Lancet HivPub Date : 2024-11-01Epub Date: 2024-09-20DOI: 10.1016/S2352-3018(24)00242-X
Dvora Joseph Davey, Lise Jamieson
{"title":"Cost-effectiveness of lenacapavir for PrEP in Africa.","authors":"Dvora Joseph Davey, Lise Jamieson","doi":"10.1016/S2352-3018(24)00242-X","DOIUrl":"10.1016/S2352-3018(24)00242-X","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e722-e723"},"PeriodicalIF":12.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308844","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}
Lancet HivPub Date : 2024-11-01Epub Date: 2024-09-20DOI: 10.1016/S2352-3018(24)00239-X
Linxuan Wu, David Kaftan, Rachel Wittenauer, Cory Arrouzet, Nishali Patel, Arden L Saravis, Brian Pfau, Edinah Mudimu, Anna Bershteyn, Monisha Sharma
{"title":"Health impact, budget impact, and price threshold for cost-effectiveness of lenacapavir for HIV pre-exposure prophylaxis in eastern and southern Africa: a modelling analysis.","authors":"Linxuan Wu, David Kaftan, Rachel Wittenauer, Cory Arrouzet, Nishali Patel, Arden L Saravis, Brian Pfau, Edinah Mudimu, Anna Bershteyn, Monisha Sharma","doi":"10.1016/S2352-3018(24)00239-X","DOIUrl":"10.1016/S2352-3018(24)00239-X","url":null,"abstract":"<p><strong>Background: </strong>Injectable lenacapavir administered every 6 months is a promising product for HIV pre-exposure prophylaxis (PrEP). We aimed to estimate the health and budget impacts and threshold price at which lenacapavir could be cost-effective in eastern and southern Africa.</p><p><strong>Methods: </strong>We adapted an agent-based network model, EMOD-HIV, to simulate lenacapavir scale-up in Zimbabwe, South Africa, and western Kenya from 2026 to 2035. Uptake assumptions were informed by a literature review of PrEP product preferences. In the main analysis, we varied lenacapavir coverage by subgroup: female sex workers (40% coverage); male clients of female sex workers (40%); adolescent girls and young women aged 15-24 years with more than one sexual partner (32%); women aged 25 years and older with more than one sexual partner (36%); and males with more than one sexual partner (32%). We also assessed a higher coverage scenario (64-76% across subgroups) and scenarios of expanding lenacapavir use, varying from concentrated among those at highest HIV risk to broader coverage including those at medium HIV risk. We estimated the maximum per-dose lenacapavir price that achieved cost-effectiveness (<US$500 per disability-adjusted life-year averted), infections averted, and 5-year budget impact, compared with daily oral PrEP only.</p><p><strong>Findings: </strong>In the main analysis, lenacapavir was projected to achieve from 1·6% (95% uncertainty interval [UI] 1·5-1·8) to 4·0% (3·4-5·1) population coverage across settings and to avert from 12·3% (5·4-19·5) to 18·0% (11·0-22·9) of infections over 10 years. The maximum price per dose was highest in South Africa ($106·28 [95% UI 95·72-115·87]), followed by Zimbabwe ($21·15 [17·70-24·89]), and lowest in western Kenya ($16·58 [15·44-17·70]). The 5-year budget impact was US$507·25 million (95% UI 436·14-585·42) in South Africa, $16·80 million (13·95-22·64) in Zimbabwe, and $4·09 million (3·86-4·30) in western Kenya. In the higher coverage scenario, lenacapavir distribution was projected to reach from 3·2% (95% UI 2·9-3·6) to 8·1% (6·8-10·5) population coverage and to avert from 21·2% (95% UI 14·7-18·5) to 33·3% (28·5-36·9) of HIV infections across settings over 10 years. Price thresholds were lower than in the main analysis: $88·34 (95% UI 83·02-94·19) in South Africa, $17·71 (15·61-20·05) in Zimbabwe, and $14·78 (14·33-15·30) in western Kenya. The 5-year budget impact was higher than the main analysis: $835·29 million (95% UI 736·98-962·98) in South Africa, $29·50 million (24·62-39·52) in Zimbabwe, and $7·45 million (7·11-7·85) in western Kenya. Expanding lenacapavir coverage resulted in higher HIV infections averted but lower price thresholds than scenarios of concentrated use among those with highest HIV risk.</p><p><strong>Interpretation: </strong>Our findings suggest that lenacapavir could avert substantial HIV incidence and that price thresholds and budget impacts vary by setting and ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e765-e773"},"PeriodicalIF":12.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11519315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308845","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}
Lancet HivPub Date : 2024-11-01DOI: 10.1016/S2352-3018(24)00274-1
Roger Pebody
{"title":"Injectable PrEP comes to southern Africa.","authors":"Roger Pebody","doi":"10.1016/S2352-3018(24)00274-1","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00274-1","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 11","pages":"e724-e725"},"PeriodicalIF":12.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548452","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}
Lancet HivPub Date : 2024-11-01Epub Date: 2024-09-27DOI: 10.1016/S2352-3018(24)00213-3
Nicholas A Medland, Hamish McManus, Benjamin R Bavinton, Doug Fraser, Michael W Traeger, Andrew E Grulich, Mark A Stoove, Skye McGregor, Jonathan M King, Dash Heath-Paynter, Rebecca J Guy
{"title":"HIV incidence in people receiving government-subsidised pre-exposure prophylaxis in Australia: a whole-of-population retrospective cohort study.","authors":"Nicholas A Medland, Hamish McManus, Benjamin R Bavinton, Doug Fraser, Michael W Traeger, Andrew E Grulich, Mark A Stoove, Skye McGregor, Jonathan M King, Dash Heath-Paynter, Rebecca J Guy","doi":"10.1016/S2352-3018(24)00213-3","DOIUrl":"10.1016/S2352-3018(24)00213-3","url":null,"abstract":"<p><strong>Background: </strong>HIV pre-exposure prophylaxis (PrEP) is highly effective and has been government subsidised in Australia since April, 2018. We examined HIV incidence over 5 years in a retrospective observational cohort of people who had received subsidised PrEP.</p><p><strong>Methods: </strong>Linked de-identified dispensing records for all government-subsidised oral PrEP, HIV antiretroviral therapy (ART), and hepatitis C treatment were used. We included all people dispensed subsidised PrEP from April 1, 2018, to March 31, 2023, and examined records up to Sept 30, 2023. Exposure was measured from date of first PrEP prescription and days covered by PrEP calculated for individuals based on quantity and date supplied. Assuming that HIV was diagnosed 30 days before ART initiation, we imputed the date of acquisition as the midpoint between the diagnosis and the later of the last PrEP prescription or 6 months before the diagnosis. We calculated HIV incidence and its predictors using Poisson regression.</p><p><strong>Findings: </strong>We included 66 206 people dispensed PrEP: 64 757 (97·8%) were men; median age was 33 years (IQR 27-43). 207 people acquired HIV, with an overall incidence of 1·07 per 1000 person-years (95% CI 0·93-1·23). Incidence was 2·61 per 1000 person-years among those dispensed PrEP once only. Using this group as a comparator, those with 60% or more days covered by PrEP had a 78·5% reduction in incidence (0·56 per 1000 person-years, p<0·0001) and those with less than 60% days covered had a 61·6% reduction (0·99 per 1000 person-years, p=0·0045). Independent predictors of HIV acquisition were a record of hepatitis C treatment (9·83 per 1000 person-years, adjusted incident rate ratio [aIRR] 8·70, 95% CI 4·86-15·56), only attending prescribers outside of areas with a high estimated prevalence of gay men (1·66 per 1000 person-years, aIRR 1·50, 1·08-2·09), age 18-29 years (1·33 per 1000 person-years, aIRR 1·56, 1·11-2·21), and earlier year of first PrEP.</p><p><strong>Interpretation: </strong>The low observed incidence of HIV among people receiving government-subsidised PrEP highlights the success of a national programme of oral PrEP scale-up in achieving sustained reduction in community HIV transmission. However, incidence varied greatly, indicating that more research is needed to understand why people were not taking PrEP at times of risk and emphasising the need for new interventions focused on this population to achieve elimination of HIV transmission. Individuals dispensed PrEP once only and less frequent users might benefit from more support.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":" ","pages":"e756-e764"},"PeriodicalIF":12.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142356513","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}
Lancet HivPub Date : 2024-11-01DOI: 10.1016/S2352-3018(24)00241-8
Emi E Okamoto, Florence Riako Anam, Solange Batiste, Mandisa Dukashe, Erika Castellanos, Midnight Poonkasetwattana, Bruce Richman
{"title":"Ending AIDS as a public health threat: the imperative for clear messaging on U=U, viral suppression, and zero risk.","authors":"Emi E Okamoto, Florence Riako Anam, Solange Batiste, Mandisa Dukashe, Erika Castellanos, Midnight Poonkasetwattana, Bruce Richman","doi":"10.1016/S2352-3018(24)00241-8","DOIUrl":"10.1016/S2352-3018(24)00241-8","url":null,"abstract":"<p><p>To end AIDS as a public health threat by 2030, we must leverage both the impactful message of U=U (undetectable equals untransmittable) and viral suppression to improve the wellbeing of individuals living with HIV, increase engagement with HIV services, and reduce barriers such as stigma, discrimination, and criminalisation. This message requires clear and unambiguous evidence-based narratives that emphasise the message that there is zero risk of sexual transmission when an undetectable viral load is maintained and negligible risk when viral suppression (as defined by 200-1000 copies per mL) is maintained. Dissemination of this information to individuals living with or affected by HIV, health-care workers, communities, the general public, and policy makers will increase awareness and credibility of this message and challenge deep-seated misperceptions. Furthermore, understanding the impact of this evidence underscores the necessity to urgently prioritise universal access to quality care, including viral load testing; leverage community leadership to address structural barriers; and monitor for ongoing success. Responsible and equitable messaging, which includes attention to women and marginalised groups, should be used to realise benefits for personal wellbeing and work towards an AIDS-free future.</p>","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 11","pages":"e783-e790"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142550106","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}
Lancet HivPub Date : 2024-11-01DOI: 10.1016/S2352-3018(24)00273-X
The Lancet Hiv
{"title":"Lenacapavir licenses will not deliver on all opportunities.","authors":"The Lancet Hiv","doi":"10.1016/S2352-3018(24)00273-X","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00273-X","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 11","pages":"e717"},"PeriodicalIF":12.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548453","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}
Lancet HivPub Date : 2024-11-01DOI: 10.1016/S2352-3018(24)00240-6
Dvora Leah Joseph Davey, Rufaro Mvududu, Nyiko Mashele, Kalisha Bheemraj, Nehaa Khadka, Leigh F Johnson, Sarah Schoetz Dean, Pamina Gorbach, Linda-Gail Bekker, Thomas J Coates, Landon Myer
{"title":"Initiation and continued use of oral pre-exposure prophylaxis among pregnant and postpartum women in South Africa (PrEP-PP): a demonstration cohort study.","authors":"Dvora Leah Joseph Davey, Rufaro Mvududu, Nyiko Mashele, Kalisha Bheemraj, Nehaa Khadka, Leigh F Johnson, Sarah Schoetz Dean, Pamina Gorbach, Linda-Gail Bekker, Thomas J Coates, Landon Myer","doi":"10.1016/S2352-3018(24)00240-6","DOIUrl":"https://doi.org/10.1016/S2352-3018(24)00240-6","url":null,"abstract":"<p><strong>Background: </strong>When used effectively, oral pre-exposure prophylaxis (PrEP; tenofovir disoproxil fumarate and emtricitabine) prevents maternal HIV acquisition and reduces the risk of vertical transmission. Our study aimed to better understand PrEP initiation, continued use, and adherence in pregnant and postpartum women.</p><p><strong>Methods: </strong>The PrEP in Pregnancy and Postpartum (PrEP-PP) study is a demonstration cohort study that enrolled pregnant women aged 16 years and older without HIV attending their first antenatal care visit in Cape Town, South Africa, between Aug 29, 2019, and Oct 10, 2021. Eligible, consenting women were followed up quarterly up to 12 months postpartum with regular HIV testing and offer of PrEP with ongoing adherence counselling. The primary outcome was distribution of women across the PrEP cascade (ie, initiation and continuation up to 12 months postpartum) with crude and adjusted hazard ratios (HRs). We also report on HIV incidence by pregnancy and postpartum status.</p><p><strong>Findings: </strong>Overall, 1195 pregnant women were recruited and followed up (median age 26 years, IQR 23-31; median gestational age 21 weeks, IQR 15-31); 1009 (84·4%) started PrEP at enrolment. Among women who initiated PrEP at enrolment, 668 (67·5%) of 990 continued PrEP at the 1-month follow-up, 485 (49·9%) of 972 continued at 3 months, 392 (39·4%) of 994 at 6 months, and 275 (27·4%) of 1005 at 12 months. Of 186 women who did not accept PrEP at enrolment, 70 (37·6%) of 186 subsequently initiated PrEP. Overall, 200 (18·6%) of 1076 women continued PrEP at 12 months postpartum. Of 186 women who did not initiate PrEP at baseline, 70 (37·6%) subsequently initiated PrEP during the study. Factors associated with PrEP discontinuation up to 12 months postpartum included being married or cohabiting (adjusted HR 1·32, 95% CI 1·16-1·50), condomless sex since last visit (1·43, 1·23-1·65), reporting intimate partner violence (2·03, 1·59-2·59), or depression in the past 12 months (1·53, 1·14-2·05). Overall, 16 women seroconverted over 1673·8 woman-years (HIV incidence rate 0·96 per 100 woman-years, 95% CI 0·49-1·42); 14 discontinued PrEP use and two never initiated PrEP. HIV incidence was 0·28 per 100 woman-years during pregnancy (95% CI 0·22-0·33), and the incidence rate ratio was 1·77 per 100 woman-years (0·53-5·90) 0-6 months postpartum and 2·19 per 100 woman-years (0·61-7·83) 6-12 months postpartum compared with pregnant women.</p><p><strong>Interpretation: </strong>There is an urgent need for the integration of PrEP into antenatal and postnatal care and interventions that address barriers to continued use, including targeted counselling during pregnancy and postpartum to reduce PrEP discontinuation.</p><p><strong>Funding: </strong>National Institute of Mental Health and Fogarty International, US National Institutes of Health.</p><p><strong>Translation: </strong>For the French translation of the abstract see Supplementary ","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"11 11","pages":"e746-e755"},"PeriodicalIF":12.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548451","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}
Lancet HivPub Date : 2024-10-11DOI: 10.1016/s2352-3018(24)00238-8
Anne E P Frosch,Victor Musiime,Christopher Staley,Andrea L Conroy,Diana Rutebarika,Gilbert Ategeka,Sarah E Cusick
{"title":"Safety and efficacy of iron supplementation with 3 months of daily ferrous sulphate in children living with HIV and mild-to-moderate anaemia in Uganda: a double-blind, randomised, placebo-controlled trial.","authors":"Anne E P Frosch,Victor Musiime,Christopher Staley,Andrea L Conroy,Diana Rutebarika,Gilbert Ategeka,Sarah E Cusick","doi":"10.1016/s2352-3018(24)00238-8","DOIUrl":"https://doi.org/10.1016/s2352-3018(24)00238-8","url":null,"abstract":"BACKGROUNDIron deficiency is the most common nutritional deficiency in the world, but iron supplementation can increase risk of opportunistic infections, especially in children living with HIV. We aimed to assess the effect of supplemental iron on haemoglobin concentration in children living with HIV and mild-to-moderate anaemia in Uganda.METHODSWe did a double-blind, randomised, placebo-controlled trial of iron supplementation in children aged 6 months to 12 years living with HIV at two sites (ie, Kampala and Fort Portal, Uganda). Inclusion criteria were confirmed diagnosis of HIV and stable treatment with antiretroviral therapy for at least 6 months. Exclusion criteria were already taking iron supplementation, acute illness, current opportunistic infection, fever, known sickle cell disease, severe undernutrition, or any chronic illness requiring medical attention. Children were randomly assigned (1:1) via simple randomisation to an 84-day course of either ferrous sulphate or identical placebo tablets once per day. Randomisation codes were computer-generated and stratified by age (ie, 6-23 months or 24 months and older) by the Toronto Institute of Pharmaceutical Technology, the tablet manufacturer. Participants and all individuals giving the interventions, assessing outcomes, and analysing data were masked to group assignment. Children aged 6-23 months received tablets of 12·5 mg ferrous sulphate or identical placebo; children aged 24 months or older received tablets of 30·0 mg ferrous sulphate or identical placebo. Caregivers were instructed to give the supplement after a meal, preferably after an evening meal. The primary outcome was mean haemoglobin concentration at day 84. All analyses were intention to treat. This trial is registered at ClinicalTrials.gov (NCT03596996).FINDINGSBetween May 5, 2018, and Nov 6, 2019, 973 children living with HIV were screened, of whom 200 (20%) met all inclusion criteria and were enrolled. 102 (51%) were randomly assigned to receive iron and 98 (49%) to receive placebo. In the iron group, 57 (56%) of 102 children were male and 45 (44%) were female. In the placebo group, 44 (45%) of 98 children were male and 54 (55%) were female. Iron supplementation was associated with improvement in haemoglobin in unadjusted analysis (p=0·029), but not adjusted analysis (p=0·10), and with improvement in ferritin and hepcidin in both adjusted (p=0·0046; p=0·0079) and unadjusted (p<0·0001; p<0·0001) analyses at day 84. There were four hospital admissions, all for children in the iron group; none were fatal: two children were admitted to hospital with pneumonia, one with severe malaria, and one with hepatitis. Frequency of admissions was not significantly different between groups (p=0·12).INTERPRETATIONIron could have haematological benefit and improve iron status in children living with HIV in Uganda. Future studies powered for morbidity outcomes with longer follow-up are needed, as are those that evaluate the effects of iron s","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"230 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142439222","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}
Lancet HivPub Date : 2024-10-11DOI: 10.1016/s2352-3018(24)00267-4
Ajibola I Abioye,Wafaie W Fawzi
{"title":"Iron supplementation among children living with HIV.","authors":"Ajibola I Abioye,Wafaie W Fawzi","doi":"10.1016/s2352-3018(24)00267-4","DOIUrl":"https://doi.org/10.1016/s2352-3018(24)00267-4","url":null,"abstract":"","PeriodicalId":48725,"journal":{"name":"Lancet Hiv","volume":"17 1","pages":""},"PeriodicalIF":16.1,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142439224","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}