JAIDS Journal of Acquired Immune Deficiency Syndromes最新文献

{"title":"Brief Report: Effect of Improved Provider Communication and Adherence to Guidelines on PrEP Initiation in Kisumu Kenya.","authors":"Melissa Vera, Joseph Sila, Barbra A Richardson, Felix Otieno, George Owiti, Valarie Kemunto, John Kinuthia, Kristin Beima-Sofie, Anna Larsen, Julia C Dettinger, Jillian Pintye, Grace John-Stewart, Pamela Kohler","doi":"10.1097/QAI.0000000000003567","DOIUrl":"10.1097/QAI.0000000000003567","url":null,"abstract":"<p><strong>Introduction: </strong>Adolescent girls and young women (AGYW) in Kenya have low pre-exposure prophylaxis (PrEP) initiation rates in part because of stigmatizing interactions with health care providers. Our recent randomized clinical trial of a standardized patient actor (SP) training intervention for providers found higher quality PrEP delivery at intervention sites; however, it was unclear whether improved service quality improved PrEP initiation.</p><p><strong>Methods: </strong>This analysis used routine records from facilities participating in the randomized trial that aimed to improve provider communication and adherence to Kenyan guidelines when offering PrEP to AGYW. We used facility-level PrEP registers from May to December 2019 as the baseline period and December 2020 to June 2021 as the postintervention period. We used linear regression with percentage initiating as the outcome, intervention and baseline initiation levels as covariates, and the number eligible postintervention at each facility as frequency weights.</p><p><strong>Results: </strong>Overall, 1375 AGYW presented to study sites, were eligible for PrEP, and were included in analyses (baseline: n = 706, postintervention: n = 669). Among 669 PrEP-eligible AGYW in the postintervention period (intervention: n = 360, control: n = 309), 591 (88.3%) initiated PrEP (intervention: n = 335, control: n = 256). PrEP initiation was 93.1% at intervention sites (range: 0%-100%) and 82.8% at control sites (range: 0%-100%). Adjusted for baseline initiation rates, initiation was 12.1% higher at intervention sites than at control sites ( P < 0.001, [95% CI: 0.09 to 0.15]).</p><p><strong>Conclusions: </strong>Our study found significant improvement in PrEP initiation among AGYW who presented to intervention facilities. SP training interventions that improve quality of service delivery for AGYW could lead to higher population-level PrEP coverage.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"252-256"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing Whether Providing Regular, Free HIV Self-Testing Kits Reduces the Time to HIV Diagnosis: An Internet-Based, Randomized Controlled Trial in Men Who Have Sex With Men.","authors":"David T Dunn, Leanne McCabe, Denise Ward, Andrew N Phillips, Fiona C Lampe, Fiona Burns, Valerie Delpech, Peter Weatherburn, T Charles Witzel, Roger Pebody, Peter Kirwan, Jameel Khawam, Sara Croxford, Michael Brady, Kevin A Fenton, Roy Trevelion, Yolanda Collaco-Moraes, Sheena McCormack, Alison J Rodger","doi":"10.1097/QAI.0000000000003564","DOIUrl":"10.1097/QAI.0000000000003564","url":null,"abstract":"<p><strong>Background: </strong>The risk of onward HIV transmission is strongly influenced by the interval between HIV infection and its diagnosis. The SELPHI trial examined whether this interval could be reduced by offering free HIV self-testing kits to men who have sex with men (MSM).</p><p><strong>Setting: </strong>Internet-based RCT of MSM aged ≥16 years, resident in England/Wales, recruited through sexual and social networking sites.</p><p><strong>Methods: </strong>The second-stage randomization of SELPHI was open to participants who used an initial free HIV self-test kit, were HIV seronegative, and reported recent condomless anal sex. They were randomized to receive a free HIV self-test kit every 3 months (repeat testing [RT] group) versus no such offer (nRT group). The primary outcome was time from randomization to a confirmed HIV diagnosis, determined from linkage to national HIV surveillance databases. The key secondary outcome was the frequency of HIV testing regardless of test modality.</p><p><strong>Results: </strong>In total, 2308 eligible participants (1161 RT, 1147 nRT) were randomized between April 2017 and June 2018, and followed for 15-27 months. The proportion of participants reporting an HIV test in the previous 3 months was much higher in the RT group (86%) than in the nRT group (39%). Overall, 16 (9 RT, 7 nRT) confirmed HIV diagnoses were observed (0.35/100 person-years), with no difference between the groups (hazard ratio = 1.27 [95% CI: 0.47 to 3.41], P = 0.63).</p><p><strong>Conclusions: </strong>Providing regular free self-testing kits to sexually active MSM was highly acceptable and markedly increased HIV testing. However, in this low incidence cohort, it did not result in a demonstrably more rapid diagnosis of incident infections.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"274-281"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801452/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Incognito Standardized Patient Approach for Measuring and Reducing Intersectional Healthcare Stigma: A Pilot Cluster Randomized Control Trial.","authors":"M Kumi Smith, Danyang Luo, Siyan Meng, Yunqing Fei, Wei Zhang, Joseph Tucker, Chongyi Wei, Weiming Tang, Ligang Yang, Benny L Joyner, Shujie Huang, Cheng Wang, Bin Yang, Sean Y Sylvia","doi":"10.1097/QAI.0000000000003565","DOIUrl":"10.1097/QAI.0000000000003565","url":null,"abstract":"<p><strong>Background: </strong>Consistent evidence shows stigma impedes healthcare access in people living with HIV (PLWH) and men who have sex with men (MSM). We evaluated the impact of stigma reduction training for providers whose design was informed by direct observation of their clinical behaviors obtained through visits by incognito standardized patients (SPs).</p><p><strong>Setting: </strong>We conducted this study in sexually transmitted disease clinics in Guangzhou, China.</p><p><strong>Methods: </strong>This pilot cluster randomized control trial assessed the feasibility, acceptability, and preliminary efficacy of an intervention whose design was informed by a baseline round of incognito visits in which SPs presented standardized cases to consenting doctors. By randomly varying the HIV status and sexual orientation of each case, we could quantify stigma as differences in care quality across scenarios. We then conducted a follow-up round of SP visits and assessed the impact using linear fixed effects regression.</p><p><strong>Results: </strong>Feasibility and acceptability among the 55 provider participants were high, with no adverse visit events. The provider training improved the offering of testing to HIV-negative MSM (0.05 percentage points, 95% confidence interval, -0.24 to 0.33) and diagnostic effort for HIV-positive MSM (0.23 SD improvement, 95% CI: -0.92 to 1.37). Patient-centered care only improved for HIV-positive straight cases (SD, 0.57; 95% CI: -0.39 to 1.53). All estimates lacked statistical precision, an expected outcome of a pilot randomized control trial.</p><p><strong>Conclusions: </strong>Our training reduced stigma in several domains of care, but least of all for PLWH, suggesting that future trainings should include more clinical content to strengthen clinical skills in PLWH management.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"98 3","pages":"224-233"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics and Safety of Bictegravir in Pregnant and Postpartum Persons With HIV and Their Infants.","authors":"Kathleen M Powis, Mauricio Pinilla, Flynn McMorrow, Alice Stek, Kristina M Brooks, David E Shapiro, Kevin Knowles, Ahizechukwu C Eke, Elizabeth Greene, Allison Agwu, Lourdes Topete, Renee Browning, Nahida Chakhtoura, Priyanka Arora, Xiaoying Huang, Brookie M Best, Mark Mirochnick, Jeremiah D Momper","doi":"10.1097/QAI.0000000000003571","DOIUrl":"10.1097/QAI.0000000000003571","url":null,"abstract":"<p><strong>Background: </strong>Limited data exist on bictegravir pharmacokinetics in pregnancy among persons with HIV (PWH) and infant washout.</p><p><strong>Setting: </strong>Nonrandomized, open-label, multicenter phase-IV prospective study of bictegravir pharmacokinetics and safety in pregnant PWH and their infants.</p><p><strong>Methods: </strong>Steady-state 24-hour pharmacokinetic sampling of oral bictegravir 50 mg once daily (a component of fixed-dose combination bictegravir/emtricitabine/tenofovir alafenamide) during the second and third trimesters and postpartum was performed. Cord blood and infant washout samples were collected. Total and free bictegravir concentrations were measured by validated liquid chromatography with tandem mass spectrometry methods. Within-participant geometric mean ratios (GMR) with 90% confidence intervals (CI) were calculated to compare pharmacokinetics between second and third trimester versus postpartum. Infant HIV testing results were obtained.</p><p><strong>Results: </strong>Twenty-seven maternal-infant pairs were enrolled. Bictegravir area under the concentration-time curve from time 0 through 24 hours post-dose was 46% lower in the second trimester (n = 12; P = 0.002; GMR 0.54; 90% CI: 0.43 to 0.69) and 52% lower in the third trimester (n = 24; P < 0.0001; GMR 0.48; 90% CI: 0.43 to 0.55), compared with postpartum. C 24 concentrations were above the estimated bictegravir protein-adjusted 95% effective concentration of 0.162 μg/mL. The median ratio of cord-to-maternal blood concentration was 1.38 (n = 17; quartiles: 1.17-1.63). Median T 1/2 for infant bictegravir washout was 33.2 hours (quartiles: 25.7-45.9) with a C max of 2.06 μg/mL (quartiles: 1.37-2.72). Overall, 88%-92% of participants maintained suppression <40 copies/mL throughout pregnancy and postpartum. All available infant HIV testing results were negative. The safety profile for pregnant PWH and infants was acceptable.</p><p><strong>Conclusions: </strong>Bictegravir exposure was lower during pregnancy compared with postpartum, yet C 24 concentrations were greater than the bictegravir protein-adjusted 95% effective concentration.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"300-307"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Age of Sexual Debut on HIV Care Engagement Among Sexual and Gender Minorities in Nigeria.","authors":"Connor Volpi, Ruxton Adebiyi, John Chama, Uche Ononaku, Abayomi Aka, Andrew Mitchell, Ashley Shutt, Afoke Kokogho, Abdulwasiu B Tiamiyu, Stefan D Baral, Man Charurat, Sylvia Adebajo, Trevor A Crowell, Rebecca G Nowak","doi":"10.1097/QAI.0000000000003574","DOIUrl":"10.1097/QAI.0000000000003574","url":null,"abstract":"<p><strong>Background: </strong>Sexual and gender minorities (SGM) bear a high burden of HIV. The age of anal sexual debut may influence HIV care engagement. Our objective was to evaluate this relationship to help health care providers promote and anticipate future HIV care engagement among at-risk SGM.</p><p><strong>Methods: </strong>The TRUST/RV368 study provided HIV testing and treatment at SGM-friendly clinics in Abuja and Lagos, Nigeria. Self-reported age of sexual debut was dichotomized as <16 or ≥16 years. Multivariable logistic models estimated adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the association of sexual debut with (1) HIV testing history, (2) HIV testing at the clinics, (3) initiation of antiretroviral therapy (ART) within 6 months of a clinic diagnosis, and (4) viral suppression within 12 months of ART initiation.</p><p><strong>Results: </strong>Of the 2680 participants, 30% (n = 805) reported a sexual debut <16 years. Those with an <16-year debut had significantly more receptive sex partners, condomless sex, and transactional sex (all P < 0.01) and were 24% less likely to have tested for HIV before enrollment (aOR: 0.76; CI: 0.62 to 0.93). However, <16-year debut was not associated with HIV testing, receiving ART, or achieving viral suppression once engaged with TRUST/RV368 (all P > 0.05).</p><p><strong>Conclusions: </strong>SGM with <16-year debut engaged in behaviors that could increase HIV risk and were less likely to have a history of HIV testing. However, once enrolled in SGM-friendly clinics, uptake of HIV care was not associated with <16-year debut, suggesting that SGM-friendly care models may promote HIV care engagement.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"242-251"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bone mineral content, growth, and renal health of infants with perinatal exposure to maternal dolutegravir vs efavirenz and tenofovir disoproxil fumarate vs tenofovir alafenamide: the randomized IMPAACT 2010 (VESTED) trial.","authors":"Tapiwa Mbengeranwa, Lauren Ziemba, Sean S Brummel, Ben Johnston, Haseena Cassim, Gerhard Theron, Zukiswa Ngqawana, Deo Wabwire, Katie McCarthy, John Shepherd, Shahin Lockman, Lameck Chinula, Lynda Stranix-Chibanda","doi":"10.1097/QAI.0000000000003656","DOIUrl":"10.1097/QAI.0000000000003656","url":null,"abstract":"<p><strong>Background: </strong>The impact on infant bone, growth, and renal health of in utero and breastmilk exposure to contemporary antiretroviral treatment (ART) remains unclear.</p><p><strong>Methods: </strong>643 pregnant women with HIV in nine countries in Africa, Asia and the Americas were randomized to start ART with dolutegravir (DTG) + emtricitabine (FTC)/tenofovir alafenamide (TAF), DTG + FTC/tenofovir disoproxil fumarate (TDF), or efavirenz (EFV)/FTC/TDF between 14-28 weeks' gestation and continued for 50 weeks postpartum. Pairwise comparisons used two-sample t-tests of mean week 26 infant bone mineral content (BMC) assessed by dual-energy X-ray absorptiometry (DXA) in a subset; mean infant z-scores for length-for-age (LAZ), weight-for-age (WAZ), and weight-for-length (WLZ) at 26 and 50 weeks; and mean infant creatinine and estimated creatinine clearance at birth and 26 weeks.</p><p><strong>Results: </strong>577 infants were included in the growth analysis, and 169 in the DXA analysis. Week 26 infant spine BMC was significantly lower in the EFV/FTC/TDF arm (133.5g) compared to the DTG+FTC/TAF (143.4g; mean difference [95% CI]: 0.22 [0.02, 0.42] g) and DTG+FTC/TDF (137.4; mean difference [95%CI]: 0.20 [0.01, 0.40] g) arms. Mean LAZ and WAZ scores through week 50 were also significantly lower in the EFV/FTC/TDF versus DTG arms, but not WLZ. Infant obesity was rare (2-4%) and similar between arms. There was no apparent by-arm difference in infant creatinine or estimated creatinine clearance through week 50 (p-values ≥ 0.18).</p><p><strong>Conclusion: </strong>It is reassuring that maternal DTG-based ART during pregnancy and breastfeeding was associated with higher infant spine bone mineral content, better growth, and less stunting than EFV/FTC/TDF.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143501379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes following prenatal exposure to raltegravir-containing antiretroviral therapy: a multi-cohort European study.","authors":"Rebecca Sconza, Georgina Fernandes, Heather Bailey, Helen Peters, Luis Manuel Prieto Tato, Marta Illán Ramos, Karoline Aebi-Popp, Christian Kahlert, Anna Maria Gamell, Antoinette Frick, Luminita Ene, Anna Samarina, Claire Thorne","doi":"10.1097/QAI.0000000000003645","DOIUrl":"https://doi.org/10.1097/QAI.0000000000003645","url":null,"abstract":"<p><strong>Background: </strong>Raltegravir is an HIV integrase strand transfer inhibitor recommended for use in pregnancy. The aim of this study was to assess risk of birth defects and other suboptimal outcomes following prenatal exposure to raltegravir.</p><p><strong>Methods: </strong>We used pooled, prospectively-collected individual patient data from studies in the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC). Pregnancies with any prenatal exposure to raltegravir with outcomes in 2008-2020 were included. Birth defects were classified according to World Health Organization's International Classification of Diseases: Tenth Revision (ICD-10) and EUROCAT criteria. Earliest prenatal exposure timing was classified as periconception (exposure at ≤6 completed gestational weeks [GWs]), later first trimester (T1) (exposure in T1 at >6 completed GWs), and second/third trimester (exposure at >12 completed GWs).</p><p><strong>Results: </strong>A total of 1499 pregnancies across nine cohorts were included. Where timing was available (n=1449), earliest raltegravir exposure was in the periconception period for 505 (34.8%), later T1 in 65 (4.5%), and T2/T3 in 879 (60.7%). The overall prevalence of birth defects among live-born infants with prenatal raltegravir exposure was 3.9% (95% CI 2.9, 5.0) (1443/1466) (ICD-10), with no increased risk observed for those exposed in the periconception period (p=0.290). Among singleton live-born infants, 11.9% (160/1346) were born preterm, 11.3% (148/1307) low birthweight, and 8.6% (111/1291) small for gestational age, with no difference in outcomes observed by timing of raltegravir exposure.</p><p><strong>Conclusion: </strong>These findings add to the evidence base around safety of raltegravir use in pregnancy, though ongoing safety monitoring is needed to rule out risk of rare outcomes.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Social Impacts of Multi-City HIV Research Participation Among Sexual and Gender Expansive Individuals in Kazakhstan.","authors":"Vitaliy Vinogradov, Yong Gun Lee, Gulnara Zhakupova, Gaukhar Mergenova, Alissa Davis, Emily Allen Paine, Kelsey G Reeder, Caitlin I Laughney, Jimin Sung, Sholpan Primbetova, Assel Terlikbayeva, Jeremy Sugarman, Elwin Wu","doi":"10.1097/QAI.0000000000003654","DOIUrl":"https://doi.org/10.1097/QAI.0000000000003654","url":null,"abstract":"<p><strong>Background: </strong>Sexual and gender expansive (SGE) individuals in Kazakhstan are disproportionately affected by HIV yet stigma and discrimination pose ethical and practical challenges for HIV prevention research involving them. Although researchers are tasked with ensuring that risks of research participation are reasonable in relation to its benefits, participant-reported risks and benefits of research participation-including negative (NSIs) and positive social impacts (PSIs) on personal relationships, social status, health, and other life domains-among SGE populations have received little attention.</p><p><strong>Methods: </strong>We examined NSIs and PSIs of research participation among SGE individuals in a three-city HIV prevention study in Kazakhstan at the trial's follow-up visits. We analyzed responses from 579 unique participants who completed a total of 2648 follow-up visits over the 36-month study period (2019-2022).</p><p><strong>Results: </strong>Overall, NSIs were rare: 9 (2%) participants reported NSIs during the study; nearly no NSIs ( =0.0037, SD=0.03) were reported at follow-up visits. These few NSIs included 'trouble with friends, family, or acquaintances' and 'other'. By contrast, PSIs were extensive: 515 (89%) participants reported PSIs during the study; an average of almost five PSIs ( =4.8, SD=3.4) were reported at follow-up visits. The most frequently reported PSIs were 'gained knowledge', 'improvement in HIV-related issues', and 'improvement in mental health'.</p><p><strong>Conclusions: </strong>Our findings demonstrate the potential for HIV prevention research to be associated with PSIs for SGE individuals experiencing stigmatization and discrimination. Future research should address NSIs, particularly confidentiality breaches and interpersonal challenges, within HIV prevention research to minimize risks and burdens of participation.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143483092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of the Two-Drug Regimen Dolutegravir/Lamivudine in Adolescents Living With HIV-1 Naive to Antiretroviral Therapy at 48 Weeks (DANCE): A Single-Arm, Open-label, Phase 3b Trial.","authors":"Thanyawee Puthanakit, Linda Aurpibul, Monica Lopez, Marcia Wang, Marika Ciuffa, Gilda Bontempo, S Y Amy Cheung, Isabelle Deprez, Ann M Buchanan, Cindy Vavro, Michael McKenna, Sherene Min, Lionel K Tan","doi":"10.1097/QAI.0000000000003655","DOIUrl":"https://doi.org/10.1097/QAI.0000000000003655","url":null,"abstract":"<p><strong>Background: </strong>Dolutegravir/Lamivudine is recommended for initial antiretroviral therapy (ART) in adults living with HIV-1; however, no clinical trials have assessed this regimen in adolescents, a potentially more challenging population to treat. We evaluated efficacy, safety, and pharmacokinetics of dolutegravir/lamivudine as initial ART in adolescents living with HIV-1.</p><p><strong>Setting: </strong>Nine centers in Thailand, Kenya, and South Africa.</p><p><strong>Methods: </strong>In the single-arm, open-label, phase 3b DANCE study (NCT03682848), adolescents naive to ART aged ≥12 to <18 years, weighing ≥25 kg, with plasma HIV-1 RNA 1000 to ≤500,000 copies/mL received single once-daily dolutegravir/lamivudine fixed-dose combination tablet orally for 48 weeks (treatment phase). The primary endpoint was proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 (Snapshot; intention-to-treat-exposed [ITT-E] population). Safety outcomes were evaluated in the safety population. Both the ITT-E and safety populations consisted of participants who received ≥1 dose of dolutegravir/lamivudine (N=32). A sensitivity analysis was performed using data from all but two participants who were withdrawn before Week 48 due to site closure (n=30).</p><p><strong>Results: </strong>At Week 48, 26/32 (81%; 95% CI, 64%-93%) participants had HIV-1 RNA <50 copies/mL; in sensitivity analyses, 26/30 (87%; 95% CI, 69%-96%) achieved virologic suppression. No confirmed virologic withdrawals or deaths were reported. One drug-related adverse event was reported (grade 3 decreased glomerular filtration rate) and was the only adverse event leading to study withdrawal at data cut. Pharmacokinetic parameters were comparable to adult systemic exposure ranges.</p><p><strong>Conclusion: </strong>Dolutegravir/Lamivudine demonstrated efficacy and safety as initial ART in adolescents with HIV-1 through 48 weeks.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143483090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Association of Anemia on Non-AIDS Defining Cancer and Subsequent Survival among People with HIV following Antiretroviral Initiation.","authors":"Raynell Lang, Sally B Coburn, M John Gill, Jennifer Grossman, Angel Mayor, Michael A Horberg, Michael J Silverberg, Charles S Rabkin, Richard D Moore, Greg D Kirk, Maile Y Karris, Amy C Justice, Keri N Althoff","doi":"10.1097/QAI.0000000000003647","DOIUrl":"10.1097/QAI.0000000000003647","url":null,"abstract":"<p><strong>Background: </strong>The association of anemia as a predictive and prognostic indicator of non-AIDS defining cancer (NADC) among people with HIV (PWH) remains unknown. We evaluated the presence of anemia and its severity as a predictor of NADC and 5-year all-cause survival following an NADC diagnosis among PWH who had initiated antiretroviral therapy.</p><p><strong>Setting: </strong>North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD).</p><p><strong>Methods: </strong>We included PWH (≥18 years) on ART between 01/01/2007-12/31/2016 with no prior cancer diagnosis. Annual median hemoglobin was categorized into mild (11.0-12.9g/dL men, 11.0-11.9g/dL women) and moderate/severe (<10.9g/dL regardless of sex) anemia. Discrete time-to-event models using a complementary log-log link estimated crude and adjusted hazards ratios (aHR) and 95% confidence intervals for NADC by anemia severity. Five-year mortality following NADC diagnosis by anemia was evaluated.</p><p><strong>Results: </strong>Among 67,228 PWH contributing 301,421 annual median hemoglobin observations, 244,658 (81%) were not anemic, 40,134 (13%) had mild and 16,629 (6%) had moderate/severe anemia. The risk of NADC was higher among PWH with anemia (aHR 2.40[2.19-2.63]) (vs. no anemia) and greater among males (aHR 2.42[2.20-2.66]) than females (aHR 2.02[1.42-2.89]). NADC risk increased with worsening anemia (mild: aHR 2.01[1.81-2.23], moderate/severe: aHR 3.59[3.13-4.11]). The five-year all-cause mortality following NADC diagnosis was higher (aHR 1.37[1.21-1.55]) among PWH with anemia.</p><p><strong>Conclusions: </strong>Among PWH who initiated ART, anemia may serve as a predictive indicator of NADC risk. Identification of anemia should warrant investigations into the underlying etiology, including evaluation for NADC. Anemia is also a prognostic indicator among PWH diagnosed with NADC.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}