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Pre-exposure prophylaxis in the perinatal period. 围产期接触前预防。
IF 12.8 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-11-01 DOI: 10.1016/S2352-3018(24)00244-3
Sheree Schwartz, Friday Saidi
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引用次数: 0
Initiation and continued use of oral pre-exposure prophylaxis among pregnant and postpartum women in South Africa (PrEP-PP): a demonstration cohort study. 南非孕妇和产后妇女开始和继续使用口服暴露前预防药物(PrEP-PP):一项示范性队列研究。
IF 12.8 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-11-01 DOI: 10.1016/S2352-3018(24)00240-6
Dvora Leah Joseph Davey, Rufaro Mvududu, Nyiko Mashele, Kalisha Bheemraj, Nehaa Khadka, Leigh F Johnson, Sarah Schoetz Dean, Pamina Gorbach, Linda-Gail Bekker, Thomas J Coates, Landon Myer
<p><strong>Background: </strong>When used effectively, oral pre-exposure prophylaxis (PrEP; tenofovir disoproxil fumarate and emtricitabine) prevents maternal HIV acquisition and reduces the risk of vertical transmission. Our study aimed to better understand PrEP initiation, continued use, and adherence in pregnant and postpartum women.</p><p><strong>Methods: </strong>The PrEP in Pregnancy and Postpartum (PrEP-PP) study is a demonstration cohort study that enrolled pregnant women aged 16 years and older without HIV attending their first antenatal care visit in Cape Town, South Africa, between Aug 29, 2019, and Oct 10, 2021. Eligible, consenting women were followed up quarterly up to 12 months postpartum with regular HIV testing and offer of PrEP with ongoing adherence counselling. The primary outcome was distribution of women across the PrEP cascade (ie, initiation and continuation up to 12 months postpartum) with crude and adjusted hazard ratios (HRs). We also report on HIV incidence by pregnancy and postpartum status.</p><p><strong>Findings: </strong>Overall, 1195 pregnant women were recruited and followed up (median age 26 years, IQR 23-31; median gestational age 21 weeks, IQR 15-31); 1009 (84·4%) started PrEP at enrolment. Among women who initiated PrEP at enrolment, 668 (67·5%) of 990 continued PrEP at the 1-month follow-up, 485 (49·9%) of 972 continued at 3 months, 392 (39·4%) of 994 at 6 months, and 275 (27·4%) of 1005 at 12 months. Of 186 women who did not accept PrEP at enrolment, 70 (37·6%) of 186 subsequently initiated PrEP. Overall, 200 (18·6%) of 1076 women continued PrEP at 12 months postpartum. Of 186 women who did not initiate PrEP at baseline, 70 (37·6%) subsequently initiated PrEP during the study. Factors associated with PrEP discontinuation up to 12 months postpartum included being married or cohabiting (adjusted HR 1·32, 95% CI 1·16-1·50), condomless sex since last visit (1·43, 1·23-1·65), reporting intimate partner violence (2·03, 1·59-2·59), or depression in the past 12 months (1·53, 1·14-2·05). Overall, 16 women seroconverted over 1673·8 woman-years (HIV incidence rate 0·96 per 100 woman-years, 95% CI 0·49-1·42); 14 discontinued PrEP use and two never initiated PrEP. HIV incidence was 0·28 per 100 woman-years during pregnancy (95% CI 0·22-0·33), and the incidence rate ratio was 1·77 per 100 woman-years (0·53-5·90) 0-6 months postpartum and 2·19 per 100 woman-years (0·61-7·83) 6-12 months postpartum compared with pregnant women.</p><p><strong>Interpretation: </strong>There is an urgent need for the integration of PrEP into antenatal and postnatal care and interventions that address barriers to continued use, including targeted counselling during pregnancy and postpartum to reduce PrEP discontinuation.</p><p><strong>Funding: </strong>National Institute of Mental Health and Fogarty International, US National Institutes of Health.</p><p><strong>Translation: </strong>For the French translation of the abstract see Supplementary
背景:如果有效使用口服暴露前预防药物(PrEP;富马酸替诺福韦二吡呋酯和恩曲他滨),可预防孕产妇感染艾滋病毒并降低垂直传播的风险。我们的研究旨在更好地了解孕妇和产后妇女开始、继续使用和坚持使用 PrEP 的情况:妊娠期和产后 PrEP(PrEP-PP)研究是一项示范性队列研究,该研究招募了 2019 年 8 月 29 日至 2021 年 10 月 10 日期间在南非开普敦接受首次产前检查的 16 岁及以上未感染艾滋病毒的孕妇。每季度对符合条件、征得同意的妇女进行随访,直至产后 12 个月,并定期进行 HIV 检测、提供 PrEP 和持续的依从性咨询。主要结果是妇女在 PrEP 级联中的分布情况(即启动和产后 12 个月内的持续情况)以及粗略和调整后的危险比 (HR)。我们还报告了按孕期和产后状况分列的艾滋病发病率:总共招募并随访了 1195 名孕妇(中位年龄 26 岁,IQR 23-31;中位孕龄 21 周,IQR 15-31);其中 1009 人(84-4%)在入组时开始 PrEP。在报名时开始 PrEP 的妇女中,990 人中有 668 人(67-5%)在随访 1 个月时继续 PrEP,972 人中有 485 人(49-9%)在随访 3 个月时继续 PrEP,994 人中有 392 人(39-4%)在随访 6 个月时继续 PrEP,1005 人中有 275 人(27-4%)在随访 12 个月时继续 PrEP。在 186 名在注册时未接受 PrEP 的女性中,有 70 人(37-6%)后来开始接受 PrEP。总体而言,1076 名妇女中有 200 名(18-6%)在产后 12 个月继续接受 PrEP。在基线时未开始 PrEP 的 186 名妇女中,有 70 人(37-6%)随后在研究期间开始了 PrEP。与产后 12 个月内停止 PrEP 相关的因素包括:已婚或同居(调整后 HR 1-32,95% CI 1-16-1-50)、自上次就诊以来无避孕套性行为(1-43,1-23-1-65)、报告亲密伴侣暴力(2-03,1-59-2-59)或过去 12 个月内抑郁(1-53,1-14-2-05)。总体而言,在 1673-8 个妇女年中,有 16 名妇女发生了血清转换(HIV 感染率为每 100 个妇女年 0-96 例,95% CI 为 0-49-1-42);14 名妇女停止使用 PrEP,2 名妇女从未开始使用 PrEP。与孕妇相比,孕期的艾滋病毒发病率为每 100 名妇女年 0-28 例(95% CI 0-22-0-33),产后 0-6 个月的发病率比率为每 100 名妇女年 1-77 例(0-53-5-90),产后 6-12 个月的发病率比率为每 100 名妇女年 2-19 例(0-61-7-83):迫切需要将 PrEP 纳入产前和产后护理,并采取干预措施解决继续使用的障碍,包括在孕期和产后提供有针对性的咨询,以减少 PrEP 的中断:资金来源:美国国立卫生研究院国家精神卫生研究所和 Fogarty 国际:摘要的法文译文请参见补充材料部分。
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引用次数: 0
Safety and efficacy of iron supplementation with 3 months of daily ferrous sulphate in children living with HIV and mild-to-moderate anaemia in Uganda: a double-blind, randomised, placebo-controlled trial. 乌干达感染艾滋病毒并患有轻度至中度贫血症的儿童每天服用硫酸亚铁 3 个月的安全性和有效性:一项双盲、随机、安慰剂对照试验。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-10-11 DOI: 10.1016/s2352-3018(24)00238-8
Anne E P Frosch,Victor Musiime,Christopher Staley,Andrea L Conroy,Diana Rutebarika,Gilbert Ategeka,Sarah E Cusick
BACKGROUNDIron deficiency is the most common nutritional deficiency in the world, but iron supplementation can increase risk of opportunistic infections, especially in children living with HIV. We aimed to assess the effect of supplemental iron on haemoglobin concentration in children living with HIV and mild-to-moderate anaemia in Uganda.METHODSWe did a double-blind, randomised, placebo-controlled trial of iron supplementation in children aged 6 months to 12 years living with HIV at two sites (ie, Kampala and Fort Portal, Uganda). Inclusion criteria were confirmed diagnosis of HIV and stable treatment with antiretroviral therapy for at least 6 months. Exclusion criteria were already taking iron supplementation, acute illness, current opportunistic infection, fever, known sickle cell disease, severe undernutrition, or any chronic illness requiring medical attention. Children were randomly assigned (1:1) via simple randomisation to an 84-day course of either ferrous sulphate or identical placebo tablets once per day. Randomisation codes were computer-generated and stratified by age (ie, 6-23 months or 24 months and older) by the Toronto Institute of Pharmaceutical Technology, the tablet manufacturer. Participants and all individuals giving the interventions, assessing outcomes, and analysing data were masked to group assignment. Children aged 6-23 months received tablets of 12·5 mg ferrous sulphate or identical placebo; children aged 24 months or older received tablets of 30·0 mg ferrous sulphate or identical placebo. Caregivers were instructed to give the supplement after a meal, preferably after an evening meal. The primary outcome was mean haemoglobin concentration at day 84. All analyses were intention to treat. This trial is registered at ClinicalTrials.gov (NCT03596996).FINDINGSBetween May 5, 2018, and Nov 6, 2019, 973 children living with HIV were screened, of whom 200 (20%) met all inclusion criteria and were enrolled. 102 (51%) were randomly assigned to receive iron and 98 (49%) to receive placebo. In the iron group, 57 (56%) of 102 children were male and 45 (44%) were female. In the placebo group, 44 (45%) of 98 children were male and 54 (55%) were female. Iron supplementation was associated with improvement in haemoglobin in unadjusted analysis (p=0·029), but not adjusted analysis (p=0·10), and with improvement in ferritin and hepcidin in both adjusted (p=0·0046; p=0·0079) and unadjusted (p<0·0001; p<0·0001) analyses at day 84. There were four hospital admissions, all for children in the iron group; none were fatal: two children were admitted to hospital with pneumonia, one with severe malaria, and one with hepatitis. Frequency of admissions was not significantly different between groups (p=0·12).INTERPRETATIONIron could have haematological benefit and improve iron status in children living with HIV in Uganda. Future studies powered for morbidity outcomes with longer follow-up are needed, as are those that evaluate the effects of iron s
背景缺铁是世界上最常见的营养缺乏症,但补铁会增加机会性感染的风险,尤其是在感染艾滋病病毒的儿童中。我们在两个地点(即乌干达坎帕拉和波塔尔堡)对 6 个月至 12 岁的艾滋病病毒感染儿童进行了补铁的双盲、随机、安慰剂对照试验。纳入标准是确诊感染了艾滋病病毒,并接受了至少 6 个月的稳定的抗逆转录病毒治疗。排除标准包括:已服用铁剂、患有急性疾病、目前患有机会性感染、发烧、已知患有镰状细胞病、严重营养不良或任何需要医疗护理的慢性疾病。儿童通过简单的随机分配(1:1)被分配到硫酸亚铁或相同的安慰剂片剂中,每天一次,疗程为84天。随机码由计算机生成,并由药片生产商多伦多制药技术研究所按年龄(即 6-23 个月或 24 个月及以上)进行分层。参与者以及所有提供干预、评估结果和分析数据的人员都被蒙上了组别分配的面具。6-23个月大的儿童服用12-5毫克硫酸亚铁片剂或相同的安慰剂;24个月或以上的儿童服用30-0毫克硫酸亚铁片剂或相同的安慰剂。护理人员被要求在餐后服用补充剂,最好是在晚饭后。主要结果是第 84 天的平均血红蛋白浓度。所有分析均为意向治疗。该试验已在ClinicalTrials.gov(NCT03596996)上注册。结果在2018年5月5日至2019年11月6日期间,筛查了973名感染艾滋病毒的儿童,其中200人(20%)符合所有纳入标准并被纳入。102名(51%)被随机分配接受铁剂治疗,98名(49%)接受安慰剂治疗。在铁剂组中,102 名儿童中有 57 名(56%)为男性,45 名(44%)为女性。在安慰剂组中,98名儿童中有44名(45%)为男性,54名(55%)为女性。在第 84 天的未调整分析中,补铁与血红蛋白的改善有关(p=0-029),但与调整分析无关(p=0-10);在调整分析(p=0-0046;p=0-0079)和未调整分析(p<0-0001;p<0-0001)中,补铁与铁蛋白和降血磷素的改善有关。有四名患儿入院治疗,均为铁剂组患儿,但无一死亡:两名患儿因肺炎入院,一名患严重疟疾,一名患肝炎。各组之间的入院频率无明显差异(P=0-12)。未来需要进行更长时间的随访研究,以评估铁补充剂对神经认知结果的影响。
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引用次数: 0
Iron supplementation among children living with HIV. 为感染艾滋病毒的儿童补充铁质。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-10-11 DOI: 10.1016/s2352-3018(24)00267-4
Ajibola I Abioye,Wafaie W Fawzi
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引用次数: 0
Another step forward in implementing long-acting PrEP. 在实施长效 PrEP 方面又向前迈进了一步。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-10-09 DOI: 10.1016/s2352-3018(24)00266-2
Quanhathai Kaewpoowat,Michael E Ohl
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引用次数: 0
Dynamic choice HIV prevention with cabotegravir long-acting injectable in rural Uganda and Kenya: a randomised trial extension. 乌干达和肯尼亚农村地区使用卡博替拉韦长效注射剂预防艾滋病的动态选择:随机试验推广。
IF 16.1 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-10-09 DOI: 10.1016/s2352-3018(24)00235-2
Moses R Kamya,Laura B Balzer,James Ayieko,Jane Kabami,Elijah Kakande,Gabriel Chamie,Nicole Sutter,Helen Sunday,Janice Litunya,Joshua Schwab,John Schrom,Melanie Bacon,Catherine A Koss,Alex R Rinehart,Maya Petersen,Diane V Havlir,
BACKGROUNDHIV infections are ongoing globally despite efficacious biomedical prevention options. We sought to determine whether an HIV prevention package providing choice of daily pills or long-acting injectable cabotegravir and opportunities to change prevention options could increase biomedical prevention coverage and reduce new HIV infections.METHODSThis study was an extension of three randomised trials that used SEARCH dynamic choice HIV prevention to recruit adults (aged ≥15 years) at risk for HIV from antenatal, outpatient, and community settings in rural Uganda and Kenya. In this 48-week open-label extension, participants maintained their original (1:1) randomisation group; the option to choose cabotegravir long-acting injectable was added for intervention participants. Inclusion criteria for the extension were previous enrolment in a SEARCH dynamic choice HIV prevention trial, negative HIV rapid test, and residence in study region. The intervention provided person-centred choice of oral pre-exposure prophylaxis (PrEP) or post-exposure HIV prophylaxis (PEP) or cabotegravir long-acting injectable, with the option to switch according to participant preference. The control provided standard-of-care access to oral PrEP and PEP, but not cabotegravir long-acting injectable. Biomedical prevention coverage (proportion of follow-up covered by oral PrEP, PEP, or cabotegravir long-acting injectable; primary outcome) and HIV incidence (secondary outcome) were compared between groups using targeted minimum loss-based estimation. The trial (NCT05549726) is closed to recruitment.FINDINGSOf 1534 participants initially randomly assigned (from April 15, 2021 to Sept 29, 2022), 984 (487 in the intervention group and 497 in the standard-of-care group) reconsented to the extension (from Jan 2 to March 3, 2023). The mean proportion of follow-up covered by biomedical HIV prevention was 69·7% (95% CI 64·9-74·5) in the intervention group versus 13·3% (10·2-16·3) in the standard-of-care group, corresponding to an absolute difference of 56·4 percentage points (95% CI 50·8-62·1; p<0·0001). The intervention significantly improved coverage across prespecified subgroups (sex and age groups). During the study, 274 (56%) of 485 intervention participants used cabotegravir long-acting injectable, 255 (53%) used oral PrEP, and ten (2%) used PEP. Among cabotegravir long-acting injectable initiators, 118 (43%) of 274 were not previously using oral PrEP or PEP. There were seven incident HIV infections in 390 person-years of follow-up in the standard-of-care group and no infections in 400 person-years of follow-up in the intervention group (incidence rate difference per 100 person-years 1·8, 95% CI 0·4-3·2; p=0·014).INTERPRETATIONOffering people the choice of HIV biomedical prevention options including cabotegravir long-acting injectable in a flexible model can increase prevention coverage and reduce incident HIV infections. HIV programmes should support dynamic choice HIV preve
背景尽管有有效的生物医学预防方案,但全球范围内艾滋病毒感染仍在持续。本研究是三项随机试验的延伸,这些试验采用 SEARCH 动态选择艾滋病预防方法,从乌干达和肯尼亚农村地区的产前、门诊和社区环境中招募有艾滋病风险的成年人(年龄≥15 岁)。在这项为期 48 周的开放标签扩展研究中,参与者保持原有的(1:1)随机分组;干预参与者可选择卡博替拉韦长效注射剂。扩展研究的纳入标准为:曾参加过 SEARCH 动态选择艾滋病预防试验、艾滋病快速检测呈阴性、居住在研究地区。干预方案以人为本,提供暴露前口服预防药物(PrEP)或暴露后艾滋病毒预防药物(PEP)或卡博替拉韦长效注射剂,参与者可根据自己的偏好进行选择。对照组提供口服 PrEP 和 PEP 的标准护理服务,但不提供卡博替拉韦长效注射剂。采用基于最小损失的目标估算法比较了各组之间的生物医学预防覆盖率(口服 PrEP、PEP 或卡博替拉韦长效注射剂覆盖的随访比例;主要结果)和 HIV 感染率(次要结果)。在最初随机分配(2021 年 4 月 15 日至 2022 年 9 月 29 日)的 1534 名参与者中,有 984 人(干预组 487 人,标准护理组 497 人)再次同意延期(2023 年 1 月 2 日至 3 月 3 日)。干预组接受生物医学艾滋病预防的平均随访比例为 69-7%(95% CI 64-9-74-5),而标准护理组为 13-3%(10-2-16-3),绝对差异为 56-4 个百分点(95% CI 50-8-62-1;P<0-0001)。干预措施大大提高了预设亚组(性别和年龄组)的覆盖率。研究期间,485 名干预参与者中有 274 人(56%)使用了卡博替拉韦长效注射剂,255 人(53%)使用了口服 PrEP,10 人(2%)使用了 PEP。在卡博特拉韦长效注射剂的启动者中,274 人中有 118 人(43%)以前没有使用过口服 PrEP 或 PEP。标准护理组在 390 人/年的随访中发生了 7 例艾滋病感染,而干预组在 400 人/年的随访中没有发生感染(每 100 人/年的发病率差异为 1-8,95% CI 为 0-4-3-2;P=0-014)。艾滋病防治计划应支持动态选择艾滋病预防计划,其中包括有效的口服和注射长效产品。
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引用次数: 0
Untangling the causal ties between antiretrovirals and obesity. 解开抗逆转录病毒药物与肥胖之间的因果关系。
IF 12.8 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-10-01 Epub Date: 2024-08-23 DOI: 10.1016/S2352-3018(24)00214-5
Jennifer Manne-Goehler, Mark J Siedner
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引用次数: 0
Optimising HIV spending in eastern Europe and central Asia. 优化东欧和中亚的艾滋病毒防治支出。
IF 12.8 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-10-01 Epub Date: 2024-09-05 DOI: 10.1016/S2352-3018(24)00237-6
Gesine Meyer-Rath, Jeffrey W Imai-Eaton
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引用次数: 0
Reflections on a decade of The Lancet HIV. 对《柳叶刀》HIV 杂志十年的反思。
IF 12.8 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1016/S2352-3018(24)00245-5
The Lancet Hiv
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引用次数: 0
The London patient-5 years on from identifying himself. 伦敦病人--5 年后才确认自己的身份。
IF 12.8 1区 医学 Q1 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1016/S2352-3018(24)00246-7
Tony Kirby
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引用次数: 0
期刊
Lancet Hiv
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