Pub Date : 2025-01-17DOI: 10.1016/s2352-3018(24)00276-5
Steven K Grinspoon,Markella V Zanni,Virginia A Triant,Amy Kantor,Triin Umbleja,Marissa R Diggs,Sarah M Chu,Kathleen V Fitch,Judith S Currier,Gerald S Bloomfield,José L Casado,Mireia de la Peña,Lori E Fantry,Edward Gardner,Judith A Aberg,Carlos D Malvestutto,Carl J Fichtenbaum,Michael T Lu,Heather J Ribaudo,Pamela S Douglas
BACKGROUNDRisk estimation is an essential component of cardiovascular disease prevention among people with HIV. We aimed to characterise how well atherosclerotic cardiovascular disease (ASCVD) risk scores used in clinical guidelines perform among people with HIV globally.METHODSIn this prospective cohort study leveraging REPRIEVE data, we included participants aged 40-75 years, with low-to-moderate traditional cardiovascular risk, not taking statin therapy. REPRIEVE participants were enrolled from sites in 12 countries across Global Burden of Disease Study (GBD) regions. We assessed the performance of the pooled cohort equations (PCE) risk score for ASCVD and the data-collection on adverse effects of anti-HIV drugs (D:A:D) risk score. We calculated C statistics, observed-to-expected (OE) event ratios, and Greenwood-Nam-D'Agostino goodness-of-fit (GND) statistics, overall and in subgroups by race, sex, and GBD regions (clustering low-income and middle-income countries and high-income countries). We did a recalibration for PCE risk score among people with HIV in high-income countries. REPRIEVE was registered with ClinicalTrials.gov, NCT02344290.FINDINGSWe included 3893 participants, recruited between March 26, 2015, and July 31, 2019. The median age was 50 years (IQR 45-55), with 2684 (69%) male and 1209 (31%) female participants. 1643 (42%) were Black or African American, 1346 (35%) participants were White, 566 (15%) were Asian, and 338 (9%) were recorded as other race. Overall, discrimination of the PCE risk score was moderate (C statistic 0·72 [95% CI 0·68-0·76]) and calibration was good (OE event ratio 1·11; GND p=0·87). However, calibration suggested overprediction of risk in low-income and middle-income countries and corresponding underprediction in high-income countries. When restricted to high-income countries, we found underprediction (OE event ratio >1·0) among women (2·39) and Black or African American participants (1·64). Findings were similar for the D:A:D risk score (C statistic 0·71 [0·65-0·77]; OE event ratio 0·89; p=0·68). Improved calibration of the PCE risk score in high-income countries was achieved by multiplying the original score by 2·8 in Black or African American women, 2·6 in women who were not Black or African American, and 1·25 in Black or African American men.INTERPRETATIONAmong the global cohort of people with HIV in REPRIEVE, the PCE risk score underpredicted cardiovascular events in women and Black or African American men in high-income countries and overpredicted cardiovascular events in low-income and middle-income countries. Underprediction in subgroups should be considered when using the PCE risk score to guide statin prescribing for cardiovascular prevention among people with HIV in high-income countries. Additional research is needed to develop risk scores accurate in predicting ASCVD among people with HIV in low-income and middle-income countries.FUNDINGUS National Institutes of Health, Kowa Pharmaceuticals Am
{"title":"Performance of the pooled cohort equations and D:A:D risk scores among individuals with HIV in a global cardiovascular disease prevention trial: a cohort study leveraging data from REPRIEVE.","authors":"Steven K Grinspoon,Markella V Zanni,Virginia A Triant,Amy Kantor,Triin Umbleja,Marissa R Diggs,Sarah M Chu,Kathleen V Fitch,Judith S Currier,Gerald S Bloomfield,José L Casado,Mireia de la Peña,Lori E Fantry,Edward Gardner,Judith A Aberg,Carlos D Malvestutto,Carl J Fichtenbaum,Michael T Lu,Heather J Ribaudo,Pamela S Douglas","doi":"10.1016/s2352-3018(24)00276-5","DOIUrl":"https://doi.org/10.1016/s2352-3018(24)00276-5","url":null,"abstract":"BACKGROUNDRisk estimation is an essential component of cardiovascular disease prevention among people with HIV. We aimed to characterise how well atherosclerotic cardiovascular disease (ASCVD) risk scores used in clinical guidelines perform among people with HIV globally.METHODSIn this prospective cohort study leveraging REPRIEVE data, we included participants aged 40-75 years, with low-to-moderate traditional cardiovascular risk, not taking statin therapy. REPRIEVE participants were enrolled from sites in 12 countries across Global Burden of Disease Study (GBD) regions. We assessed the performance of the pooled cohort equations (PCE) risk score for ASCVD and the data-collection on adverse effects of anti-HIV drugs (D:A:D) risk score. We calculated C statistics, observed-to-expected (OE) event ratios, and Greenwood-Nam-D'Agostino goodness-of-fit (GND) statistics, overall and in subgroups by race, sex, and GBD regions (clustering low-income and middle-income countries and high-income countries). We did a recalibration for PCE risk score among people with HIV in high-income countries. REPRIEVE was registered with ClinicalTrials.gov, NCT02344290.FINDINGSWe included 3893 participants, recruited between March 26, 2015, and July 31, 2019. The median age was 50 years (IQR 45-55), with 2684 (69%) male and 1209 (31%) female participants. 1643 (42%) were Black or African American, 1346 (35%) participants were White, 566 (15%) were Asian, and 338 (9%) were recorded as other race. Overall, discrimination of the PCE risk score was moderate (C statistic 0·72 [95% CI 0·68-0·76]) and calibration was good (OE event ratio 1·11; GND p=0·87). However, calibration suggested overprediction of risk in low-income and middle-income countries and corresponding underprediction in high-income countries. When restricted to high-income countries, we found underprediction (OE event ratio >1·0) among women (2·39) and Black or African American participants (1·64). Findings were similar for the D:A:D risk score (C statistic 0·71 [0·65-0·77]; OE event ratio 0·89; p=0·68). Improved calibration of the PCE risk score in high-income countries was achieved by multiplying the original score by 2·8 in Black or African American women, 2·6 in women who were not Black or African American, and 1·25 in Black or African American men.INTERPRETATIONAmong the global cohort of people with HIV in REPRIEVE, the PCE risk score underpredicted cardiovascular events in women and Black or African American men in high-income countries and overpredicted cardiovascular events in low-income and middle-income countries. Underprediction in subgroups should be considered when using the PCE risk score to guide statin prescribing for cardiovascular prevention among people with HIV in high-income countries. Additional research is needed to develop risk scores accurate in predicting ASCVD among people with HIV in low-income and middle-income countries.FUNDINGUS National Institutes of Health, Kowa Pharmaceuticals Am","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"10 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142991815","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 : 2025-01-15DOI: 10.1016/s2352-3018(24)00301-1
Josep M Llibre
{"title":"Dolutegravir plus lamivudine treatment without HIV drug-resistance tests.","authors":"Josep M Llibre","doi":"10.1016/s2352-3018(24)00301-1","DOIUrl":"https://doi.org/10.1016/s2352-3018(24)00301-1","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"31 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142991702","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}
BACKGROUNDDolutegravir plus lamivudine has emerged as a preferred treatment for HIV; however, initiating this regimen without baseline resistance testing raises concerns about the potential presence of pretreatment lamivudine resistance. We aimed to evaluate the efficacy of dolutegravir plus lamivudine in the absence of information on baseline resistance testing in treatment-naive people with HIV.METHODSWe did an open-label, non-inferiority, single-centre, phase 4, randomised controlled study (D2ARLING), designed to assess the efficacy and safety of dolutegravir plus lamivudine in treatment-naive people with HIV with no available baseline resistance testing. We included participants aged 18 years or older with HIV-1 diagnosis who were naive to antiretroviral therapy and had no baseline genotypic resistance testing result available. We randomly assigned (1:1) participants to receive dolutegravir 50 mg plus lamivudine 300 mg or a three-drug regimen including dolutegravir 50 mg plus tenofovir disoproxil fumarate 300 mg and either emtricitabine 200 mg or lamivudine 300 mg. Randomisation was stratified by baseline HIV-1 RNA (≤100 000 vs >100 000 copies per mL) and CD4 cell count (<200 vs ≥200 cells per μL). Per protocol, we performed genotypic drug-resistance testing on day 1 and it remained double-masked throughout the study, simulating a scenario of inaccessibility of baseline resistance testing. The primary endpoint was the proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 48 (intention-to-treat exposed analysis via the Snapshot algorithm) with prespecified non-inferiority margin of 10%. This trial is registered with ClinicalTrials.gov (NCT04549467).FINDINGSBetween Nov 17, 2020, and Aug 31, 2022, 214 participants were randomly assigned to and treated with dolutegravir plus lamivudine (n=106) or dolutegravir plus tenofovir disoproxil fumarate and either emtricitabine or lamivudine (n=108). Median age of participants was 31 years (IQR 26-39) and 49 (23%) were female. At baseline, 66 (31%) of participants had an HIV-1 RNA viral load of more than 100 000 copies per mL, and 44 (21%) had a CD4 T-cell count of less than 200 cells per μL. At week 48, 97 (92%) of 106 participants in the dolutegravir plus lamivudine group and 96 (89%) of 108 participants in the dolutegravir plus tenofovir disoproxil fumarate with either emtricitabine or lamivudine group had HIV-1 RNA of less than 50 copies per mL (difference 2·62%; 95% CI -5·3 to 10·6), showing non-inferiority of dolutegravir plus lamivudine to the three-drug regimen. None of the participants in the dolutegravir plus lamivudine group and two in the control group had protocol-defined virological failure, and none developed treatment-emergent resistance mutations to any of the study drugs. Overall adverse event rates were similar between arms. Less than 1% of participants in both groups were discontinued due to adverse events.INTERPRETATIONThis study provides evidence supporti
{"title":"Efficacy of dolutegravir plus lamivudine in treatment-naive people living with HIV without baseline drug-resistance testing available (D2ARLING): 48-week results of a phase 4, randomised, open-label, non-inferiority trial.","authors":"Ezequiel Cordova,Jeniffer Hernandez Rendon,Veronica Mingrone,Patricio Martin,Gisela Arevalo Calderon,Soledad Seleme,Jamile Ballivian,Norma Porteiro","doi":"10.1016/s2352-3018(24)00294-7","DOIUrl":"https://doi.org/10.1016/s2352-3018(24)00294-7","url":null,"abstract":"BACKGROUNDDolutegravir plus lamivudine has emerged as a preferred treatment for HIV; however, initiating this regimen without baseline resistance testing raises concerns about the potential presence of pretreatment lamivudine resistance. We aimed to evaluate the efficacy of dolutegravir plus lamivudine in the absence of information on baseline resistance testing in treatment-naive people with HIV.METHODSWe did an open-label, non-inferiority, single-centre, phase 4, randomised controlled study (D2ARLING), designed to assess the efficacy and safety of dolutegravir plus lamivudine in treatment-naive people with HIV with no available baseline resistance testing. We included participants aged 18 years or older with HIV-1 diagnosis who were naive to antiretroviral therapy and had no baseline genotypic resistance testing result available. We randomly assigned (1:1) participants to receive dolutegravir 50 mg plus lamivudine 300 mg or a three-drug regimen including dolutegravir 50 mg plus tenofovir disoproxil fumarate 300 mg and either emtricitabine 200 mg or lamivudine 300 mg. Randomisation was stratified by baseline HIV-1 RNA (≤100 000 vs >100 000 copies per mL) and CD4 cell count (<200 vs ≥200 cells per μL). Per protocol, we performed genotypic drug-resistance testing on day 1 and it remained double-masked throughout the study, simulating a scenario of inaccessibility of baseline resistance testing. The primary endpoint was the proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 48 (intention-to-treat exposed analysis via the Snapshot algorithm) with prespecified non-inferiority margin of 10%. This trial is registered with ClinicalTrials.gov (NCT04549467).FINDINGSBetween Nov 17, 2020, and Aug 31, 2022, 214 participants were randomly assigned to and treated with dolutegravir plus lamivudine (n=106) or dolutegravir plus tenofovir disoproxil fumarate and either emtricitabine or lamivudine (n=108). Median age of participants was 31 years (IQR 26-39) and 49 (23%) were female. At baseline, 66 (31%) of participants had an HIV-1 RNA viral load of more than 100 000 copies per mL, and 44 (21%) had a CD4 T-cell count of less than 200 cells per μL. At week 48, 97 (92%) of 106 participants in the dolutegravir plus lamivudine group and 96 (89%) of 108 participants in the dolutegravir plus tenofovir disoproxil fumarate with either emtricitabine or lamivudine group had HIV-1 RNA of less than 50 copies per mL (difference 2·62%; 95% CI -5·3 to 10·6), showing non-inferiority of dolutegravir plus lamivudine to the three-drug regimen. None of the participants in the dolutegravir plus lamivudine group and two in the control group had protocol-defined virological failure, and none developed treatment-emergent resistance mutations to any of the study drugs. Overall adverse event rates were similar between arms. Less than 1% of participants in both groups were discontinued due to adverse events.INTERPRETATIONThis study provides evidence supporti","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"10 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142991739","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 : 2025-01-06DOI: 10.1016/S2352-3018(24)00300-X
Whitney C Irie, Melanie R Nicol, Meredith Clement, Elizabeth Anne Bukusi, Linda-Gail Bekker, Jean-Michel Molina, Jenell Stewart
Despite advancements in existing antiretroviral-based prevention strategies, including daily oral, locally acting, and injectable options, there is a pressing need for more inclusive and flexible event-driven pre-exposure prophylaxis (PrEP) strategies for all. Event-driven or intermittent dosing of PrEP in populations beyond cisgender men who have sex with men would offer a promising alternative by fitting prevention into the diverse lifestyles of affected populations and thereby advancing health equity. Evidence from PrEP clinical trials, pharmacokinetic studies, modelling studies, and real-world observational research suggests that event-driven PrEP could be a flexible and inclusive option, yet optimal dosing has not been established across sex and gender spectrums. To advance PrEP equity through inclusivity, studies on event-driven PrEP should include people across the gender spectrum. Real-world demonstration studies and simulation studies of optimal dosing strategies are needed. While awaiting further evidence, clinical providers can offer shared decision making and counselling on available data to include event-driven dosing as an option, especially when daily oral, locally acting, or injectable PrEP are not acceptable or preferred methods. Wider access to diverse PrEP options for all populations fosters a more inclusive and effective global HIV prevention strategy.
{"title":"Event-driven PrEP beyond cisgender men who have sex with men.","authors":"Whitney C Irie, Melanie R Nicol, Meredith Clement, Elizabeth Anne Bukusi, Linda-Gail Bekker, Jean-Michel Molina, Jenell Stewart","doi":"10.1016/S2352-3018(24)00300-X","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00300-X","url":null,"abstract":"<p><p>Despite advancements in existing antiretroviral-based prevention strategies, including daily oral, locally acting, and injectable options, there is a pressing need for more inclusive and flexible event-driven pre-exposure prophylaxis (PrEP) strategies for all. Event-driven or intermittent dosing of PrEP in populations beyond cisgender men who have sex with men would offer a promising alternative by fitting prevention into the diverse lifestyles of affected populations and thereby advancing health equity. Evidence from PrEP clinical trials, pharmacokinetic studies, modelling studies, and real-world observational research suggests that event-driven PrEP could be a flexible and inclusive option, yet optimal dosing has not been established across sex and gender spectrums. To advance PrEP equity through inclusivity, studies on event-driven PrEP should include people across the gender spectrum. Real-world demonstration studies and simulation studies of optimal dosing strategies are needed. While awaiting further evidence, clinical providers can offer shared decision making and counselling on available data to include event-driven dosing as an option, especially when daily oral, locally acting, or injectable PrEP are not acceptable or preferred methods. Wider access to diverse PrEP options for all populations fosters a more inclusive and effective global HIV prevention strategy.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":12.8,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957281","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 : 2025-01-01Epub Date: 2024-12-10DOI: 10.1016/S2352-3018(24)00314-X
Karin Hatzold, Yasmin Dunkley
{"title":"Closing the gap to UNAIDS 95-95-95: Lesotho's success story.","authors":"Karin Hatzold, Yasmin Dunkley","doi":"10.1016/S2352-3018(24)00314-X","DOIUrl":"10.1016/S2352-3018(24)00314-X","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e6-e8"},"PeriodicalIF":12.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142822735","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 : 2025-01-01Epub Date: 2024-12-05DOI: 10.1016/S2352-3018(24)00311-4
Kwena Tlhaku, Jienchi Dorward
{"title":"Improving quality of interpersonal care in HIV programmes.","authors":"Kwena Tlhaku, Jienchi Dorward","doi":"10.1016/S2352-3018(24)00311-4","DOIUrl":"10.1016/S2352-3018(24)00311-4","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e3-e5"},"PeriodicalIF":12.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142796572","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 : 2025-01-01DOI: 10.1016/S2352-3018(24)00349-7
Tony Kirby
{"title":"Coffee with IAS President Beatriz Grinsztejn.","authors":"Tony Kirby","doi":"10.1016/S2352-3018(24)00349-7","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00349-7","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 1","pages":"e10-e11"},"PeriodicalIF":12.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957285","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 : 2025-01-01DOI: 10.1016/S2352-3018(24)00304-7
Marianne Harris
{"title":"Injectable antiretrovirals: real world or ideal world?","authors":"Marianne Harris","doi":"10.1016/S2352-3018(24)00304-7","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00304-7","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 1","pages":"e5-e6"},"PeriodicalIF":12.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957286","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 : 2025-01-01DOI: 10.1016/S2352-3018(24)00348-5
The Lancet Hiv
{"title":"Bleak prospects for HIV response under new US administration.","authors":"The Lancet Hiv","doi":"10.1016/S2352-3018(24)00348-5","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00348-5","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 1","pages":"e1"},"PeriodicalIF":12.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957283","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：