Rena Janamnuaysook, Ratee Taesombat, Joe Wong, Ravipa Vannakit, Stephen Mills, Maarten Schim van der Loeff, Peter Reiss, Frits van Griensven
{"title":"Innovating healthcare: Tangerine Clinic's role in implementing inclusive and equitable HIV care for transgender people in Thailand.","authors":"Rena Janamnuaysook, Ratee Taesombat, Joe Wong, Ravipa Vannakit, Stephen Mills, Maarten Schim van der Loeff, Peter Reiss, Frits van Griensven","doi":"10.1002/jia2.26405","DOIUrl":"10.1002/jia2.26405","url":null,"abstract":"","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 1","pages":"e26405"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11666330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to \"Updated guidelines on HIV post-exposure prophylaxis: continued efforts towards increased accessibility\".","authors":"","doi":"10.1002/jia2.26409","DOIUrl":"10.1002/jia2.26409","url":null,"abstract":"","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 1","pages":"e26409"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11710929/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142941980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lauren A Graybill, Caroline N McKay, Jiayu Wang, Nadia A Sam-Agudu, Marcel Yotebieng, Friday Saidi, Linda-Gail Bekker, Bonnie E Shook-Sa, Benjamin H Chi, Nora E Rosenberg
Introduction: While African countries have expanded access to HIV pre-exposure prophylaxis (PrEP) since 2015, regional targets for PrEP uptake remain unmet. Understanding which populations are prioritized for PrEP at the policy level is an important step in determining the scope of PrEP distribution across Africa and identifying gaps in programme implementation. We reviewed national guidance to characterize populations prioritized for PrEP in Africa.
Methods: Between January and June 2023, we searched for current National HIV Treatment and Prevention Guidelines, National HIV Strategic Plans, and the United States President's Emergency Plan for AIDS Relief (PEPFAR) Country Operational Plans (COPs) for all African countries implementing PrEP programmes supported by PEPFAR in 2022. From each document, we summarize the populations prioritized for PrEP within a country and describe PrEP eligibility.
Results: In 2022, 19 African countries implemented PrEP programmes supported by PEPFAR. Eighteen of these countries contributed National Guidelines (2016-2022), 18 contributed National Strategic Plans (2017-2023) and 19 contributed COPs (2022) to this review. Twenty-nine population groups were prioritized for PrEP in these documents. All countries prioritized HIV-serodifferent couples, female sex workers (FSWs), adolescent girls and young women (AGYW), pregnant and breastfeeding women (PBFW) and people who inject drugs (PWID), and most prioritized men who have sex with men (MSM; n = 18), transgender people (n = 18) and people in prisons (n = 17). The remaining 21 populations were prioritized in fewer than two-thirds of countries.
Discussion: FSWs, MSM, PWID, transgender people and people in prisons were typically prioritized for PrEP with no eligibility restrictions. In contrast, most countries had at least one document indicating that HIV-serodifferent couples, AGYW and PBFW were only eligible for PrEP if classified as high risk. Few documents specified how risk was determined, and no document included validated HIV risk assessment tools to guide implementation. We observed similarities in priority populations across countries with different HIV epidemics and inconsistencies in who was prioritized for PrEP within a country's own set of policy documents.
Conclusions: Understanding how PrEP prioritization policies impact HIV incidence in different epidemiologic settings is critical for strengthening PrEP implementation across the continent.
{"title":"Characterizing populations prioritized for PrEP in 19 African countries: a review of national guidance.","authors":"Lauren A Graybill, Caroline N McKay, Jiayu Wang, Nadia A Sam-Agudu, Marcel Yotebieng, Friday Saidi, Linda-Gail Bekker, Bonnie E Shook-Sa, Benjamin H Chi, Nora E Rosenberg","doi":"10.1002/jia2.26407","DOIUrl":"https://doi.org/10.1002/jia2.26407","url":null,"abstract":"<p><strong>Introduction: </strong>While African countries have expanded access to HIV pre-exposure prophylaxis (PrEP) since 2015, regional targets for PrEP uptake remain unmet. Understanding which populations are prioritized for PrEP at the policy level is an important step in determining the scope of PrEP distribution across Africa and identifying gaps in programme implementation. We reviewed national guidance to characterize populations prioritized for PrEP in Africa.</p><p><strong>Methods: </strong>Between January and June 2023, we searched for current National HIV Treatment and Prevention Guidelines, National HIV Strategic Plans, and the United States President's Emergency Plan for AIDS Relief (PEPFAR) Country Operational Plans (COPs) for all African countries implementing PrEP programmes supported by PEPFAR in 2022. From each document, we summarize the populations prioritized for PrEP within a country and describe PrEP eligibility.</p><p><strong>Results: </strong>In 2022, 19 African countries implemented PrEP programmes supported by PEPFAR. Eighteen of these countries contributed National Guidelines (2016-2022), 18 contributed National Strategic Plans (2017-2023) and 19 contributed COPs (2022) to this review. Twenty-nine population groups were prioritized for PrEP in these documents. All countries prioritized HIV-serodifferent couples, female sex workers (FSWs), adolescent girls and young women (AGYW), pregnant and breastfeeding women (PBFW) and people who inject drugs (PWID), and most prioritized men who have sex with men (MSM; n = 18), transgender people (n = 18) and people in prisons (n = 17). The remaining 21 populations were prioritized in fewer than two-thirds of countries.</p><p><strong>Discussion: </strong>FSWs, MSM, PWID, transgender people and people in prisons were typically prioritized for PrEP with no eligibility restrictions. In contrast, most countries had at least one document indicating that HIV-serodifferent couples, AGYW and PBFW were only eligible for PrEP if classified as high risk. Few documents specified how risk was determined, and no document included validated HIV risk assessment tools to guide implementation. We observed similarities in priority populations across countries with different HIV epidemics and inconsistencies in who was prioritized for PrEP within a country's own set of policy documents.</p><p><strong>Conclusions: </strong>Understanding how PrEP prioritization policies impact HIV incidence in different epidemiologic settings is critical for strengthening PrEP implementation across the continent.</p>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 1","pages":"e26407"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sirinya Teeraananchai, David C Boettiger, Cheewanan Lertpiriyasuwat, Rattaphon Triamwichanon, Patchara Benjarattanaporn, Nittaya Phanuphak
Introduction: Antiretroviral therapy (ART) initiation, regardless of CD4 count, has been recommended in Thailand since 2014, with same-day initiation recommended since 2021. We assessed HIV treatment outcomes among Thai people living with HIV (PLHIV) by the time from HIV diagnosis to ART initiation under the Universal Health Coverage (UHC) programme and identified factors associated with virological failure (VF).
Methods: PLHIV aged ≥15 years initiating ART between 2014 and 2022 were included from the UHC database. We categorized participants into four groups using the duration from HIV diagnosis to ART initiation: (1) ≤ 7 days (same-day ART); (2) 8 days to <1 month; (3) 1-3 months; and (4) >3 months. Viral load (VL) was measured 6 months after starting ART, and annually thereafter. VF was defined as VL ≥1000 copies/ml. Factors associated with VF were analysed using competing risk models considering death and loss to follow-up (LTFU) as competing events.
Results: Among 252,239 PLHIV who started ART, the median age at initiation was 34 years (interquartile range [IQR]: 26-43 years). The median (IQR) pre-ART CD4 count was 233 (76-420) cells/mm3. ART initiation occurred within 7 days for 25% (17% on the same day, 8% in 2-7 days), 24% in 8 days to <1 month, 23% in 1-3 months and 28% in >3 months. ART initiation within 7 days increased from 20% (2014-2016) to 32% (2021-2022). VF occurred with a rate of 3.11 (95% CI 3.07-3.159) per 100 person-years (PYs). PLHIV initiating ART 8 days to 1 month were at lower risk of VF (aSHR 0.52, 95% CI 0.50-0.54) when compared to ART initiation >3 months. ART initiation within 7 days resulted in the lowest mortality (6%: 1.28 [95% CI 1.24-1.32] per 100 PYs), but the highest rate of LTFU (12%: 2.69 [95% CI 2.63-2.75] per 100 PYs) when compared to other ART initiation groups.
Conclusions: Although ART initiation within 7 days has increased in Thailand, the overall rate of early initiation remains low. ART initiation within 1 month significantly lowered the risk of VF. ART initiation within 7 days significantly reduced mortality. To further optimize health outcomes, innovative strategies are urgently needed to promote earlier ART initiation in Thailand.
{"title":"The impact of same-day and rapid ART initiation under the Universal Health Coverage programme on HIV outcomes in Thailand: a retrospective real-life cohort study.","authors":"Sirinya Teeraananchai, David C Boettiger, Cheewanan Lertpiriyasuwat, Rattaphon Triamwichanon, Patchara Benjarattanaporn, Nittaya Phanuphak","doi":"10.1002/jia2.26406","DOIUrl":"10.1002/jia2.26406","url":null,"abstract":"<p><strong>Introduction: </strong>Antiretroviral therapy (ART) initiation, regardless of CD4 count, has been recommended in Thailand since 2014, with same-day initiation recommended since 2021. We assessed HIV treatment outcomes among Thai people living with HIV (PLHIV) by the time from HIV diagnosis to ART initiation under the Universal Health Coverage (UHC) programme and identified factors associated with virological failure (VF).</p><p><strong>Methods: </strong>PLHIV aged ≥15 years initiating ART between 2014 and 2022 were included from the UHC database. We categorized participants into four groups using the duration from HIV diagnosis to ART initiation: (1) ≤ 7 days (same-day ART); (2) 8 days to <1 month; (3) 1-3 months; and (4) >3 months. Viral load (VL) was measured 6 months after starting ART, and annually thereafter. VF was defined as VL ≥1000 copies/ml. Factors associated with VF were analysed using competing risk models considering death and loss to follow-up (LTFU) as competing events.</p><p><strong>Results: </strong>Among 252,239 PLHIV who started ART, the median age at initiation was 34 years (interquartile range [IQR]: 26-43 years). The median (IQR) pre-ART CD4 count was 233 (76-420) cells/mm<sup>3</sup>. ART initiation occurred within 7 days for 25% (17% on the same day, 8% in 2-7 days), 24% in 8 days to <1 month, 23% in 1-3 months and 28% in >3 months. ART initiation within 7 days increased from 20% (2014-2016) to 32% (2021-2022). VF occurred with a rate of 3.11 (95% CI 3.07-3.159) per 100 person-years (PYs). PLHIV initiating ART 8 days to 1 month were at lower risk of VF (aSHR 0.52, 95% CI 0.50-0.54) when compared to ART initiation >3 months. ART initiation within 7 days resulted in the lowest mortality (6%: 1.28 [95% CI 1.24-1.32] per 100 PYs), but the highest rate of LTFU (12%: 2.69 [95% CI 2.63-2.75] per 100 PYs) when compared to other ART initiation groups.</p><p><strong>Conclusions: </strong>Although ART initiation within 7 days has increased in Thailand, the overall rate of early initiation remains low. ART initiation within 1 month significantly lowered the risk of VF. ART initiation within 7 days significantly reduced mortality. To further optimize health outcomes, innovative strategies are urgently needed to promote earlier ART initiation in Thailand.</p>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 1","pages":"e26406"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11695198/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142918840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Reena Rajasuriar, Syaza Hisham, John Son Lim, Jean Yi Cheong, Wen Ying Ho, Siew Hwei Yap, Nurul Syuhada Zulhaimi, Malinee Neelamegam, Catherine Cheung, Vivian Wong, Ruhana Che Yusof, Kejal Hasmukharay, Shahrul Bahyah Kamaruzzaman, Sharifah Faridah Syed Omar, Meng Li Chong, Pui Li Wong, Grace Chung-Yan Lui
Introduction: WHO's Integrated Care for Older People (ICOPE) proposes we measure the functional construct of intrinsic capacity (IC) to monitor and identify individuals with age-associated vulnerabilities. Assessments of IC may be useful to address the evolving, non-HV care needs of ageing people with HIV (PWH). However, to date, its utility within the context of HIV has not been assessed.
Methods: Participants included 200 PWH attending out-patient care (2021-2023) in Universiti Malaya Medical Centre, Malaysia and 101 community controls aged 35 years and above. The ICOPE framework was adapted to derive aggregate IC scores (ranging 0-6) encompassing the five domains of cognition, sensory (hearing and vision), mobility, mood and vitality. Multivariable analyses were used to explore the association of IC scores in PWH with multiple health outcomes including frailty, difficulties performing instrumental activities of daily living (IADL) and inflammatory markers. Area under the receiver operator characteristic (AUC-ROC) was calculated to predict frailty and IADL deficits in the current cohort and an independent cohort of 275 PWH from Hong Kong (HK).
Results: Median (interquartile range, IQR) age among PWH and controls were 50 (42-56) and 50 (39-59) years, respectively. There were more males among PWH (83% vs. 56%, p<0.001). All PWH received antiretroviral therapy (ART) for a median duration of 11 (8-14) years. Aggregate IC scores were lower in PWH but not significantly different compared to controls, (5.4 vs. 5.6, p = 0.093) and PWH performed significantly worse than controls only in the cognitive domain. Aggregate IC scores in PWH was independently associated with frailty (OR 0.17 95% CI 0.07-0.42, p<0.001), IADL deficits (OR 0.25 95% CI 0.14-0.46, p<0.001) and all other patient-reported outcomes assessed. Aggregate IC scores correlated with IL-6 but not sCD14 and sCD163 levels. IC scores performed well in identifying PWH with frailty (AUC-ROC ≥ 0.80) in the HK and Malaysian cohorts but more modestly (AUC-ROC ≥ 0.64) for IADL deficits.
Conclusions: IC is a good composite measure to monitor non-HIV, age-associated physical and social vulnerabilities in PWH on ART and should complement disease-based monitoring in routine HIV care. Assessments of IC should be validated in larger, longitudinal cohorts of PWH from diverse settings.
{"title":"Assessing intrinsic capacity for person-centred HIV care: a cross-sectional study in ageing populations in Malaysia and Hong Kong.","authors":"Reena Rajasuriar, Syaza Hisham, John Son Lim, Jean Yi Cheong, Wen Ying Ho, Siew Hwei Yap, Nurul Syuhada Zulhaimi, Malinee Neelamegam, Catherine Cheung, Vivian Wong, Ruhana Che Yusof, Kejal Hasmukharay, Shahrul Bahyah Kamaruzzaman, Sharifah Faridah Syed Omar, Meng Li Chong, Pui Li Wong, Grace Chung-Yan Lui","doi":"10.1002/jia2.26404","DOIUrl":"10.1002/jia2.26404","url":null,"abstract":"<p><strong>Introduction: </strong>WHO's Integrated Care for Older People (ICOPE) proposes we measure the functional construct of intrinsic capacity (IC) to monitor and identify individuals with age-associated vulnerabilities. Assessments of IC may be useful to address the evolving, non-HV care needs of ageing people with HIV (PWH). However, to date, its utility within the context of HIV has not been assessed.</p><p><strong>Methods: </strong>Participants included 200 PWH attending out-patient care (2021-2023) in Universiti Malaya Medical Centre, Malaysia and 101 community controls aged 35 years and above. The ICOPE framework was adapted to derive aggregate IC scores (ranging 0-6) encompassing the five domains of cognition, sensory (hearing and vision), mobility, mood and vitality. Multivariable analyses were used to explore the association of IC scores in PWH with multiple health outcomes including frailty, difficulties performing instrumental activities of daily living (IADL) and inflammatory markers. Area under the receiver operator characteristic (AUC-ROC) was calculated to predict frailty and IADL deficits in the current cohort and an independent cohort of 275 PWH from Hong Kong (HK).</p><p><strong>Results: </strong>Median (interquartile range, IQR) age among PWH and controls were 50 (42-56) and 50 (39-59) years, respectively. There were more males among PWH (83% vs. 56%, p<0.001). All PWH received antiretroviral therapy (ART) for a median duration of 11 (8-14) years. Aggregate IC scores were lower in PWH but not significantly different compared to controls, (5.4 vs. 5.6, p = 0.093) and PWH performed significantly worse than controls only in the cognitive domain. Aggregate IC scores in PWH was independently associated with frailty (OR 0.17 95% CI 0.07-0.42, p<0.001), IADL deficits (OR 0.25 95% CI 0.14-0.46, p<0.001) and all other patient-reported outcomes assessed. Aggregate IC scores correlated with IL-6 but not sCD14 and sCD163 levels. IC scores performed well in identifying PWH with frailty (AUC-ROC ≥ 0.80) in the HK and Malaysian cohorts but more modestly (AUC-ROC ≥ 0.64) for IADL deficits.</p><p><strong>Conclusions: </strong>IC is a good composite measure to monitor non-HIV, age-associated physical and social vulnerabilities in PWH on ART and should complement disease-based monitoring in routine HIV care. Assessments of IC should be validated in larger, longitudinal cohorts of PWH from diverse settings.</p>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 1","pages":"e26404"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11670474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142891095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sinead Delany-Moretlwe, Brett Hanscom, Xu Guo, Clemensia Nkabiito, Patricia Mandima, Patricia Ntege Nahirya, Juliet Mpendo, Muchaneta Bhondai-Mhuri, Nyaradzo Mgodi, Rebecca Berhanu, Jennifer Farrior, Estelle Piwowar-Manning, Susan L Ford, Craig W Hendrix, Alex R Rinehart, James F Rooney, Adeola Adeyeye, Raphael J Landovitz, Myron S Cohen, Mina C Hosseinipour, Mark A Marzinke
Introduction: Long-acting injectable cabotegravir (CAB-LA) for pre-exposure prophylaxis significantly reduced HIV acquisition in HPTN 084. We report on the safety and CAB-LA pharmacokinetics in pregnant women during the blinded period of HPTN 084.
Methods: Participants were randomized 1:1 to either active cabotegravir (CAB) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) placebo or active TDF/FTC plus CAB placebo. Pregnancy testing was performed at each visit; participants with a positive test had study product withheld and were offered open-label TDF/FTC. Pregnancies were confirmed on two tests at least 4 weeks apart. All participants with a positive pregnancy test prior to November 5, 2020 are included in this analysis. Pregnancy incidence, maternal adverse event (AE) incidence, pregnancy outcomes (including composite outcome of spontaneous abortion <20 weeks, intrauterine foetal death or stillbirth ≥20 weeks, premature birth <37 weeks, or small for gestational age) were assessed. The apparent terminal phase half-life (t1/2app) of CAB-LA in pregnant women in HPTN 084 was compared to non-pregnant women from the phase 2a HPTN 077 trial. Multivariable models assessed associations with t1/2app. RESULTS: Fifty-seven pregnancies (30 CAB-LA, 27 TDF/FTC) were confirmed over 3845 person-years [py] (incidence 1.5/100 py, 95% CI 1.1-1.9). CAB-LA group participants had a median 342 days (IQR 192, 497) of CAB-LA exposure prior to pregnancy detection. Grade 2 or higher maternal AE incidence did not differ by study arm (CAB 157, 95% CI 91-271 per 100 py vs. TDF/FTC 217, 95% CI 124-380 per 100 py; p = 0.256). Most pregnancies (81%) resulted in live births (25 CAB-LA, 22 TDF/FTC). Composite poor pregnancy outcomes did not differ significantly by group (CAB 6/30 vs. TDF/FTC 4/27; p = 0.476). No congenital anomalies were observed. The CAB t1/2app geometric mean was 52.8 days (95% CI 40.7-68.4) in pregnant women compared to 60.3 days (95% CI 47.7-76.3; p = 0.66) in non-pregnant women; neither pregnancy nor body mass index were significantly associated with t1/2app.
Conclusions: CAB-LA concentrations post-cessation of injections were generally well tolerated in pregnant women. The t1/2app was comparable between pregnant and non-pregnant women. Ongoing studies will examine the safety and pharmacology of CAB-LA in women who choose to continue CAB-LA through pregnancy and lactation.
简介在 HPTN 084 中,用于暴露前预防的长效注射卡博替拉韦(CAB-LA)显著降低了 HIV 感染率。我们报告了 HPTN 084 盲法期间孕妇使用 CAB-LA 的安全性和药代动力学:参与者按 1:1 随机分配到活性卡博特拉韦 (CAB) 加替诺福韦二吡呋酯/恩曲他滨(TDF/FTC)安慰剂或活性 TDF/FTC 加 CAB 安慰剂。每次就诊时都进行妊娠检测;检测结果呈阳性的受试者将被扣留研究产品,并接受开放标签 TDF/FTC。两次检测至少间隔 4 周才能确认是否怀孕。所有在 2020 年 11 月 5 日之前妊娠检测呈阳性的参与者均纳入本次分析。HPTN 084试验中孕妇的妊娠发生率、母体不良事件(AE)发生率、CAB-LA的妊娠结局(包括自然流产1/2app的复合结局)与2a期HPTN 077试验中的非孕妇进行了比较。多变量模型评估了与 t1/2app 的关联。结果:在3845人/年[py]的时间里,确认了57例妊娠(30例CAB-LA,27例TDF/FTC)(发生率为1.5/100 py,95% CI为1.1-1.9)。CAB-LA 组参与者在检测到妊娠之前的 CAB-LA 暴露时间中位数为 342 天(IQR 192,497)。不同研究臂的 2 级或以上孕产妇 AE 发生率没有差异(CAB 157,95% CI 91-271 per 100 py vs. TDF/FTC 217,95% CI 124-380 per 100 py; p = 0.256)。大多数妊娠(81%)均为活产(25 例 CAB-LA,22 例 TDF/FTC)。各组的综合不良妊娠结局无显著差异(CAB 6/30 vs. TDF/FTC 4/27; p = 0.476)。未观察到先天性畸形。孕妇的 CAB t1/2app 几何平均数为 52.8 天(95% CI 40.7-68.4),而非孕妇为 60.3 天(95% CI 47.7-76.3;p = 0.66);妊娠和体重指数均与 t1/2app 无显著相关性:结论:孕妇对停止注射后 CAB-LA 浓度的耐受性普遍良好。孕妇和非孕妇的 t1/2app 值相当。正在进行的研究将对选择在妊娠期和哺乳期继续使用 CAB-LA 的妇女进行 CAB-LA 的安全性和药理学研究。
{"title":"Evaluation of long-acting cabotegravir safety and pharmacokinetics in pregnant women in eastern and southern Africa: a secondary analysis of HPTN 084.","authors":"Sinead Delany-Moretlwe, Brett Hanscom, Xu Guo, Clemensia Nkabiito, Patricia Mandima, Patricia Ntege Nahirya, Juliet Mpendo, Muchaneta Bhondai-Mhuri, Nyaradzo Mgodi, Rebecca Berhanu, Jennifer Farrior, Estelle Piwowar-Manning, Susan L Ford, Craig W Hendrix, Alex R Rinehart, James F Rooney, Adeola Adeyeye, Raphael J Landovitz, Myron S Cohen, Mina C Hosseinipour, Mark A Marzinke","doi":"10.1002/jia2.26401","DOIUrl":"10.1002/jia2.26401","url":null,"abstract":"<p><strong>Introduction: </strong>Long-acting injectable cabotegravir (CAB-LA) for pre-exposure prophylaxis significantly reduced HIV acquisition in HPTN 084. We report on the safety and CAB-LA pharmacokinetics in pregnant women during the blinded period of HPTN 084.</p><p><strong>Methods: </strong>Participants were randomized 1:1 to either active cabotegravir (CAB) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) placebo or active TDF/FTC plus CAB placebo. Pregnancy testing was performed at each visit; participants with a positive test had study product withheld and were offered open-label TDF/FTC. Pregnancies were confirmed on two tests at least 4 weeks apart. All participants with a positive pregnancy test prior to November 5, 2020 are included in this analysis. Pregnancy incidence, maternal adverse event (AE) incidence, pregnancy outcomes (including composite outcome of spontaneous abortion <20 weeks, intrauterine foetal death or stillbirth ≥20 weeks, premature birth <37 weeks, or small for gestational age) were assessed. The apparent terminal phase half-life (t<sub>1/2app</sub>) of CAB-LA in pregnant women in HPTN 084 was compared to non-pregnant women from the phase 2a HPTN 077 trial. Multivariable models assessed associations with t<sub>1/2app.</sub> RESULTS: Fifty-seven pregnancies (30 CAB-LA, 27 TDF/FTC) were confirmed over 3845 person-years [py] (incidence 1.5/100 py, 95% CI 1.1-1.9). CAB-LA group participants had a median 342 days (IQR 192, 497) of CAB-LA exposure prior to pregnancy detection. Grade 2 or higher maternal AE incidence did not differ by study arm (CAB 157, 95% CI 91-271 per 100 py vs. TDF/FTC 217, 95% CI 124-380 per 100 py; p = 0.256). Most pregnancies (81%) resulted in live births (25 CAB-LA, 22 TDF/FTC). Composite poor pregnancy outcomes did not differ significantly by group (CAB 6/30 vs. TDF/FTC 4/27; p = 0.476). No congenital anomalies were observed. The CAB t<sub>1/2app</sub> geometric mean was 52.8 days (95% CI 40.7-68.4) in pregnant women compared to 60.3 days (95% CI 47.7-76.3; p = 0.66) in non-pregnant women; neither pregnancy nor body mass index were significantly associated with t<sub>1/2app</sub>.</p><p><strong>Conclusions: </strong>CAB-LA concentrations post-cessation of injections were generally well tolerated in pregnant women. The t<sub>1/2app</sub> was comparable between pregnant and non-pregnant women. Ongoing studies will examine the safety and pharmacology of CAB-LA in women who choose to continue CAB-LA through pregnancy and lactation.</p>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 1","pages":"e26401"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11695207/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142918839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Qingling Zeng, Yuhui Yang, Limin Zhang, Jiangyu Yan, Jian Wang, Jingmin Nie, Qingmei Wang, Yu Luo, Gaoming Li
Introduction: In 2010, China launched the 10-year National Syphilis Prevention and Control Program to curb the spread of syphilis by integrating syphilis screening and treatment with HIV services. Herein, we aimed to evaluate changes in the prevalence of syphilis among people living with HIV (PLHIV) in China.
Methods: We conducted this systematic review and meta-analysis by searching the PubMed, Embase, Web of Science, China Biomedical Literature, China National Knowledge Infrastructure, Wanfang and CQVIP databases from inception to 1 June 2024 to obtain relevant articles. A total of 75 studies were ultimately included. We used a DerSimonian‒Laird random effects model to estimate the prevalence and 95% confidence interval of syphilis among PLHIV.
Results: The overall prevalence of syphilis among PLHIV in China was 18.6% (95% CI 16.5-21.0). Regional differences (R2 = 15.29%) were observed in the prevalence rates: 22.2% (18.9-25.8) in the eastern region, 19.0% (15.1-23.8) in the central region and 14.0% (11.1-17.5) in the western region. The prevalence decreased from 22.8% (18.4-27.9) before 2010 to 17.0% (14.6-19.6) in 2010 and thereafter (R2 = 5.82%). Among PLHIV via homosexual transmission, the prevalence of syphilis was 24.9% (21.3-28.9), which significantly declined from 33.8% (27.5-40.8) to 21.4% (18.3-24.9) in 2010 and thereafter (R2 = 22.35%). The prevalence of syphilis was significantly higher in men living with HIV than in women living with HIV (pooled odds ratio 1.67, 95% CI 1.29-2.15), with the highest prevalence in the eastern region (2.55, 95% CI 1.80-3.59).
Discussion: The prevalence of syphilis among PLHIV, particularly in cases of homosexual transmission, has declined. There was a correlation between the prevalence of syphilis and regional economic conditions, with a greater burden in developed eastern coastal areas. Additionally, the risk of syphilis differed across sexes, with men living with HIV having a higher risk.
Conclusions: There has been preliminary success in the control of syphilis among PLHIV, but there is still a long way to go to meet the WHO's 2030 syphilis prevention and control goal. Syphilis prevention measures should be integrated into broader health policies and development plans, particularly in high-burden regions and populations.
{"title":"The impact of the National Syphilis Prevention Program on the prevalence of syphilis among people living with HIV in China: a systematic review and meta-analysis.","authors":"Qingling Zeng, Yuhui Yang, Limin Zhang, Jiangyu Yan, Jian Wang, Jingmin Nie, Qingmei Wang, Yu Luo, Gaoming Li","doi":"10.1002/jia2.26408","DOIUrl":"https://doi.org/10.1002/jia2.26408","url":null,"abstract":"<p><strong>Introduction: </strong>In 2010, China launched the 10-year National Syphilis Prevention and Control Program to curb the spread of syphilis by integrating syphilis screening and treatment with HIV services. Herein, we aimed to evaluate changes in the prevalence of syphilis among people living with HIV (PLHIV) in China.</p><p><strong>Methods: </strong>We conducted this systematic review and meta-analysis by searching the PubMed, Embase, Web of Science, China Biomedical Literature, China National Knowledge Infrastructure, Wanfang and CQVIP databases from inception to 1 June 2024 to obtain relevant articles. A total of 75 studies were ultimately included. We used a DerSimonian‒Laird random effects model to estimate the prevalence and 95% confidence interval of syphilis among PLHIV.</p><p><strong>Results: </strong>The overall prevalence of syphilis among PLHIV in China was 18.6% (95% CI 16.5-21.0). Regional differences (R<sup>2</sup> = 15.29%) were observed in the prevalence rates: 22.2% (18.9-25.8) in the eastern region, 19.0% (15.1-23.8) in the central region and 14.0% (11.1-17.5) in the western region. The prevalence decreased from 22.8% (18.4-27.9) before 2010 to 17.0% (14.6-19.6) in 2010 and thereafter (R<sup>2</sup> = 5.82%). Among PLHIV via homosexual transmission, the prevalence of syphilis was 24.9% (21.3-28.9), which significantly declined from 33.8% (27.5-40.8) to 21.4% (18.3-24.9) in 2010 and thereafter (R<sup>2</sup> = 22.35%). The prevalence of syphilis was significantly higher in men living with HIV than in women living with HIV (pooled odds ratio 1.67, 95% CI 1.29-2.15), with the highest prevalence in the eastern region (2.55, 95% CI 1.80-3.59).</p><p><strong>Discussion: </strong>The prevalence of syphilis among PLHIV, particularly in cases of homosexual transmission, has declined. There was a correlation between the prevalence of syphilis and regional economic conditions, with a greater burden in developed eastern coastal areas. Additionally, the risk of syphilis differed across sexes, with men living with HIV having a higher risk.</p><p><strong>Conclusions: </strong>There has been preliminary success in the control of syphilis among PLHIV, but there is still a long way to go to meet the WHO's 2030 syphilis prevention and control goal. Syphilis prevention measures should be integrated into broader health policies and development plans, particularly in high-burden regions and populations.</p>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 1","pages":"e26408"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11705538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142941982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}