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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 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 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: 621-624A 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 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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Journal articleHarvala H, Davison K, Webster M, et al., 2025,
HTLV screening of blood donations in England between 2002 and 2021—comparison of screening strategies
, Clinical Infectious Diseases, ISSN: 1058-4838BackgroundHuman T-lymphotropic virus (HTLV) is associated with adult T-cell leukemia/lymphoma and myelopathy. Here we present virological and epidemiological data on HTLV screening of blood donations in England between 2002 and 2021, implemented to prevent its transmission via blood transfusion.MethodsData on HTLV testing of blood donations was reviewed; it was initially conducted in pools (2002–2012) and subsequently using individual samples (all donors, 2013–2016; first-time donors and non-leucodepleted component donors, 2017–2021). Data included annual number of donations screened, initial and repeat reactives as well as confirmed positives. Further information, such as likely source of infection, was obtained for HTLV-positives.ResultsOver the 20-year study period, a total of 30 679 741 blood donations were screened for HTLV in England. Under pooled screening strategy, the annual rate of repeat reactive donations remained <5:100 000. However, this rate increased to 51:100 000 with individual screening and further to 123:100 000 with selective screening. A total of 5032 samples were repeat reactive, of which 278 were confirmed HTLV-positives. Although the specificity under each scenario exceeded 99.9%, the rate of repeat reactives was around 50-fold higher in individual compared to pooled screening. Most HTLV infected were UK-born, most likely acquired their infection unknowingly through breast feeding or heterosexual intercourse with an individual associated with an HTLV-endemic country.ConclusionsThese data highlight that pooled testing can be advantageous in low-prevalence settings due to its high specificity and reduced non-specific reactivity. Whether pooling is an applicable strategy to tackle the burden of HTLV infection in resource-poor, HTLV-endemic countries requires further investigations.
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Journal articleGondwe M, Simuyaba M, Phiri M, et al., 2025,
Acceptability of and experiences with menstrual hygiene cups among adolescent girls and young women aged 15-24 in two communities in Lusaka, Zambia: an exploratory study nested in the Yathu Yathu trial.
, Reprod Health, Vol: 22BACKGROUND: Menstrual cups could be a sustainable menstrual material for adolescent girls and young women (AGYW) in sub-Saharan Africa. Yathu Yathu was a cluster-randomized trial of community-based delivery of HIV and sexual and reproductive health services to young people in Lusaka, Zambia. Among services available through the intervention were menstrual products, including menstrual cups. We explored knowledge of menstruation and menstrual products, acceptability, and experiences of using cups among AGYW aged 15-24. We share lessons learned on how to distribute cups through community-based strategies to AGYW in urban communities. METHODS: Through community-based, peer-led spaces (hubs), AGYW could access menstrual products, including pads and menstrual cups. We conducted four focus group discussions, two with AGYW aged 15-19 (n = 9) and 20-21 (n = 8) who had accessed different menstrual products through Yathu Yathu and two with AGYW aged 15-19 (n = 5) and 20-24 (n = 9) who had accessed menstrual cups. Four interviews were conducted with four AGYW (15-19, n = 2; 20-24, n = 2) who had accessed cups, and four with two AGYW who were enrolled in a qualitative cohort. Data were analyzed thematically. RESULTS: 'Surprise' and 'fear' were initial reactions from most AGYW who saw the cups for the first time at Yathu Yathu hubs. Misconceptions that cups cause cancer and fears that they could get stuck in the vagina, cause sore, vagina enlargement, and loss of virginity were raised by AGYW. The desire to try the cup, use an alternative menstrual product and information gained at the hubs facilitated access. Use of the cup was comfortable, and cups were said to be cost-effective and durable. Advantages over pads included: the absence of odor, easy to maintain, and environmentally friendly: "it is hygienic, and it is even easy to maintain". Challenges included pain, discomfort, and fai
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Journal articleLuintel A, Healy J, Blank M, et al., 2025,
The global prevalence of reported penicillin allergy: A systematic review and meta-analysis.
, J Infect, Vol: 90OBJECTIVES: Patients labelled with penicillin allergy (PenA) often receive broader spectrum antibiotics, associated with antimicrobial resistance and poorer outcomes. However, ∼95% of patients are likely mis-labelled. Whilst de-labelling programmes are gaining momentum, they have been restricted to a few countries. Here, we address the global prevalence of PenA, to inform the wider potential impact for de-labelling programmes. METHODS: We conducted a systematic review and meta-analysis including all studies on adult PenA prevalence between January 2003 and June 2023. Data on PenA prevalence, allergy recording methods, healthcare setting, and country income were extracted. This study is registered on PROSPERO (CRD42023437718). RESULTS: 174 studies from 28 countries were included (18,352 screened). Global PenA prevalence was 9·4% (95% CI 8·4-10·4%). 92% of peer-reviewed publications were from high-income countries(HICs), with 72% from the UK, USA or Australia. HICs had higher PenA prevalence 9·9% (95% CI 8·8-11·0%), compared to middle-income countries (MICs), 4·4% (95% CI 2·8-6·2%), p<0.0001. Primary care data was seldom reported (16% of studies), and the method of allergy recording significantly influenced reported prevalence. CONCLUSIONS: Studies reporting PenA prevalence are skewed towards HICs and secondary care, with little data from Africa, most of Asia and South America. This highlights an unmet need to broaden epidemiological analysis in under-represented regions.
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Journal articleJonnerby J, Fenn J, Hakki S, et al., 2025,
Inferring transmission risk of respiratory viral infection from the viral load kinetics of SARS-CoV-2, England, 2020 to 2021 and influenza A virus, Hong Kong, 2008 to 2012.
, Euro Surveill, Vol: 30BackgroundInfectiousness of respiratory viral infections is quantified as plaque forming units (PFU), requiring resource-intensive viral culture that is not routinely performed. We hypothesised that RNA viral load (VL) decline time (e-folding time) in people might serve as an alternative marker of infectiousness.AimThis study's objective was to evaluate the association of RNA VL decline time with RNA and PFU VL area under the curve (AUC) and transmission risk for SARS-CoV-2 and influenza A virus.MethodsIn SARS-CoV-2 and influenza A virus community cohorts, viral RNA was quantified by reverse transcription quantitative PCR in serial upper respiratory tract (URT)-samples collected within households after an initial household-member tested positive for one virus. We evaluated correlations between RNA VL decline time and RNA and PFU-VL AUC. Associations between VL decline time and transmission risk in index-contact pairs were assessed.ResultsIn SARS-CoV-2 cases, we observed positive correlations between RNA VL decline time and RNA and PFU VL AUC with posterior probabilities 1 and 0.96 respectively. In influenza A cases a positive correlation between RNA VL decline time and RNA VL AUC was observed, with posterior probability of 0.87. Index case VL decline times one standard deviation above the cohort-mean showed a relative increase in secondary attack rates of 39% (95% credible interval (CrI): -6.9 to 95%) for SARS-CoV-2 and 25% (95% CrI: -11 to 71%) for influenza A virus.ConclusionWe identify VL decline time as a potential marker of infectiousness and transmission risk for SARS-CoV-2 and influenza A virus. Early ascertainment of VL kinetics as part of surveillance of new viruses or variants could inform public health decision making.
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Journal articleMumford L, Hogg R, Taylor A, et al., 2025,
Impact of SARS-CoV-2 spike antibody positivity on infection and hospitalisation rates in immunosuppressed populations during the omicron period: the MELODY study.
, Lancet, Vol: 405, Pages: 314-328BACKGROUND: In the UK, booster COVID-19 vaccinations have been recommended biannually to people considered immune vulnerable. We investigated, at a population level, whether the absence of detectable anti-SARS-CoV-2 spike protein IgG antibody (anti-S Ab) following three or more vaccinations in immunosuppressed individuals was associated with greater risks of infection and severity of infection. METHODS: In this prospective cohort study using UK national disease registers, we recruited participants with solid organ transplants (SOTs), rare autoimmune rheumatic diseases (RAIRDs), and lymphoid malignancies. All participants were tested for anti-S Ab using a lateral flow immunoassay, completed a questionnaire on sociodemographic and clinical characteristics, and were followed up for 6 months using linked data from the National Health Service in England. SARS-CoV-2 infection was primarily defined using UK Health Security Agency data and supplemented with hospitalisation and therapeutics data, and hospitalisation due to SARS-CoV-2 was defined as an admission within 14 days of a positive test. FINDINGS: Between Dec 7, 2021, and June 26, 2022, we recruited 21 575 participants. Anti-S Ab was detected in 6519 (77·0%) of 8466 participants with SOTs, 5594 (85·9%) of 6516 with RAIRDs, and 5227 (79·3%) of 6593 with lymphoid malignancies. COVID-19 infection was recorded in 3907 (18·5%) participants, with 556 requiring a COVID-19-related hospital admission and 17 dying within 28 days of infection. Rates of infection varied by sociodemographic and clinical characteristics but, in adjusted analysis, having detectable anti-S Ab was independently associated with a reduced incidence of infection, with incident rate ratios (IRRs) of 0·69 (95% CI 0·65-0·73) in the SOT cohort, 0·57 (0·49-0·67) in the RAIRD cohort, and 0·62 (0·54-0·71) in the lymphoid malignancy cohort. In adjusted analysis, having de
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