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Long-overdue conclusion to the UK Infected Blood Inquiry. 早该结束的英国血液感染调查。
IF 12.8 1区 医学
Lancet Hiv Pub Date : 2024-07-01 Epub Date: 2024-06-13 DOI: 10.1016/S2352-3018(24)00156-5
The Lancet Hiv
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引用次数: 0
Effectiveness of integrating HIV prevention within sexual reproductive health services with or without peer support among adolescents and young adults in rural KwaZulu-Natal, South Africa (Isisekelo Sempilo): 2 × 2 factorial, open-label, randomised controlled trial. 在南非夸祖鲁-纳塔尔省农村地区的青少年和年轻成年人中,将艾滋病预防纳入性生殖健康服务并提供或不提供同伴支持的效果(Isisekelo Sempilo):2 × 2因子、开放标签、随机对照试验。
IF 12.8 1区 医学
Lancet Hiv Pub Date : 2024-07-01 DOI: 10.1016/S2352-3018(24)00119-X
Maryam Shahmanesh, Natsayi Chimbindi, Jacob Busang, Glory Chidumwa, Nondumiso Mthiyani, Carina Herbst, Nonhlanhla Okesola, Jaco Dreyer, Thembelihle Zuma, Manono Luthuli, Dumsani Gumede, Siphesihle Hlongwane, Simphiwe Mdluli, Sithembile Msane, Theresa Smit, Jean-Michel Molina, Thandeka Khoza, Ngundu Osee Behuhuma, Nuala McGrath, Janet Seeley, Guy Harling, Lorraine Sherr, Andrew Copas, Kathy Baisley
{"title":"Effectiveness of integrating HIV prevention within sexual reproductive health services with or without peer support among adolescents and young adults in rural KwaZulu-Natal, South Africa (Isisekelo Sempilo): 2 × 2 factorial, open-label, randomised controlled trial.","authors":"Maryam Shahmanesh, Natsayi Chimbindi, Jacob Busang, Glory Chidumwa, Nondumiso Mthiyani, Carina Herbst, Nonhlanhla Okesola, Jaco Dreyer, Thembelihle Zuma, Manono Luthuli, Dumsani Gumede, Siphesihle Hlongwane, Simphiwe Mdluli, Sithembile Msane, Theresa Smit, Jean-Michel Molina, Thandeka Khoza, Ngundu Osee Behuhuma, Nuala McGrath, Janet Seeley, Guy Harling, Lorraine Sherr, Andrew Copas, Kathy Baisley","doi":"10.1016/S2352-3018(24)00119-X","DOIUrl":"10.1016/S2352-3018(24)00119-X","url":null,"abstract":"<p><strong>Background: </strong>Approximately 200 000 South Africans acquired HIV in 2021 despite the availability of universal HIV test and treat and pre-exposure prophylaxis (PrEP). The aim of this study was to test the effectiveness of sexual and reproductive health services or peer support, or both, on the uptake of serostatus neutral HIV services or reduction of sexually transmissible HIV.</p><p><strong>Methods: </strong>We did an open-label, 2 × 2 randomised factorial trial among young people in a mostly rural area of KwaZulu-Natal, South Africa. Inclusion criteria included being aged 16-29 years, living in the mapped geographical areas that were accessible to the area-based peer navigators, being willing and able to provide informed consent, and being willing to provide a dried blood spot for anonymous HIV testing and HIV viral load measurement at 12 months. Participants were randomly allocated by computer-generated algorithm to one of four groups: those in the standard-of-care group were referred to youth-friendly services for differentiated HIV prevention (condoms, universal HIV test and treat with antiretroviral therapy, and PrEP if eligible); those in the sexual and reproductive health services group received baseline self-collected specimens for sexually transmitted infection (STI) testing and referral to integrated sexual and reproductive health and HIV prevention services; those in the peer support group were referred to peer navigators for health promotion, condom provision, and facilitation of attendance for differentiated HIV prevention services; and those in the final group received a combination of sexual and reproductive health services and peer support. Coprimary outcomes were linkage to clinical services within 60 days of enrolment, proportion of participants who had sexually transmissible HIV at 12 months after enrolment, and proportion of sampled individuals who consented to participation and gave a dried blood spot for HIV testing at 12 months. Logistic regression was used for analyses, and adjusted for age, sex, and rural or peri-urban area of residence. This study is registered with ClinicalTrials.gov (NCT04532307) and is closed.</p><p><strong>Findings: </strong>Between March 2, 2020, and July 7, 2022, 1743 (75·7%) of 2301 eligible individuals were enrolled and followed up. 12-month dried blood spots were collected from 1168 participants (67·0%). The median age of the participants was 21 years (IQR 18-25), 51·4% were female, and 51·1% had secondary level education. Baseline characteristics and 12-month outcome ascertainment were similar between groups. 755 (43·3%) linked to services by 60 days. 430 (49·8%) of 863 who were in the sexual reproductive health services group were linked to care compared with 325 (36·9%) of 880 who were not in the sexual and reproductive health services group (adjusted odds ratio [aOR] 1·68; 95% CI 1·39-2·04); peer support had no effect: 385 (43·5%) of 858 compared with 370 (43·1%) of 885 (1·","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 7","pages":"e449-e460"},"PeriodicalIF":12.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141460173","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}
引用次数: 0
Is HIV epidemic control by 2030 realistic? 到 2030 年控制艾滋病毒疫情是否现实?
IF 12.8 1区 医学
Lancet Hiv Pub Date : 2024-07-01 DOI: 10.1016/S2352-3018(24)00098-5
Chris Beyrer, Georgia D Tomaras, Huub C Gelderblom, Glenda E Gray, Holly E Janes, Linda-Gail Bekker, Gregorio Millett, Giuseppe Pantaleo, Susan Buchbinder, Lawrence Corey
{"title":"Is HIV epidemic control by 2030 realistic?","authors":"Chris Beyrer, Georgia D Tomaras, Huub C Gelderblom, Glenda E Gray, Holly E Janes, Linda-Gail Bekker, Gregorio Millett, Giuseppe Pantaleo, Susan Buchbinder, Lawrence Corey","doi":"10.1016/S2352-3018(24)00098-5","DOIUrl":"10.1016/S2352-3018(24)00098-5","url":null,"abstract":"<p><p>Rates of new HIV acquisition remain unacceptably high in most populations in low-income, middle-income, and high-income settings despite advances in treatment and prevention strategies. Although biomedical advances in primary prevention of new infections exist, systematic scale-up of these interventions has not occurred at the pace required to end AIDS by 2030. Low population coverage, adherence to oral pre-exposure prophylaxis in settings with high rates of HIV acquisition, and the fact that a significant proportion of new HIV infections occurs in populations not identified as high risk and are hence not targeted for prevention approaches impedes current prevention strategies. Although long-acting injectables and monoclonal antibodies are promising approaches to help reduce incidence, high cost and the need for high coverage rates mean that a vaccine or vaccine-like intervention still remains the most likely scenario to produce a population-level impact on HIV incidence, especially in countries with generalised epidemics. Current global efforts are not sufficient to meet 2030 HIV epidemic goals; acknowledgment of this issue is required to ensure persistent advocacy for population-based control of the ongoing HIV pandemic.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 7","pages":"e489-e494"},"PeriodicalIF":12.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11416730/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141460175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recent gay Black history in the UK. 英国最近的黑人同性恋历史
IF 12.8 1区 医学
Lancet Hiv Pub Date : 2024-06-17 DOI: 10.1016/S2352-3018(24)00159-0
Talha Burki
{"title":"Recent gay Black history in the UK.","authors":"Talha Burki","doi":"10.1016/S2352-3018(24)00159-0","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00159-0","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":""},"PeriodicalIF":12.8,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141433160","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}
引用次数: 0
Closing the equity gap in the treatment of HIV-2 infection. 缩小 HIV-2 感染治疗中的公平差距。
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2024-06-01 Epub Date: 2024-05-10 DOI: 10.1016/S2352-3018(24)00122-X
Sarah Rowland-Jones, Ester Gea-Mallorquí
{"title":"Closing the equity gap in the treatment of HIV-2 infection.","authors":"Sarah Rowland-Jones, Ester Gea-Mallorquí","doi":"10.1016/S2352-3018(24)00122-X","DOIUrl":"10.1016/S2352-3018(24)00122-X","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e347-e349"},"PeriodicalIF":16.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140916452","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}
引用次数: 0
Responding to the global epidemic of amphetamine-type stimulant use compromising biomedical HIV prevention among men who have sex with men. 应对全球流行的使用苯丙胺类兴奋剂损害男男性行为者艾滋病毒生物医学预防的问题。
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2024-06-01 DOI: 10.1016/S2352-3018(24)00086-9
Adam W Carrico, Leah Davis Ewart, Udi Davidovich, Lisa Maher, Kai J Jonas, Keith J Horvath, Sabina Hirshfield, Thomas E Guadamuz, Tara Carney, Christian Grov
{"title":"Responding to the global epidemic of amphetamine-type stimulant use compromising biomedical HIV prevention among men who have sex with men.","authors":"Adam W Carrico, Leah Davis Ewart, Udi Davidovich, Lisa Maher, Kai J Jonas, Keith J Horvath, Sabina Hirshfield, Thomas E Guadamuz, Tara Carney, Christian Grov","doi":"10.1016/S2352-3018(24)00086-9","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00086-9","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 6","pages":"e350-e352"},"PeriodicalIF":16.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181065","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}
引用次数: 0
Is this the end of the road for daily islatravir 0·75 mg? Islatravir 0-75 毫克日剂量是否就此结束?
IF 16.1 1区 医学
Lancet Hiv Pub Date : 2024-06-01 Epub Date: 2024-05-08 DOI: 10.1016/S2352-3018(24)00120-6
Jennifer Hoy, James McMahon
{"title":"Is this the end of the road for daily islatravir 0·75 mg?","authors":"Jennifer Hoy, James McMahon","doi":"10.1016/S2352-3018(24)00120-6","DOIUrl":"10.1016/S2352-3018(24)00120-6","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e346-e347"},"PeriodicalIF":16.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140909671","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}
引用次数: 0
Efficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial. 针对非洲成年 HIV-2 病毒感染者的三种抗逆转录病毒疗法的疗效和安全性(FIT-2):一项试验性、第 2 阶段、非比较性、开放标签、随机对照试验。
IF 12.8 1区 医学
Lancet Hiv Pub Date : 2024-06-01 Epub Date: 2024-05-10 DOI: 10.1016/S2352-3018(24)00085-7
Serge P Eholie, Didier K Ekouevi, Corine Chazallon, Charlotte Charpentier, Eugène Messou, Zelica Diallo, Jacques Zoungrana, Albert Minga, Ndeye Fatou Ngom Gueye, Denise Hawerlander, Fassery Dembele, Géraldine Colin, Boris Tchounga, Sophie Karcher, Jérome Le Carrou, Annick Tchabert-Guié, Thomas-d'Aquin Toni, Abdoul-Salam Ouédraogo, Guillaume Bado, Coumba Toure Kane, Moussa Seydi, Armel Poda, Ephrem Mensah, Illah Diallo, Youssouf Joseph Drabo, Xavier Anglaret, Françoise Brun-Vezinet
{"title":"Efficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial.","authors":"Serge P Eholie, Didier K Ekouevi, Corine Chazallon, Charlotte Charpentier, Eugène Messou, Zelica Diallo, Jacques Zoungrana, Albert Minga, Ndeye Fatou Ngom Gueye, Denise Hawerlander, Fassery Dembele, Géraldine Colin, Boris Tchounga, Sophie Karcher, Jérome Le Carrou, Annick Tchabert-Guié, Thomas-d'Aquin Toni, Abdoul-Salam Ouédraogo, Guillaume Bado, Coumba Toure Kane, Moussa Seydi, Armel Poda, Ephrem Mensah, Illah Diallo, Youssouf Joseph Drabo, Xavier Anglaret, Françoise Brun-Vezinet","doi":"10.1016/S2352-3018(24)00085-7","DOIUrl":"10.1016/S2352-3018(24)00085-7","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Due to the low number of individuals with HIV-2, no randomised trials of HIV-2 treatment have ever been done. We hypothesised that a non-comparative study describing the outcomes of several antiretroviral therapy (ART) regimens in parallel groups would improve understanding of how differences between HIV-1 and HIV-2 might lead to different therapeutic approaches.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This pilot, phase 2, non-comparative, open-label, randomised controlled trial was done in Burkina Faso, Côte d'Ivoire, Senegal, and Togo. Adults with HIV-2 who were ART naive with CD4 counts of 200 cells per μL or greater were randomly assigned 1:1:1 to one of three treatment groups. A computer-generated sequentially numbered block randomisation list stratified by country was used for online allocation to the next available treatment group. In all groups, tenofovir disoproxil fumarate (henceforth tenofovir) was dosed at 245 mg once daily with either emtricitabine at 200 mg once daily or lamivudine at 300 mg once daily. The triple nucleoside reverse transcriptase inhibitor (NRTI) group received zidovudine at 250 mg twice daily. The ritonavir-boosted lopinavir group received lopinavir at 400 mg twice daily boosted with ritonavir at 100 mg twice daily. The raltegravir group received raltegravir at 400 mg twice daily. The primary outcome was the rate of treatment success at week 96, defined as an absence of serious morbidity event during follow-up, plasma HIV-2 RNA less than 50 copies per mL at week 96, and a substantial increase in CD4 cells between baseline and week 96. This trial is registered at ClinicalTrials.gov, NCT02150993, and is closed to new participants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between Jan 26, 2016, and June 29, 2017, 210 participants were randomly assigned to treatment groups. Five participants died during the 96 weeks of follow-up (triple NRTI group, n=2; ritonavir-boosted lopinavir group, n=2; and raltegravir group, n=1), eight had a serious morbidity event (triple NRTI group, n=4; ritonavir-boosted lopinavir group, n=3; and raltegravir group, n=1), 17 had plasma HIV-2 RNA of 50 copies per mL or greater at least once (triple NRTI group, n=11; ritonavir-boosted lopinavir group, n=4; and raltegravir group, n=2), 32 (all in the triple NRTI group) switched to another ART regimen, and 18 permanently discontinued ART (triple NRTI group, n=5; ritonavir-boosted lopinavir group, n=7; and raltegravir group, n=6). The Data Safety Monitoring Board recommended premature termination of the triple NRTI regimen for safety reasons. The overall treatment success rate was 57% (95% CI 47-66) in the ritonavir-boosted lopinavir group and 59% (49-68) in the raltegravir group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;The raltegravir and ritonavir-boosted lopinavir regimens were efficient and safe in adults with HIV-2. Both regimens could be compared in future phase 3 trials. The results of this pilot study suggest a trend towards ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e380-e388"},"PeriodicalIF":12.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140916453","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}
引用次数: 0
Reduction of HIV reservoir after stem cell transplantation. 减少干细胞移植后的艾滋病病毒库。
IF 12.8 1区 医学
Lancet Hiv Pub Date : 2024-06-01 DOI: 10.1016/S2352-3018(24)00121-8
Sharon R Lewin, Jillian Lau
{"title":"Reduction of HIV reservoir after stem cell transplantation.","authors":"Sharon R Lewin, Jillian Lau","doi":"10.1016/S2352-3018(24)00121-8","DOIUrl":"10.1016/S2352-3018(24)00121-8","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 6","pages":"e349-e350"},"PeriodicalIF":12.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181063","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}
引用次数: 0
Switch to fixed-dose doravirine (100 mg) with islatravir (0·75 mg) once daily in virologically suppressed adults with HIV-1 on antiretroviral therapy: 48-week results of a phase 3, randomised, open-label, non-inferiority trial. 正在接受抗逆转录病毒疗法的病毒学抑制成人HIV-1感染者改用固定剂量多拉韦林(100毫克)联合伊斯拉特韦(0-75毫克)每日一次:一项第3期随机、开放标签、非劣效试验的48周结果。
IF 12.8 1区 医学
Lancet Hiv Pub Date : 2024-06-01 Epub Date: 2024-05-08 DOI: 10.1016/S2352-3018(24)00031-6
Jean-Michel Molina, Giuliano Rizzardini, Catherine Orrell, Alejandro Afani, Alexandra Calmy, Shinichi Oka, Federico Hinestrosa, Princy Kumar, Pablo Tebas, Sharon Walmsley, Anjana Grandhi, Stephanie Klopfer, Isaias Gendrano, Karen Eves, Todd A Correll, Michelle C Fox, Jason Kim
{"title":"Switch to fixed-dose doravirine (100 mg) with islatravir (0·75 mg) once daily in virologically suppressed adults with HIV-1 on antiretroviral therapy: 48-week results of a phase 3, randomised, open-label, non-inferiority trial.","authors":"Jean-Michel Molina, Giuliano Rizzardini, Catherine Orrell, Alejandro Afani, Alexandra Calmy, Shinichi Oka, Federico Hinestrosa, Princy Kumar, Pablo Tebas, Sharon Walmsley, Anjana Grandhi, Stephanie Klopfer, Isaias Gendrano, Karen Eves, Todd A Correll, Michelle C Fox, Jason Kim","doi":"10.1016/S2352-3018(24)00031-6","DOIUrl":"10.1016/S2352-3018(24)00031-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Doravirine and islatravir is an investigational, once-daily, single-tablet regimen with high antiviral potency, favourable safety and tolerability, and low propensity for resistance. We report week 48 results from a phase 3 trial evaluating switch from stable, oral antiretroviral therapy (ART) to the fixed combination of doravirine (100 mg) and islatravir (0·75 mg).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This phase 3, multicentre, randomised, active-controlled, open-label, non-inferiority trial was conducted at 77 research, community, and hospital-based clinics in 15 countries. Adults aged 18 years or older with fewer than 50 HIV-1 RNA copies per mL on any oral, two-drug or three-drug ART regimen for at least 3 months, and no history of previous virological failure on any past or current regimen were randomly assigned (1:1) by a computer-generated randomisation schedule to switch to doravirine (100 mg) and islatravir (0·75 mg) or to continue their baseline ART regimen. Block randomisation was based on a block size of four, and randomisation was stratified by baseline regimen (ie, protease inhibitor, integrase inhibitor, or other). Participants in the doravirine and islatravir group were instructed to take one tablet at approximately the same time each day, and participants in the baseline ART group continued to take the medication according to the locally approved label. HIV-1 RNA and safety evaluations were done at baseline and weeks 4, 12, 24, 36, and 48. CD4 cell counts were measured at baseline, week 24, and week 48. The primary endpoint was 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) using the US Food and Drug Administration snapshot approach and prespecified non-inferiority margin of 4%. This study is registered with ClinicalTrials.gov (NCT04223778) and is completed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between Feb 18 and Oct 2, 2020, 740 individuals were screened for eligibility, of whom 672 (90·8%) participants (249 [37·1%] women and 423 [62·9%] men; median CD4 count of 678 cells per μL [IQR 496-868]) were randomly assigned to doravirine (100 mg) and islatravir (0·75 mg; n=336) or to continue baseline ART (n=336). The last follow-up visit occurred on Sept 8, 2021. At week 48, zero of 336 participants in the doravirine and islatravir group versus five (1·5%) of 336 participants in the baseline ART group had greater than or equal to 50 HIV-1 RNA copies per mL (difference -1·5, 95% CI -3·4 to -0·3). The per-protocol analysis showed consistent results. Headache was the most common adverse event in both groups (35 [10·4%] of 336 participants in the doravirine and islatravir group, 16 [4·8%] of 336 in the baseline ART group), infection rates were similar (113 [33·6%] in both groups), and discontinuations due to adverse events were low (seven [2·1%] vs one [0·3%]). 66 (19·6%) of 336 ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e369-e379"},"PeriodicalIF":12.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140909679","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}
引用次数: 0
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