clinical Trials ISRCTN20269066. [Mh] Termos MeSH primário: Pessários Nascimento Prematuro/prevenção & controle Progesterona/administração & dosagem Síndrome do Desconforto Respiratório do Recém-Nascido/prevenção & controle [Mh] Termos MeSH secundário: Administração Intravaginal Adulto Austrália Canadá Feminino Seres Humanos Recém-Nascido Nova Zelândia Placebos Gravidez Resultado da Gravidez Índice de Gravidade de Doença [Pt] Tipo de publicação: JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Placebos); 4G7DS2Q64Y (Progesterone) [Em] Mês de entrada: 1709 [Cu] Atualização por classe: 171030 [Lr] Data última revisão: 171030 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170927 [St] Status: MEDLINE [do] DOI: 10.1371/journal.pmed.1002390

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