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Doxycycline post-exposure prophylaxis for sexually transmitted infections in South Africa. 多西环素暴露后预防南非性传播感染。
Pub Date : 2023-09-28 eCollection Date: 2023-01-01 DOI: 10.4102/sajhivmed.v24i1.1510
Remco P H Peters, James A McIntyre, Nigel Garrett, Adrian J Brink, Connie L Celum, Linda-Gail Bekker

South Africa has a large burden of bacterial sexually transmitted infections (STIs) with high rates among men who have sex with men (MSM). Randomised controlled trials have recently demonstrated high effectiveness of doxycycline post-exposure prophylaxis (PEP) for prevention of bacterial STIs in MSM, with 70% - 85% reductions in Chlamydia trachomatis infection and syphilis, and approximately 50% reduction in Neisseria gonorrhoeae infection. Doxycycline PEP was not demonstrated to be effective in reducing C. trachomatis and N. gonorrhoeae infection among Kenyan cisgender women. Although no worrisome trends in antimicrobial resistance (AMR) were observed in the trials, important concerns remain about doxycycline PEP and AMR development in STIs, other pathogens, commensals, and the microbiome. Tetracycline resistance in N. gonorrhoeae is already widespread in South Africa, but emergence of AMR in other STIs would be concerning. Larger sample sizes of doxycycline PEP users with longer follow-up time are needed to understand the impact that doxycycline PEP may have on AMR at individual and population level. In this opinion article, we weigh the benefits of doxycycline PEP for prevention of bacterial STIs against the existing AMR concerns and data gaps in the South African context. Based on the current evidence, we conclude that it would be reasonable to offer doxycycline PEP to high-risk MSM on a case-by-case basis, provided that it is offered by experienced sexual health clinicians in settings that have access to diagnostic STI testing and ongoing AMR surveillance.

南非有大量细菌性传播感染(STIs),男男性行为者的感染率很高。随机对照试验最近证明,多西环素暴露后预防(PEP)在预防MSM细菌性传播感染方面具有很高的有效性,沙眼衣原体感染和梅毒减少了70%-85%,淋病奈瑟菌感染减少了约50%。在肯尼亚顺性别妇女中,多西环素PEP未被证明能有效减少沙眼衣原体和淋病奈瑟菌感染。尽管在试验中没有观察到令人担忧的抗微生物耐药性(AMR)趋势,但对强力霉素PEP和AMR在性传播感染、其他病原体、共生体和微生物组中的发展仍存在重要担忧。淋病奈瑟菌对四环素的耐药性在南非已经很普遍,但AMR在其他性传播感染中的出现将令人担忧。需要更大的样本量和更长的随访时间来了解多西环素PEP在个体和人群水平上对AMR的影响。在这篇观点文章中,我们权衡了多西环素PEP预防细菌性传播感染的益处与南非现有的AMR问题和数据差距。根据目前的证据,我们得出的结论是,如果由经验丰富的性健康临床医生在能够进行STI诊断检测和持续AMR监测的环境中提供多西环素PEP,那么根据具体情况向高危MSM提供该药物是合理的。
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引用次数: 0
Southern African HIV Clinicians Society 2023 Guideline for post-exposure prophylaxis: Updated recommendations. 南部非洲艾滋病毒临床医生协会2023暴露后预防指南:更新建议。
Pub Date : 2023-09-28 eCollection Date: 2023-01-01 DOI: 10.4102/sajhivmed.v24i1.1522
Jaco Horak, Willem D F Venter, Camilla Wattrus, Nectarios Papavarnavas, Pauline Howell, Gillian Sorour, Carole Wallis, Katherine Gill, Francesca Conradie, Linda-Gail Bekker
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引用次数: 0
Diminished health and social outcomes among men who have sex with men who use drugs in Zimbabwe. 津巴布韦与吸毒男子发生性关系的男子的健康和社会结果下降。
Pub Date : 2023-09-27 eCollection Date: 2023-01-01 DOI: 10.4102/sajhivmed.v24i1.1513
Munyaradzi Mapingure, Innocent Chingombe, Tafadzwa Dzinamarira, Chesterfield Samba, Brian Moyo, Owen Mugurungi, Godfrey Musuka
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引用次数: 0
The prevalence of multimorbidity in virally suppressed HIV-positive patients in Limpopo. 林波波病毒抑制型HIV阳性患者多发病率。
Pub Date : 2023-09-18 eCollection Date: 2023-01-01 DOI: 10.4102/sajhivmed.v24i1.1495
Limakatso Lebina, Tumiso Malatji, Firdaus Nabeemeeah, Kegaugetswe Motsomi, Tsundzukani Siwelana, Khuthadzo Hlongwane, Neil Martinson

Background: Non-communicable diseases (NCDs) are an emerging global public health problem.

Objectives: To assess the prevalence of NCDs and their risk factors among adults on antiretroviral therapy (ART).

Method: This was a cross-sectional study (July 2019 - January 2020) in Limpopo, South Africa. Patients were enrolled if they were ≥ 40 years, HIV-positive, and virologically suppressed on ART. Data were analysed descriptively, and a binomial regression model was used to identify risk factors for NCDs.

Results: The majority of participants (65%; 319/488) were women. Most (83%; 405/488) were aged 40-59 years; 60% (285/472) were overweight or obese. Based on self-report, 22% (107/488) were currently smokers. Almost half (44%) 213/488) reported daily consumption of vegetables and 65% (319/488) exercised regularly and 39% (190/488) reported treatment for another chronic disease. The leading comorbid conditions were hypertension (32%; 158/488) and diabetes mellitus (5%; 24/488). Risk factors for hypertension included age 60 years and older (relative risk [RR]: 1.72; 95% confidence interval [CI]: 1.29-2.30) diabetes (RR: 1.42; 95% CI: 1.08-1.87), overweight (RR: 1.32; 95% CI: 1.03-1.69) and obesity (RR: 1.69; 95% CI: 1.32-2.17).

Conclusion: There is a high prevalence, both of risk factors for NCDs and multimorbidity (> 1 chronic disease) in patients who are ≥ 40 years and virologically suppressed on ART.

背景:非传染性疾病是一个新出现的全球性公共卫生问题。目的:评估接受抗逆转录病毒疗法(ART)的成年人中非传染性疾病的患病率及其风险因素。方法:这是一项在南非林波波进行的横断面研究(2019年7月-2020年1月)。如果患者年龄≥40岁,HIV阳性,且ART病毒抑制,则将其纳入研究。对数据进行描述性分析,并使用二项回归模型来确定非传染性疾病的风险因素。结果:大多数参与者(65%;319/488)为女性。大多数(83%;405/488)年龄在40-59岁之间;60%(285/472)超重或肥胖。根据自我报告,22%(107/488)目前是吸烟者。近一半(44%)(213/488)报告每天食用蔬菜,65%(319/488)定期锻炼,39%(190/488)报道治疗另一种慢性病。主要的合并症是高血压(32%;158/488)和糖尿病(5%;24/488)。高血压的危险因素包括年龄60岁及以上(相对风险[RR]:1.72;95%置信区间[CI]:1.29-2.30)糖尿病(RR:1.42;95%CI:1.08-1.87)、超重(RR:1.32;95%CI:1.03-1.69)和肥胖(RR:1.69;95%CI:1.32-2.17),非传染性疾病和多发病(>1种慢性病)的风险因素,这些患者年龄≥40岁且在ART中受到病毒抑制。
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引用次数: 0
Assessing very advanced HIV disease in adolescent girls and young women. 评估青春期少女和年轻女性的艾滋病晚期病情。
Pub Date : 2023-07-20 eCollection Date: 2023-01-01 DOI: 10.4102/sajhivmed.v24i1.1501
Naseem Cassim, Lindi-Marie Coetzee, Manuel P da Silva, Deborah K Glencross, Wendy S Stevens

Background: South Africa has the largest HIV epidemic globally, with ~7.5 million people living with HIV in 2021. Adolescent girls (AG) and young women (YW), aged 15-19 years and 20-24 years, are twice as likely to be living with HIV as their male counterparts. The national HIV prevalence for young women was 9.1% (2021), with limited data on disease severity.

Objectives: This study assessed very advanced HIV disease (CD4 < 100 cells/μL) in adolescent girls and young women (AGYW) in South Africa.

Method: A retrospective descriptive study analysed data collated from the National Health Laboratory Service database for 2017 to 2021 calendar years for AGYW. National and provincial specimen volumes, the percentage of tests with a CD4 < 100 cells/μL and ≥ 100 cells/μL, and the median and interquartile ranges, were calculated. Logistic regression determined the odds ratio for a CD4 < 100 cells/μL, controlling for age category.

Results: Data for 1 199 010 CD4 specimens indicated a significant decrease in volumes of 34% from 287 410 (2017) to 189 533 (2021). The percentage of samples with a count < 100 cells/μL ranged from 4.9% to 5.2% for YW versus 5.6% to 6.1% for AG. Provincial data for a CD4 count < 100 cells/μL ranged between 4.5% and 8.3% in AG and 3.6% to 6.3% for YW. Logistic regression indicated a 24% higher likelihood for AG having a CD4 count < 100 cells/μL.

Conclusion: The study reported a higher proportion of very advanced HIV disease for AG versus YW nationally, with provincial disparity needing further analysis.

背景:南非是全球艾滋病疫情最严重的国家,到 2021 年将有约 750 万人感染艾滋病毒。15-19 岁和 20-24 岁的少女(AG)和年轻女性(YW)感染 HIV 的几率是男性的两倍。全国年轻女性的 HIV 感染率为 9.1%(2021 年),但有关疾病严重程度的数据有限:本研究评估了南非少女和年轻女性(AGYW)的晚期艾滋病病毒感染情况(CD4 < 100 cells/μL):这项回顾性描述性研究分析了国家卫生实验室服务数据库中整理的2017至2021日历年少女和青年妇女的数据。计算了全国和各省的标本量、CD4<100 cells/μL和≥100 cells/μL的检测百分比、中位数和四分位数间距。逻辑回归确定了CD4<100个细胞/μL的几率,并对年龄进行了控制:1 199 010 份 CD4 标本的数据显示,CD4 数量从 287 410 份(2017 年)到 189 533 份(2021 年)大幅减少了 34%。计数<100个细胞/μL的样本百分比在4.9%至5.2%之间,而青年妇女为5.6%至6.1%。CD4细胞计数小于100 cells/μL的省级数据在4.5%至8.3%之间,而在青壮年妇女中为3.6%至6.3%。Logistic 回归表明,AG 的 CD4 细胞数小于 100 cells/μL 的可能性比 YW 高 24%:该研究报告显示,在全国范围内,AG 的艾滋病晚期比例高于 YW,各省之间的差异需要进一步分析。
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引用次数: 0
Paediatric antiretroviral update. 儿科抗逆转录病毒疗法的最新进展。
Pub Date : 2023-07-06 eCollection Date: 2023-01-01 DOI: 10.4102/sajhivmed.v24i1.1506
Gillian Sorour, Nosisa Sipambo, Moherndran Archary
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引用次数: 0
Evaluation of a health system intervention to improve virological management in an antiretroviral programme at a municipal clinic in central Durban. 在德班市中心的一个市政诊所评估卫生系统干预措施,以改善抗逆转录病毒方案中的病毒学管理。
Pub Date : 2019-09-26 eCollection Date: 2019-01-01 DOI: 10.4102/sajhivmed.v20i1.985
Christie M Cloete, Jane Hampton, Terusha Chetty, Thando Ngomane, Elizabeth Spooner, Linda M G Zako, Shabashini Reddy, Tarylee Reddy, Nozipho Luthuli, Hope Ngobese, Gita Ramjee, Anna Coutsoudis, Photini Kiepiela

Background: With the largest antiretroviral therapy (ART) programme globally, demand for effective HIV management is increasing in South Africa. While viral load (VL) testing is conducted, VL follow-up and management are sub-optimal.

Objectives: The objective of this study was to address gaps in the VL cascade to improve VL testing and management.

Methods: Antiretroviral therapy records were sampled for an in-depth review. The study team then reviewed individual records, focusing on ART management, virological suppression and retention. Multifaceted interventions focused on virological control, including a clinical summary chart for ART care; streamlining laboratory results receipt and management; monitoring VL suppression, flagging virological failure and missed visits for follow-up; down-referral of stable patients eligible for the chronic club system; and training of personnel and patients.

Results: Pre-intervention, 78% (94/120) of eligible patients had VL tests, versus 92% (145/158) post-intervention (p = 0.0009). Pre-intervention, 59% (71/120) of patients accessed their VL results, versus 86% (136/158) post-intervention (p < 0.0001). Post-intervention, 73% (19/26) of patients eligible for ART change were appropriately managed, versus 11% (4/36) pre-intervention (p < 0.0001). Only 27% had no regimen changes (7/26) post-intervention, versus 81% (29/36) pre-intervention (p < 0.0001).

Conclusion: Service delivery was streamlined to facilitate HIV services by focusing on VL test monitoring, protocol training and accessibility of results, thereby improving clinical management.

背景:南非拥有全球最大的抗逆转录病毒治疗计划,对有效管理艾滋病毒的需求正在增加。当进行病毒载量(VL)检测时,VL的随访和管理是次优的。目的:本研究的目的是解决VL级联中的差距,以改进VL测试和管理。方法:对抗逆转录病毒治疗记录进行抽样,进行深入回顾。研究小组随后审查了个人记录,重点关注ART管理、病毒学抑制和保留。侧重于病毒学控制的多方面干预措施,包括ART护理的临床总结图;简化实验室结果的接收和管理;监测VL抑制,标记病毒学失败和错过随访;向下转诊符合慢性俱乐部制度条件的稳定患者;以及人员和病人的培训。结果:干预前,78%(94/120)符合条件的患者进行了VL测试,而干预后为92%(145/158)(p=0.0009)。干预前,59%(71/120)的患者获得了VL结果,而干预前为86%(136/158)。干预后,73%(19/26)符合ART改变条件的患者得到了适当的管理,与干预前的11%(4/36)相比(p<0.0001)。只有27%的患者在干预后没有改变方案(7/26),而干预前的81%(29/36)(p<0.001)。结论:通过关注VL检测监测、方案培训和结果可及性,简化了服务提供,以促进HIV服务,从而改善了临床管理。
{"title":"Evaluation of a health system intervention to improve virological management in an antiretroviral programme at a municipal clinic in central Durban.","authors":"Christie M Cloete,&nbsp;Jane Hampton,&nbsp;Terusha Chetty,&nbsp;Thando Ngomane,&nbsp;Elizabeth Spooner,&nbsp;Linda M G Zako,&nbsp;Shabashini Reddy,&nbsp;Tarylee Reddy,&nbsp;Nozipho Luthuli,&nbsp;Hope Ngobese,&nbsp;Gita Ramjee,&nbsp;Anna Coutsoudis,&nbsp;Photini Kiepiela","doi":"10.4102/sajhivmed.v20i1.985","DOIUrl":"https://doi.org/10.4102/sajhivmed.v20i1.985","url":null,"abstract":"<p><strong>Background: </strong>With the largest antiretroviral therapy (ART) programme globally, demand for effective HIV management is increasing in South Africa. While viral load (VL) testing is conducted, VL follow-up and management are sub-optimal.</p><p><strong>Objectives: </strong>The objective of this study was to address gaps in the VL cascade to improve VL testing and management.</p><p><strong>Methods: </strong>Antiretroviral therapy records were sampled for an in-depth review. The study team then reviewed individual records, focusing on ART management, virological suppression and retention. Multifaceted interventions focused on virological control, including a clinical summary chart for ART care; streamlining laboratory results receipt and management; monitoring VL suppression, flagging virological failure and missed visits for follow-up; down-referral of stable patients eligible for the chronic club system; and training of personnel and patients.</p><p><strong>Results: </strong>Pre-intervention, 78% (94/120) of eligible patients had VL tests, versus 92% (145/158) post-intervention (<i>p</i> = 0.0009). Pre-intervention, 59% (71/120) of patients accessed their VL results, versus 86% (136/158) post-intervention (<i>p</i> < 0.0001). Post-intervention, 73% (19/26) of patients eligible for ART change were appropriately managed, versus 11% (4/36) pre-intervention (<i>p</i> < 0.0001). Only 27% had no regimen changes (7/26) post-intervention, versus 81% (29/36) pre-intervention (<i>p</i> < 0.0001).</p><p><strong>Conclusion: </strong>Service delivery was streamlined to facilitate HIV services by focusing on VL test monitoring, protocol training and accessibility of results, thereby improving clinical management.</p>","PeriodicalId":94212,"journal":{"name":"Southern African journal of HIV medicine","volume":"20 1","pages":"985"},"PeriodicalIF":0.0,"publicationDate":"2019-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6779997/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41224422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Associations of visceral fat thickness and anthropometric measurements with non-alcoholic fatty liver disease development in male patients mono-infected with human immunodeficiency virus. 单感染人类免疫缺陷病毒的男性患者内脏脂肪厚度和人体测量与非酒精性脂肪肝发展的关系。
Pub Date : 2019-08-07 eCollection Date: 2019-01-01 DOI: 10.4102/sajhivmed.v20i1.968
Miloš Vujanović, Nina Brkić-Jovanović, Dalibor Ilić, Zorka Drvendžija, Biljana Srdić-Galić, Vesna Turkulov, Snežana Brkić, Daniela Marić

Background: Non-alcoholic fatty liver disease (NAFLD) represents the most common form of chronic liver disease in mono-infected (without concomitant hepatitis B and/or C virus infection) people living with human immunodeficiency virus (HIV). The proper and on time identification of at-risk HIV-positive individuals would be relevant in order to reduce the rate of progression from NAFLD into non-alcoholic steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma.

Objectives: The aim of this study was to explore visceral fat thickness (VFT) and anthropometric measurements associated with the development of NAFLD in patients mono-infected with HIV and on long-standing combination antiretroviral therapy (cART).

Method: Eighty-eight (n = 88) HIV-positive male patients, average age 39.94 ± 9.91 years, and stable on cART, were included in this prospective study. VFT was measured using ultrasonography. Anthropometric measurements included body mass index (BMI), waist-to-hip ratio (W/H), waist-to-height ratio (WHtR), waist and hip circumference (WC, HC). Differences between variables were determined using the chi-square test. The receiver operating characteristic (ROC) curve and the Youden index were used to determine optimal cut-off values of VFT and hepatic steatosis. The area under the curve (AUC), 95% confidence intervals, sensitivity and specificity are reported for the complete sample. Significance was set at p < 0.05.

Results: Patients with steatosis had significantly higher values of BMI, HC, WC, W/H and WHtR. The VFT was higher in patients with steatosis (p < 0.001). Specifically, VFT values above 31.98 mm and age > 38.5 years correlated with steatosis in HIV-positive patients, namely sensitivity 89%, specificity 72%, AUC 0.84 (95% CI, 0.76-0.93, p < 0.001), with the highest Youden index = 0.61. The sensitivity of the age determinant above this cut-off point was 84%, specificity 73% and AUC 0.83 (95% CI, 0.75-0.92, p < 0.001), with the highest Youden index of 0.57.

Conclusion: In the absence of more advanced radiographic and histological tools, simple anthropometric measurements and VFT could assist in the early identification of persons at risk of hepatic steatosis in low- and middle-income regions.

背景:非酒精性脂肪肝(NAFLD)是人类免疫缺陷病毒(HIV)感染者中最常见的慢性肝病。正确及时地识别高危HIV阳性个体对于降低NAFLD发展为非酒精性脂肪性肝炎(NASH)、肝硬化和肝细胞癌的几率至关重要。目的:本研究的目的是探讨单感染HIV和长期联合抗逆转录病毒治疗(cART)患者的内脏脂肪厚度(VFT)和人体测量与NAFLD发展相关。方法:88名HIV阳性男性患者,平均年龄39.94±9.91岁,cART稳定,纳入本前瞻性研究。VFT采用超声测量。人体测量包括体重指数(BMI)、腰臀比(W/H)、腰高比(WHtR)、腰围和臀围(WC,HC)。使用卡方检验确定变量之间的差异。受试者工作特性(ROC)曲线和尤登指数用于确定VFT和肝脂肪变性的最佳临界值。报告了完整样本的曲线下面积(AUC)、95%置信区间、敏感性和特异性。显著性设定为p<0.05。结果:脂肪变性患者的BMI、HC、WC、W/H和WHtR值显著较高。脂肪变性患者的VFT更高(p<0.001)。特别是,在HIV阳性患者中,VFT值超过31.98 mm和年龄>38.5岁与脂肪变性相关,即敏感性89%,特异性72%,AUC 0.84(95%CI,0.76-0.93,p<0.001,最高的Youden指数=0.61。年龄决定因素在该临界点以上的敏感性为84%,特异性为73%,AUC为0.83(95%CI,0.75-0.92,p<0.001),最高Youden指数为0.57。结论:在缺乏更先进的放射学和组织学工具的情况下,简单的人体测量和VFT可以帮助早期识别中低收入地区有肝脂肪变性风险的人。
{"title":"Associations of visceral fat thickness and anthropometric measurements with non-alcoholic fatty liver disease development in male patients mono-infected with human immunodeficiency virus.","authors":"Miloš Vujanović,&nbsp;Nina Brkić-Jovanović,&nbsp;Dalibor Ilić,&nbsp;Zorka Drvendžija,&nbsp;Biljana Srdić-Galić,&nbsp;Vesna Turkulov,&nbsp;Snežana Brkić,&nbsp;Daniela Marić","doi":"10.4102/sajhivmed.v20i1.968","DOIUrl":"https://doi.org/10.4102/sajhivmed.v20i1.968","url":null,"abstract":"<p><strong>Background: </strong>Non-alcoholic fatty liver disease (NAFLD) represents the most common form of chronic liver disease in mono-infected (without concomitant hepatitis B and/or C virus infection) people living with human immunodeficiency virus (HIV). The proper and on time identification of at-risk HIV-positive individuals would be relevant in order to reduce the rate of progression from NAFLD into non-alcoholic steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma.</p><p><strong>Objectives: </strong>The aim of this study was to explore visceral fat thickness (VFT) and anthropometric measurements associated with the development of NAFLD in patients mono-infected with HIV and on long-standing combination antiretroviral therapy (cART).</p><p><strong>Method: </strong>Eighty-eight (<i>n</i> = 88) HIV-positive male patients, average age 39.94 ± 9.91 years, and stable on cART, were included in this prospective study. VFT was measured using ultrasonography. Anthropometric measurements included body mass index (BMI), waist-to-hip ratio (W/H), waist-to-height ratio (WHtR), waist and hip circumference (WC, HC). Differences between variables were determined using the chi-square test. The receiver operating characteristic (ROC) curve and the Youden index were used to determine optimal cut-off values of VFT and hepatic steatosis. The area under the curve (AUC), 95% confidence intervals, sensitivity and specificity are reported for the complete sample. Significance was set at <i>p</i> < 0.05.</p><p><strong>Results: </strong>Patients with steatosis had significantly higher values of BMI, HC, WC, W/H and WHtR. The VFT was higher in patients with steatosis (<i>p</i> < 0.001). Specifically, VFT values above 31.98 mm and age > 38.5 years correlated with steatosis in HIV-positive patients, namely sensitivity 89%, specificity 72%, AUC 0.84 (95% CI, 0.76-0.93, <i>p</i> < 0.001), with the highest Youden index = 0.61. The sensitivity of the age determinant above this cut-off point was 84%, specificity 73% and AUC 0.83 (95% CI, 0.75-0.92, <i>p</i> < 0.001), with the highest Youden index of 0.57.</p><p><strong>Conclusion: </strong>In the absence of more advanced radiographic and histological tools, simple anthropometric measurements and VFT could assist in the early identification of persons at risk of hepatic steatosis in low- and middle-income regions.</p>","PeriodicalId":94212,"journal":{"name":"Southern African journal of HIV medicine","volume":"20 1","pages":"968"},"PeriodicalIF":0.0,"publicationDate":"2019-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6739542/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41224421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Switching at Low HIV-1 RNA into Fixed Dose Combinations: TDF/FTC/RPV is non-inferior to TDF/FTC/EFV in first-line suppressed patients living with HIV. 将低HIV-1 RNA转换为固定剂量组合:在一线受抑制的HIV感染者中,TDF/FTC/RPV不劣于TDF/FTC/EFV。
Pub Date : 2019-07-23 eCollection Date: 2019-01-01 DOI: 10.4102/sajhivmed.v20i1.949
Paula Munderi, Edwin Were, Anchalee Avihingsanon, Pascale A M Mbida, Lerato Mohapi, Samba B Moussa, Marjolein Jansen, Ceyhun Bicer, Perry Mohammed, Yvon van Delft

Background: In low- and middle-income countries (LMICs), a substantial unmet need for affordable single-tablet regimen (STR) options remains. Rilpivirine (RPV, TMC278) is formulated in a low-cost STR with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC).

Objectives: Switching at Low HIV-1 RNA into Fixed Dose Combinations (SALIF) compared RPV with efavirenz (EFV), both as STRs with TDF and FTC, in maintaining virologic suppression.

Methods: SALIF was a phase 3b, randomised, open-label, non-inferiority study in virologically suppressed adults (HIV-1 RNA < 50 copies/mL) on non-nucleoside reverse transcriptase inhibitor (NNRTI)-based first-line antiretroviral therapy (ART) in Cameroon, Kenya, Senegal, South Africa, Uganda and Thailand. Patients (N = 426), stratified by NNRTI use, were randomised 1:1 to receive TDF/FTC/RPV (300/200/25 mg qd) or TDF/FTC/EFV (300/200/600 mg qd). Primary endpoint was proportion of patients with virologic suppression (HIV-1 RNA < 400 copies/mL) at week 48 (intent-to-treat, modified Food and Drug Administration Snapshot, 10% non-inferiority margin).

Results: Patients received TDF/FTC/RPV (n = 213) or TDF/FTC/EFV (n = 211). At week 48, virologic suppression was maintained in 200/213 (93.9%) patients in the RPV arm and 203/211 (96.2%) in the EFV arm (difference -2.3%; 95% confidence interval: -6.4, +1.8), demonstrating non-inferiority of TDF/FTC/RPV. One patient in each arm experienced virologic failure without treatment-emergent resistance. Twenty-seven patients discontinued prematurely (8.0% RPV vs. 4.7% EFV), the most frequent reasons being adverse events (3.3% vs. 0.5%, respectively), site closure (1.9% vs. 0.5%), loss to follow-up (0.9% vs. 1.4%) and consent withdrawal (0.9% vs. 1.4%).

Conclusion: In adults with suppressed viral load on first-line NNRTI-based ART in LMICs, switching to an STR of TDF/FTC/RPV was non-inferior to TDF/FTC/EFV in maintaining high rates of viral suppression with a comparable tolerability profile.

背景:在低收入和中等收入国家(LMIC),对负担得起的单片方案(STR)的需求仍未得到满足。利匹韦林(RPV,TMC278)与富马酸替诺福韦二普罗西(TDF)和恩曲他滨(FTC)在低成本STR中配制。目的:将低HIV-1 RNA转换为固定剂量组合(SALIF),将RPV与依非韦伦(EFV)作为与TDF和FTC的STR,以维持病毒学抑制。方法:SALIF是一项3b期、随机、开放标签、非劣效性研究,在喀麦隆、肯尼亚、塞内加尔、南非、乌干达和泰国对受病毒抑制的成年人(HIV-1 RNA<50拷贝/mL)进行基于非核苷逆转录酶抑制剂(NNRTI)的一线抗逆转录病毒疗法(ART)。根据NNRTI的使用对患者(N=426)进行分层,以1:1的比例随机接受TDF/FTC/RPV(300/200/25 mg qd)或TDF/FTC/CFV(300/200/600 mg qd。主要终点是病毒抑制患者的比例(HIV-1 RNA结果:患者接受TDF/FTC/RPV(n=213)或TDF/FTC/EFV(n=211)。在第48周,RPV组的200/213名(93.9%)患者和EFV组的203/211名(96.2%)患者的病毒学抑制得以维持(差异-2.3%;95%置信区间:-6.4,+1.8),表明TDF/FTC/RPV的非劣效性。每只手臂中有一名患者出现病毒学失败,没有出现治疗突发耐药性。27名患者过早停药(8.0%RPV vs.4.7%EFV),最常见的原因是不良事件(分别为3.3%vs.0.5%)、部位闭合(1.9%vs.0.5%),失访(0.9%vs.1.4%)和同意退出(0.9%vs.1.4%),在保持具有可比耐受性的高病毒抑制率方面,转换为TDF/FTC/RPV的STR并不劣于TDF/FTC/CFV。
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引用次数: 3
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Southern African journal of HIV medicine
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