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Background: Older people with HIV (PWH) are at risk of polypharmacy (taking multiple medications). Most medications may be necessary and indicated to manage HIV (e.g., antiretroviral therapy [ART]) and HIV-associated comorbidities. However, some are potentially inappropriate medications (PIMs), defined as causing greater harm than benefit, which leads to medication overload. The objective of this study was to characterize polypharmacy (taking multiple medications) and medication overload (prescription of ≥ 1 PIMs) among older PWH., Methods: This retrospective study included older PWH (aged ≥ 50 years old) attending the tertiary care HIV clinic at the McGill University Health Centre (Montreal, Canada), from June 2022-June 2023. Patient characteristics, medications, and select laboratory values (e.g., CD4 count, hemoglobin A1C) were entered into the MedSafer software identifying PIMs and classifying them according to risk of adverse drug event. We measured the prevalence of polypharmacy (≥ 5 medications prescribed, both including and excluding ART) and medication overload (≥ 1 PIMs). Multivariable logistic regression identified factors associated with medication overload., Results: The study included 100 patients, with a median age of 59 years (IQR = 54-63; range 50-82); 42% female. Polypharmacy affected 89% of patients when including antiretroviral therapy (ART) and 60% when excluding ART. Medication overload was present in 58% of patients, and 37.4% of identified PIMs were classified as high-risk. Polypharmacy was the sole predictor of medication overload., Conclusion: Older PWH are at significant risk of medication overload and receiving higher risk PIMs. Deprescribing PIMs in this population could improve medication appropriateness while reducing the risk of ADEs., (© 2024. The Author(s).)

Background: Anemia is a common complication of HIV infected children and it is enabling HIV disease progression, and decreasing survival. In Ethiopia, there is limited evidence on the prevalence of anemia and its associated factors among HIV infected children particularly in the Awi Zone. Therefore, this study aimed to assess the magnitude and associated factors of anemia among HIV infected children on ART aged from 6 months to 15 year-old in ART Clinic, Awi-Zone, Ethiopia., Objective: To assess the magnitude and associated factors of anemia among HIV infected children on antiretroviral therapy in Awi zone health facilities, Northwest, Ethiopia, 2022., Methods: A facility based cross-sectional study design was conducted from October to December 2022. A simple random sampling method was used to select the study participants. Descriptive statistics, including frequencies and proportions was used to summarize the study variables and data had been entered in to Epi data 4.2 and exported to SPSS version 25. Bivariable logistic regression followed by multivariable logistic regression was performed. Degree of association between dependent and independent variables had been assessed using adjusted odds ratio with 95% CI at p value of ≤ 0.05., Result: From 346 participants in the selected sample 339 (97.9%) of them responded. Prevalence of anemia was 13.3% (n = 45) among which, majority (44.4%) of them had mild anemia, while about (42.2%,) had moderate anemia and around 13.3%, of them were severely anemic. Baseline CD4 count (AOR = 6.58, 95% CI: 2.85-15.22), WHO clinical stage III or IV (AOR = 8.42, 95% CI = 3.47, 20.45), hookworm infection (AOR = 5.06, 95% CI = 2.04, 12) and malaria infection (AOR = 4.92, 95% CI (2.19-11.02) were significantly associated with anemia among children on HAART., Conclusion: The prevalence of anemia among participants was relatively low in this study. However, a considerable proportion of participants had moderate to severe anemia. Lower CD4 count at enrolment, advanced HIV clinical stage, malaria and hookworm infection were significantly linked with anemia. Thus, it requires regular monitoring of anemia status in these patients for better clinical outcomes and quality of life improvements., (© 2024. The Author(s).)

Aim: This study aimed to assess the impact of Mobile health (M-health) on medication time adherence among people living with HIV/AIDS (PLWHA)., Methods: The study included all PLWHA who were receiving care at the Federal University Teaching Hospital Owerri (FUTH) and Imo State Specialist Hospital (ISSH) Umugumma during the study duration. The test group (FUTH) received a 2-way text message sent three times a week and a once-a-week phone call, while the control group (ISSH) received only the standard care., Findings: The result shows that the adherence was higher among PLWHA in the test group compared to those in the control group (P = 0.000, χ2 = 168.62, 95% confidence interval (CI): 7.22 to 16.19)., Conclusion: M-health intervention significantly improved the medication time adherence among the participants in the test group compared to those in the control group., (© 2024. The Author(s).)

Background: In Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services., Methods: We conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.gov: NCT03593629). Eligible participants were ≥ 18 years, refilling PrEP for the first time, and either in an HIV serodifferent relationship (men and women) or singly enrolled (women only). A subset of participants in the intervention group completed serial in-depth interviews (IDIs) at enrollment, six months, and 12 months. We utilized stratified purposive sampling to ensure representation across participant groups. We analyzed our qualitative data thematically using a combination of inductive and deductive approaches, the latter guided by the Theoretical Framework of Acceptability (TFA)., Results: Between May 2018 and June 2021, we conducted 120 serial IDIs with 55 participants; 64% (35/55) were in a serodifferent relationship, 64% (35/55) were women, and the median age was 32 years (IQR 27-40). Overall, participants found this novel PrEP delivery model highly acceptable; it was well-liked, private (TFA construct: affective attitude), and less burdensome (TFA construct: burden) compared to standard PrEP delivery. Additionally, participants were confident in their ability to participate in the intervention (TFA construct: self-efficacy). Some participants, however, highlighted model disadvantages, including fewer opportunities for in-person counseling and potentially less accurate HIV testing (TFA construct: opportunity costs). Ultimately, most participants reported that the intervention allowed them to achieve their HIV prevention goals (TFA construct: perceived effectiveness) and that their confidence in at-home HIVST and PrEP continuation increased following each semiannual clinic visit., Conclusions: Semiannual PrEP clinic visits supported with six-monthly drug dispensing and interim HIVST was acceptable among PrEP users who experienced the intervention in Kenya. More comprehensive pre-intervention counseling and training on HIVST may help alleviate the client concerns presented, which were often resolved over time with intervention experience., (© 2024. The Author(s).)

Background: Protease inhibitor (PI)-based Antiretroviral Therapy (ART) regimens are key drugs in HIV management, especially when used as second line drugs. However, some PI-based ART have high adherence demands or tolerable adverse effects which may affect adherence and subsequently viral suppression. We assessed the extent of viral suppression, its determinants, and the experiences of clients on PI-based ART undergoing intensive adherence counselling (IAC) in a public HIV clinic., Methods: Mixed methods sequential explanatory study involving a quantitative retrospective chart review for clients on PI-based ART who had received IAC from Dec 2016 to May 2023 and qualitative interviews for clients on PI-based ART who had received IAC in the past six months at an urban public HIV clinic in Uganda., Results: In this study, a total of 189 client charts were included. The median number of IAC sessions received was three (interquartile range, IQR, of 3 to 4) with median time of receiving IAC of three ( IQR, of 2 to 4). One half (51%, 95/186) of the clients had achieved viral suppression and the odds of suppression increased by 30% for every additional month on IAC. Respondents perceived the effectiveness of PI-based ART and IAC in achieving and supporting viral suppression, respectively., Conclusion: Despite the perceived effectiveness of PI-based ART and IAC, suboptimal levels of viral suppression were observed among clients on PI-based ART who had received IAC. Therefore, it is important to provide IAC for optimal duration as it increases the chances of viral suppression. Further investigation of the barriers of viral suppression for clients on PI-based ART undergoing IAC is needed., (© 2024. The Author(s).)

Background: Although long-acting, injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention in clinical trials, research is needed to guide effective implementation in real-world settings. Formative work with community members and health care providers (HCPs) is important to provide insight into the needs and contexts of specific populations and reveal potential barriers and facilitators for implementation projects., Objective: We aimed to describe the results from formative work to develop an implementation package for CAB-LA PrEP within the ImPrEP CAB Brasil study., Methods: ImPrEP CAB Brasil is an implementation study of same-day delivery of CAB-LA PrEP for young sexual and gender minority (SGM) groups (aged 18-30 years) in 6 existing oral PrEP public health clinics. We conducted formative research to prepare for the implementation of ImPrEP CAB Brasil through community mobilization, process mapping with HCPs with experience in CAB-LA, and focus group discussions (FGDs) with young SGM groups (n=92) and HCPs (n=20) to identify initial perceptions of facilitators and barriers for CAB-LA PrEP implementation, refine the mobile health (mHealth) educational tool, and evaluate the acceptability of using a text message appointment reminder intervention through WhatsApp. FGDs were recorded, transcribed, systematically coded, and analyzed with thematic categorization by trained researchers using a qualitative data analysis program ATLAS.ti (version 7)., Results: A community mobilization team comprising 34 SGM community leaders collaborated in creating a prototype for an mHealth educational tool and contributed to the planning of peer education activities. We created 3 process maps for each site to describe the initial visit, follow-up visits, and laboratory flow. The main challenge identified for same-day CAB-LA PrEP delivery was the extended duration of clinic visits due to the numerous laboratory tests and HIV counseling steps required. Proposed solutions included having point-of-care HIV rapid tests instead of laboratory tests and additional counseling staff. Barriers for CAB-LA PrEP implementation identified through FGDs were the training of HCPs, support for adherence to injection appointments, and stigma or discrimination against SGM groups and persons using PrEP. The mHealth educational tool and WhatsApp reminders were highly acceptable by SGM groups and HCPs, indicating their potential to support PrEP choice and adherence. Content analysis on the cultural appropriateness of the language and overall clarity of the material contributed to the refinement of the mHealth tool., Conclusions: Structured formative work with SGM persons and HCPs generated important refinements to context-specific materials and plans to launch ImPrEP CAB Brasil in public health clinics. Ongoing implementation monitoring will use the process maps to identify additional barriers and potential solutions to same-day delivery of CAB-LA PrEP. Summative evaluations are needed to measure the effectiveness of the mHealth educational tool to support PrEP choice and the use of WhatsApp appointment reminders., (©M Cristina Pimenta, Thiago Silva Torres, Brenda Hoagland, Mirian Cohen, Claudio Gruber Mann, Cristina M Jalil, Eduardo Carvalheira, Lucilene Freitas, Nilo Fernandes, Debora Castanheira, Marcos Benedetti, Julio Moreira, Keila Simpson, Roberta Trefiglio, Gabrielle O’Malley, Valdilea G Veloso, Beatriz Grinsztejn. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 24.10.2024.)

Background: HPTN 084 compared the safety and efficacy of long-acting injectable cabotegravir (CAB) to daily oral TDF/FTC for prevention of HIV-1 in uninfected African women. Like a similar trial in MSM/TGW (HPTN 083), the trial was stopped early for efficacy, expediting the need to consider introduction strategies for different populations. We examine survey and qualitative data from a four-country sub-study to examine oral and injectable PrEP acceptability and considerations for CAB access among African women., Methods: Participants completed baseline and follow-up surveys on HIV risk perception, sexual behavior. product acceptability and adherence during the blinded trial. Additionally, up to two in-depth interviews each with 73 sub-study participants explored product use and trial-related experiences, during the blinded and unblinded study periods. Using survey data, we classified participants as: engaged in female sex work (FSW), having multiple non-transactional partners, or monogamous. A study statistician identified participants' assigned study arm. We followed a thematic analysis process to read transcripts, develop a codebook and apply codes in NVivo to transcripts with intermittent intercoder reliability checks; using Excel matrices to explore differences across risk categories and study arms., Findings: Participants overwhelmingly preferred injections to pills, appreciating the ease, convenience, and privacy of a long-acting formulation. Many participants described challenges with contraceptive and/or study pill adherence, impeded by late night work, unexpected travel, or heavy drinking. Women in the TDF/FTC arm were more likely to describe side effects, compared to those in the CAB arm. Pain also varied widely by study arm. When considering post-trial access to CAB, limited PrEP knowledge, cost and concerns around stigma and poor service quality were potential access barriers., Conclusion: Women's desire for privacy and ease of use outweighed injectable concerns, resulting in a strong preference for CAB. Cost and accessibility will need to be addressed by implementation programs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Tolley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

This study aimed to ascertain how the current two ART regimens used in Ghana affected HIV patients' coagulation profiles. A case-control study was conducted on 102 HIV positive patients at the Mampong Municipal Hospital. Coagulation parameters measured showed APTT was normal in majority of ART-experienced participants but prolonged in majority of ART-naïve participants. The mean platelet count was significantly higher in ART-experienced participants. No significant differences were found between the coagulation profiles of ART-experienced patients on two different drug regimens. In conclusion, current ART can enhance the coagulation profiles in HIV-infected patients, by improving platelet count and APTT., (© 2024. The Author(s).)

Background: Adherence to option B+antiretroviral therapy medication is crucial for the effective implementation of the Prevention of Mother-to-Child Transmission (PMTCT) programme. Ethiopia has adopted the WHO's target of achieving over 95% adherence. However, research conducted in southern Ethiopia found that only 81.4% of women adhered to option B+medication, which reflects a poor level of adherence and remains a concern., Objective: The objective of the study was to assess the level of option B+PMTCT drug adherence and associated factors among women who were breast feeding for up to 18 months in government health facilities of North Gojjam Zone, Amhara region, Northwest Ethiopia, 2022 DESIGN: An institution-based cross-sectional study was conducted., Setting: The study was carried out in hospitals located in the North Gojjam Zone of Northwest Ethiopia., Participants: The study was conducted with 223 HIV-positive women who were breast feeding for up to 18 months, from 1 March 2022 to 30 April 2022., Primary and Secondary Outcomes: The primary outcome was to assess the level of option B+PMTCT drug adherence, while the secondary outcome was to identify factors associated with option B+PMTCT drug adherence among HIV-positive women who were breast feeding for up to 18 months. Associations between variables were analysed using both bivariate and multivariable logistic regression models, with a p<0.05 considered statistically significant at the 95% confidence level., Results: A total of 223 participants were included, yielding a response rate of 97.8%. The adherence to option B+PMTCT drugs was 62.8%. The type of health facility (adjusted OR, AOR=0.17 (95% CI: 0.008 to 0.35)), partner support involvement (AOR=3.03 (95% CI: 1.12 to 9.13)) and the time taken to reach the facility from home (AOR=6.34 (95% CI: 2.92 to 13.75)) were significantly associated with the level of option B+PMTCT drug adherence., Conclusion: Option B+PMTCT drug adherence was lower than the recommended level. The type of health facility, partner support and the time required to travel from home to the facility were factors associated with adherence to option B+PMTCT medication. Support from a partner is crucial for improving adherence to option B+medication., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Ainuovirine (ANV) is a new generation of non-nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) type 1 infection. This study aimed to evaluate the population pharmacokinetic (PopPK) profile and exposure-response relationship of ANV among people living with HIV., Methods: Plasma concentration-time data from phase 1 and phase 3 clinical trials of ANV were pooled for developing the PopPK model. Exposure estimates obtained from the final model were used in exposure-response analysis for virologic responses and safety responses., Results: ANV exhibited a nonlinear pharmacokinetic profile, which was best described by a two-compartment model with first-order elimination. There were no significant covariates correlated to the pharmacokinetic parameters of ANV. The PopPK parameter estimate (relative standard error [%]) for clearance adjusted for bioavailability (CL/F) was 6.46 (15.00) L/h, and the clearance of ANV increased after multiple doses. The exposure-response model revealed no significant correlation between the virologic response (HIV-RNA <50 copies/mL) at 48 weeks and the exposure, but the incidence of adverse events increased with the increasing exposure ( P value of steady-state trough concentration and area under the steady-state curve were 0.0177 and 0.0141, respectively)., Conclusions: Our PopPK model supported ANV 150 mg once daily as the recommended dose for people living with HIV, requiring no dose adjustment for the studied factors. Optimization of ANV dose may be warranted in clinical practice due to an increasing trend in adverse reactions with increasing exposure., Trial Registration: Chinese Clinical Trial Registry https://www.chictr.org.cn (Nos. ChiCTR1800018022 and ChiCTR1800019041)., (Copyright © 2024 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.)

HIV-1 drug resistance (HIVDR) impedes treatment and control of HIV-1, especially in high-prevalence settings such as KwaZulu-Natal (KZN) province, South Africa. This study merged routine HIV-1 genotypic resistance test (GRT) data with Geographic Information Systems coordinates to assess patterns and geographic distribution of HIVDR in KZN, among ART-experienced adults with virological failure. We curated 3133 GRT records generated between 1 January 2018 and 30 June 2022, which includes the early phase of dolutegravir (DTG) rollout, of which 2735 (87.30%) had HIVDR. Of the 2735, major protease, nucleoside, and non-nucleoside reverse transcriptase inhibitor mutations were detected in 41.24%, 84.97% and 88.08% of GRTs, respectively. Additional genotyping of HIV-1 integrase for 41/3133 (1.31%) GRTs showed that 17/41 (41.46%) had integrase strand transfer inhibitor resistance. Notably, of 26 patients on DTG with integrase genotyping, 9 (34.62%) had DTG-associated resistance mutations. Dual- or triple-class resistance was observed in four of every five GRTs. The odds of HIVDR increased significantly with age, with ≥60 years having 5 times higher odds of HIVDR compared to 18-29 years ( p = 0.001). We identified geospatial differences in the burden of HIVDR, providing proof of concept that this could be used for data-driven public health decision making. Ongoing real-time HIVDR surveillance is essential for evaluating the outcomes of the updated South African HIV treatment programme.

Peptide-based inhibitors represent a promising approach for the treatment of HIV-1, offering a range of potential advantages, including specificity, low toxicity, and the ability to target various stages of the viral lifecycle. This review outlines the current state of research on peptide-based anti-HIV therapies, highlighting key advancements and identifying future research directions. Over the past few years, there has been significant progress in developing synthetic peptide-based drugs that target various stages of the viral life cycle, including entry and replication. These approaches aim to create effective anti-HIV therapies. Additionally, peptides have proven valuable in the development of anti-HIV vaccines. In the quest for effective HIV vaccines, discovering potent antigens and designing suitable vaccine strategies are crucial for overcoming challenges such as low immunogenicity, safety concerns, and increased viral load. Innovative strategies for vaccine development through peptide research are, therefore, a key focus area for achieving effective HIV prevention. This review aims to explore the strategies for designing peptides with anti-HIV activity and to highlight their role in advancing both therapeutic and preventive measures against HIV.

Despite the efficacy of antiretroviral therapy (ART) in reducing the global incidence of vertical HIV transmissions, more than 120,000 children are still infected with the virus each year. Since ART cannot clear the HIV reservoir that is established soon after infection, children living with HIV (CLWH) are forced to rely on therapy for their lives and suffer from long-term drug-related complications. Pediatric HIV infection, like adult infection, is associated with gut microbial dysbiosis, loss of gut epithelial integrity, bacterial translocation, CD4 + T cell depletion, systemic immune activation, and viral reservoir establishment. However, unlike in adults, HIV that is vertically acquired by infants interacts with a gut microbiome that is continuously evolving while concomitantly shaping the infant's immune ontogeny. Therefore, to determine whether there may be interventions that target the HIV reservoir through microbiome-directed approaches, understanding the complex tripartite interactions between the transmitted HIV, the maturing gut microbiome, and the developing immune system during early life is crucial. Importantly, early life is the time when the gut microbiome of an individual is highly dynamic, and this temporal development of the gut microbiome plays a crucial role in educating the maturing immune system of a child. Therefore, manipulation of the gut microbiome of CLWH to a phenotype that can reduce HIV persistence by fostering an antiviral immune system might be an opportune strategy to achieve ART-free viral suppression in CLWH. This review summarizes the current state of knowledge on the vertical transmission of HIV, the developing gut microbiome of CLWH, and the immune landscape of pediatric elite controllers, and explores the prospect of employing microbial modulation as a potential therapeutic approach to achieve ART-free viral suppression in the pediatric population., (© 2024. The Author(s).)

Background and Objective : The complexity of antiretroviral therapy (ART) regimens in people living with HIV (PLHIV) poses significant challenges for medication management, impacting adherence and overall health outcomes. The Medication Regimen Complexity Index (MRCI) is a tool that quantifies regimen complexity, yet its correlation with hospitalization rates and adverse drug reactions (ADRs) in PLHIV remains underexplored. Materials and Methods : This prospective study, which was conducted at a government-funded antiretroviral treatment center, investigated the relationships among MRCI scores, hospitalization due to ADRs, and the ADR rates in 285 PLHIV participants over 18 months. Results : The study revealed a significant association between higher baseline MRCI scores and hospitalization due to ADRs, with a threshold MRCI score of 8 indicating increased risk. There was no significant association between average MRCI scores and overall ADR rates or non-ADR-related hospitalizations. Conclusions : These findings emphasize the importance of monitoring medication regimen complexity in PLHIV, particularly in the context of preventing hospitalizations related to ADRs. Further research is needed to understand the multifactorial influences on ADR occurrence and to optimize ART regimens for better patient outcomes.

Background: Transmitted drug resistance (TDR) increases the risk of antiretroviral therapy (ART) failure in HIV-1 patients. This study investigated the molecular epidemiology of TDR and its transmission networks among newly diagnosed HIV-1 patients in Wenzhou, China., Methods: We enrolled 1878 ART-naive HIV-1 patients from January 2020 to October 2023. TDR was evaluated using the Stanford University HIV Drug Resistance Database. We performed phylogenetic analysis, genotyping, transmission clustering, and population-based TDR-related factor analysis., Results: Among 1782 patients with successful genotyping, TDR prevalence was 5.7%. Multivariable analysis identified CRF08&#95;BC subtype (adjusted odds ratio [aOR] 18.59, 95% CI 3.79-336.18, p = 0.004), CD4 > 500 cells/mm³ (aOR 2.19, 95% CI 1.16-4.03, p = 0.013), and year 2023 (aOR 1.83, 95% CI 1.11-4.89, p = 0.039) as factors associated with higher TDR risk. The most prevalent NNRTI mutations were K103N, E138A, and V179E. Seven TDR transmission clusters were identified, notably one with V179D that expanded during 2020-2023., Conclusions: While TDR prevalence in Wenzhou remained lower than in other Chinese regions, an upward trend was observed. Most resistant individuals were in transmission clusters, predominantly middle-aged and elderly. NNRTI resistance was severe and concentrated in efavirenz, nevirapine, and rilpivirine. Enhanced HIV surveillance and wider free antiretroviral options are crucial to control drug-resistant HIV spread in Wenzhou., (© 2024. The Author(s).)

Objective: HIV-1 management has advanced significantly with antiretroviral therapy (ART), yet challenges persist, including low-level HIV-1 viraemia (LLV). LLV presents a complex scenario, with varied definitions in the literature, reflecting uncertainties in its clinical interpretation. Questions arise regarding the underlying mechanisms of LLV, whether it signifies ongoing viral replication or stems from other factors. This study aimed to systematically review strategies for LLV management, providing insights into optimal clinical approaches., Methods: MEDLINE, EMBASE, Cochrane Library, Web of Science and Canadian Agency for Drugs and Technologies in Health were searched for relevant literature on LLV management. We included studies published between 2004 and 2024, assessing interventions such as ART modification, genotypic resistance testing, adherence assessment, performing therapeutic drug monitoring, testing for chronic coinfections and assessing the viral reservoir via HIV DNA quantification. Meta-analyses were conducted where feasible., Results: The systematic review identified 48 eligible records. Findings indicated limited evidence supporting the effectiveness of ART regimen modification in achieving virological suppression among individuals with LLV. However, studies assessing genotypic resistance testing revealed a significant association between resistance-associated mutations and virological suppression during LLV. Adherence to ART emerged as a critical determinant of treatment efficacy, with interventions showing promise in achieving viral suppression. The clinical utility of therapeutic drug monitoring in managing LLV remained inconclusive. Gaps in the literature were identified regarding follow-up scheduling, managing concurrent chronic infections and assessing inflammatory markers in LLV management., Conclusions: While ART modification may not consistently achieve virological suppression, genotypic resistance testing may offer insights into treatment outcomes. Adherence to ART emerged as a crucial factor, necessitating tailored interventions. However, further research is needed to elucidate the clinical utility of therapeutic drug monitoring and other management strategies. The study highlights the importance of ongoing research to refine therapeutic approaches and improve patient outcomes in LLV management., Prospero Registration Number: CRD42024511492., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: While antiretroviral therapy (ART) is highly effective, detection of low levels of HIV-1 RNA in plasma is common in treated individuals. Given the uncertainties on the topic, we convened a panel of experts to consider different clinical scenarios, producing a Delphi consensus to help guide clinical practice., Methods: A panel of 17 experts in infectious diseases, virology and immunology rated 32 statements related to four distinct scenarios: (1) low-level viremia during stable (≥6 months) first-line ART (≥2 consecutive HIV-1 RNA measurements 50-500 copies/mL); (2) a viral blip during otherwise suppressive ART (a HIV-1 RNA measurement 50-1000 copies/mL with adjacent measurements <50 copies/mL); (3) low-level viral rebound during previously suppressive ART (≥2 consecutive HIV-1 RNA measurements 50-500 copies/mL); (4) residual viremia during suppressive ART (persistent HIV-1 RNA quantification below 50 copies/mL). A systematic review, conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement, informed the 32 statements. The Delphi procedure was modified to include two voting rounds separated by a moderated group discussion. Grading of Recommendations, Assessment, Development, and Evaluations-based recommendations were developed., Results: Overall, 18/32 statements (56.2%) achieved a strong consensus, 3/32 (9.4%) achieved a moderate consensus and 11/32 (34.4%) did not achieve a consensus. Across the four scenarios, the panel unanimously emphasised the importance of implementing specific interventions prior to considering therapy changes, including assessing adherence, testing for genotypic drug resistance and scheduling more frequent follow-up visits. Strategies indicated in selected circumstances included therapeutic drug monitoring, quantifying total HIV-1 DNA and evaluating concomitant chronic infections., Conclusions: While acknowledging the many uncertainties about source, significance and optimal management of low-level viremia during ART, the findings provide insights to help harmonise clinical practice. There is a need for well-designed randomised studies assessing different interventions to manage low-level viremia and future research regarding its definition., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

: Background : ART forgiveness is the ability of a regimen to maintain HIV-RNA suppression despite a documented imperfect adherence. We explored forgiveness of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). : Methods : In this retrospective cohort study pharmacy drug refills were used to calculate the proportion of days covered (PDC) as a proxy of adherence. Forgiveness was defined as the possibility to achieve a selected HIV-RNA threshold by a given level of imperfect adherence. A logistic model was applied to verify the impact of baseline variables and adherence on the virologic outcomes. : Results : We enrolled 420 adults. From them, 787 one-year time-periods were derived for a median cohort follow-up of 873 person/years. Most of them were males (73.1%); the most frequent risk factor for HIV infection was heterosexual contacts (49.5% of cases), followed by 22.5% MSM and 22.5% intravenous drug users. The median age of enrolled persons with HIV was 51 years (IQR 45-57 years); the median duration of HIV infection was 7.9 years (IQR 4-18 years) and the median nadir of CD4 cells was 277 cells/mcL (IQR 100-513 cells/mcL). Adherence showed a median of 0.97 (IQR 0.91-1.00), consequently only 17 time-periods (2.2%) in 17 different individuals (4.0%) showed HIV-RNA blood levels above 200 copies/ml. A PDC of 0.75 was sufficient to obtain in > 90% of cases the virologic outcome for both 200 copies/ml or 50 copies/ml. An adherence value of 0.85 obtained a positive response in virtually all subjects either for a cut-off of 50 or 200 copies/ml. : Conclusions : Long-term success of ART needs effective, well tolerated, friendly regimens. Adherence remains a crucial determinant of long-term success, but suboptimal adherence levels are relatively common. Given this, an elevated forgiveness plays a relevant role to further improve long-term outcomes and should be considered a fundamental characteristic of any antiretroviral regimen. B/F/TAF has been proved to have all of these characteristics., Competing Interests: Competing interests: FM has received research funding, fees for scientific advisory boards and speaker honoraria from ViiV Healthcare, Gilead, Janssen and MSD. LT attended advisory boards or served as consultant or received grants for conference participations from Gilead Sciences, ViiV Healthcare and Janssen. ADB has received funding for scientific advisory boards, travel and speaker honoraria from ViiV Healthcare, Gilead, Janssen, AbbVie and MSD. All other no disclosure., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Pharmacy-based PrEP service delivery models can help address many of the barriers that inhibit the uptake of PrEP. In an increasing number of states, legislation has been passed, or is under consideration, to allow pharmacists to initiate PrEP without a prescription from a physician or other prescriber. However, there is not yet legislation in Washington, DC to allow pharmacy-based PrEP despite its potential to curb new cases of HIV, which disproportionately affect the Black community in the area. The DC Ends HIV Plan has a goal of less than 130 new cases of HIV per year by 2030, which would require that over 13,000 high-risk residents use PrEP. However, in 2021 only 6,724 Washingtonians were taking PrEP. This study seeks to address the absence of critical formative research into the factors that would influence the implementation of pharmacy-based PrEP in Washington DC using the Implementation Mapping (IM) framework. A needs assessment will be conducted through in-depth interviews (IDIs) with pharmacists (n = 6), PrEP providers (n = 6), current PrEP users (n = 6), DC Department of Health officials (n = 2), DC Board of Pharmacy officials (n = 4) and pharmacy-based PrEP experts (n = 4) to provide input on the operational aspects of pharmacy-based PrEP model as a strategy to increase PrEP uptake. Information gathered through this needs assessment will be used to develop standard operating procedures for the introduction of pilot pharmacy-based PrEP into community-based retail pharmacies., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Tun et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: The Joint United Nations Programme on Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) (UNAIDS) aims to eradicate AIDS by 2030 through 95:95:95 targets: identifying 95% of persons living with HIV (PLHIV), initiating 95% of those identified on antiretroviral therapy (ART), and ensuring that 95% of those initiated on ART are virally suppressed. Virally suppressed patients pose minimal risk of HIV transmission. ART aims to suppress the HIV-viral load (VL) and increase immunity, reducing morbidity and mortality. This study aimed to determine the trends in VL suppression among HIV patients on ART from 2019 to 2023 at Asante Mampong Municipal Hospital., Methods: This study adopted a retrospective Hospital-based design in which secondary data from 842 patients on ART from 2019 to 2023 were used. The study design specifically involved conducting serial cross-sectional studies to measure the prevalence of VL suppression each year from 2019 to 2023. This approach allowed the researchers to analyse the annual prevalence of VL suppression among study participants without following individual participants longitudinally throughout the entire period. The data were analysed via STATA version 17.0. Chi-square and logistic regressions were used to determine the associations between VL suppression and the independent variables at p < 0.05 and 95% confidence intervals (CIs)., Results: In 2019, VL suppression was 79.6%, decreasing to 40.0% in 2020 and then rising to 82.7% in 2021, dropping to 67.8% in 2022 and 66.7% in the first quarter of 2023. Clients aged 40-49, 50-59, and 60-69 years were more likely to have VL suppression [aOR = 4.4 (1.36-14.25), p = 0.013], [aOR = 5.5 (1.65-18.39), p = 0.006] and [aOR = 5.0 (1.42-17.46), p = 0.012], respectively. Clients who were consistently on the same type of ART for more than a year were more likely to have VL suppression [aOR = 10.6 (4.18-26.76), p < 0.001]., Conclusion: VL suppression was low among patients. Advanced age and being on the same ART for more than 12 months were significantly associated with VL suppression. Health promotion activities are needed for people who have been suppressed to maintain and achieve a lifetime undetectable VL, targeting the younger age group., (© 2024. The Author(s).)

Despite the success in the management of HIV with antiretroviral therapy (ART), people with HIV (PWH) have a heightened state of immune activation and inflammation, and an estimated 10%-40% demonstrate poor CD4 T-cell reconstitution, thereby increasing their mortality and morbidity risk burden. Soluble immunoregulatory proteins that function in lymphocyte activation or inhibition are elevated in PWH and associate with T-cell dysfunction, HIV persistence, and are predictive of comorbid outcomes. Here, we measured a panel of 35 circulating immunoregulatory proteins in 116 PWH with variations in CD4 T-cell counts (poor CD4 trajectory: <200 cells/μl, n = 34 or immune competent: CD4 >500 cells/μl, n = 82) by Luminex. Participants were enrolled in the AIDS Clinical Trials Group Longitudinal Linked Randomized Trials cohort, had initiated ART on enrollment, and had been on suppressive ART for 1 year. Using non-parametric analysis, we found that the levels of CD276, ICOSL, BAFF, OX40, galectin-1, and galectin-9 were significantly higher in PWH with poor CD4 trajectories compared to individuals with immune-competent CD4 T-cell count. Notably, in logistic models, ICOSL and OX40 remained significant after adjusting for age and baseline plasma HIV RNA. Furthermore, Extreme Gradient Boosting machine learning models comprising co-stimulatory and inhibitory checkpoint proteins yielded high accuracy in classification of individuals with poor CD4 trajectories. In summary, we identified a novel signature of circulating immunoregulatory proteins indicative of poor CD4 trajectories that may serve as potential targets to monitor and manage immune perturbations more accurately in PWH during suppressive ART., Importance: It is essential to track immune perturbations related to insufficient CD4 T-cell recovery in PWH on suppressive ART as those with incomplete reconstitution are at a greater risk of non-AIDS-related morbidity and mortality. Several inflammatory soluble mediators have associated with poor immune reconstitution and adverse morbid outcomes in PWH, yet their implementation into routine clinical care to guide management remains inconsistent. Circulating immune checkpoint proteins have been linked to dysregulated immune pathways during suppressive ART and may serve as improved surrogate markers of clinical relevance. Here we investigate soluble lymphocyte-associated immunoregulatory proteins in virally suppressed PWH with no reported co-morbid outcomes and varying CD4 T-cell counts, to reveal underlying pathways that remain perturbed despite ART. This novel signature of immunoregulatory markers pertaining to poor CD4 T-cell trajectories uncover previously overlooked immune checkpoints as important targets for clinical monitoring of PWH in the setting of durable viral suppression by ART., Competing Interests: The authors declare no conflict of interest.

Background: We evaluated long-term trajectories of circulating hepatitis B virus (HBV) RNA and hepatitis B core-related antigen (HBcrAg) in persons with and without hepatitis B surface antigen (HBsAg) loss during tenofovir therapy in the Swiss HIV Cohort Study., Methods: We included 29 persons with HIV with HBsAg loss and 29 matched persons with HIV without HBsAg loss. We compared HBV RNA and HBcrAg decline and assessed the cumulative proportions with undetectable HBV RNA and HBcrAg levels during tenofovir therapy using Kaplan-Meier estimates., Results: HBsAg loss occurred after a median of 4 years (IQR, 1-8). All participants with HBsAg loss achieved suppressed HBV DNA and undetectable HBV RNA preceding undetectable quantitative HBsAg levels, whereas 79% achieved negative HBcrAg. In comparison, 79% of participants without HBsAg loss achieved undetectable HBV-RNA and 48% negative HBcrAg. After 2 years of tenofovir therapy, an HBV RNA decline ≥1 log10 copies/mL had 100% sensitivity and 36.4% specificity for HBsAg loss, whereas an HBcrAg decline ≥1 log10 U/mL had 91.0% sensitivity and 64.5% specificity., Conclusions: HBV RNA suppression preceded undetectable quantitative HBsAg levels and had high sensitivity but low specificity for HBsAg loss during tenofovir therapy in persons with HIV. HBcrAg remained detectable in approximately 20% of persons with HBsAg loss and 50% of persons without HBsAg loss., Competing Interests: Potential conflicts of interest. L. B. reports support for travel and conference participation from the CROI Foundation and the SAFE-ID Foundation. A. B. has received speaker honoraria from Gilead unrelated to this work. M.-L. P. reported support for the present article from the CirB-RNA-RHU program paid to her institution. B. T. has received honoraria for lectures from Gilead Sciences France, Hopital Vall D’Hebron, and the Belgian Association for the Study of the Liver and payment for expert testimony and travel support from the International Hepatology Education Program. L. S.-V. has received honoraria for consulting from Gilead paid to her institution and unrelated to this work. F. S.-R. reports no potential conflicts. C. S. received speaker honoraria and travel support from Gilead and a grant from Roche Diagnostics paid to her institution and unrelated to this work. C. B. has received advisory board membership fees from Gilead paid to his institution. J. K. R. has received honoraria for consulting or speaking at educational events from Boehringer, Gilead, Merck, Janssen, and ViiV. H. F. G. has received unrestricted research grants from Gilead Sciences; fees for data and safety monitoring board membership from Merck; consulting/advisory board membership fees from Gilead Sciences, Merck, Johnson & Johnson, Janssen, GSK, Novartis, and ViiV Healthcare; and grants from the Swiss National Science Foundation, the Bill & Melinda Gates Foundation, the Yvonne Jacob Foundation, Gilead, ViiV, and the National Institutes of Health. A. C. reported unrestricted educational grants from ViiV, Gilead, and MSD and industry-sponsored clinical trials at her HIV unit. M. C.'s institution received research grants from Gilead, MSD, and ViiV and financial compensation for expert opinion given to Gilead, MSD, and ViiV. H. H. H. received grant support from Moderna paid to his institution and honoraria for consulting or speaking at educational events from AICuris, Allovir, Moderna, VeraTx, Roche, Takeda, Biotest, and Gilead. P.S.'s institution has received travel grants and congress/advisory fees from Gilead and ViiV unrelated to this work. The institution of E. B. received grants from MSD; consulting fees from Moderna; speaker fees from Pfizer AG Switzerland; and payments for the participation of E. B. to advisory boards or travel grants from Gilead Sciences, ViiV Healthcare, MSD, Pfizer AG Switzerland, Moderna, Astra Zeneca, Eli Lilly, and Abbvie. M. L. has received lecture and presentation fees from Abbvie and Gilead and coverage and reimbursement of travel expenses from Abbvie, Gilead, Inventiva, Madrigal, and MSD. G. W. received unrestricted research grants from Gilead Sciences and Roche Diagnostics and lecture/advisory board membership fees from Gilead Sciences, MSD, and ViiV Healthcare, all paid to his institution. F. Z. has received speaker fees from Gilead; consulting fees from Aligos, Assembly, Blue Jay, and GSK; and research grants through INSERM from Assembly, Beam, Blue Jay, and Janssen. A. R. reports support to his institution for advisory boards and/or travel grants from MSD, Gilead Sciences, Pfizer, and Moderna and an investigator-initiated trial grant from Gilead Sciences. All remuneration went to his home institution and not to A. R. personally, and all remuneration was provided outside the submitted work. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: One month of daily rifapentine + isoniazid (1HP) is an effective, ultrashort option for tuberculosis prevention in people with human immunodeficiency virus (HIV). However, rifapentine may decrease antiretroviral drug concentrations and increase the risk of virologic failure. AIDS Clinical Trials Group A5372 evaluated the effect of 1HP on the pharmacokinetics of twice-daily dolutegravir., Methods: A5372 was a multicenter, pharmacokinetic study in people with HIV (≥18 years) already on dolutegravir-containing antiretroviral therapy with HIV RNA <50 copies/mL. Participants received daily rifapentine/isoniazid (600 mg/300 mg) for 28 days as part of 1HP. Dolutegravir was increased to 50 mg twice daily during 1HP, and intensive pharmacokinetic sampling was performed on day 0 (before 1HP) and on the final day of 1HP treatment., Results: Thirty-two participants (41% female; 66% Black/African; median [Q1, Q3] age, 42 [34, 49] years) were included in the pharmacokinetic analysis; 31 had HIV RNA <50 copies/mL at the end of 1HP dosing. One participant had an HIV RNA of 160 copies/mL at day 28, with HIV RNA <50 copies/mL upon repeat testing on day 42. The median (Q1, Q3) dolutegravir trough concentration was 1751 ng/mL (1195, 2542) on day 0 versus 1987 ng/mL (1331, 2278) on day 28 (day 28:day 0 geometric mean ratio, 1.05 [90% confidence interval, .93-1.2]; P = .43). No serious adverse events were reported., Conclusions: Dolutegravir trough concentrations with 50 mg twice-daily dosing during 1HP treatment were greater than those with standard-dose dolutegravir once daily without 1HP. These pharmacokinetic, virologic, and safety data provide support for twice-daily dolutegravir use in combination with 1HP for tuberculosis prevention., Clinical Trials Registration: NCT04272242., Competing Interests: Potential conflicts of interest. A.F.L. has contracts for clinical research unrelated to this work from Gilead, ViiV, and Merck; consulting fees from ViiV. A.A. reports grants from Gilead, ViiV, Roche, GSK and MSD unrelated to this work. S.S. reports grants from ViiV unrelated to the present work. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Body weight is influenced by an interplay of individual and environmental factors. In people with human immunodeficiency virus (HIV), weight is also influenced by disease status with loss accompanying disease progression that is reversed with effective antiretroviral therapy. Weight changes in comparative antiretroviral therapy trials differ by regimen, with greater gains observed with the integrase strand transfer inhibitors dolutegravir and bictegravir, particularly when coadministered with tenofovir alafenamide fumarate, compared with regimens that include agents such as tenofovir disoproxil fumarate that attenuate weight gain. We review weight changes in major randomized trials of preexposure prophylaxis and initial and switch HIV therapy, highlighting the challenges to assessing the role of antiretroviral therapy in weight change. This examination forms the basis for a model that questions assumptions regarding an association between integrase strand transfer inhibitors and tenofovir alafenamide fumarate and excessive weight gain and calls for more careful consideration of these data when making HIV treatment decisions., Competing Interests: Potential conflicts of interest . D. A. W. has received honoraria for consultancy from Gilead Sciences, ViiV Healthcare, Janssen Pharmaceuticals, Merck & Co, Theratechnologies, and EMD Serono. His institution has received grant funding to support his research from Gilead Sciences, ViiV Healthcare, and Merck & Co. J. R. K. has served as a consultant to Gilead, Merck, Theratechnologies, and Janssen Pharmaceuticals and has received research support from Gilead Sciences and Merck. P. E. S. has served as a scientific advisory board member/consultant for Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck & Co, and Janssen Pharmaceuticals, He has received research support from Gilead Sciences, and GlaxoSmithKline/ViiV Healthcare. G. A. M. has received consultant fees from Janssen Pharmaceuticals, Gilead Sciences, ViiV Healthcare, Merck, and Theratechnologies. D. R. K. is a consultant to and received honoraria from AbbVie, Gilead Sciences, GlaxoSmithKline, Janssen, Pharmaceuticals, Merck & Co, Roche, and ViiV Healthcare. He has received research support from Gilead Sciences, ViiV Healthcare, Merck & Co, and Roche and has provided expert testimony on behalf of Gilead Sciences and Janssen. G. M. has served as an advisor to Novartis and Ipsen Pharmaceuticals and a speaker for Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme UK, and ViiV Healthcare. L. K. is a scientific and/or medical consultant to Altimmune, Boehringer Ingelheim, Gilead Sciences, Glyscend, Intellihealth, Johnson & Johnson, Eli Lilly, Novo Nordisk, Pfizer, Sidekick Health, twenty30.health, and Xeno Biosciences. J. v. W. is employed by ViiV Healthcare. R. E. C. is employed by Merck & Co. C. C. is employed by Gilead Sciences. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Antiretroviral therapy (ART)-related weight gain is of particular concern in people with HIV (PWH). Although weight gain was observed among PWH receiving tenofovir alafenamide (TAF), little is known about the potential reversibility after TAF discontinuation. We evaluated weight and metabolic changes 12 months after TAF discontinuation in the Swiss HIV Cohort Study., Methods: We included participants who received at least 6 months of TAF-containing ART between January 2016 and March 2023. Using multivariable mixed-effect models, changes in weight and lipid levels were compared between individuals who continued TAF and those who switched to one of the following TAF-free regimens: (1) tenofovir disoproxil fumarate (TDF)-based ART, (2) dolutegravir/lamivudine (DTG/3TC), or (3) long-acting cabotegravir/rilpivirine (CAB/RPV)., Results: Of 6555 participants (median age 54 years, 24.3% female, 13% Black), 5485 (83.7%) continued, and 1070 (16.3%) stopped TAF. Overall, discontinuing TAF was associated with an adjusted mean weight change of -0.54 kg (95% confidence interval [CI] -.98 to -.11) after 12 months. In stratified analyses, switching from TAF to TDF led to an adjusted mean weight decrease of -1.84 kg (95% CI -2.72 to -.97), and to a decrease in mean total cholesterol (-0.44 mmol/L) and triglycerides (-0.38 mmol/L) after 12 months. Switching from TAF-based ART to DTG/3TC (-0.17 kg, 95% CI -.82 to .48) or long-acting CAB/RPV (-0.64 kg, 95% CI -2.16 to .89) did not lead to reductions in weight., Conclusions: Replacing TAF with TDF in PWH led to a decrease in body weight and an improved lipid profile within 1 year. Weight changes were not observed among individuals who switched to DTG/3TC or long-acting CAB/RPV., Competing Interests: Potential conflicts of interest . P. E. T. received grants, and educational and advisory fees to institution from Gilead, MSD, and ViiV outside the submitted work. O. N. T.’s institution received expenses compensation for expert opinion from ViiV Healthcare. K. E. A. D.'s institution has received research grants from Gilead Sciences and travel grants and lecture fees from Gilead and MSD. B. S. reports support to his institution for travel grants from Gilead Sciences and ViiV healthcare. G. W. reports unrestricted research grants from Gilead Sciences and Roche Diagnostics, as well as travel grants and advisory board/lecture fees from ViiV, Gilead Sciences and MSD, all paid to his institution. M. C.’s institution received research grants and payment for expert testimony from Gilead, MSD, and ViiV. E. B.'s institution received research grants from MSD, consulting fees from Moderna, payment for lectures from Pfizer AG as well as fees for the participation of E. B. to advisory boards and/or travel grants from Gilead Sciences, ViiV, MSD, Abbvie, Pfizer, AstraZeneca, Moderna, and Ely Lilly. C. B. reports participation on the Gilead advisory board on Bulevirtide. K. D. reports grants, payment for lectures, and support for meetings and/or travel from Gilead Sciences, as well as payment for expert testimony from MSD. C. A. F. reports grants from Gilead, as well as Advisory Board attendance support from Gilead, Menarini, Moderna, MSD, and ViiV. M. S. reports support for meetings and/or travel from Gilead, participation on an advisory board for Gilead Sciences, Moderna, MSD, and ViiV Healthcare. O. N. T. reports payment or honoraria for lectures from ViiV Healthcare. C. M. reports speaker honoraria from Gilead, ViiV, and MSD. P. T. reports grants and payment for lectures from Gielad, ViiV, and MSD. D. H. reports grants from Abbvie, AstraZeneka, Gilead, GSK, ViiV, MDF, and Pfizer, consulting fees from AstraZeneca, Gilead, ViiV Healthcare, and Bavarian Nordic, support for travel and/or meetings from Gilead, and payment for leadership or fiduciary role from PFMD and Positive Council. D. L. B. reports payment for lectures, consulting fees,and participation on advisory board from Gilead, ViiV, MSD, Pfizer, and consulting fees from AstraZeneka, support for attending meetings from Gilead. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Competing Interests: Potential conflicts of interest. The author: No reported conflicts of interest. The author has submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.

Competing Interests: Intérêts concurrents :: Maxime Billick déclare avoir reçu des honoraires de consultation de l’Association des infirmières et infirmiers autorisés de l’Ontario. Isaac Bogoch déclare des honoraires de consultant du Programme de réduction de la menace liée aux armes d’Affaires mondiales Canada. Aucun autre intérêt concurrent n’a été déclaré.

Competing Interests: Competing interests: GY declares research funding from the following organisations that fund HIV research or service delivery: the World Health Organization, the Gates Foundation, the Carnegie Corporation of New York, the UN Economic and Social Commission for Asia and the Pacific, and the Economic and Social Research Council. He is a member of the PEPFAR financing and sustainability committee and is co-chair of the Economics and Finance Working Group of the Partnership for Maternal, Newborn, and Child Health. SM declares she has no competing interests.

Objective: To evaluate whether adolescents from sexual minorities who initiated pre-exposure prophylaxis (PrEP) in community-based organizations (COs) are more socially and HIV-vulnerable compared with their counterparts from a conventional health service. In addition, to evaluate whether these adolescents had more timely access to prophylaxis., Methods: A PrEP demonstration study was conducted in the city of São Paulo in two COs, located in the center (CO-center) and the outskirts (CO-outskirts), and a conventional HIV testing service (CTA-center). Between 2020 and 2022, cisgender male adolescents who have sex with men (aMSM), transgender and gender diverse adolescents (aTTrans) aged 15 to 19 years, HIV-negative, with higher-risk practices for HIV were eligible for PrEP. Indicators of timely access and vulnerabilities of adolescents initiating PrEP in COs were analyzed using CTA-center as a reference and multinomial logistic regression., Results: 608 adolescents initiated PrEP in COs and CTA-center. Adolescents from COs were associated with a shorter time to PrEP initiation (1-7 days; CO-outskirts: ORa = 2.91; 95%CI 1.22-6.92; CO-center: ORa = 1.91; 95%CI 1.10-3.31); and a lower housing Human Development Index (HDI) (CO-center: ORa = 0.97; 95%CI 0.94-1.00; CO-outskirts: ORa = 0.82; 95%CI 0.78-0.86). In CO-outskirts, there was an increased chance of adolescents being younger (ORa = 3.06; 95%CI 1.63-5.75) and living closer to the service (ORa = 0.82; 95%CI 0.78-0.86, mean 7.8 km). While adolescents from the CO-center were associated with greater prior knowledge of PrEP (ORa = 2.01; 95%CI 1.10-3.91) and high-risk perception (ORa = 2.02; 95%CI 1.18-3.44), adolescents from the COs were not associated with higher-risk sexual practices and situations of vulnerability to HIV., Conclusion: The provision of PrEP in the COs facilitated access for vulnerable adolescents and may contribute to reducing inequities.

Objective: This article discusses how Pre-Exposure Prophylaxis (PrEP) and the undetectable viral load=untransmissible (UVL=U) have produced reconfigurations in the contexts of affective-sexual encounters of young gay men/men who have sex with men (MSM) living with HIV (YLHIV)., Methods: In-depth interviews were conducted with nine YLHIV, aged 18 to 29, from two studies conducted in Salvador, Bahia, in 2019 and 2021. The narratives focused on unprecedented events in the prevention and treatment of HIV/AIDS, which have allowed experiences of greater intimacy and safety but also challenges and tensions in affective-sexual relationships., Results: Different moments in the experience of living with HIV reveal different narratives of YLHIV concerning the new PrEP and UVL biotechnologies. Concerns surrounding possible HIV transmission or the obligation to reveal serology are more prominent among young people with the most recent diagnosis. In contrast, those with more extended serology experience are more comfortable and confident in the face of new technologies and their significant effects on sexual encounters. However, controversies remain regarding the moral and behavioral consequences of their use. Some YLHIV re-update concerns and bring reports about the continuity of stigma toward people living with HIV. Others emphasize the benefits of biomedical advances, opening up new interactive possibilities, including without the use of condoms, highlighting the existence of other practices, knowledge, dynamics, and ways of negotiating risk/care, with tensions in the field of sexuality itself., Conclusions: We reiterate the need to resume public policies in the field of HIV/AIDS beyond biomedical strategies, highlighting vulnerabilities, the dissemination of information about new HIV prevention and treatment technologies, respect for people's autonomy in their preventive choices, and the development of strategies to combat the stigma associated with HIV/AIDS.

Objective: This study aims to analyze the knowledge about the HIV event-driven pre-exposure prophylaxis (event-driven PrEP) scheme and the perception of its potential use among young men who have sex with men (MSM), travestis, and transgender women (TrTW) who were followed up in the cohort., Methods: This qualitative study included 50 interviews with participants from the municipalities of Salvador and São Paulo, aged 15 to 19 years, who made daily use of PrEP or other preventive methods. They were addressed by different demand creation strategies. The in-depth interviews covered topics such as sexual practices, event-driven PrEP knowledge, acceptability, and motivations for its use. A two-stage thematic analysis was carried out on Nvivo, version 12., Results: Most participants were unaware of event-driven PrEP, and many questioned its effectiveness and safety when receiving information about it. However, on learning about the program, many young people saw advantages, such as not having to take daily medication and the possibility of using it only at times of greater risk. Participants also found barriers to using event-driven PrEP, such as the unpredictability of sexual relations and the difficulty in administering dosages in this modality., Conclusion: Limited knowledge and experiences with daily oral PrEP influenced interest in event-driven PrEP, which highlights the need for information strategies that enable young MSM and TrTW to read about event-driven PrEP. Young people valued the autonomy and management of preventive methods provides by this new modality, which is more in line with the dynamics of their sexual lives, but they face challenges in managing event-driven PrEP.

Objective: This study aims to understand the perceptions and practices of healthcare providers regarding the offer of HIV pre-exposure prophylaxis (PrEP) to gay and trans adolescents and young adults., Methods: This qualitative research was developed as part of the PrEP1519 study, which was conducted from 2018 to 2021 to analyze the effectiveness of PrEP in adolescents and young adults. Data were collected from July 2020 to February 2021 at the municipality of São Paulo by combining participant observations and semi-structured interviews. The analytical process involved immersion in the empirical material and coding and categorizing it with the support of NVivo®. Interpretation followed the hermeneutic-dialectical principle and had the concept of Care in health practices as its horizon., Results: The construction of trust-based relationships followed practices that acknowledge the uniqueness of youth and their demands and sought to strengthen their autonomy. Sensitive and supportive listening was pointed out as a welcoming practice that propelled care actions. Welcoming attitudes and support in facing stigma and violence (related or not to the use of PrEP) acknowledged the need to support adolescents and young adults to develop autonomy for prevention. The use of language close to young people's everyday life favored the construction of relationships of trust and positively influenced the development of autonomy and adherence to PrEP. The tension between technical and practical success occurred in the idealized search for adult-centric normativity as opposed to intersubjectivity., Conclusion: The perceptions and practices of healthcare providers are aligned with the concept of Care as they include actions beyond technical knowledge and recognize the contexts that increase the vulnerability of adolescents and young adults to HIV.

The PURPOSE 1 trial 1 demonstrated that after 52 weeks, no cisgender women acquired HIV infection after receiving subcutaneous twice-yearly lenacapavir. HIV incidence with lenacapavir was significantly lower than HIV incidence with daily oral emtricitabine/tenofovir alafenamide (F/TAF) or daily oral emtricitabine/tenofovir disoproxil fumarate (F/TDF). It is the first pre-exposure prophylaxis regimen with 100% efficacy in young women., Competing Interests: Declaration of interests The authors declare no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Poor mental health occurs more frequently among people living with HIV. Understanding what mental health problems occur and at what point during the continuum of HIV care is critical to ensure these problems are identified and appropriately addressed. We explored how mental health is experienced along the HIV care continuum in Rakai, Uganda., Methods: We conducted qualitative semi-structured in-depth interviews with 20 adults living with HIV and 10 health workers from March to December 2020. Interviews followed a timeline approach. Responses were analyzed using content analysis., Results: At the time of HIV diagnosis, nearly all participants described a range of strong emotions, including shock, fear and intense worry. Most participants described continued fear and intense worry leading up to, and at the time of, ART initiation. However, they said these emotions often subside after ART is initiated and viral suppression is achieved. Across interviews and at multiple points of the continuum, participants discussed how fear and worry led individuals to be "thinking too much" or be in "deep thoughts" and experience self-hatred. Individuals who stopped taking ART were thought to have more severe mental health problems ("madness", psychosis, suicidality). Participants were divided about the mental health of persons who returned to care after disengagement., Conclusion: In this setting, mental health problems experienced by people living with HIV are dynamic across the care continuum. With expanded HIV testing campaigns and Universal Test and Treat policies, targeted interventions for psychosocial support at the time of testing and ART initiation remain critical., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 West et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Although combination antiretroviral therapy (ART) has been a landmark achievement for the treatment of human immunodeficiency virus (HIV), an HIV cure has remained elusive. Elimination of latent HIV reservoirs that persist throughout HIV infection is the most challenging barrier to an HIV cure. The progressive HIV infection is marked by the increasing size and diversity of latent HIV reservoirs until an effective immune response is mobilized, which can control but not eliminate HIV infection. The stalemate between HIV replication and the immune response is manifested by the establishment of a viral set point. ART initiation during the early stage limits HIV reservoir development, preserves immune function, improves the quality of life, and may lead to ART-free viral remission in a few people living with HIV (PLWH). However, for the overwhelming majority of PLWH, early ART initiation alone does not cure HIV, and lifelong ART is needed to sustain viral suppression. A critical area of research is focused on determining whether HIV could be functionally cured if additional treatments are provided alongside early ART. Several HIV interventions including Block and Lock, Shock and Kill, broadly neutralizing antibody (bNAb) therapy, adoptive CD8+ T cell therapy, and gene therapy have demonstrated delayed viral rebound and/or viral remission in animal models and/or some PLWH. Whether or not their application during early infection can improve the success of HIV remission is less studied. Herein, we review the current state of clinical and investigative HIV interventions and discuss their potential to improve the likelihood of post-treatment remission if initiated during early infection.

Integrating gender-affirming care with biomedical HIV prevention could help address the disproportionate HIV risk experienced by transgender and nonbinary (trans) adults. This discrete choice experiment assesses and identifies the most important programming factors influencing the decisions of trans adults to use injectable long-acting HIV pre-exposure prophylaxes (LA-PrEP). From March to April 2023 n = 366 trans adults in Washington state chose between four different choice profiles that presented hypothetical programs (each comprised of 5 attributes with 4 levels). We analyzed ranked choice responses using a mixed rank-ordered logit model for main effects. Respondents preferred to receive LA-PrEP from a gender-affirming care provider and a co-prescription for both oral and injectable hormones. Trans adults strongly favored 12-month protection and injection in the upper arm. No strong preferences emerged surrounding the type of health facility offering the gender-affirming LA-PrEP program. Our findings show that integrating and leveraging gender-affirming health systems, inclusive of medical services such as hormone therapy, with HIV biomedical products like LA-PrEP is strongly preferred and influential to trans adults' decision to use LA-PrEP. Leveraging choice-based design experiments provides informative results for optimizing gender-affirming LA-PrEP programming tailored to trans adults., (© 2024. The Author(s).)

Adherence to antiretroviral therapy (ART) is essential for the effective management of HIV, which includes keeping the HIV viral load undetectable. This study aimed to determine whether certain ART medications are more "forgiving" of poor adherence in achieving viral suppression. We identified subgroups of ART medication usage and determined the extent to which ART adherence is associated with viral suppression across those subgroups. Data came from claims and clinical records (2017-2019) of 3,552 HIV-positive adult members of a Medicaid managed care plan. Pharmacy fill data were examined to characterize ART medications using latent class analysis (LCA), which captures the complexity of real-world ART usage (i.e., multiple medications, ART switching). LCA yielded five ART medication patterns over three years, mostly characterized by recent medications and formulations of ART, though they varied in number of tablets and in medication class. Mixed effects logistic regression models were estimated to determine whether odds of viral suppression differed by ART adherence level. After adjusting for covariates, those with at least 90% adherence (i.e., 90 to < 95%) did not significantly differ from those with 95% adherence or greater in terms of viral suppression, which corroborates existing clinical recommendations. These findings can inform provider-patient communication for people with HIV, especially those who have difficulty maintaining adherence. This includes those experiencing unstable housing, mental health conditions, or substance use., (© 2024. The Author(s).)

Despite the dramatic decline in the incidence of common opportunistic infections (OIs) after antiretroviral therapy initiation, they remain a significant cause of morbidity and mortality among children with HIV. For better interventions, information regarding the incidence and predictors of common OIs is essential for Children living with HIV. Still, there is a lack of studies in low and middle-income countries, including Ethiopia. Therefore, this study aims to assess the incidence and predictors of common OIs among Children living with HIV on anti-retroviral therapy (ART) at public health institutions in Bahir Dar City, Northwest Ethiopia. The reasons for excluding children not on ART is we want to study the effectiveness of chronic HIV care service, ART drugs and OIs prophylaxis drugs for the prevention of common OIs because it is obvious that the occurrence of OIs in children not on ART and OIs prophylaxis drugs is high. A health institution-based retrospective cohort study was done among 403 Human Immunodeficiency Virus-infected children at public health institutions in Bahir Dar City from 2010 to 2020. Data was entered using Epi-data version 4.6 and analyzed using STATA 14.0. A bivariable Cox-proportional hazards regression model was employed to appreciate the relationship between each explanatory variable with the outcome variable. In the bivariable analysis, variables with a p-value of less than 0.25 were candidates for the multivariable proportional hazard model. The Cox proportional hazards model was used to determine predictors of common opportunistic infections at a 5% significance level. The overall incidence rate of common opportunistic infections was 7.06 with a 95% confidence interval ((CI) 5.78, 9.75) per 100 person-years of observation. Statically significant predictors were World Health Organization (WHO) clinical stage III and IV (adjusted hazard ratio (AHR) = 1.90; (95% CI 1.34, 2.75), having fair/poor adherence to anti-retroviral therapy (ART) (AHR) = 1.80; (95% CI 1.25, 2.94) and hemoglobin level < 10 g/dl (AHR) = 2.00; (95% CI 1.36, 2.89). The overall incidence rate of common OIs among children living with HIV on ART was high. Independent predictors of common OIs among children on ART were advanced-stage of HIV disease, poor ART adherence, and lower hemoglobin level. Therefore, we recommend strongly working on the prevention of advanced stages of HIV disease and improving poor ART adherence to prevent the incidence of OIs among children living with HIV on ART., (© 2024. The Author(s).)

Background: Drug-drug interactions (DDIs) between antiretroviral therapy (ART) and commonly used co-medications in HIV patients, especially women, impact treatment efficacy and patient safety., Objective: This study aimed to study the prevalence and types of drug-drug interactions (DDIs) between antiretroviral therapy drugs (ARTs) and comedications among a female population with HIV. Additionally, the study investigates the association of these DDIs with ART medication changes and treatment adherence., Methods: This cross-sectional study included 632 adult women living with HIV (WLHIV). Data was retrospectively extracted from patient files. Drug.com interaction checker website was used to assess DDIs between ART and non-ART medications. Changes to the ART regimen previously attributed to ART side effects or patient non-adherence were considered drug changes., Results: A total of 429 WLHIV (mean age: 44.05 ± 9.50) were eligible. The prevalence of DDIs between ART and non-ART medications was 21.4%, with 4.7% minor, 18.4% moderate, and 8.9% major interactions. The highest prevalence of DDI was among cardiovascular medication users (71.7%), followed by central nervous system drugs (69.2%). Changing medications resulted in a decrease in DDIs, with significant reductions in total and minor interactions. Participants without DDIs had better adherence to ART. DDI between ART and non-ART medications was significantly associated with ART drug change, even after accounting for side effects attributed to ARTs, indicating an independent twofold association (OR = 1.99, CI 1.04-3.77). Moreover, further adjustments for HIV viral load and CD4 + cell count did not change the significance of the association (OR = 2.01, CI 1.03-3.92)., Conclusion: DDIs in WLHIV impact adherence to ART. Altering ART may not be directly related to ART side effects, but rather primarily due to interactions with non-ART medications. Modifying non-ART drug regimens can reduce the likelihood of DDIs., (© 2024. The Author(s).)

Background: HIV has an effect on lowering CD4 cell count, which lowers the ability to resist contamination. For patients on ART in areas with limited resources, the CD4 cell count assessment is crucial for determining treatment responses and therapeutic decisions. The volatility of CD4 counts following the introduction of ART over time is still largely uncharacterized, and there are few fresh datasets on CD4 cell count progressions. The goal of this study was to identify the key factors that change over time in CD4 cells for HIV/AIDS patients receiving ART follow-up in northern Ethiopia., Methods: A total of 216 HIV/AIDS patients who initiated ART in the Mekelle General Hospital between 2013 and 2016 were involved using systematic random selection techniques. An examination of exploratory data was used to describe the individual profiles of HIV patients. A multivariable random intercept and slope linear mixed regression analysis regarded predictor variables to be statistically significant if their p-value was less than 0.05., Results: The random intercept and slope linear mixed model result indicated that there were statistically significant predictors of baseline CD4 cell count (β = 0.0125, P-value = 0.001*) and bedridden functional status (β = -2.459, p = 0.02*) on the change of CD4 cell count over time in HIV/AIDS patients at the 5% significance level., Conclusions: Changes in CD4 counts were influenced by the baseline CD4 cell count and the functional status of being bedridden. Because their CD4 cell counts were lower at baseline and they had a functional status of bedridden, the majority of HIV/AIDS patients on ART had substantial predictors on the change of CD4 cell count over time. So, public health service providers should give exceptional guidance and attention is also necessary for those patients who have lower baseline CD4 cell count and bedridden functional status., (© 2024. The Author(s).)

Background: Adverse drug reaction is one of the emerging challenges in antiretroviral treatment. Determining the incidence rate and predictors among children on antiretroviral treatment (ART) is essential to improve treatment outcomes and minimize harm. And also, evidence regarding the time to major adverse drug reactions and its predictors among children on antiretroviral treatment is limited in Ethiopia., Objective: This study aimed to assess the time to major adverse drug reaction and its predictors among children on antiretroviral treatment at selected public hospitals in Northwest Amhara, Ethiopia, 2023., Method: A retrospective cohort study was conducted among 380 children on antiretroviral treatment who enrolled from June 27, 2017, to May 31, 2022. Data was collected using a structured data extraction checklist. Data were entered into Epidata 4.6 and analyzed using STATA 14. The incidence rate of major adverse drug reactions was determined per person/months. The Cox proportional hazards regression model was used to identify predictors of major adverse drug responses. A p-value less than 0.05 with a 95% CI was used to declare statistical significance., Result: The minimum and maximum follow-up time was 6 and 59 months, respectively. The study participants were followed for a total of 9916 person-months. The incidence rate of major adverse drug reactions was 3.5 /1000 person-months. Advanced clinical stages of HIV/AIDS (III and IV) [adjusted hazard ratio = 7.3, 95% CI: 2.74-19.60)], poor treatment adherence [adjusted hazard ratio = 0.33, 95% CI: 0.21-0.42], taking antiretroviral treatment twice and more [adjusted hazard ratio = 3.43, 955 CI: (1.26-9.33)] and not taking opportunistic infection prophylaxis [adjusted hazard ratio = 0.35, 95% CI: 0.23-0.52)] were predictors of major adverse drug reactions., Conclusion: The incidence rate of major adverse drug reactions among children on antiretroviral treatment was congruent with studies in Ethiopia. Advanced clinical stages of HIV/AIDS, poor treatment adherence, taking antiretroviral treatment medications twice or more, and not taking opportunistic infection prophylaxis were predictors of major adverse drug reactions., Competing Interests: The author(s) received no specific funding for this work., (Copyright: © 2024 Tsega et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

BackgroundSweden reached the UNAIDS 90-90-90 target in 2015. It is important to reassess the HIV epidemiological situation due to ever-changing migration patterns, the roll-out of PrEP and the impact of the COVID-19 pandemic.AimWe aimed to assess the progress towards the UNAIDS 95-95-95 targets in Sweden by estimating the proportion of undiagnosed people with HIV (PWHIV) and HIV incidence trends.MethodsWe used routine laboratory data to inform a biomarker model of time since infection. When available, we used previous negative test dates, arrival dates for PWHIV from abroad and transmission modes to inform our incidence model. We also used data collected from the Swedish InfCareHIV register on antiretroviral therapy (ART).ResultsThe yearly incidence of HIV in Sweden decreased after 2014. In part, this was because the fraction of undiagnosed PWHIV had decreased almost twofold since 2006. After 2015, three of four PWHIV in Sweden were diagnosed within 1.9 and 3.2 years after infection among men who have sex with men and in heterosexual groups, respectively. While 80% of new PWHIV in Sweden acquired HIV before immigration, they make up 50% of the current PWHIV in Sweden. By 2022, 96% of all PWHIV in Sweden had been diagnosed, and 99% of them were on ART, with 98% virally suppressed.ConclusionsBy 2022, about half of all PWHIV in Sweden acquired HIV abroad. Using our new biomarker model, we assess that Sweden has reached the UNAIDS goal at 96-99-98.

Introduction: The rapid initiation of antiretroviral therapy (ART) and its impact on treatment outcomes have been a subject of global public health interest. However, the precise mechanisms underlying the effects of rapid ART initiation remain unclear., Methods: This retrospective cohort study examined data from 1846 HIV-infected individuals in Jiulongpo District, Chongqing, China, spanning from 2016 to 2022. Logistic regression models and serial mediation analysis were used to explore the influence of rapid ART initiation on treatment outcomes and the role of medication adherence as a mediating factor., Results: The findings revealed a significant association between rapid ART initiation and reduced risk of viral failure (adjusted odds ratio [OR] = 0.320, 95% confidence interval [CI] = [0.161, 0.637]), as well as an increased likelihood of improved adherence (adjusted OR = 2.053, 95% CI = [1.226, 3.438]). Medication adherence was identified as a partial mediator in the relationship between rapid ART initiation and viral failure, explaining 10.5% of the total effect., Discussion: In conclusion,rapid initiation of antiretroviral therapy was found to enhance treatment outcomes, emphasizing the importance of early adherence education. The study recommends early initiation of ART coupled with adherence education and psychological counseling for HIV-infected individuals., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Chen, Tao, Wu, Chen and He.)

Introduction: Barriers to pre-exposure prophylaxis (PrEP) access have limited its reach to priority populations. Community-based mobile clinics have potential to broaden PrEP engagement. We evaluated reach and persistence for fixed and mobile clinic cohorts in Miami-Dade County, Florida., Methods: This observational cohort study analysed data from 1896 clients engaged through our fixed or mobile clinic from August 2018 to March 2023. Services were offered at no cost to clients. The same staff and package of barrier-lowering strategies was deployed across fixed and mobile clinic sites. Chi-square and Fisher's exact test or the Kruskal-Wallis test were used to test for differences in characteristics across sites as well as across services sought. Kaplan-Meier curves were generated to evaluate persistence on PrEP and in care, defined as completion of at least one clinic visit (including PrEP prescribing, for PrEP persistence, or for any reason, for persistence in care) within 24 weeks of the prior visit. Cox proportional hazards models were used to evaluate risk factors for discontinuation of PrEP or clinic care by 48 weeks by gender, race, ethnicity, insurance status and site., Results: The fixed and mobile clinics reached 781 and 1109 clients, respectively, during the study period. The median client age was 35 years; the majority (70.4%) of clients were cisgender men, identified as Hispanic/Latino (62.5%) and were men who have sex with men (54.5%). The mobile clinic extended reach to a higher proportion of cisgender women (32.1% mobile vs. 12.9% for fixed clinic), Black clients (34.5% vs. 13.1%) and older clients (median 37 vs. 33 years) compared with the fixed setting. Uninsured individuals, men and those who initiated services in the mobile clinic were more likely to continue PrEP to 48 weeks (HR: 1.20, p = 0.01; HR: 2.02, p<0.01; HR: 1.68, p<0.01, respectively). Persistence did not differ by race or ethnicity., Conclusions: A mobile clinic strategy for PrEP engagement can increase reach to key populations underrepresented in HIV prevention care including cisgender women and Black clients. Persistence in PrEP was increased for the mobile clinic cohort, suggesting an additional benefit to this modality beyond other barrier-lowering strategies employed in our fixed and mobile clinics., (© 2024 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Accurate HIV-1 genome sequencing is necessary to identify drug resistance mutations (DRMs) in people with HIV-1 (PWH). Next-generation-sequencing (NGS) allows the detection of minor variants and is now available in many laboratories. Our study aimed to compare two NGS approaches, a "short read" sequencing protocol using DeepChek® Whole Genome HIV-1 Assay on Illumina, and a "long read" sequencing protocol of HIV-1 pol and env single-molecule real-time sequencing (SMRT) on Pacific Biosciences (PacBio). We analyzed 16 plasma samples and 13 cellular samples from PWH. HIV-1 whole genome was amplified into five amplicons using DeepChek® Whole Genome HIV-1 Assay and sequenced on an iSeq. 100. In parallel, HIV-1 pol and env genes were separately amplified and sequenced using PacBio SMRT system with the circular consensus sequencing mode on a Sequel IIe. Concordance rates for determining DRMs with both approaches varied depending on the HIV-1 region, with higher concordance in the integrase region compared to the reverse transcriptase and protease regions. DeepChek® Whole Genome HIV-1 Assay exhibited better sensitivity in HIV-1 RNA sequencing of plasmas with lower viral loads. In cell HIV-1 DNA sequencing, the DeepChek® Whole Genome HIV-1 Assay performed better in pol and env sequencing but detected more APOBEC-induced DRMs, which can represent defective proviruses. Our findings indicate that both DeepChek® Whole Genome HIV-1 Assay and PacBio SMRT sequencing exhibit good performance for subtype determination, detection, and quantification of DRMs of the HIV-1 genome. However, some discrepancies were found in cellular samples, highlighting the challenges of interpreting HIV-1 DNA DRMs., (© 2024 The Author(s). Journal of Medical Virology published by Wiley Periodicals LLC.)

Introduction: The vertical transmission rate (VTR) of HIV has decreased to less than 2% in high-income countries, in spite of which perinatal infections continue to occur. We present data from the national cohort of pregnant women living with HIV and their children in Spain. The objectives were to describe the characteristics of this population, evaluate the VTR of HIV, the safety of antiretroviral therapy (ART) and the prevalence of coinfection., Patients and Methods: Multicentre prospective, observational and descriptive study with participation of 62 hospitals. The sample included pegnant women living with HIV whose children were born between January 2020 and December 2022. We collected prospective data on the characteristics of mothers and children using an online questionnaire (REDCap web application)., Results: The study included 414 mother-child dyads. Most mothers were immigrants (227/349; 65.1%). The main route of HIV infection was heterosexual transmission (160/402; 39.8%), followed by vertical transmission (44/402; 10.9%). The diagnosis was made before conception in 313/389 women (80.4%), 394/402 (98%) received ART during pregnancy and 356/402 (89.3%) had an undetectable viral load at the time of delivery. The delivery was vaginal in 230/388 children (59.3%). The proportion of preterm birth was 11.1%. The most frequent neonatal prophylaxis approach was monotherapy with zidovudine (358/414; 86.5%). There were 3 cases of vertical transmission of HIV (95% CI, 0%-1.54%). Only one newborn was breastfed., Conclusions: At present, most women living with HIV in Spain receive the diagnosis before conception, are of foreign ancestry and achieve good control of the infection. Although the VTR is very low in Spain, there are still infections that could be prevented with early diagnosis and treatment., (Copyright © 2024 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.)