Lancet Hiv最新文献

{"title":"Interpreting unit costs of PrEP services by effective use.","authors":"Fern Terris-Prestholt, Heather-Marie A Schmidt","doi":"10.1016/S2352-3018(24)00368-0","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00368-0","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 2","pages":"e86-e87"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143365903","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}

{"title":"Artificial intelligence powers HIV testing services in Kenya.","authors":"Roger Pebody","doi":"10.1016/S2352-3018(25)00003-7","DOIUrl":"https://doi.org/10.1016/S2352-3018(25)00003-7","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 2","pages":"e92-e93"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143365085","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}

{"title":"Adaptive HIV pre-exposure prophylaxis adherence interventions for young women in Johannesburg, South Africa: a sequential multiple-assignment randomised trial.","authors":"Jennifer Velloza, Nicole Poovan, Allison Meisner, Nontokozo Ndlovu, Nomhle Ndimande-Khoza, Cole Grabow, Phumzile Zwane, Samukelo Mbele, Mapaseka Molefe, Deborah Donnell, Jared M Baeten, Sybil Hosek, Connie Celum, Sinead Delany-Moretlwe","doi":"10.1016/S2352-3018(24)00268-6","DOIUrl":"10.1016/S2352-3018(24)00268-6","url":null,"abstract":"<p><strong>Background: </strong>Adherence to daily oral pre-exposure prophylaxis (PrEP) is low among African young women, and layered support strategies are needed to improve PrEP adherence in this population. We aimed to evaluate potentially scalable adherence-support strategies for young women aged 18-25 years who initiated PrEP in Johannesburg, South Africa.</p><p><strong>Methods: </strong>We conducted a sequential multiple-assignment randomised trial at Ward 21 of the Wits Reproductive Health and HIV Institute clinical research site, affiliated with University of the Witwatersrand, Johannesburg, South Africa. Participants were eligible if they were assigned female sex at birth, aged 18-25 years, not living with HIV, sexually active, newly initiating PrEP, had regular access to a mobile telephone, and could read. Using sequentially numbered, sealed, opaque envelopes containing group allocation, a staff member assigned enrolled participants (1:1) to receive one of two adherence-support interventions: once per week two-way SMS communication or participation in a WhatsApp peer-support group. Participants assigned to WhatsApp were put into groups with approximately 25 participants, during which they were prompted by staff facilitators to discuss any challenges with PrEP use or other events happening in their lives. The allocation sequence was generated by the data manager using random numbers with variable block sizes between 10 and 14. Only trial investigators were masked to participant intervention assignments; participants, people giving interventions, people assessing outcomes, and people analysing data were not masked to group assignment. All enrolled participants were offered PrEP (ie, co-formulated, once per day oral emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg). The primary outcome was high PrEP adherence at month 9, defined as concentration of tenofovir diphosphate on dried blood sample of 700 fmol per punch or more. At month 3, participants with low PrEP adherence were randomly assigned to a secondary, intensified intervention of issue-focused counselling once per month or drug-level feedback counselling based on PrEP drug concentrations at months 3 and 6. The protocol was registered at ClinicalTrials.gov (NCT04038060) and the trial is complete.</p><p><strong>Findings: </strong>Participants were enrolled and followed up between May 16, 2019, and Jan 25, 2022. From May 16, 2019, to Jan 29, 2021, 401 participants were screened and 360 were enrolled and initiated PrEP. 180 (50%) were randomly assigned to two-way SMS and 180 (50%) were randomly assigned to WhatsApp support groups. At month 9, 34 (20%) of 174 participants in the two-way SMS arm had tenofovir diphosphate 700 fmol per punch or more, compared with 32 (18%) of 174 in the WhatsApp arm (relative risk 1·06, 95% CI 0·69-1·64; p=0·78). At month 9, four (5%) of 76 participants in the drug-level feedback arm had tenofovir diphosphate 700 fmol per punch or more, compared","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e105-e117"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142839948","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}

{"title":"Target product profile for cell-based and gene-based therapies to achieve a cure for HIV.","authors":"Sharon R Lewin, Cathy Bansbach, Dominic Kemps, Lauren Mathae, Kumitaa Theva Das, Joseph M McCune, Steven G Deeks, Thumbi Ndung'u","doi":"10.1016/S2352-3018(24)00277-7","DOIUrl":"10.1016/S2352-3018(24)00277-7","url":null,"abstract":"<p><p>This target product profile (TPP) highlights the minimal and optimal characteristics for ex-vivo and in-vivo cell and gene therapy-based products aimed at achieving an HIV cure (ie, durable antiretroviral-free viral control). The need for an effective, safe, scalable, affordable, accessible, and acceptable cure for HIV infection remains a major global priority. The possibilities for cell and gene therapy-based products for an HIV cure are rapidly expanding. In a multi-stakeholder consensus process of clinical experts and civil society, including representatives from low-income and middle-income countries, participants generally agreed on the optimal targets, whereas consensus on the minimal targets was not reached on every parameter. There was less agreement on the minimal targets for ex-vivo than in-vivo therapies given the complexity of ex-vivo interventions. The TPP is planned to be updated at regular intervals. Building a TPP, such as this one, is an important process for stakeholder engagement and aligning ambitions for the development of products that are acceptable to both clinicians and civil society.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 2","pages":"e154-e162"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143366212","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}

{"title":"Risk estimation in HIV reveals our usual blind spots.","authors":"Madeleine Durand","doi":"10.1016/s2352-3018(24)00351-5","DOIUrl":"https://doi.org/10.1016/s2352-3018(24)00351-5","url":null,"abstract":"","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":"142991816","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}

{"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 &gt;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}

{"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}

{"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 &gt;100 000 copies per mL) and CD4 cell count (&lt;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}

{"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}

{"title":"Effectiveness of bi-monthly long-acting injectable cabotegravir and rilpivirine as maintenance treatment for HIV-1 in the Netherlands: results from the Dutch ATHENA national observational cohort.","authors":"Vita W Jongen, Ferdinand W N M Wit, Anders Boyd, Arne van Eeden, Annemarie E Brouwer, Robert Soetekouw, Rachida El Moussaoui, Janneke Stalenhoef, Kim C E Sigaloff, Tatiana Mudrikova, Jet Gisolf, David Burger, Annemarie M J Wensing, Marc van der Valk","doi":"10.1016/S2352-3018(24)00269-8","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00269-8","url":null,"abstract":"<p><strong>Background: </strong>Real-world data showing the long-term effectiveness of long-acting injectable cabotegravir and rilpivirine are scarce. We assessed the effectiveness of cabotegravir and rilpivirine in all individuals who switched to cabotegravir and rilpivirine in the Netherlands.</p><p><strong>Methods: </strong>We used data from the ATHENA cohort, an ongoing observational nationwide HIV cohort in the Netherlands. In the primary analysis, we matched individuals who commenced cabotegravir and rilpivirine and had no history of virological failure (ie, one or more measurements of a plasma HIV RNA ≥1000 copies per mL; hereafter referred to as exposed) 1:2 with individuals using oral antiretroviral therapy (ART; hereafter referred to as unexposed). We assessed the effectiveness of cabotegravir and rilpivirine using restricted mean survival time (RMST) until loss of virological control (one or more measurements of plasma HIV RNA ≥200 copies per mL). In the secondary analysis, we assessed loss of virological control in individuals who commenced cabotegravir and rilpivirine with previous virological failure or unsuppressed HIV-1 RNA at cabotegravir and rilpivirine initiation, or both.</p><p><strong>Findings: </strong>In primary analysis, 585 exposed and 1170 unexposed individuals were included between Feb 27, 2018, and Aug 17, 2023. Median follow-up was 1·3 years (IQR 0·9 to 1·7). 14 exposed (2%) and 29 unexposed (2%) individuals had a loss of virological control, with no difference in RMST (difference=0·026, 95% CI -0·029 to -0·080). Seven (50%) exposed individuals re-suppressed without a regimen change. Seven (50%) switched ART, and six (43%) of 14 had documented integrase strand transfer inhibitor (INSTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. No unexposed individuals switched ART after loss of virological control. In the secondary analysis, 105 individuals were included between July 1, 2016, and Aug 17, 2023. During a median follow up of 1·4 years (IQR 0·8 to 1·8), nine (9%) had a loss of virological control, of which five (56%) had INSTI or NNRTI resistance.</p><p><strong>Interpretation: </strong>Switching to cabotegravir and rilpivirine was not associated with a higher risk of loss of virological control among individuals without previous virological failure compared with oral ART. The high risk of loss of virological control among individuals with previous virological failure or an unsuppressed HIV-1 RNA at cabotegravir and rilpivirine initiation warrants more careful monitoring.</p><p><strong>Funding: </strong>Dutch Ministry of Health, Welfare, and Sport.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"12 1","pages":"e40-e50"},"PeriodicalIF":12.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143056131","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}