Pub Date : 2025-12-02DOI: 10.1016/s1473-3099(25)00630-9
Yumi Sheehan, Akhil Garg, Julia Sheehan, Nonso Maduka, Frederick L Altice, Filipa Alves da Costa, Sean Cox, Ahmed M Elsharkawy, Ehab Salah, Mark Stoové, Lara Tavoschi, Alexander J Thompson, Karla Thornton, Andrew R Lloyd, Joaquín Cabezas, Matthew J Akiyama, Nadine Kronfli
{"title":"Best practice guidelines for viral hepatitis service delivery in prisons","authors":"Yumi Sheehan, Akhil Garg, Julia Sheehan, Nonso Maduka, Frederick L Altice, Filipa Alves da Costa, Sean Cox, Ahmed M Elsharkawy, Ehab Salah, Mark Stoové, Lara Tavoschi, Alexander J Thompson, Karla Thornton, Andrew R Lloyd, Joaquín Cabezas, Matthew J Akiyama, Nadine Kronfli","doi":"10.1016/s1473-3099(25)00630-9","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00630-9","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"198200 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145657376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/s1473-3099(25)00681-4
Georg M N Behrens, Lambert Assoumou, Geoffroy Liegeon, Andrea Antinori, Rafael Micán, Francesco G Genderini, Frank A Post, Jürgen K Rockstroh, Lisa Hamzah, Pere Domingo, Adrian Curran, Monserrat Laguno, Carl Fletcher, Jack Moody, Anton Pozniak
<h3>Background</h3>To date, clinical trials have been underpowered to assess which antiretrovirals perform best in people with advanced HIV disease. We aimed to investigate the efficacy and safety of an integrase inhibitor-containing versus a boosted protease inhibitor-containing regimen for this population.<h3>Methods</h3>In this open-label, multicentre, non-inferiority trial in seven European countries (Spain, France, Italy, Germany, Belgium, Ireland, and the UK), therapy-naive adults with advanced HIV disease were randomly allocated (1:1) to receive either bictegravir, emtricitabine, and tenofovir alafenamide (integrase inhibitor group) or darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (boosted protease inhibitor group) for 48 weeks. Randomisation was computer generated in permuted blocks within strata with block sizes of four and stratified by country and baseline CD4 cell count. The primary composite outcome (time to first occurrence of specified virological or clinical events) and its components were evaluated by Kaplan–Meier and Cox regression analyses in both modified intention-to-treat (mITT) and per-protocol populations. The mITT population included all randomly allocated participants who received at least one dose of the study drug, whereas the per-protocol population excluded those who received incorrect treatment. Non-inferiority of the integrase inhibitor-based regimen versus the boosted protease inhibitor-containing regimen was declared if the upper limit of the 95% CI of the hazard ratio (HR) for the primary composite endpoint was less than 1·606, corresponding to a 12% difference in the cumulative probability of the composite primary endpoint. Adverse events, a secondary endpoint, were recorded at eight visits in all participants. This trial is registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, <span><span>NCT03696160</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, and is completed.<h3>Findings</h3>Between May 13, 2019, and June 26, 2023, 222 people were randomly assigned to the integrase inhibitor group and 225 to the boosted protease inhibitor group. Of these 447 recruited participants, 442 (99%) participants with a median CD4 count of 41 cells per μL (IQR 17–79) received at least one dose. 358 (81%) of the 442 treated participants self-reported as male and 84 (19%) female, and 276 (62%) were of White ethnicity, 83 (19%) Black, and 83 (19%) other. In the mITT analysis, the 48-week composite primary outcome event occurred in 49 (22%) of 220 participants in the integrase inhibitor group versus 70 (32%) of 222 participants in the boosted protease
{"title":"Integrase versus protease inhibitor therapy in advanced HIV disease (LAPTOP): a multicountry, randomised, open-label, non-inferiority trial","authors":"Georg M N Behrens, Lambert Assoumou, Geoffroy Liegeon, Andrea Antinori, Rafael Micán, Francesco G Genderini, Frank A Post, Jürgen K Rockstroh, Lisa Hamzah, Pere Domingo, Adrian Curran, Monserrat Laguno, Carl Fletcher, Jack Moody, Anton Pozniak","doi":"10.1016/s1473-3099(25)00681-4","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00681-4","url":null,"abstract":"<h3>Background</h3>To date, clinical trials have been underpowered to assess which antiretrovirals perform best in people with advanced HIV disease. We aimed to investigate the efficacy and safety of an integrase inhibitor-containing versus a boosted protease inhibitor-containing regimen for this population.<h3>Methods</h3>In this open-label, multicentre, non-inferiority trial in seven European countries (Spain, France, Italy, Germany, Belgium, Ireland, and the UK), therapy-naive adults with advanced HIV disease were randomly allocated (1:1) to receive either bictegravir, emtricitabine, and tenofovir alafenamide (integrase inhibitor group) or darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (boosted protease inhibitor group) for 48 weeks. Randomisation was computer generated in permuted blocks within strata with block sizes of four and stratified by country and baseline CD4 cell count. The primary composite outcome (time to first occurrence of specified virological or clinical events) and its components were evaluated by Kaplan–Meier and Cox regression analyses in both modified intention-to-treat (mITT) and per-protocol populations. The mITT population included all randomly allocated participants who received at least one dose of the study drug, whereas the per-protocol population excluded those who received incorrect treatment. Non-inferiority of the integrase inhibitor-based regimen versus the boosted protease inhibitor-containing regimen was declared if the upper limit of the 95% CI of the hazard ratio (HR) for the primary composite endpoint was less than 1·606, corresponding to a 12% difference in the cumulative probability of the composite primary endpoint. Adverse events, a secondary endpoint, were recorded at eight visits in all participants. This trial is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT03696160</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and is completed.<h3>Findings</h3>Between May 13, 2019, and June 26, 2023, 222 people were randomly assigned to the integrase inhibitor group and 225 to the boosted protease inhibitor group. Of these 447 recruited participants, 442 (99%) participants with a median CD4 count of 41 cells per μL (IQR 17–79) received at least one dose. 358 (81%) of the 442 treated participants self-reported as male and 84 (19%) female, and 276 (62%) were of White ethnicity, 83 (19%) Black, and 83 (19%) other. In the mITT analysis, the 48-week composite primary outcome event occurred in 49 (22%) of 220 participants in the integrase inhibitor group versus 70 (32%) of 222 participants in the boosted protease ","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"7 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145645159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-21DOI: 10.1016/S1473-3099(25)00632-2
David N Durrheim, Ilisapeci Vereti Tuibeqa, Saia Ma'u Piukala
{"title":"Elimination of measles and rubella in Pacific island countries and areas.","authors":"David N Durrheim, Ilisapeci Vereti Tuibeqa, Saia Ma'u Piukala","doi":"10.1016/S1473-3099(25)00632-2","DOIUrl":"10.1016/S1473-3099(25)00632-2","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"1272-1273"},"PeriodicalIF":31.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145369172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-22DOI: 10.1016/S1473-3099(25)00661-9
{"title":"Correction to Lancet Infect Dis 2025; published online Oct 10. https://doi.org/10.1016/S1473-3099(25)00549-3.","authors":"","doi":"10.1016/S1473-3099(25)00661-9","DOIUrl":"10.1016/S1473-3099(25)00661-9","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"e684"},"PeriodicalIF":31.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145370515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-21DOI: 10.1016/S1473-3099(25)00625-5
Philip J Budge, Catherine M Bjerum, Allassane Foungoye Ouattara, Peter U Fischer, Guibehi Benjamin Koudou
{"title":"Moxidectin combination therapies for lymphatic filariasis-36-month follow-up.","authors":"Philip J Budge, Catherine M Bjerum, Allassane Foungoye Ouattara, Peter U Fischer, Guibehi Benjamin Koudou","doi":"10.1016/S1473-3099(25)00625-5","DOIUrl":"10.1016/S1473-3099(25)00625-5","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"e683"},"PeriodicalIF":31.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145369182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/s1473-3099(25)00716-9
Thomas A Smith, Samuel I Watson
{"title":"Spillover in dengue trials","authors":"Thomas A Smith, Samuel I Watson","doi":"10.1016/s1473-3099(25)00716-9","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00716-9","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"72 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145657381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-21DOI: 10.1016/S1473-3099(25)00660-7
{"title":"Correction to Lancet Infect Dis 2025; published online Aug 18. https://doi.org/10.1016/S1473-3099(25)00364-0.","authors":"","doi":"10.1016/S1473-3099(25)00660-7","DOIUrl":"10.1016/S1473-3099(25)00660-7","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":" ","pages":"e684"},"PeriodicalIF":31.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145369248","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-29DOI: 10.1016/s1473-3099(25)00624-3
Isobel McLachlan, Chris Robertson, Kirsty E Morrison, Ross McQueenie, Safraj Shahul Hameed, Cheryl Gibbons, Rachael Wood, Rachel Merrick, Louisa Pollock, Antonia Ho, Ting Shi, Thomas C Williams, Sir Aziz Sheikh, Jim McMenamin, Sam Ghebrehewet, Kimberly Marsh
<h3>Background</h3>Respiratory syncytial virus (RSV) is a leading cause of infant hospitalisation, particularly in infants younger than 6 months. On Aug 12, 2024, Scotland introduced a maternal vaccination programme with bivalent RSV prefusion F (RSVpreF) vaccine, offered from 28 weeks' gestation. Although clinical trials have shown high efficacy of maternal RSVpreF vaccination, this study assessed RSVpreF vaccine effectiveness in a real-world setting, to inform policy and programme delivery.<h3>Methods</h3>We did a retrospective, nested case–control study with a cohort sensitivity analysis. The source population comprised all singleton livebirths in Scotland between Aug 12, 2024, and March 31, 2025, as recorded in the Scottish Linked Pregnancy and Baby Dataset (SLiPBD). Within this population, cases were defined as infants aged 90 days or younger with an RSV-related hospital admission for lower respiratory tract infection (LRTI; first event only) and an RSV-positive PCR test within 14 days before or 2 days after hospital admission, within the study period up to March 31, 2025. At the time of hospital admission, cases were matched to ten controls each (1:10 case:control ratio) from the source population by ISO week of birth and gestational age at birth, with controls defined as infants with no previous RSV-positive test or RSV-related hospital admission at the time of matching. Linked datasets on maternal RSV vaccination and RSV-related hospital admissions were accessed through the recently established Scottish Infectious Respiratory Surveillance Platform. Infants were classified as vaccinated if the RSV vaccine was received more than 14 days before delivery, suboptimally immunised if received 0–14 days before delivery, and unvaccinated if not received during pregnancy. The study outcome was RSV-related LRTI hospital admissions among infants aged 90 days or younger. Vaccine effectiveness against RSV-related LRTI hospital admissions was estimated with adjusted conditional logistic regression comparing vaccination status among cases and controls, adjusting for infant sex and birthweight, maternal ethnicity, maternal age and Scottish Index of Multiple Deprivation at infant birth, maternal smoking status at the first antenatal appointment, and parity. From this model, adjusted vaccine effectiveness was calculated as 100 × (1 – adjusted odds ratio).<h3>Findings</h3>During the study period, 27 565 singleton livebirths were recorded in the SLiPBD. 13 842 (50·2%) of the 27 565 pregnant women received the RSVpreF vaccine, 12 747 (92·1%) of whom were vaccinated more than 14 days before delivery. 354 infants aged 90 days or younger had an RSV-related LRTI hospital admission during the study period (cases), with 3511 matched controls. 33 controls later became cases. Among the 354 cases, 43 (12·1%) were vaccinated (>14 days before delivery) against RSV, compared with 1518 (43·2%) of the 3511 controls. Suboptimal immunisation (≤14 days before delivery) occu
{"title":"Effectiveness of the maternal RSVpreF vaccine against severe disease in infants in Scotland, UK: a national, population-based case–control study and cohort analysis","authors":"Isobel McLachlan, Chris Robertson, Kirsty E Morrison, Ross McQueenie, Safraj Shahul Hameed, Cheryl Gibbons, Rachael Wood, Rachel Merrick, Louisa Pollock, Antonia Ho, Ting Shi, Thomas C Williams, Sir Aziz Sheikh, Jim McMenamin, Sam Ghebrehewet, Kimberly Marsh","doi":"10.1016/s1473-3099(25)00624-3","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00624-3","url":null,"abstract":"<h3>Background</h3>Respiratory syncytial virus (RSV) is a leading cause of infant hospitalisation, particularly in infants younger than 6 months. On Aug 12, 2024, Scotland introduced a maternal vaccination programme with bivalent RSV prefusion F (RSVpreF) vaccine, offered from 28 weeks' gestation. Although clinical trials have shown high efficacy of maternal RSVpreF vaccination, this study assessed RSVpreF vaccine effectiveness in a real-world setting, to inform policy and programme delivery.<h3>Methods</h3>We did a retrospective, nested case–control study with a cohort sensitivity analysis. The source population comprised all singleton livebirths in Scotland between Aug 12, 2024, and March 31, 2025, as recorded in the Scottish Linked Pregnancy and Baby Dataset (SLiPBD). Within this population, cases were defined as infants aged 90 days or younger with an RSV-related hospital admission for lower respiratory tract infection (LRTI; first event only) and an RSV-positive PCR test within 14 days before or 2 days after hospital admission, within the study period up to March 31, 2025. At the time of hospital admission, cases were matched to ten controls each (1:10 case:control ratio) from the source population by ISO week of birth and gestational age at birth, with controls defined as infants with no previous RSV-positive test or RSV-related hospital admission at the time of matching. Linked datasets on maternal RSV vaccination and RSV-related hospital admissions were accessed through the recently established Scottish Infectious Respiratory Surveillance Platform. Infants were classified as vaccinated if the RSV vaccine was received more than 14 days before delivery, suboptimally immunised if received 0–14 days before delivery, and unvaccinated if not received during pregnancy. The study outcome was RSV-related LRTI hospital admissions among infants aged 90 days or younger. Vaccine effectiveness against RSV-related LRTI hospital admissions was estimated with adjusted conditional logistic regression comparing vaccination status among cases and controls, adjusting for infant sex and birthweight, maternal ethnicity, maternal age and Scottish Index of Multiple Deprivation at infant birth, maternal smoking status at the first antenatal appointment, and parity. From this model, adjusted vaccine effectiveness was calculated as 100 × (1 – adjusted odds ratio).<h3>Findings</h3>During the study period, 27 565 singleton livebirths were recorded in the SLiPBD. 13 842 (50·2%) of the 27 565 pregnant women received the RSVpreF vaccine, 12 747 (92·1%) of whom were vaccinated more than 14 days before delivery. 354 infants aged 90 days or younger had an RSV-related LRTI hospital admission during the study period (cases), with 3511 matched controls. 33 controls later became cases. Among the 354 cases, 43 (12·1%) were vaccinated (>14 days before delivery) against RSV, compared with 1518 (43·2%) of the 3511 controls. Suboptimal immunisation (≤14 days before delivery) occu","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"71 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145613427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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