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Journal articleKhawaja AA, Whitlock G, Fidler S, et al., 2025,
Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start.
, HIV Res Clin Pract, Vol: 26INTRODUCTION: 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 αIIbβ3 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.
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Journal articleFenn J, Koycheva A, Kundu R, et al., 2025,
Early de novo T cell expansion following SARS-CoV-2 infection predicts favourable clinical and virological outcomes
, Ebiomedicine, Vol: 117Background: De novo T cell expansion to a novel viral infection is assumed to confer protection, but empirical evidence in humans is limited. The SARS-CoV-2 pandemic provided a unique opportunity to investigate de novo T cell-mediated protection in antigen-naïve individuals without the confounding effects of preexisting immune memory. Methods: We leveraged a prospective household contact study to recruit new COVID-19 cases a median of 4 days post-SARS-CoV-2 exposure. We longitudinally enumerated SARS-CoV-2 antigen-specific functional T cell subsets using dual IFN-γ/IL-2 fluorescence-linked immunospot (FLISpot) assays. We then correlated T cell dynamics with detailed clinical and virological outcomes derived from longitudinal measurement of symptom burden and viral load. Findings: Early expansion (day 0–7) of SARS-CoV-2-specific IFN-γ-secreting T cells correlated with lower peak viral load and symptom burden. Conversely, late T cell expansion (day 7–28) correlated with higher symptom burden. Neither pre-existing cross-reactive T cells nor early antibody induction correlated with virological outcomes. Interpretation: These findings provide empiric evidence for early antigen-specific T cell expansion being protective against naturally acquired viral infection in humans. Funding: This work is supported by the NIHR Health Protection Research Unit in Respiratory Infections, Imperial College London in partnership with the UK Health Security Agency (Grant number: NIHR200927; AL) and the Medical Research Council (Grant number: MR/X004058/1).
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Journal articleWhitaker M, Rodrigues S, Cooke G, et al., 2025,
How COVID-19 affected academic publishing: a three-year study of 17 million research papers
, International Journal of Epidemiology, ISSN: 0300-5771 -
Journal articleCooke GS, Hung LM, Flower B, et al., 2025,
Treatment options to support the elimination of hepatitis C: an open-label, factorial, randomised controlled non-inferiority trial
, The Lancet, ISSN: 0140-6736BackgroundWHO recommends treating hepatitis C infection with one of three antiviral combinations for 8–12 weeks. No randomised trials have compared these regimens, and high cure rates might be achievable with shorter durations of therapy. We aimed to compare sofosbuvir–daclatasvir with sofosbuvir–velpatasvir, and to evaluate potential novel treatment strategies.MethodsWe conducted a multi-arm, open-label, randomised controlled non-inferiority trial in two public hospitals in Viet Nam. Adults (aged ≥18 years) with chronic hepatitis C infection and mild-to-moderate liver fibrosis were eligible. Recruitment was stratified by centre and viral genotype (1–5 vs 6) with 1:1 random allocation to an oral fixed-dose combination of sofosbuvir 400 mg plus daclatasvir 60 mg (sofosbuvir–daclatasvir) or sofosbuvir 400 mg plus velpatasvir 100 mg (sofosbuvir–velpatasvir). Participants were simultaneously factorially randomly assigned to one of four treatment strategies: 12 weeks’ standard of care (SOC); 4 weeks’ therapy with four weekly PEGylated interferon alfa-2a subcutaneous injections; induction and maintenance therapy with 2 weeks’ standard therapy followed by 10 weeks’ therapy 5 days a week; and response-guided therapy (RGT) for 4, 8, or 12 weeks determined by viral load on day 7. The primary outcome was sustained virological response (SVR) 12 weeks after treatment completion, analysed in all evaluable participants regardless of actual treatment received. We chose a 5% non-inferiority margin for the drug comparison, and a 10% non-inferiority margin for the treatment strategy comparisons. Safety was assessed in all randomised participants. This trial is registered with ISRCTN, 61522291, and is completed.FindingsBetween June 19, 2020, and May 10, 2023, 624 participants were randomised (470 [75%] were male and 154 [25%] were female). 296 (47%) had genotype 6 and 328 (53%) had genotypes 1–5. The primary outcome w
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Journal articleElliott T, Bradshaw D, Fidler S, 2025,
HIV diagnosis during acute infection: implications of long-acting preexposure prophylaxis and other evolving challenges.
, Curr Opin HIV AIDS, Vol: 20, Pages: 228-235PURPOSE OF REVIEW: Tests for HIV may perform differently in some circumstances such as with preexposure prophylaxis (PrEP) or other HIV prevention agents. Testing algorithms may not account for this, with a risk of false negative or positive HIV results. In this review we have explored the challenges of HIV testing in these special circumstances. RECENT FINDINGS: Long-acting injectable PrEP using cabotegravir or lenacapavir has been studied in large randomized controlled trials (HPTN083/084 and PURPOSE1/2 respectively). Injectable PrEP was significantly more efficacious than oral PrEP, but infections still occurred risking the emergence of HIV drug-resistance. HIV diagnostic test results were atypical in those receiving injectable PrEP, with low or undetectable HIV viral loads, delayed or diminished antibody, and HIV detection assays reverting from reactive to unreactive; so-called long acting early viral inhibition (LEVI) syndrome. In these cases, missed or delayed HIV diagnoses could be reduced with the use of HIV nucleic acid amplification tests in addition to routine testing, but this remains unfeasible in many settings. SUMMARY: Finding HIV testing strategies that are affordable and practical in low- and middle-income countries that can accurately diagnose HIV in the context of HIV prevention is of high importance, but more research is needed in this area.
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Journal articleBurger R, Bell-Mandla N, Harper A, et al., 2025,
Does enhanced HIV prevention, diagnosis, and linkage to care reduce hospitalisation in high HIV-burden communities in Zambia and South Africa? findings from the HPTN 071 (PopART) randomised trial
, PLOS Global Public Health, Vol: 5The objective of this study is to explore if a community-based HIV combination prevention intervention reduced inpatient hospitalisations in Zambia and South Africa by diagnosing HIV and TB in earlier stages of disease progression, thereby preventing severe disease and new infections. As part of the HIV Prevention Trials Network (HPTN) 071 trial, hospitalisation data from a cohort of 16 968 consenting randomly sampled adults aged 18–44 years were collected between 28 November 2013 and 16 November 2018 across 21 communities in Zambia and South Africa across three study arms. Arm A included annual visits by Community HIV-care Providers (CHiPs) and universal linkage to care for ART initiation for all PLWH (irrespective of CD4 count); arm B included annual CHiPs visits and ART per local guidelines; control arm C received the standard of care provided at government clinics, including HIV testing and ART offered according to local guidelines. For this study, we used a cluster-level two-stage analysis and adjusted for covariates that were unbalanced across intervention arms. Covariates included in the models were the cluster’s baseline HIV prevalence and hospitalisation rate and data on the respondent’s gender, age, educational attainment, and socio-economic status. Out of the pooled sample of 13 964 responses from the three post-baseline surveys, 439 (3.14%) reported hospitalisation in the past 12 months – 234 (1.68%) when excluding hospital admissions for births or injury. Comparing hospitalisations in the intervention and control arm clusters, the estimated adjusted risk ratio was 1.03 [0.64–1.66] for the full sample and 0.82 [0.39–1.74] for PLWH. We find no compelling evidence of impact of the HPTN071 (PopART) community-wide combination HIV prevention intervention on in-patient hospitalisation among a general population sample.
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Journal articleShah S, Short C-E, Taylor G, et al., 2025,
Comparison of pregnancy outcomes between people with perinatally acquired HIV, horizontally acquired HIV and those without HIV
, AIDS, Vol: 39, Pages: 621-624, ISSN: 0269-9370A retrospective case-controlled study compared pregnancy outcomes between people with perinatally acquired HIV (PaHIV), horizontally acquired HIV (HaHIV), and those without HIV. PaHIV were more likely to be viraemic in early pregnancy than HaHIV. When matched for age and ethnicity, babies born to PaHIV were more likely to be premature, small for gestational age, delivered by caesarean section and require enhanced neonatal and social care involvement than infants born to age/ethnically matched HIV-uninfected individuals.
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Journal articleO'Keeffe A, Price J, Seeley J, et al., 2025,
"It empowered me to move my timeline forward": first person thematically analysed accounts of a novel behavioural intervention to support status-sharing in young adults with perinatally acquired HIV in UK and Uganda.
, AIDS Care, Pages: 1-12Young adults living with perinatally acquired HIV (PAH) face many stressors. Sharing one's status may help with coping with these challenges but there are no rigorously evaluated interventions to support HIV status sharing in this population. The aim of this study was to explore the experiences of participants in a novel HIV status-sharing intervention guided by motivational interviewing. We used a cross-sectional, qualitative design. Ten young adults from Uganda (20-25 years; 6 female), nine from the UK (19-29 years; 7 female) and five therapists (2 UK; 3 Uganda) participated in individual semi-structured interviews. The data were analysed using thematic analysis. Seven theoretical themes were identified. Participants reported positive experiences of the intervention, a desire for more support and the importance of peer interaction. This study provides evidence for the acceptability of a novel HIV-sharing intervention for young adults with PAH. The intervention could inform HIV sharing guidance and clinical practice.
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Journal articleSkalland TM, de Dieu Tapsoba J, Zangeneh SZ, et al., 2025,
A survey weighted analysis of HPTN 071 (PopART) primary outcome of HIV incidence.
, AIDS Res Ther, Vol: 22INTRODUCTION: HPTN 071 (PopART) implemented a comprehensive HIV prevention package which aimed to reduce HIV incidence within 21 communities of Zambia and South Africa: Arm A, PopART intervention of universal HIV testing and treatment; Arm B, PopART intervention of universal HIV testing with ART provided according to local guidelines; and Arm C, standard of care. Analyses so far have not accounted for the sampling design of the enrolled cohort. We performed a sample-weighted re-analysis of the primary outcome of the PopART trial to derive a population-based estimate of the intervention effect. METHODS: Enrollment used a two-stage sampling design: household and adult participant within each household. We constructed post-stratification weights to match the age and sex distribution of the target population in these communities. Weighted Poisson regression was used to estimate community-level HIV incidence. The PopART intervention effect was estimated using log-transformed community-level incidence estimates in an ANCOVA model. RESULTS: The analysis based on community-level incidence shows a 25% reduction in incidence for Arm B communities compared to standard of care (RR: 0.75, 95% CI: 0.56-1.02, p = 0.06) while Arm A communities show no difference in HIV incidence compared to standard of care (RR: 1.08, 95% CI: 0.81-1.46, p = 0.56). CONCLUSIONS: Our re-analysis shows 25% reduction in HIV incidence comparing Arm B to Arm C communities. No effect was observed comparing Arm A communities to Arm C communities. These results align with the primary results of the PopART trial. CLINICALTRIALS: gov number, NCT01900977, HPTN 071 [PopArt].
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Journal articleHenderson M, Lyons D, Beddows S, et al., 2025,
High-risk human papillomavirus prevalence and serostatus in a cohort of cisgender women and people with a cervix living with perinatally acquired HIV.
, HIV MedOBJECTIVES: Human papillomavirus (HPV)-associated cervical cancer risk is greater in people with HIV, although this has been at least partially attenuated by antiretroviral medication, enhanced cervical screening and HPV vaccination. People with perinatally acquired HIV may remain at higher risk due to lifelong immunosuppression and potentially reduced vaccine effectiveness. In this study in people with a cervix with perinatally acquired HIV, we explored cervical high-risk HPV (hrHPV) prevalence and HPV serostatus. METHODS: Participants were recruited from a London HIV service between 2020 and 2022. Cervical samples from those sexually active were analysed for hrHPV (Cepheid GeneXpert) and cytology, and, if abnormal, a referral was made to colposcopy. Serum samples were tested for antibodies against HPV6/11/16/18/31/33/45/52/58. A self-reported questionnaire including HPV vaccination history was completed. RESULTS: Fifty-seven people were recruited with a median age of 25 years (range 18-34). Of those providing a cervical sample, 15/47 (32%) were hrHPV-positive and 12/40 (30%) had abnormal cytology; 1/17 referred for colposcopy had CIN2 (6%); 7/15 (47%) with hrHPV were below the national screening age of 24.5 years (range 19-23), and 9/15 (60%) reported previous HPV vaccination. No vaccinated participants had hrHPV16/18. Of those vaccinated, 37/39 (95%) were seropositive for HPV16 and 30/39 (77%) for HPV18. Two vaccinated participants were seronegative for HPV16/18; both had detectable HIV viral loads and CD4 counts <200 cells/μL at recruitment. CONCLUSION: In this small observational study we identified a 32% prevalence of cervical hrHPV. Cervical screening and HPV vaccination remain vital in this group, with further data required to inform screening guidelines for this population.
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