HIV Research & Clinical Practice最新文献

Introduction: The BIC-T&T study aimed to determine the efficacy of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF) at suppressing viral load in a two-arm, open-label, multi-centre, randomised trial under a UK test-and-treat setting. This sub-study aimed to evaluate potential off-target cardiovascular impact by examining ex vivo platelet function.

Methods: Platelets were isolated by centrifugation of citrated blood from participants attending Chelsea and Westminster Hospital or St Mary's Hospital at Week 48 following enrolment. Platelet activation was assessed by real-time flow cytometry to examine integrin activation and granule release and platelet aggregation was evaluated by light transmission aggregometry. Statistical significance was determined by 2-way ANOVA with a Šidák's multiple comparisons post-test.

Results: An analysis of 21 participants was performed at Week 48 (96% male and 48% white; mean (range) age was 37 (23-78) years). No difference between arms was observed in ADP-, collagen- or thrombin receptor activator for peptide (TRAP)-6-evoked platelet α_IIbβ₃ integrin activation, granule release or platelet aggregation in response to any of the agonists tested. Despite differences in the demographics between treatment arms, the presence of an unboosted integrase inhibitor or boosted protease inhibitor in a test-and-treat setting did not impact platelet function.

Conclusions: Our study provides no evidence of differences in downstream platelet responses between participants taking BIC/F/TAF compared to DRV/c/F/TAF following 48 wk of treatment. Further data are required to explore whether there are biologically significant off-target effects, including effects on platelets and other components of the cardiovascular system between these two test-and-treat regimens.

Clinical trial number: NCT04653194.

Background: BICtegravir Single Tablet Regimen (BICSTaR) is an observational cohort study evaluating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV.

Objective: To present final pooled 24-month outcomes for the full cohort.

Methods: Prospective data were pooled from TN and TE adults with HIV initiating B/F/TAF in routine clinical practice across 14 countries (data collection: 25/06/2018-29/12/2023). Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), persistence, and safety. Outcomes were also analysed in key populations.

Results: Of 2,074 (483 TN, 1,591 TE) participants included, most were male (85%), White (70%), and had ≥1 comorbidity (66%). Median (Q1, Q3) age was 45 (35, 54) years. At 24 months, 94% of TN and 96% of TE participants had HIV-1 RNA <50 copies/mL (missing = excluded analysis). These values were 88% and 86%, respectively, in a discontinuation = failure analysis. Effectiveness remained high across all key populations at 24 months. Median (Q1, Q3) CD4 count increased by 257 (127, 447) cells/µL in TN and 40 (-70, 153) cells/µL in TE participants (both p < 0.001). There was no reported treatment-emergent resistance to B/F/TAF. Persistence was high at 24 months (TN, 95%; TE, 91%). Drug-related adverse events occurred in 11% of TN and 12% of TE participants, leading to B/F/TAF discontinuation in 5%.

Conclusions: B/F/TAF was generally well tolerated over 24 months, with high effectiveness and persistence observed among a broad range of people with HIV.

Background: Despite advances in HIV treatment, gaps in care retention threaten the individual health of people with HIV (people) and public health efforts to end the HIV epidemic.

Objective: This project aimed to identify and address gaps in retention and support re-engagement in care.

Methods: A multipronged initiative at five community HIV clinics and community-based organizations (CBOs) included patient, healthcare professional (HCP), and community-focused interventions. Patient-oriented interventions included instructional videos for patients to view before appointments and conversation guides about barriers to care for patients to use with staff during appointments. HCP-oriented interventions included baseline surveys assessing clinic practices and challenges and audit-feedback sessions to review survey findings and devise plans to improve retention strategies. Community-oriented interventions included education sessions co-led by clinics and CBOs, micro-learning engagements at community events, and social media campaigns covering topics related to HIV care. Data were collected through surveys administered before and after patient- and HCP-oriented interventions and community education sessions, follow-up surveys administered after micro-learning engagements, and reach of social media campaigns.

Results: Patient-oriented interventions led to improvements in patient-reported empowerment and confidence in their ability to remain in care. HCPs also reported improvements in patient intake and follow-up processes after audit-feedback sessions. Community interventions reached over 1,000 community members combined, with education sessions and micro-learning engagements uncovering key barriers to HIV care and leading to improvements in knowledge and awareness of local HIV services.

Conclusion: This multipronged initiative demonstrates how patient, HCP, and community-oriented education can support retention and re-engagement in care.

Objective: Treatment, adherence and linkage to care are lower in Black African and Black Caribbean heritage women living with HIV, affected by significant psychosocial challenges compared to other groups. The COVID-19 lockdowns further amplified these inequalities. We aimed to assess its impact on this population across Chelsea and Westminster Hospitals NHS Foundation Trust.

Methods: We used an online survey and in-depth interviews to collect data between 01-10-2022 and 01-06-2023. Descriptive statistics were used to summarize the survey data and thematic analysis was adopted to analyze the qualitative data.

Results: Of 393 women contacted, 36 completed the survey and 22 took part in interviews. The survey found that COVID-19 lockdown restrictions worsened anxiety (48%) and low mood (45%). 54% reported that the experience of COVID-19 triggered the trauma of their initial HIV diagnosis. Interviewed participants discussed how their psychological issues and co-morbidities were not always addressed by their care system. Stigma and being forced to share their HIV information were also prominent issues.

Conclusions: There is continued institutional stigma and discrimination in health care settings for women living with HIV of African or Caribbean heritage, and there is an urgent need to address the inequity in care to improve patients' experience post-pandemic.

Background: HIV remains a major challenge in KwaZulu-Natal, South Africa, particularly for young women who face disproportionate risks and barriers to prevention and treatment. Most HIV cure trials, however, occur in high-income countries.

Objective: To examine the perspectives of young women diagnosed with acute HIV in a longitudinal study, focusing on their perceptions on ATI-inclusive HIV cure trials and the barriers and facilitators to participation.

Materials and methods: Between October 2022 and February 2024, we conducted closed-ended surveys and in-depth interviews with 20 women aged 19-33 living with HIV, who were willing but ineligible or unable to participate in an HIV cure trial.

Results: Many participants reported mental health challenges, including major depression (40%), moderate to severe anxiety (35%), and low self-esteem (35%). While women diagnosed during acute HIV supported pausing antiretroviral treatment (ART) during analytical treatment interruption (ATI) to advance HIV cure research, concerns about health risks and HIV-related stigma were significant barriers to enrollment. Trust in the research team and close monitoring were seen as positive factors, while fears around sharing of HIV/ATI status and transmission to sex partners complicated decision-making. Participants expressed a need for psychological counseling and access to community resources to manage ATI-related stressors.

Conclusions: Understanding women's perspectives on HIV cure research, especially ATI trials, is vital. Building trust and addressing psychosocial challenges through a healing-centered approach can facilitate trial participation. Socio-behavioral research before and during HIV cure trials will be essential to inform participant-centered protocol design.

Background: In Trinidad and Tobago, high HIV prevalence among key populations necessitates studying factors that impact durable viral suppression (DVS), crucial for effective HIV management and reducing transmission among at-risk networks. This study investigates these factors using clinical data from a major HIV care clinic in the Caribbean.

Methods: A retrospective analysis of 533 adult people with HIV (people) at MRFTT from 2017 to 2021 assessed the proportion achieving DVS, defined as a sustained viral load <200 copies/ml over one year. Initial univariate analysis characterized individuals with DVS, followed by bivariate analysis to explore socio-demographic differences. Significant variables from bivariate analysis were examined in a regression model to identify DVS covariates.

Results: The average age of the sample was 45 years (SD = 10.88), with 52.0% male and 72.1% of African descent. 31.5% achieved durable viral suppression (DVS). Those with DVS were predominantly women (54.1%), older (mean age 45, SD = 11.32), with more frequent clinic visits over five years (mean = 101, SD = 33.26). Regression analysis showed that women (OR = 1.43, 95% CI 0.99-2.07), individuals on long-term antiretroviral therapy (ART) (>5 years) (OR = 1.66, 95% CI 1.03-2.66), and those with extended clinic enrolment (>5 years) (OR = 1.82, 95% CI 1.08-3.06) had higher odds of achieving DVS.

Conclusions: Only a third of the study sample achieved DVS, with men less likely to reach this goal. Lesser engagement in care correlated with lower DVS rates. Further research into social and structural barriers to clinic attendance, particularly among younger men, is recommended.

The PROMISE study assessed revisions designed to facilitate implementation of an HIV care coordination program (CCP) addressing gaps in care and treatment engagement among people living with HIV in New York City (NYC). Through latent class analysis (LCA) of a discrete choice experiment (DCE), we explored heterogeneity of provider preferences regarding CCP features. From January-March 2020, 152 NYC CCP providers completed a DCE with 3-4 levels on each of 4 program attributes: 1) Help with Adherence to Antiretroviral Therapy (ART), 2) Help with Primary Care Appointments, 3) Help with Issues Other than Primary Care, and 4) Where Program Visits Happen. We used LCA to assess patterns of preference, and choice simulation to estimate providers' endorsement of hypothetical CCPs. LCA identified three subgroups. The two larger subgroups (n = 133) endorsed more intensive individual program features, including directly observed therapy, home visits, and appointment reminders with accompaniment of clients to their appointments. The smallest subgroup (n = 19) endorsed medication reminders only, appointment reminders without accompaniment, and meeting at the program location rather than clients' homes. Choice simulation analysis affirmed the highest degree of endorsement (62%) for hypothetical programs combining the intensive features described above. Results indicated providers' preference for intensive program features and also reinforced the need for flexible service delivery options. Provider perspectives on service delivery approaches can inform program adjustments for successful long-term implementation, which in turn can improve patient outcomes.

Background: Resistance to antiretrovirals against human immunodeficiency virus (HIV) poses a threat to zero transmission of HIV by 2030. Few studies have been conducted on HIV drug resistance (HIVDR) mutations targeting adolescents. We determined the prevalence, pattern of HIVDR mutations, and factors associated with unsuppressed HIV viral load among adolescents on antiretroviral therapy (ART).

Methods: From March to June 2020, we conducted a cross-sectional study at the Infectious Disease Clinic in Dar es Salaam, Tanzania. HIV-1 viral load was tested using m2000rt Real-Time HIV-1 assay. A sample with a viral load equal or more than 1,000 copies/ml was tested for HIVDR mutations. We determined the factors associated with unsuppressed viral load using logistic regression. A p-value less than 0.05 was considered significant.

Results: We enrolled 131 participants with a median age (interquartile range) of 15 (13-18) years. Of all, 24(18.3%) had a viral load above 1000 copies/ml. HIVDR mutations were found in 19/24(68.4%). Mutation to protease inhibitors, nucleotide reverse transcriptase inhibitors, and non-nucleoside reverse transcriptase inhibitors were 1(5.2%), 9(47.4%), and 11(57.9%), respectively. Non-antiretroviral therapy and orphanages were independently associated with unsuppressed viral load.

Conclusion: The prevalence of HIVDR and unsuppressed HIV viral load among adolescents are relatively high. The use of non-antiretroviral therapy and orphanage influenced the persistence of high viral load. Strategies for surveillance of HIVDR early warning signs should be devised among adolescents.

Background: HIV-related stigma is associated with worse health outcomes and lower adherence to antiretroviral therapy. There is limited data on the stigma faced by Latin American cisgender women, although they are among the populations most affected by HIV. This study aims to provide insight into the Stigma Index Brazil, with the objective of estimating the prevalence of HIV-related stigma among cisgender women in Brazil and to investigate the role of low socioeconomic status in stigma experience.

Methods: This is a cross-sectional community-based study. A total of 30 people with HIV were trained to recruit participants from their peer networks; 1,768 people with HIV from all regions of Brazil participated in the study, of which 566 participants were cisgender women. We used the Stigma Index, an instrument that assesses global trends in HIV-related stigma from the perspective of people with HIV.

Results: Approximately 70% of participants reported some form of HIV-related stigma. The most prevalent forms were discriminatory comments or gossiping (51.26%) and verbal harassment (30.99%). More than 20% experienced any health care related HIV-stigma in the last 12 months, the most frequent being the avoidance of physical contact (10.02%). Women in social vulnerability faced more stigma compared to the group without social vulnerability, both in general contexts (75.79% vs 64.32%; χ2 = 8.67, p < 0.05) and in healthcare contexts (24.12% vs 16.02%; χ2 = 4.06, p < 0.05).

Conclusion: We found a high prevalence of stigma associated with HIV faced by Brazilian women from all regions of the country, both in everyday life and in healthcare contexts. Evidence-based interventions to reduce stigma in the general population, and specific mental health care aimed at women with HIV in Brazil, especially among those with greater socioeconomic vulnerability, are urgent.