Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003675
Samuel R Bunting, Brian A Feinstein, Allison Wilson, Juan Rivera, Dustin A Ehsan, Aniruddha Hazra
Introduction: People living with mental illness (PLWMI) experience disproportionate HIV incidence. Research suggests use of HIV pre-exposure prophylaxis (PrEP) is low among PLWMI. This study was conducted to understand self-reported HIV vulnerability, previous experiences with PrEP, interest in using PrEP, and preferences for PrEP modality and prescribers among PLWMI.
Methods: We conducted a survey-based study among PLWMI seeking outpatient psychiatric care in Cook County, IL. The survey was completed online after a scheduled appointment with their psychiatric provider. Data were collected between February 2023 and February 2024. Only HIV-negative PLWMI who met at least 1 PrEP eligibility criteria were eligible for the survey (eg, condomless sex, injection drug use, sexually transmitted infection [STI] diagnosis). Outcomes were stratified by psychiatric diagnosis.
Results: A total of 417 PLWMI completed the study (response rate = 66.7%) representing a diversity of diagnoses, including depression (43.4%), bipolar disorder (24.9%), and schizophrenia/schizoaffective disorder (6.7%). Awareness of PrEP was 74.8%, and among those without prior PrEP use, 70.5% were interested. We found 27.6% of PLWMI had used PrEP previously. Long-acting injectable was equally preferable (58.2%) to daily oral PrEP (58.8%) among PLWMI. Primary care providers (94.6%) were the most acceptable PrEP prescriber and 47.6% indicated acceptability of a psychiatrist as a PrEP prescriber.
Conclusions: PLWMI were interested in PrEP, including both oral and long-acting injectable formulations. Psychiatric care may serve as an efficient point of integration for PrEP prescription including LAI-PrEP. Further research is needed to understand how to best implement PrEP prescription and management for PLWMI across clinical settings.
{"title":"Preferences for Pre-Exposure Prophylaxis Implementation and Engagement in the HIV Pre-Exposure Prophylaxis Care Continuum Among Patients Receiving Psychiatric Care in an Ending the HIV Epidemic Priority County.","authors":"Samuel R Bunting, Brian A Feinstein, Allison Wilson, Juan Rivera, Dustin A Ehsan, Aniruddha Hazra","doi":"10.1097/QAI.0000000000003675","DOIUrl":"10.1097/QAI.0000000000003675","url":null,"abstract":"<p><strong>Introduction: </strong>People living with mental illness (PLWMI) experience disproportionate HIV incidence. Research suggests use of HIV pre-exposure prophylaxis (PrEP) is low among PLWMI. This study was conducted to understand self-reported HIV vulnerability, previous experiences with PrEP, interest in using PrEP, and preferences for PrEP modality and prescribers among PLWMI.</p><p><strong>Methods: </strong>We conducted a survey-based study among PLWMI seeking outpatient psychiatric care in Cook County, IL. The survey was completed online after a scheduled appointment with their psychiatric provider. Data were collected between February 2023 and February 2024. Only HIV-negative PLWMI who met at least 1 PrEP eligibility criteria were eligible for the survey (eg, condomless sex, injection drug use, sexually transmitted infection [STI] diagnosis). Outcomes were stratified by psychiatric diagnosis.</p><p><strong>Results: </strong>A total of 417 PLWMI completed the study (response rate = 66.7%) representing a diversity of diagnoses, including depression (43.4%), bipolar disorder (24.9%), and schizophrenia/schizoaffective disorder (6.7%). Awareness of PrEP was 74.8%, and among those without prior PrEP use, 70.5% were interested. We found 27.6% of PLWMI had used PrEP previously. Long-acting injectable was equally preferable (58.2%) to daily oral PrEP (58.8%) among PLWMI. Primary care providers (94.6%) were the most acceptable PrEP prescriber and 47.6% indicated acceptability of a psychiatrist as a PrEP prescriber.</p><p><strong>Conclusions: </strong>PLWMI were interested in PrEP, including both oral and long-acting injectable formulations. Psychiatric care may serve as an efficient point of integration for PrEP prescription including LAI-PrEP. Further research is needed to understand how to best implement PrEP prescription and management for PLWMI across clinical settings.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"349-358"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12341459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795558","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}
Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003672
Caroline E Dunk, Kathleen M Powis, Justine Legbedze, Shan Sun, Keolebogile N Mmasa, Samuel W Kgole, Gosego Masasa, Sikhulile Moyo, Terence Mohammed, Lynn M Yee, Mompati O Mmalane, Joseph M Makhema, Jennifer Jao, Lena Serghides
Background: Placental growth factor (PlGF) and soluble Fms-like tyrosine kinase 1 (sFlt-1) are angiogenic factors essential for placental and fetal growth. Associations between these factors and birth outcomes among pregnant women with HIV are limited.
Methods: PlGF and sFlt-1 levels were quantified by ELISA in plasma samples collected between gestational weeks 24-29 from 114 women (46 with HIV, 68 without HIV). PlGF and sFlt-1:PlGF ratios were assessed using cutoffs used for prediction of preeclampsia (PlGF <12 pg/mL, PlGF <100 pg/mL, sFlt-1:PlGF >85) and compared by HIV status using χ 2 testing. Logistic regression models were fit to assess associations of dichotomized PlGF and sFlt1:PlGF with preterm (<37 weeks) and small for gestational age (SGA) birth (<10 th percentile) in all participants and stratified by HIV status.
Results: Women with HIV were older than women without HIV. More women with HIV had low or very low PlGF levels (<100 pg/mL: 30.4% vs 7.4%, P = 0.001; <12 pg/mL: 17.4% vs 1.5%, P = 0.002) and sFlt-1:PlGF >85 (19.5% vs 2.9%, P = 0.0036) than women without HIV. Among all pregnancies, low PlGF and high sFlt-1:PlGF ratios were significantly associated with SGA (odds ratio [95% confidence interval] for PlGF <12 pg/mL: 10.3 [2.0-53], P = 0.005; PlGF <100 pg/mL: 5.9 [1.7-21], P = 0.006; sFlt-1:PlGF >85: 10.6 [2.5-46], P = 0.002), but not preterm birth. Associations remained significant after adjusting for maternal age, BMI, and elevated blood pressure. Stratification by maternal HIV status showed this association was limited to the women with HIV.
Conclusions: Low PlGF levels may be a good predictive biomarker of SGA specifically for pregnant women with HIV.
{"title":"Brief Report: Low Placental Growth Factor Levels Mid-gestation Predict Small for Gestational Age in Pregnant Women With HIV.","authors":"Caroline E Dunk, Kathleen M Powis, Justine Legbedze, Shan Sun, Keolebogile N Mmasa, Samuel W Kgole, Gosego Masasa, Sikhulile Moyo, Terence Mohammed, Lynn M Yee, Mompati O Mmalane, Joseph M Makhema, Jennifer Jao, Lena Serghides","doi":"10.1097/QAI.0000000000003672","DOIUrl":"10.1097/QAI.0000000000003672","url":null,"abstract":"<p><strong>Background: </strong>Placental growth factor (PlGF) and soluble Fms-like tyrosine kinase 1 (sFlt-1) are angiogenic factors essential for placental and fetal growth. Associations between these factors and birth outcomes among pregnant women with HIV are limited.</p><p><strong>Methods: </strong>PlGF and sFlt-1 levels were quantified by ELISA in plasma samples collected between gestational weeks 24-29 from 114 women (46 with HIV, 68 without HIV). PlGF and sFlt-1:PlGF ratios were assessed using cutoffs used for prediction of preeclampsia (PlGF <12 pg/mL, PlGF <100 pg/mL, sFlt-1:PlGF >85) and compared by HIV status using χ 2 testing. Logistic regression models were fit to assess associations of dichotomized PlGF and sFlt1:PlGF with preterm (<37 weeks) and small for gestational age (SGA) birth (<10 th percentile) in all participants and stratified by HIV status.</p><p><strong>Results: </strong>Women with HIV were older than women without HIV. More women with HIV had low or very low PlGF levels (<100 pg/mL: 30.4% vs 7.4%, P = 0.001; <12 pg/mL: 17.4% vs 1.5%, P = 0.002) and sFlt-1:PlGF >85 (19.5% vs 2.9%, P = 0.0036) than women without HIV. Among all pregnancies, low PlGF and high sFlt-1:PlGF ratios were significantly associated with SGA (odds ratio [95% confidence interval] for PlGF <12 pg/mL: 10.3 [2.0-53], P = 0.005; PlGF <100 pg/mL: 5.9 [1.7-21], P = 0.006; sFlt-1:PlGF >85: 10.6 [2.5-46], P = 0.002), but not preterm birth. Associations remained significant after adjusting for maternal age, BMI, and elevated blood pressure. Stratification by maternal HIV status showed this association was limited to the women with HIV.</p><p><strong>Conclusions: </strong>Low PlGF levels may be a good predictive biomarker of SGA specifically for pregnant women with HIV.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"368-373"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779987","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}
Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003673
Abubaker Ibrahim Elbur, Ali Mirzazadeh, Moranda Tate, Bow Suprasert, Erin C Wilson, Willi McFarland
Background: Overall progress in getting to zero new HIV infections in San Francisco has been made since 2012. However, among people who inject drugs (PWID), there has been no clear downward trend in new HIV infections in recent years. Direct measures of the rate of HIV acquisition and characterization of factors associated with higher rates among PWID are needed to help achieve HIV elimination.
Methods: This study is a secondary analysis of the National HIV Behavioral Surveillance survey of PWID in San Francisco in 2022. HIV incidence is estimated using age of first injection drug use and date of first HIV-positive test or interview date as the exposure period. Factors associated with HIV seroconversion were identified by Cox regression.
Results: Of 518 PWID, 12 newly tested HIV positive in the survey and 38 reported a prior positive test. HIV incidence was calculated as 0.46 per 100 person-years (95% confidence interval [CI]: 0.35 to 0.61). HIV incidence rates were significantly higher among PWID who were men who have sex with men (adjusted hazard ratio [aHR] 15.98, 95% Cl 7.77 to 32.87, P < 0.001), transgender (aHR 8.64, 95% Cl 2.76 to 27.08, P < 0.001), and Hispanic (aHR 2.85, 95% Cl 1.23 to 6.63, P < 0.001).
Conclusions: We found a moderate HIV incidence of ∼5 per 1000 person-years among PWID in San Francisco, with significantly higher rates among sexual, gender, and ethnic minority groups of PWID. Further progress in getting to zero new HIV infections will require more vigorous scale-up of effective prevention interventions, such as PrEP, specifically reaching vulnerable groups of PWID.
背景:自 2012 年以来,旧金山在实现零艾滋病毒新感染方面取得了总体进展。然而,在注射吸毒者(PWID)中,近年来新感染 HIV 的人数并没有明显的下降趋势。我们需要直接测量艾滋病毒的感染率,并确定与注射吸毒者中感染率较高相关的因素,以帮助实现消除艾滋病毒的目标:本研究是对 2022 年旧金山吸毒者全国 HIV 行为监测调查的二次分析。以首次注射使用毒品的年龄和首次 HIV 检测呈阳性的日期或访谈日期作为暴露期来估算 HIV 感染率。通过 Cox 回归确定了与 HIV 血清转换相关的因素:在 518 名注射吸毒者中,有 12 人在调查中新检测出艾滋病毒呈阳性,38 人报告之前的检测结果呈阳性。根据计算,HIV 感染率为每 100 人年 0.46 例(95% CI 0.35-0.61)。在男男性行为者中,艾滋病病毒感染率明显更高(调整后危险比 [aHR] 15.98,95% Cl 7.77-32.87,pConclusions):我们发现,在旧金山的吸毒者中,艾滋病毒的发病率处于中等水平,为每千人年 5 例,而在性取向、性别和少数族裔群体中,吸毒者的发病率明显更高。要进一步实现艾滋病毒新感染率为零的目标,就必须加大力度推广有效的预防干预措施,如 PrEP,特别是针对易感染群体的吸毒者。
{"title":"Brief Report: HIV Incidence Among People Who Inject Drugs, San Francisco, 2022.","authors":"Abubaker Ibrahim Elbur, Ali Mirzazadeh, Moranda Tate, Bow Suprasert, Erin C Wilson, Willi McFarland","doi":"10.1097/QAI.0000000000003673","DOIUrl":"10.1097/QAI.0000000000003673","url":null,"abstract":"<p><strong>Background: </strong>Overall progress in getting to zero new HIV infections in San Francisco has been made since 2012. However, among people who inject drugs (PWID), there has been no clear downward trend in new HIV infections in recent years. Direct measures of the rate of HIV acquisition and characterization of factors associated with higher rates among PWID are needed to help achieve HIV elimination.</p><p><strong>Methods: </strong>This study is a secondary analysis of the National HIV Behavioral Surveillance survey of PWID in San Francisco in 2022. HIV incidence is estimated using age of first injection drug use and date of first HIV-positive test or interview date as the exposure period. Factors associated with HIV seroconversion were identified by Cox regression.</p><p><strong>Results: </strong>Of 518 PWID, 12 newly tested HIV positive in the survey and 38 reported a prior positive test. HIV incidence was calculated as 0.46 per 100 person-years (95% confidence interval [CI]: 0.35 to 0.61). HIV incidence rates were significantly higher among PWID who were men who have sex with men (adjusted hazard ratio [aHR] 15.98, 95% Cl 7.77 to 32.87, P < 0.001), transgender (aHR 8.64, 95% Cl 2.76 to 27.08, P < 0.001), and Hispanic (aHR 2.85, 95% Cl 1.23 to 6.63, P < 0.001).</p><p><strong>Conclusions: </strong>We found a moderate HIV incidence of ∼5 per 1000 person-years among PWID in San Francisco, with significantly higher rates among sexual, gender, and ethnic minority groups of PWID. Further progress in getting to zero new HIV infections will require more vigorous scale-up of effective prevention interventions, such as PrEP, specifically reaching vulnerable groups of PWID.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"321-324"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12235087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779983","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}
Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003674
Weiming Zhu, Ya-Lin A Huang, Athena P Kourtis, Robyn Neblett-Fanfair, Jonathan Mermin, Karen W Hoover
Introduction: The Ending the HIV Epidemic (EHE) in the US initiative was launched by the US Department of Health and Human Services in 2019 with the goal of decreasing new HIV infections 90% by 2030. Increasing the use of HIV preexposure prophylaxis (PrEP) is one of the EHE strategies. We assessed the impact of EHE activities on PrEP use.
Methods: Using IQVIA real-world longitudinal prescription data and the National HIV Surveillance System data, we calculated jurisdiction-level PrEP to diagnosis ratios (PDRs) in the United States from 2016 to 2023. We assessed impact of EHE with a difference-in-difference analysis.
Results: The PDR increased from 3.0 to 14.7 in EHE jurisdictions, from 1.2 to 7.2 in EHE states, and from 2.5 to 13.4 in non-EHE jurisdictions. On average, no additional increase in the PDR was found for EHE counties compared with matched non-EHE counties, (adjusted difference-in-difference: 0.2, 95% confidence interval: -1.0 to 1.3), or for EHE states (adjusted difference-in-difference: 0.4, 95% CI: -1.6 to 2.4).
Conclusions: Overall PrEP use increased markedly, with some EHE jurisdictions achieving greater increases than non-EHE jurisdictions with similar PDRs in 2019. The uneven increase in PrEP use in EHE jurisdictions underscores the need for jurisdiction-specific PrEP implementation strategies designed for the needs of each community. It also underscores the need for sufficient funding to accomplish EHE goals.
{"title":"Trends in HIV Preexposure Prophylaxis Use Before and After Launch of the Ending the HIV Epidemic in the US Initiative, 2016-2023.","authors":"Weiming Zhu, Ya-Lin A Huang, Athena P Kourtis, Robyn Neblett-Fanfair, Jonathan Mermin, Karen W Hoover","doi":"10.1097/QAI.0000000000003674","DOIUrl":"10.1097/QAI.0000000000003674","url":null,"abstract":"<p><strong>Introduction: </strong>The Ending the HIV Epidemic (EHE) in the US initiative was launched by the US Department of Health and Human Services in 2019 with the goal of decreasing new HIV infections 90% by 2030. Increasing the use of HIV preexposure prophylaxis (PrEP) is one of the EHE strategies. We assessed the impact of EHE activities on PrEP use.</p><p><strong>Methods: </strong>Using IQVIA real-world longitudinal prescription data and the National HIV Surveillance System data, we calculated jurisdiction-level PrEP to diagnosis ratios (PDRs) in the United States from 2016 to 2023. We assessed impact of EHE with a difference-in-difference analysis.</p><p><strong>Results: </strong>The PDR increased from 3.0 to 14.7 in EHE jurisdictions, from 1.2 to 7.2 in EHE states, and from 2.5 to 13.4 in non-EHE jurisdictions. On average, no additional increase in the PDR was found for EHE counties compared with matched non-EHE counties, (adjusted difference-in-difference: 0.2, 95% confidence interval: -1.0 to 1.3), or for EHE states (adjusted difference-in-difference: 0.4, 95% CI: -1.6 to 2.4).</p><p><strong>Conclusions: </strong>Overall PrEP use increased markedly, with some EHE jurisdictions achieving greater increases than non-EHE jurisdictions with similar PDRs in 2019. The uneven increase in PrEP use in EHE jurisdictions underscores the need for jurisdiction-specific PrEP implementation strategies designed for the needs of each community. It also underscores the need for sufficient funding to accomplish EHE goals.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"334-340"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12344591/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811163","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}
Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003671
Karlyn A Edwards, Kenneth J Smith, Katie Fitzgerald Jones, Matthew J Bair, Jane M Liebschutz, Lakeya S McGill, Deana Agil, Mallory O Johnson, Tammi Thomas, Olivio J Clay, Claire E Farel, Sonia Napravnik, Dustin Long, Greer Burkholder, Lindsay Browne, Amy L Durr, Bernadette Johnson, William Demonte, Sarah Margaret Orris, Jessica S Merlin
Background: Pain self-management (PSM) interventions are low risk, effective interventions for chronic pain that have high potential for scalability. Economic evaluations are a key component to assessing scalability. We evaluated the cost-effectiveness of a tailored PSM called Skills to Manage Pain (STOMP) as compared with enhanced usual care (EUC) among people with HIV and chronic pain.
Setting and methods: Data are from a randomized controlled trial of STOMP (N = 278). From a health care perspective, a Markov decision analysis model for a 12-month time horizon was used. Participants were recruited from 2 academic medical centers within the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort. STOMP involves 6 individual sessions and 6 peer-led group sessions. The EUC control group received the STOMP treatment manual. The primary outcome was the incremental cost-effectiveness ratio, defined as US dollars per quality-adjusted life-year (QALY) gained derived from trial-based Medical Outcomes Study Short-Form 12 (SF-12) data. Sensitivity analyses examined the effects of parameters varied individually and collectively on model results.
Results: Participants were middle-aged (M = 53.5, SD = 10), male (53%), and Black/African American (81%). Model calculation of effectiveness for the 12-month time horizon resulted in 0.570 QALYs for EUC and 0.603 QALYs for the STOMP intervention, or 0.033 QALYs gained by STOMP compared with EUC. In probabilistic sensitivity analyses that varied all parameters simultaneously, the STOMP intervention was favored in 98.0% of 10,000 model iterations at a $100,000/QALY threshold.
Conclusions: STOMP is a cost-effective and scalable PSM intervention for people with HIV and chronic pain.
{"title":"Cost-Effectiveness of a Tailored Pain Self-Management Intervention Compared With Enhanced Usual Care Among People With HIV and Chronic Pain: An Economic Evaluation.","authors":"Karlyn A Edwards, Kenneth J Smith, Katie Fitzgerald Jones, Matthew J Bair, Jane M Liebschutz, Lakeya S McGill, Deana Agil, Mallory O Johnson, Tammi Thomas, Olivio J Clay, Claire E Farel, Sonia Napravnik, Dustin Long, Greer Burkholder, Lindsay Browne, Amy L Durr, Bernadette Johnson, William Demonte, Sarah Margaret Orris, Jessica S Merlin","doi":"10.1097/QAI.0000000000003671","DOIUrl":"10.1097/QAI.0000000000003671","url":null,"abstract":"<p><strong>Background: </strong>Pain self-management (PSM) interventions are low risk, effective interventions for chronic pain that have high potential for scalability. Economic evaluations are a key component to assessing scalability. We evaluated the cost-effectiveness of a tailored PSM called Skills to Manage Pain (STOMP) as compared with enhanced usual care (EUC) among people with HIV and chronic pain.</p><p><strong>Setting and methods: </strong>Data are from a randomized controlled trial of STOMP (N = 278). From a health care perspective, a Markov decision analysis model for a 12-month time horizon was used. Participants were recruited from 2 academic medical centers within the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort. STOMP involves 6 individual sessions and 6 peer-led group sessions. The EUC control group received the STOMP treatment manual. The primary outcome was the incremental cost-effectiveness ratio, defined as US dollars per quality-adjusted life-year (QALY) gained derived from trial-based Medical Outcomes Study Short-Form 12 (SF-12) data. Sensitivity analyses examined the effects of parameters varied individually and collectively on model results.</p><p><strong>Results: </strong>Participants were middle-aged (M = 53.5, SD = 10), male (53%), and Black/African American (81%). Model calculation of effectiveness for the 12-month time horizon resulted in 0.570 QALYs for EUC and 0.603 QALYs for the STOMP intervention, or 0.033 QALYs gained by STOMP compared with EUC. In probabilistic sensitivity analyses that varied all parameters simultaneously, the STOMP intervention was favored in 98.0% of 10,000 model iterations at a $100,000/QALY threshold.</p><p><strong>Conclusions: </strong>STOMP is a cost-effective and scalable PSM intervention for people with HIV and chronic pain.</p><p><strong>Trial registration: </strong>Clinical Trials Registration #NCT03692611.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"341-348"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779979","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}
Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003669
Eric Remera, Frédérique Chammartin, Sabin Nsanzimana, Samuel S Malamba, Gallican N Rwibasira, David J Riedel, Jamie I Forrest, Leon Mutesa, Nathan Ford, Ayman Ahmed, Jeanine U Condo, Steven Karera, Edward J Mills, Heiner C Bucher
Introduction: Rwanda has initiated recency testing alongside existing HIV testing services of provider-initiated testing, partner notification services (PNSs), and of prevention of mother-to-child HIV transmission. We aimed to determine characteristics of the newly diagnosed population using a nationwide cohort.
Methods: We included all newly diagnosed patients with HIV aged 15 and above who consented to recency testing and assessed patient- and health center-related predictors of recent HIV infection using multivariable logistic regression models.
Results: We obtained data from 485 of 565 health facilities in Rwanda that introduced PNS and recency testing alongside preexisting testing services. From October 2018 to February 2024, 8940 individuals consented to HIV recency testing. Among them, 537 (6.0%) were recently infected. The odds of detecting a recent HIV infection increased by 1% for each month of experience in PNS. Patient-related factors associated with recent infections included female sex, younger age (15-24 years), residing in southern or northern provinces compared with the western province, and self-reported sex with a known HIV-infected person or unprotected sex outside of a relationship in the last 12 months.
Conclusions: Only 6% of newly diagnosed HIV infections were characterized as recent. Public health interventions targeting younger females may assist in reducing new infections in this group.
{"title":"Factors Associated With Recent HIV Infections Among Newly HIV Diagnosed in Rwanda.","authors":"Eric Remera, Frédérique Chammartin, Sabin Nsanzimana, Samuel S Malamba, Gallican N Rwibasira, David J Riedel, Jamie I Forrest, Leon Mutesa, Nathan Ford, Ayman Ahmed, Jeanine U Condo, Steven Karera, Edward J Mills, Heiner C Bucher","doi":"10.1097/QAI.0000000000003669","DOIUrl":"10.1097/QAI.0000000000003669","url":null,"abstract":"<p><strong>Introduction: </strong>Rwanda has initiated recency testing alongside existing HIV testing services of provider-initiated testing, partner notification services (PNSs), and of prevention of mother-to-child HIV transmission. We aimed to determine characteristics of the newly diagnosed population using a nationwide cohort.</p><p><strong>Methods: </strong>We included all newly diagnosed patients with HIV aged 15 and above who consented to recency testing and assessed patient- and health center-related predictors of recent HIV infection using multivariable logistic regression models.</p><p><strong>Results: </strong>We obtained data from 485 of 565 health facilities in Rwanda that introduced PNS and recency testing alongside preexisting testing services. From October 2018 to February 2024, 8940 individuals consented to HIV recency testing. Among them, 537 (6.0%) were recently infected. The odds of detecting a recent HIV infection increased by 1% for each month of experience in PNS. Patient-related factors associated with recent infections included female sex, younger age (15-24 years), residing in southern or northern provinces compared with the western province, and self-reported sex with a known HIV-infected person or unprotected sex outside of a relationship in the last 12 months.</p><p><strong>Conclusions: </strong>Only 6% of newly diagnosed HIV infections were characterized as recent. Public health interventions targeting younger females may assist in reducing new infections in this group.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"388-394"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12187148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772423","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}
Background: Dolutegravir (DTG), an integrase strand transfer inhibitor, is recommended as the preferred first-line HIV medication globally because of higher efficacy, better tolerability, and higher genetic barrier to resistance compared with other antiretroviral therapy (ART) drug classes. However, little is known about the comparative effectiveness of DTG in sustaining durable viral suppression (VS) in real-world settings.
Methods: We analyzed data from electronic health records of a retrospective cohort of ART-naïve (N = 3793) and ART-experienced (N = 14,367) people receiving HIV treatment in Ukraine between October 2017 and September 2018, comparing incidence of viral rebound (viral load ≥ 200 HIV RNA copies/mL) after the first documented VS among participants on DTG-, ritonavir-boosted lopinavir-, and efavirenz-based regimens. Participants were followed until June 2019. Interval censoring survival analysis with cluster-robust standard errors was used to estimate the effects of ART regimen on viral rebound adjusting for demographic and clinical characteristics.
Results: N = 714 (3.9%) participants experienced viral rebound during follow-up. In the ART-naïve cohort, the incidence of rebound was 6.9 events [95% confidence interval (CI): 5.9 to 8.0] per 100 person-years. Ritonavir-boosted lopinavir-based regimens were associated with higher hazard of rebound compared with DTG-based regimens: adjusted hazard ratio = 1.8 (95% CI: 1.3 to 2.4). Efavirenz-based regimens had similar incidence of rebound compared with DTG: adjusted hazard ratio = 1.1 (95% CI: 0.9 to 1.3).
Conclusions: Favorable performance of DTG compared with other first-line ART options in sustaining VS supports continued roll-out of DTG-based regimens. High overall incidence of viral rebound, including on DTG-based regimens, calls for targeted evidence-based adherence support interventions and improved viral load and drug resistance monitoring, especially among high-risk populations.
背景:与其他抗逆转录病毒治疗(ART)药物类别相比,整合酶链转移抑制剂Dolutegravir (DTG)具有更高的疗效、更好的耐受性和更高的耐药遗传屏障,因此被推荐为全球首选的一线HIV药物。然而,在现实环境中,DTG在维持持久病毒抑制(VS)方面的相对有效性知之甚少。方法:我们分析了2017年10月至2018年9月期间在乌克兰接受艾滋病毒治疗的ART-naïve (N=3793)和art经验(N=14367)患者的电子健康记录数据,比较了DTG、利托那韦增强洛匹那韦(LPV/r)和依非韦伦(EFV)方案的参与者在首次记录的VS后的病毒反弹发生率(病毒载量200 HIV RNA拷贝/ml)。参与者被跟踪到2019年6月。采用具有聚类稳健性标准误差的间隔筛选生存分析来估计ART方案对病毒反弹的影响,并根据人口统计学和临床特征进行调整。结果:N=714(3.9%)参与者在随访期间出现病毒反弹。在ART-naïve队列中,反弹发生率为每100人年6.9次(95%CI: 5.9-8.0)。与以dtg为基础的方案相比,以LPV/r为基础的方案与更高的反弹风险相关:aHR=1.8 (95%CI: 1.3-2.4)。与DTG相比,以efv为基础的方案有相似的反弹发生率:aHR=1.1 (95%CI: 0.9-1.3)。结论:与其他一线抗逆转录病毒治疗方案相比,DTG在维持VS中的良好表现支持了基于DTG的方案的持续推广。病毒反弹的总体发生率高,包括基于dtg的方案,需要有针对性的循证依从性支持干预措施,并改进病毒载量和耐药性监测,特别是在高危人群中。
{"title":"HIV Viral Rebound on Dolutegravir, Lopinavir, and Efavirenz: National Program Data Analysis From Ukraine.","authors":"Olga Morozova, Kyle Conroy, Serhii Riabokon, Myroslava Germanovich, Yaroslav Zelinskyi, Nancy Puttkammer, Kostyantyn Dumchev","doi":"10.1097/QAI.0000000000003676","DOIUrl":"10.1097/QAI.0000000000003676","url":null,"abstract":"<p><strong>Background: </strong>Dolutegravir (DTG), an integrase strand transfer inhibitor, is recommended as the preferred first-line HIV medication globally because of higher efficacy, better tolerability, and higher genetic barrier to resistance compared with other antiretroviral therapy (ART) drug classes. However, little is known about the comparative effectiveness of DTG in sustaining durable viral suppression (VS) in real-world settings.</p><p><strong>Methods: </strong>We analyzed data from electronic health records of a retrospective cohort of ART-naïve (N = 3793) and ART-experienced (N = 14,367) people receiving HIV treatment in Ukraine between October 2017 and September 2018, comparing incidence of viral rebound (viral load ≥ 200 HIV RNA copies/mL) after the first documented VS among participants on DTG-, ritonavir-boosted lopinavir-, and efavirenz-based regimens. Participants were followed until June 2019. Interval censoring survival analysis with cluster-robust standard errors was used to estimate the effects of ART regimen on viral rebound adjusting for demographic and clinical characteristics.</p><p><strong>Results: </strong>N = 714 (3.9%) participants experienced viral rebound during follow-up. In the ART-naïve cohort, the incidence of rebound was 6.9 events [95% confidence interval (CI): 5.9 to 8.0] per 100 person-years. Ritonavir-boosted lopinavir-based regimens were associated with higher hazard of rebound compared with DTG-based regimens: adjusted hazard ratio = 1.8 (95% CI: 1.3 to 2.4). Efavirenz-based regimens had similar incidence of rebound compared with DTG: adjusted hazard ratio = 1.1 (95% CI: 0.9 to 1.3).</p><p><strong>Conclusions: </strong>Favorable performance of DTG compared with other first-line ART options in sustaining VS supports continued roll-out of DTG-based regimens. High overall incidence of viral rebound, including on DTG-based regimens, calls for targeted evidence-based adherence support interventions and improved viral load and drug resistance monitoring, especially among high-risk populations.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"395-404"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12629402/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795545","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}
Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003668
Anjali Sharma, Donald R Hoover, Qiuhu Shi, Elizabeth Daubert, Deborah L Jones, Bradley E Aouizerat, Deborah Gustafson, Seble G Kassaye, Elizabeth Topper, Catalina Ramirez, Sushma K Cribbs, Deborah Konkle Parker, Audrey L French, Kathleen M Weber
Background: Poor sleep and frailty are prevalent among aging women with HIV (WWH). Although poor sleep quality has been associated with frailty in general aging populations, these relationships are not well characterized among WWH.
Methods: Among 1001 WWH and 371 women without HIV (WWoH) aged older than 40 years with Pittsburgh Sleep Quality Index (PSQI) and Fried Frailty Phenotype data, we analyzed relationships of poor sleep quality (PSQI>5) and sleep quality components with frailty. Separate hierarchical regression models evaluated associations between sleep and frailty status (prefrail vs. robust, frail vs robust) adjusting for the following: (1) study site and HIV status, (2) demographics, (3) substance use/central nervous system-active medications, (4) comorbidities, and (5) depressive symptoms.
Results: The median age was 53 years; 9.2% were frail while 52.8% were prefrail. Poor sleep quality was frequent (52% WWH vs. 47% WWoH; P = 0.07) and associated with double the frailty odds independent of HIV status, after adjusting for depressive symptoms (fully adjusted odds ratio AOR 1.99, 95% CI: 1.14 to 3.50, P = 0.016). Sleep-associated daytime dysfunction and very poor sleep efficiency were independently associated with being frail. Poor self-rated sleep quality and higher use of sleep medications were independently associated with being prefrail.
Conclusions: Among midlife WWH and WWoH, poor subjective sleep measures are independently associated with higher frailty odds. Longitudinal studies are needed to understand how aspects of sleep may affect progression from prefrailty to frailty after accounting for comorbidities and to elucidate the complex relationships between comorbidities and frailty, with sleep quality among midlife PWH.
{"title":"Poor Sleep Quality is Associated With Frailty Among Women With and Without HIV.","authors":"Anjali Sharma, Donald R Hoover, Qiuhu Shi, Elizabeth Daubert, Deborah L Jones, Bradley E Aouizerat, Deborah Gustafson, Seble G Kassaye, Elizabeth Topper, Catalina Ramirez, Sushma K Cribbs, Deborah Konkle Parker, Audrey L French, Kathleen M Weber","doi":"10.1097/QAI.0000000000003668","DOIUrl":"10.1097/QAI.0000000000003668","url":null,"abstract":"<p><strong>Background: </strong>Poor sleep and frailty are prevalent among aging women with HIV (WWH). Although poor sleep quality has been associated with frailty in general aging populations, these relationships are not well characterized among WWH.</p><p><strong>Methods: </strong>Among 1001 WWH and 371 women without HIV (WWoH) aged older than 40 years with Pittsburgh Sleep Quality Index (PSQI) and Fried Frailty Phenotype data, we analyzed relationships of poor sleep quality (PSQI>5) and sleep quality components with frailty. Separate hierarchical regression models evaluated associations between sleep and frailty status (prefrail vs. robust, frail vs robust) adjusting for the following: (1) study site and HIV status, (2) demographics, (3) substance use/central nervous system-active medications, (4) comorbidities, and (5) depressive symptoms.</p><p><strong>Results: </strong>The median age was 53 years; 9.2% were frail while 52.8% were prefrail. Poor sleep quality was frequent (52% WWH vs. 47% WWoH; P = 0.07) and associated with double the frailty odds independent of HIV status, after adjusting for depressive symptoms (fully adjusted odds ratio AOR 1.99, 95% CI: 1.14 to 3.50, P = 0.016). Sleep-associated daytime dysfunction and very poor sleep efficiency were independently associated with being frail. Poor self-rated sleep quality and higher use of sleep medications were independently associated with being prefrail.</p><p><strong>Conclusions: </strong>Among midlife WWH and WWoH, poor subjective sleep measures are independently associated with higher frailty odds. Longitudinal studies are needed to understand how aspects of sleep may affect progression from prefrailty to frailty after accounting for comorbidities and to elucidate the complex relationships between comorbidities and frailty, with sleep quality among midlife PWH.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"379-387"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779991","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}
Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003670
Ravi Goyal, Gordon Honerkamp-Smith, Alan Wells, Susan J Little, Thomas C S Martin
Background: Effective antiretroviral therapy to maintain durable viral suppression is key to ending the HIV epidemic in the United States. We evaluated the ability of machine learning algorithms to predict people with HIV (PWH) at risk of unsuppressed viral load.
Setting: Retrospective study among PWH from San Diego County (n = 18,916). The study used reported public health HIV data (2017-2022) to predict the outcome of HIV viral load >200 copies/mL during a year-long prediction window.
Methods: The data was partitioned by calendar date into two training and one validation datasets to accurately assess performance for predicting future observations. A random forest model was used to generate outcome predictions for the overall population and stratified by race. Mediation analysis was undertaken to assess underlying causality.
Results: The model had an area under the receiver operating characteristic curve of 82.2 (95% CI: 79.3 to 85.0), a sensitivity of 33.8% (95% CI: 28.6 to 39.0), and specificity of 96.9% (95% CI: 95.7 to 97.2) corresponding to a positive predictive value of 55.7% (95% CI: 48.7 to 62.8) and negative predictive value of 91.7% (95% CI: 90.6 to 92.8). The area under the receiver operating characteristic was similar across races. Prior viral load characteristics were identified as the most important variables; however, they partially acted as mediators of underlying demographic (eg, race) and HIV infection risk (eg, injection drug use).
Conclusions: Machine learning algorithms using mandatory reported public health HIV data can predict which PWH will have future unsuppressed viral load. Future work will assess its clinical utility compared to existing data-to-care initiatives.
背景:在美国,有效的抗逆转录病毒治疗以维持持久的病毒抑制是结束艾滋病流行的关键。我们评估了机器学习(ML)算法预测艾滋病毒感染者(PWH)病毒载量未获抑制风险的能力:对圣地亚哥县的感染者进行回顾性研究(人数=18,916)。该研究使用报告的公共卫生 HIV 数据(2017-2022 年)来预测一年预测窗口期内 HIV 病毒载量(VL)>200 拷贝/毫升的结果:方法:按日历日期将数据分为两个训练数据集和一个验证数据集,以准确评估预测未来观察结果的性能。采用随机森林模型对总体人群进行结果预测,并按种族进行分层。进行了中介分析以评估潜在的因果关系:该模型的接收者操作特征曲线下面积(AUROC)为 82.2(95% CI:79.3-85.0),灵敏度为 33.8%(95% CI:28.6-39.0),特异度为 96.9%(95% CI:95.7-97.2),相应的阳性预测值为 55.7%(95% CI:48.7-62.8),阴性预测值为 91.7%(95% CI:90.6-92.8)。不同种族的 AUROC 相似。先前的病毒载量特征被确定为最重要的变量;然而,它们部分充当了潜在人口统计(如种族)和 HIV 感染风险(如注射吸毒)的中介变量:结论:使用强制报告的公共卫生 HIV 数据的 ML 算法可以预测哪些 PWH 将在未来出现未抑制的病毒载量。未来的工作将评估其与现有的数据到护理计划相比的临床实用性。
{"title":"Predictive Models to Identify Individuals With HIV at Risk of Unsuppressed Viral Load Using Routine Public Health Data.","authors":"Ravi Goyal, Gordon Honerkamp-Smith, Alan Wells, Susan J Little, Thomas C S Martin","doi":"10.1097/QAI.0000000000003670","DOIUrl":"10.1097/QAI.0000000000003670","url":null,"abstract":"<p><strong>Background: </strong>Effective antiretroviral therapy to maintain durable viral suppression is key to ending the HIV epidemic in the United States. We evaluated the ability of machine learning algorithms to predict people with HIV (PWH) at risk of unsuppressed viral load.</p><p><strong>Setting: </strong>Retrospective study among PWH from San Diego County (n = 18,916). The study used reported public health HIV data (2017-2022) to predict the outcome of HIV viral load >200 copies/mL during a year-long prediction window.</p><p><strong>Methods: </strong>The data was partitioned by calendar date into two training and one validation datasets to accurately assess performance for predicting future observations. A random forest model was used to generate outcome predictions for the overall population and stratified by race. Mediation analysis was undertaken to assess underlying causality.</p><p><strong>Results: </strong>The model had an area under the receiver operating characteristic curve of 82.2 (95% CI: 79.3 to 85.0), a sensitivity of 33.8% (95% CI: 28.6 to 39.0), and specificity of 96.9% (95% CI: 95.7 to 97.2) corresponding to a positive predictive value of 55.7% (95% CI: 48.7 to 62.8) and negative predictive value of 91.7% (95% CI: 90.6 to 92.8). The area under the receiver operating characteristic was similar across races. Prior viral load characteristics were identified as the most important variables; however, they partially acted as mediators of underlying demographic (eg, race) and HIV infection risk (eg, injection drug use).</p><p><strong>Conclusions: </strong>Machine learning algorithms using mandatory reported public health HIV data can predict which PWH will have future unsuppressed viral load. Future work will assess its clinical utility compared to existing data-to-care initiatives.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"325-333"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12187155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779995","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}
Pub Date : 2025-08-01DOI: 10.1097/QAI.0000000000003678
Michelle Pham, Prachi Wickremasingha, Ryan Vargo, Munjal Patel, Katherine Nedrow, Brenda Homony, Michael N Robertson, Rebeca M Plank
Background: People living with, or at risk of acquiring, HIV-1 may use hormonal long-acting reversible contraceptives (LARCs). Islatravir is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment of HIV-1. We aimed to evaluate the effects of once-monthly oral islatravir on the pharmacokinetics of LARCs.
Setting: This was an exploratory substudy of a double-blind, randomized, placebo-controlled, phase 2a trial of once-monthly oral islatravir in adults at low risk of HIV-1 infection (MK-8591-016; NCT04003103).
Methods: Participants were randomized 2:2:1 to receive 6 once-monthly doses of oral islatravir 60 mg, oral islatravir 120 mg, or placebo. At randomization, participants using an etonogestrel-releasing implant, injectable medroxyprogesterone acetate, or injectable norethindrone enanthate could enroll in the LARC substudy. LARC use was not a stratification factor. Plasma samples for hormone concentrations were collected at normally scheduled study visits and assayed using high-performance liquid chromatographic-tandem mass spectrometric methods.
Results: The analyses included 36 participants (etonogestrel, n = 8; medroxyprogesterone acetate, n = 20; norethindrone enanthate, n = 9; 1 participant was in 2 groups because of contraceptive change midstudy). No differences in hormone concentrations were observed between islatravir groups and placebo. Although sampling was insufficient to characterize full pharmacokinetics parameters, hormone concentrations were above the thresholds for contraceptive effectiveness for 94.4% (34/36) of participants.
Conclusions: Coadministration with once-monthly islatravir does not seem to affect exposure to LARCs in people at low risk of HIV-1 infection. Owing to the exploratory nature of this substudy, prospective studies are needed to verify these findings.
{"title":"Brief Report: Exploratory Substudy of a Phase 2 Trial to Evaluate the Pharmacokinetic Effect of Once-Monthly Islatravir on Long-Acting Reversible Contraceptives.","authors":"Michelle Pham, Prachi Wickremasingha, Ryan Vargo, Munjal Patel, Katherine Nedrow, Brenda Homony, Michael N Robertson, Rebeca M Plank","doi":"10.1097/QAI.0000000000003678","DOIUrl":"10.1097/QAI.0000000000003678","url":null,"abstract":"<p><strong>Background: </strong>People living with, or at risk of acquiring, HIV-1 may use hormonal long-acting reversible contraceptives (LARCs). Islatravir is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment of HIV-1. We aimed to evaluate the effects of once-monthly oral islatravir on the pharmacokinetics of LARCs.</p><p><strong>Setting: </strong>This was an exploratory substudy of a double-blind, randomized, placebo-controlled, phase 2a trial of once-monthly oral islatravir in adults at low risk of HIV-1 infection (MK-8591-016; NCT04003103).</p><p><strong>Methods: </strong>Participants were randomized 2:2:1 to receive 6 once-monthly doses of oral islatravir 60 mg, oral islatravir 120 mg, or placebo. At randomization, participants using an etonogestrel-releasing implant, injectable medroxyprogesterone acetate, or injectable norethindrone enanthate could enroll in the LARC substudy. LARC use was not a stratification factor. Plasma samples for hormone concentrations were collected at normally scheduled study visits and assayed using high-performance liquid chromatographic-tandem mass spectrometric methods.</p><p><strong>Results: </strong>The analyses included 36 participants (etonogestrel, n = 8; medroxyprogesterone acetate, n = 20; norethindrone enanthate, n = 9; 1 participant was in 2 groups because of contraceptive change midstudy). No differences in hormone concentrations were observed between islatravir groups and placebo. Although sampling was insufficient to characterize full pharmacokinetics parameters, hormone concentrations were above the thresholds for contraceptive effectiveness for 94.4% (34/36) of participants.</p><p><strong>Conclusions: </strong>Coadministration with once-monthly islatravir does not seem to affect exposure to LARCs in people at low risk of HIV-1 infection. Owing to the exploratory nature of this substudy, prospective studies are needed to verify these findings.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"374-378"},"PeriodicalIF":2.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12187151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969958","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}