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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.)

Competing Interests: DLW was supported by Balvi Filantropic Fund, Barry Satz and Ronald Satz Memorial Fund and Chulalongkorn University (Second Century Fund- C2F Postdoctoral Fellowship), University of Western Australia (Overseas Research Experience Fellowship) and Yamagata Prefectural Central Hospital, Yamagata, Japan (Clinical Residency Fellowship). CM was supported by the Centre of Excellence in Mathematics, Ministry of Higher Education, Science, Research and Innovation, Thailand, Center of Excellence on Medical Biotechnology, and Thailand Center of Excellence in Physics. AKi is a Rothwell Family Fellow. The funder(s) had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. All other authors declare no competing interests. The data supporting the findings of this study are available within this paper and its additional information. All genome sequences and associated metadata in this study are published in GISAID's EpiCoV database under the mpox category (accession numbers are given in the appendix). The institutional review board at Yamagata Prefectural Central Hospital, Yamagata, Japan, waived ethical approval for this work as it determined that our project is exempt under the type of environmental surveillance study. We, the authors of this paper, embrace inclusive, diverse, and equitable conduct of research. Our team comprises individuals who self-identify as underrepresented ethnic minorities, gender minorities, members of the LGBTQIA+ community, and individuals living with disabilities. We actively promote gender balance in our reference list while maintaining scientific relevance. We thank all the volunteers, entertainment venue staff, and sanitary workers who kindly supported the sample collection. Also, thanks to the United States Centers for Disease Control and Prevention (CDC) Thailand for technical support and the previous Chargé d'Affaires of the United States of America to Thailand (U.S. Embassy & Consulate in Thailand) for facilitating collaboration with the CDC and Armed Forces Research Institute of Medical Sciences. We also thank the LGBTQIA+ community in Indonesia, Madagascar, Myanmar, Thailand, Papua New Guinea, Mozambique, Pakistan, Viet Nam, Sri Lanka, India, Philippines, Cambodia, Laos, Timor-Leste, Nepal, Maldives for generously supporting sample collection, TEDxChiangMai team for facilitating a platform for collaboration, and marginalised, vulnerable indigenous communities in Indonesia, Madagascar, Myanmar, Thailand, Papua New Guinea, Mozambique, Pakistan, Viet Nam, Sri Lanka, India, the Philippines, Cambodia, Laos, Timor-Leste, Nepal, and the Maldives for supporting sample collection. Special thanks to Nuttawut Kietchaiyakorn for helping with the illustrations. Editorial note: The Lancet Group takes a neutral position with respect to territorial claims in published maps.

Background: Torque teno virus (TTV) is part of the human virome. TTV load was related to the immune status in patients after organ transplantation. We hypothesize that TTV load could be an additional marker for immune function in people living with HIV (PLWH)., Methods: In this analysis, serum samples of PLWH from the RESINA multicenter cohort were reanalyzed for TTV. Investigated clinical and epidemiological parameters included human pegivirus load, patient age and sex, HIV load, CD4+ T-cell count (Centers for Disease Control and Prevention [CDC] stage 1, 2, or 3), and CDC clinical stage (1993 CDC classification system; stage A, B, or C) before initiation of antiretroviral therapy. Regression analysis was used to detect possible associations among parameters., Results: Our analysis confirmed TTV as a strong predictor of CD4+ T-cell count and CDC class 3. This relationship was used to propose a first classification of TTV load with regard to clinical stage. We found no association with clinical CDC stages A-C. The human pegivirus load was inversely correlated with HIV load but not TTV load., Conclusions: TTV load was associated with immunodeficiency in PLWH. Neither TTV nor HIV load were predictive for the clinical categories of HIV infection., Competing Interests: Potential conflicts of interest. B. E. O. J. has received consulting fees from Gilead, ViiV Healthcare (ViiV) and Merck Sharpe and Dohme (MSD). B. E. O. J. has received payment or honoraria for lectures and presentations from Gilead, ViiV and GSK. B. E. O. J. has received support for meetings and travel from Gilead. B. E. O. J. is scientific secretary of the German AIDS Society (unpaid). S. E. has received grants or contracts, support for meetings or travel, and payments or honoraria for lectures or presentations from Gilead, ViiV, MSD and Janssen. S. E. participated on a data safety monitoring board or advisory board for Gilead, ViiV, MSD, Janssen and GSK. S. E. is in a leadership or fiduciary role for the German AIDS Society and the National AIDS Comission NRW. S. E.reveived equipment, materials, drugs, medical writing, gifts or other services from Gilead and GSK. N. L. received consulting fees from ViiV. N. L. received honoraria for lectures from ViiV and MSD. N. L. received support for travel from the Deutsche AIDS Gesellschaft. J. K. R. received consulting fees from Behringer. J. K. R. received payment for lectures or presentations from Gilead, MSD and ViiV. J. K. R. was payed for the particpation on a data safety monitoring board or advisory board for Abivax. J. K. R. is EACS (European AIDS Clinical Society) board member. C. B. received grants or contracts from DZIF (German Center for Infection Research) and DFG (German Research Foundation). C. B. received consulting fees, payment for lectures and presentations, and support for meetings or travel from Abbvie, MSD, Janssen, Gilead and ViiV. C. B. is governing board member of EACS. R. K. received grants from DZIF. R. K. received payment for presentations or lectures from Janssen, Roche, Hologic, Abbvie, Abbott, MSD, ViiV, Gilead and Pfizer. R. K. particpated on a data safety monitoring board or advisory board for ViiV, Gilead, Pfizer, MSD and Janssen. All other authors: No reported 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.)

Objectives: To identify sexual/sex-associated risk factors for hepatitis C transmission among men who have sex with men (MSM) and visualise behavioural trajectories from 2019 to 2021., Methods: We linked a behavioural survey to a hepatitis C cohort study (NoCo), established in 2019 across six German HIV/hepatitis C virus (HCV) treatment centres, and performed a case-control analysis. Cases were MSM with recent HCV infection, and controls were matched for HIV status (model 1) or proportions of sexual partners with HIV (model 2). We conducted conditional univariable and multivariable regression analyses., Results: In all, 197 cases and 314 controls completed the baseline questionnaire and could be matched with clinical data. For regression models, we restricted cases to those with HCV diagnosed since 2018 (N = 100). Factors independently associated with case status included sex-associated rectal bleeding, shared fisting lubricant, anal douching, chemsex, intravenous and intracavernosal injections, with population-attributable fractions of 88% (model 1) and 85% (model 2). These factors remained stable over time among cases, while sexual partner numbers and group sex decreased during COVID-19 measures., Conclusions: Sexual/sex-associated practices leading to blood exposure are key factors in HCV transmission in MSM. Public health interventions should emphasize the importance of blood safety in sexual encounters. Micro-elimination efforts were temporarily aided by reduced opportunities for sexual encounters during the COVID-19 pandemic., (© 2024 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)

Purpose: The risk of developing active tuberculosis (TB) is considerably increased in people living with HIV/AIDS (PLWH). However, incidence of HIV/TB coinfection is difficult to assess as surveillance data are lacking in many countries. Here, we aimed to perform a quantitative analysis of HIV/TB coinfections within the Cologne/Bonn HIV cohort and to determine risk factors for active TB., Methods: We systematically evaluated data of patients with HIV/TB coinfection between 2006 and 2017. In this retrospective analysis, we compared HIV/TB-coinfected patients with a cohort of HIV-positive patients. The incidence density rate (IDR) was calculated for active TB cases at different time points., Results: During 2006-2017, 60 out of 4673 PLWH were diagnosed with active TB. Overall IDR was 0.181 cases/100 patient-years and ranged from 0.266 in 2006-2009 to 0.133 in 2014-2017. Patients originating from Sub-Saharan Africa had a significantly (p < 0.001) higher IDR (0.694/100 patient-years of observation, 95% CI [0.435-1.050]) in comparison to patients of German origin (0.053/100 patient-years of observation, 95% CI [0.028-0.091]). In terms of TB-free survival, individuals originating from countries with a TB incidence higher than 10/100,000 exhibited a markedly reduced TB-free survival compared to those originating from regions with lower incidence (p < 0.001). In 22 patients, TB and HIV infection were diagnosed simultaneously., Conclusion: Overall, we observed a decline in the incidence density rate (IDR) of HIV/TB coinfections between 2006 and 2017. Patients originating from regions with high incidence bear a higher risk of falling ill with active TB. For PLWH born in Germany, the observed risk of active TB appears to be lower compared to other groups within the cohort. These findings should be considered when developing TB containment and screening strategies for PLWH in low-incidence countries., (© 2024. The Author(s).)

Introduction: Direct-acting antivirals (DAAs) are key to eliminating hepatitis C virus (HCV). In men who have sex with men (MSM) with HIV co-infection, recently acquired HCV infection is common. Sexual practices and reinfection rates may hamper micro-elimination despite high treatment rates., Methods: The cohort included MSM with recently acquired HCV infection from 2014 to 2021. The patients' demographic, clinical, behavioural, and laboratory data and treatment and reinfection outcomes were documented., Results: A total of 237 men with recently acquired HCV infection were included: 216 (91%) had HIV. The median age was 46 years (interquartile range [IQR] 39-52), and the median CD4 count was 660/mm 3 (IQR 527-835). The annual incidence of recently acquired HCV remained between 0.28% and 0.43% but dropped to 0.02% in 2021 during the COVID pandemic, almost reaching micro-elimination. The reinfection incidence was 15.5 per 100 patient-years (95% confidence interval 12.6-18.8), and reinfection was associated with the use of crystal methamphetamine (p = 0.032) and ketamine (p = 0.042). In total, 31.3% had multiple reinfections, and four reinfections occurred in users of pre-exposure prophylaxis., Conclusions: High treatment and cure rates did not lead to HCV elimination. A change in sexual behaviour, potentially imposed by COVID-19 restrictions, led to micro-elimination in the NoCo cohort. As recently acquired HCV is prevalent in MSM with and without HIV, surveillance is necessary to consolidate elimination goals., (© 2024 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)

Introduction: War in Ukraine prompted an enormous refugee influx into Europe, including approximately 4200 people with HIV. The unique healthcare features of Ukrainian refugees living with HIV were compared between two infectious disease departments in Bonn, Germany, and Szczecin, Poland. Methods: This is a retrospective study on 161 people living with HIV (PLWH) refugees from Ukraine seeking care in Bonn (n = 30) and Szczecin (n = 131) between April 2022 and May 2023. Demographic, virologic, immunologic, and coinfection data were analyzed. Results: The majority of the studied individuals were female: 64% (n = 84) in Szczecin and 60% (n = 18) in Bonn. The main HIV transmission mode was heterosexual sex in 73.5% (n = 114). All were on combined antiretroviral therapy (cART) on arrival, primarily on the TLD regimen (TDF/3TC/DTG) (68.4%, n = 106). In Germany, cART was most frequently switched to BIC/TAF/FTC in 83.4% (n = 25); in Poland, the most common combination was TDF/FTC + DTG (58%, n = 76). A prevalence of replicating hepatitis C was in 11.7% (n = 15), and that for chronic hepatitis B (HBV) was in 4.7% (n = 4). History of past tuberculosis was reported in 16.9% (n = 14, Poland, and n = 7, Germany). Follow-up after 6 months showed immunological reconstitution with a mean increase of CD4+ of 10 (IQR: -69.5-120.5) cells/µL in Poland and 51.5 (IQR: -22.5-135.5) cells/µL in Germany; p = 0.04. Virologic suppression (<40 HIV-RNA/mL) was high in care entry (n = 62; 98%) for Poland, and n = 26 (92.6%) for Germany, and suppression was achieved in the majority of patients in the 6-month control (89.7% in Poland vs. 95.7% in Germany). Conclusions: Health challenges posed by war migration extend beyond HIV to coinfections as HBV, HCV, and tuberculosis give an indication for a broader search for coinfections, often less common in the new country.

Objective: People with HIV (PWH) have high risk of liver fibrosis. We investigated the effect of weight gain and metabolic dysfunction-associated steatotic liver disease (MASLD) on liver fibrosis dynamics., Design: Multicenter cohort study., Methods: Fibrosis progression was defined as development of significant fibrosis [liver stiffness measurement (LSM) ≥8 kPa], or transition to cirrhosis (LSM ≥13 kPa), for those with significant fibrosis at baseline. Fibrosis regression was defined as transition to LSM less than 8 kPa, or to LSM less than 13 kPa for those with cirrhosis at baseline. MASLD was defined as hepatic steatosis (controlled attenuation parameter >248 dB/m) with at least one metabolic abnormality. A continuous-time multistate Markov model was used to describe transitions across fibrosis states., Results: Among 1183 PWH included from three centers (25.2% with viral hepatitis coinfection), baseline prevalence of significant fibrosis and MASLD was 14.4 and 46.8%, respectively. During a median follow-up of 2.5 years (interquartile range 1.9-3.5), the incidence rate of fibrosis progression and regression was 2.8 [95% confidence interval (CI) 2.3-3.4] and 2.2 (95% CI 1.9-2.6) per 100 person-years, respectively. In Markov model, weight gain increased the odds of fibrosis progression [odds ratio (OR) 3.11, 95% CI 1.59-6.08], whereas weight gain (OR 0.30, 95% CI 0.10-0.84) and male sex (OR 0.32, 95% CI 0.14-0.75) decreased the odds of fibrosis regression. On multivariable Cox regression analysis, predictors of fibrosis progression were weight gain [adjusted hazard ratio (aHR) 3.12, 95% CI 1.41-6.90] and MASLD (aHR 2.72, 95% CI 1.05-7.02)., Conclusion: Fibrosis transitions are driven by metabolic health variables in PWH, independently of viral hepatitis coinfection and antiretroviral class therapy., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Results of a prospective study of stage-adapted treatment of human immunodeficiency virus (HIV)-associated Hodgkin lymphoma (HIV-HL) showed a 2-year overall survival (OS) of 90.7% with no significant difference between early favorable (EF), early unfavorable (EU), and advanced HL. Patients with EF HIV-HL received two to four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation, those with EU HIV-HL received four cycles of ABVD or BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) baseline + 30 Gy IF, and six to eight cycles of BEACOPP baseline were administered in advanced disease. The objective of the present analysis is to determine long-term outcomes of HIV-HL. Of 108 patients, 23 (21%) had EF HL, 14 (13%) had EU HL, and 71 (66%) had advanced-stage HL. After a median follow-up of 9.14 (range, 0-12.9) years, there were five primary refractory HL patients (5%) and 11 relapses (10%), of which seven were late relapses (>2 years). A second primary malignancy (SPM) occurred in 10 patients after a median of 7.3 years (range, 1.5-10.7) from HL diagnosis. The 10-year OS for patients with EF, EU, and advanced HL was 95.7%, 84.6%, and 76.1%, respectively. By multivariate analysis, Center for Disease Control and Prevention category C (hazard ratio [HR] 3.00, 95% confidence interval [CI]: 1.16-7.74, p  = 0.023) and achievement of complete remission were significant for OS (HR 0.03, 95% CI: 0.01-0.08, p  = 2.45 × 10 -9 ). In conclusion, a stage-adapted treatment approach for HIV-HL is highly effective with long-term survival rates similar to those reported in HIV-uninfected HL. However, the risk for late relapse and SPM is significant., Competing Interests: The authors declare no conflict of interest., (© 2024 The Authors. HemaSphere published by John Wiley & Sons Ltd on behalf of European Hematology Association.)

Purpose: Prolonged shedding of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been observed in immunocompromised hosts. Early monotherapy with direct-acting antivirals or monoclonal antibodies, as recommended by the international guidelines, does not prevent this with certainty. Dual therapies may therefore have a synergistic effect., Methods: This retrospective, multicentre study compared treatment strategies for corona virus disease-19 (COVID-19) with combinations of nirmatrelvir/ritonavir, remdesivir, molnupiravir, and/ or mABs during the Omicron surge. Co-primary endpoints were prolonged viral shedding (≥ 10 6 copies/ml at day 21 after treatment initiation) and days with SARS-CoV-2 viral load ≥ 10 6 copies/ml. Therapeutic strategies and risk groups were compared using odds ratios and Fisher's tests or Kaplan-Meier analysis and long-rank tests. Multivariable regression analysis was performed., Results: 144 patients were included with a median duration of SARS-CoV-2 viral load ≥ 10 6 copies/ml of 8.0 days (IQR 6.0-15.3). Underlying haematological malignancies (HM) (p = 0.03) and treatment initiation later than five days after diagnosis (p < 0.01) were significantly associated with longer viral shedding. Prolonged viral shedding was observed in 14.6% (n = 21/144), particularly in patients with underlying HM (OR 3.5; 95% CI 1.2-9.9; p = 0.02). Clinical courses of COVID-19 were mild to moderate with only few adverse effects potentially related to combination treatment., Conclusion: Early combination treatment of COVID-19 effectively prevented prolonged viral shedding in 85.6% of cases. Considering the rapid viral clearance rates and low toxicity, individualized dual therapy approaches may be beneficial in high-risk patients., (© 2023. The Author(s).)

Objective: To evaluate the efficacy and safety of 96 weeks of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment in participants switching from dolutegravir (DTG)-based therapy., Design: Studies 1489 (NCT02607930) and 1490 (NCT02607956) were phase 3 randomized, double-blind, active-controlled, first-line therapy trials in people with HIV-1. After 144 weeks of DTG-based or B/F/TAF treatment, participants could enter a 96-week open-label extension (OLE) of B/F/TAF., Methods: A pooled analysis evaluated viral suppression (HIV-1 RNA <50 copies/ml) and changes in CD4 + cell count at OLE Weeks 48 and 96, treatment-emergent resistance, safety, and tolerability after switch from a DTG-based regimen to B/F/TAF. Outcomes by prior treatment were summarized using descriptive statistics and compared by two-sided Wilcoxon rank sum test., Results: At OLE Week 96, participants who switched to B/F/TAF ( N  = 519) maintained high levels of virologic suppression (99.5 and 99.1% in those switching from DTG/abacavir/lamivudine and DTG+F/TAF, respectively) and CD4 + cell count, with no treatment-emergent resistance to B/F/TAF. Twenty-one participants experienced drug-related adverse events after switching, with diarrhea, weight gain, and headache occurring most commonly. There were no cases of proximal renal tubulopathy, drug-related Grade 4 adverse events, or serious adverse events. Two participants discontinued B/F/TAF due to treatment-related adverse events. Participants who switched from DTG/abacavir/lamivudine experienced statistically significant greater weight gain than those who switched from DTG+F/TAF; however, median weight change from the blinded phase baseline to OLE Week 96 was numerically similar across treatment groups., Conclusion: This medium-term analysis demonstrates the safety and efficacy of switching to B/F/TAF from a DTG-containing regimen in people with HIV-1., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Doravirine and islatravir is an investigational, once-daily regimen with high antiviral potency, favourable safety and tolerability, and a low propensity for resistance. We investigated a switch from bictegravir, emtricitabine, and tenofovir alafenamide to doravirine (100 mg) and islatravir (0·75 mg) in virologically suppressed adults with HIV-1., Methods: We conducted a phase 3, multicentre, randomised, active-controlled, double-blind, double-dummy, non-inferiority trial at 89 research, community, and hospital-based clinics in 11 countries. Adults aged 18 years or older with fewer than 50 HIV-1 RNA copies per mL for at least 3 months on bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) and no history of previous virological failure on any past or current regimen were randomly assigned (1:1) by a computer-generated randomisation allocation schedule, with block randomisation based on a block size of four, to switch to doravirine (100 mg) and islatravir (0·75 mg) or continue bictegravir, emtricitabine, and tenofovir alafenamide orally once daily, with matching placebos taken by all participants. Participants, investigators, study staff, and sponsor personnel involved in study drug administration or clinical evaluation of participants were masked to treatment assignment until week 48. Participants were instructed at each visit to take one tablet from each of the two bottles received, one of study drug and one of placebo, once daily, and participants were assessed at baseline and weeks 4, 12, 24, 36, and 48. The primary endpoint was the proportion of participants with greater than or equal to 50 HIV-1 RNA copies per mL at week 48 in the full analysis set (ie, all participants who received at least one dose of study drug; US Food and Drug Administration snapshot; prespecified non-inferiority margin 4%). The study is ongoing, with all remaining participants in post-treatment follow-up, and is registered with ClinicalTrials.gov, NCT04223791., Findings: We screened 726 individuals for eligibility between Feb 18 and Sept 3, 2020, of whom 643 (88·6%) participants were randomly assigned to a treatment group (183 [28·5%] women and 460 [71·5%] men). 322 participants were switched to doravirine (100 mg) and islatravir (0·75 mg) and 321 continued bictegravir, emtricitabine, and tenofovir alafenamide (two participants [one with a protocol deviation and one who withdrew] assigned to bictegravir, emtricitabine, and tenofovir alafenamide did not receive treatment). The last follow-up visit for the week 48 analysis occurred on Aug 26, 2021. At week 48, two (0·6%) of 322 participants in the doravirine and islatravir group compared with one (0·3%) of 319 participants in the bictegravir, emtricitabine, and tenofovir alafenamide group had greater than or equal to 50 HIV-1 RNA copies per mL (difference 0·3%, 95% CI -1·2 to 2·0). The per-protocol analysis showed consistent results. 25 (7·8%) participants in the doravirine and islatravir group had headache compared with 23 [7·2%] participants in the bictegravir, emtricitabine, and tenofovir alafenamide group; 101 (31·4%) compared with 98 (30·7%) had infections; and eight (2·5%) participants in each group discontinued therapy due to adverse events. 32 (9·9%) participants had treatment-related adverse events in the islatravir and doravirine group comapred with 38 (11·9%) in the bictegravir, emtricitabine, and tenofovir alafenamide group. In the islatravir and doravirine group, CD4 cell counts (mean change -19·7 cells per μL) and total lymphocyte counts (mean change -0·20 × 10 9 /L) were decreased at 48 weeks., Interpretation: Switching to daily doravirine (100 mg) and islatravir (0·75 mg) was non-inferior to bictegravir, emtricitabine, and tenofovir alafenamide at week 48. However, decreases in CD4 cell and total lymphocyte counts do not support the further development of once-daily doravirine (100 mg) and islatravir (0·75 mg)., Funding: Merck Sharp & Dohme, a subsidiary of Merck & Co., Competing Interests: Declaration of interests F-HS, SOK, KE, RMP, TC (former), and MCF are or were employees of Merck Sharp & Dohme, a subsidiary of Merck & Co, who might own stock, hold stock options, or both in the company. AMM has received research funding from AbbVie, Gilead Sciences, Merck, Taimed, GSK, and ViiV Healthcare; honoraria from Gilead Sciences, ViiV Healthcare, and EMD Serono; and served on advisory boards for Gilead Sciences and ViiV Healthcare. GR has received honoraria from MSD, Gilead Sciences, GSK, and ViiV Healthcare and meeting or travel support from Gilead Sciences. MNR has received consulting fees from Gilead Sciences, Merck, and ViiV Healthcare and honoraria from AbbVie, Gilead Sciences, Janssen, and ViiV Healthcare. OOO has received honoraria from Gilead Sciences and ViiV Healthcare. JRB has received consulting fees from Gilead Sciences, MSD, Pfizer, and ViiV Healthcare and honoraria from AbbVie, Gilead Sciences, MSD, Pfizer, AstraZeneca, GSK, Janssen, ViiV Healthcare, and NovoNordisk. DPH has received research funding from Gilead Sciences, MSD, ViiV Healthcare, GSK, Janssen; honoraria for speakers bureau from Gilead Sciences and ViiV Healthcare; meeting or travel support from Gilead Sciences, ViiV Healthcare, GSK, and MSD; and served on advisory boards for and received consulting fees from Gilead Sciences, ViiV Healthcare, and Janssen. RP has served on advisory boards for and received consulting fees from Pfizer, MSD, Gilead Sciences, ViiV Healthcare, GSK, Roche, Atea, and Lilly and has received research funds (awarded to institution) from MSD, Gilead Sciences, and ViiV Healthcare. JR has received honoraria from MSD, Gilead Sciences, ViiV Healthcare, and Theratechnologies, outside the submitted work; meeting or travel support from Gilead Sciences; and has served on advisory boards for MSD, Gilead Sciences, and ViiV Healthcare. JKR has received consulting fees from AbbVie, Boehringer, Gilead Sciences, Merck, and ViiV Healthcare; honoraria from Gilead, Merck, Janssen, and ViiV; has served on advisory board for Abivax; and is a member of the governing board of the European AIDS Clinical Society. AC has received research funding from MSD and ViiV Healthcare; lecture and travel sponsorships from Gilead Sciences and ViiV Healthcare; and has served on advisory boards for Gilead Sciences, MSD, and ViiV Healthcare., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Objectives: Improving the understanding of the patterns of quantitative hepatitis B surface antigen (qHBsAg) trajectories associated with HBsAg loss is important in light of novel anti-hepatitis B virus agents being developed. We evaluated long-term qHBsAg trajectories in persons with HIV and HBV during tenofovir-containing antiretroviral therapy in the Swiss HIV Cohort Study., Methods: We included 29 participants with and 29 without HBsAg loss, defined as qHBsAg <0.05 IU/mL. We assessed qHBsAg decline during therapy in both groups and used agglomerative hierarchical clustering to identify different qHBsAg trajectory profiles in persons with HBsAg loss., Results: The median follow-up time was 11.9 years (IQR 8.4-14.1), and the median time to HBsAg loss was 48 months (IQR 12-96). Among participants with HBsAg loss, 79% had a qHBsAg decline ≥1 log 10 IU/mL 2 years after starting tenofovir. The trajectories in qHBsAg levels during tenofovir therapy were heterogeneous, characterized by five distinct profiles. Among participants without HBsAg loss, only 7% had a qHBsAg decline ≥1 log 10 IU/ml after 2 years., Conclusions: Most persons with HIV who experienced HBsAg loss had an early decline in qHBsAg levels, with diverse trajectories during long-term tenofovir therapy. In persons without HBsAg loss, qHBsAg levels remained remarkably stable over time., (© 2023 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)

Background: Displacement has been associated with an increased risk of HIV transmission. In light of the lack of data from Libya on sexual behavior and HIV/AIDS knowledge, the effort was undertaken to assess HIV/AIDS knowledge and attitudes towards HIV and condom use in Libyan internally displaced males (IDPs) in Tripoli., Methods: Cross-sectional study design using purposive sampling to identify internally displaced Libyan males from five camps in Tripoli. HIV/AIDS knowledge, attitudes towards HIV and condom use, and prevention practices were evaluated through a self-administered, close/ended anonymous questionnaire in Arabic., Results: The study population consisted of 390 participants, all Muslims, with a mean age of 32.81 years (SD = 8.93). Overall, the average HIV and prevention knowledge score was 6.34 (SD = 1.98). The majority of the respondents thereby had an insufficient or low knowledge' level of HIV and prevention knowledge (58.70%). The mean attitude score indicated overall a negative attitude towards condom use (Mean = 32.60, SD = 7.97)., Conclusions: This is the first biobehavioral survey among IDPs in Libya demonstrating a low level of HIV and prevention knowledge as well as a prevailing negative attitude level of HIV/AIDS and condom use.

Introduction: Since 2013, the European Testing Week (ETW) awareness campaign has become a key regional event influencing testing efforts for HIV, viral hepatitis, and sexually transmitted infections (STIs) through participation of 720 organizations. Here, we report on a survey from May to June 2022 aimed at assessing the participant-reported impact of the campaign., Methods: All past and current participating organizations were asked to complete an online questionnaire between 12 May and 17 June 2022. Multiple choice and open-text questions included organization information, usage of ETW to engage in local testing-related activities, and the effect of a regional campaign to reach a wider audience and generate impact., Results: Of the 52 respondents, 34 (65%) stated first participating in ETW 5-10 years ago. ETW was used for awareness raising by 40 respondents (83%), new testing activities by 37 (77%), advocacy initiatives by 15 (31%), and training/capacity building by 18 (38%). For awareness raising, 95% used ETW to highlight the importance of and to encourage testing; for new testing activities, 74% used ETW to reach new groups. In total, 44 (85%) reported added benefits of a Europe-wide campaign compared with national/local campaigns, particularly the increased visibility and collaboration opportunities. Impact at the local level was observed by 24 (51%), and impact at a national level was observed by 20 (43%). A total of 28 (79%) reported increases in the number of tests performed and 25 (75%) reported increases in clients accessing services., Conclusions: Regional awareness campaigns reach wider audiences, boost local and national efforts to increase testing, and sensitize key populations about the critical value of testing compared with local/national campaigns., (© 2023 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)