Pub Date : 2024-11-01Epub Date: 2024-10-07DOI: 10.1097/QAI.0000000000003488
Luh Putu Lila Wulandari, Srila Nirmithya Salita Negara, Yusuf Ari Mashuri, Siska Dian Wahyuningtias, I Wayan Cahyadi Surya Distira Putra, Yanri W Subronto, Riris Andono Ahmad, Hasbullah Thabrany, Rebecca Guy, Matthew Law, Mohamed Hammoud, Benjamin B Bavinton, John Kaldor, Nicholas Medland, Marco Liverani, Ari Probandari, David Boettiger, Virginia Wiseman
Background: The World Health Organization is committed to strengthening access to pre-exposure prophylaxis (PrEP) for HIV prevention and its integration into primary care services. Unfortunately, the COVID-19 pandemic has disrupted the delivery of primary care, including HIV-related services. To determine the extent of this disruption, we conducted a systematic review and meta-analysis of the changes in access to PrEP services during the pandemic and the reasons for these changes.
Methods: A search was conducted using PubMed, Scopus, Embase, PsycINFO, and Cinahl for studies published between January 2020 and January 2023. Selected articles described self-reported disruptions to PrEP service access associated with the COVID-19 pandemic or its responses. Pooled effect sizes were computed using a random-effects model.
Results: Thirteen studies involving 12,652 PrEP users were included in our analysis. The proportion of participants reporting a disruption in access to PrEP services during the COVID-19 pandemic ranged from 3% to 56%, with a pooled proportion of 21% (95% confidence intervals: 8% to 38%). Social restrictions, financial constraints, and limited health insurance coverage were key factors affecting access to PrEP services during the pandemic.
Conclusions: To our knowledge, this is the first meta-analysis to quantify the extent of disruptions to accessing PrEP services because of the COVID-19 pandemic. To increase the ability of primary care services to maintain PrEP services during public health crises, a mixture of strategies is worth considering. These include multi-month PrEP prescriptions, telehealth services, deployment of peer support groups to provide a community-based service or home delivery, and provision of financial support interventions.
{"title":"A Systematic Review and Meta-analysis of the Impact of the COVID-19 Pandemic on Access to HIV Pre-exposure Prophylaxis: Lessons for Future Public Health Crises.","authors":"Luh Putu Lila Wulandari, Srila Nirmithya Salita Negara, Yusuf Ari Mashuri, Siska Dian Wahyuningtias, I Wayan Cahyadi Surya Distira Putra, Yanri W Subronto, Riris Andono Ahmad, Hasbullah Thabrany, Rebecca Guy, Matthew Law, Mohamed Hammoud, Benjamin B Bavinton, John Kaldor, Nicholas Medland, Marco Liverani, Ari Probandari, David Boettiger, Virginia Wiseman","doi":"10.1097/QAI.0000000000003488","DOIUrl":"10.1097/QAI.0000000000003488","url":null,"abstract":"<p><strong>Background: </strong>The World Health Organization is committed to strengthening access to pre-exposure prophylaxis (PrEP) for HIV prevention and its integration into primary care services. Unfortunately, the COVID-19 pandemic has disrupted the delivery of primary care, including HIV-related services. To determine the extent of this disruption, we conducted a systematic review and meta-analysis of the changes in access to PrEP services during the pandemic and the reasons for these changes.</p><p><strong>Methods: </strong>A search was conducted using PubMed, Scopus, Embase, PsycINFO, and Cinahl for studies published between January 2020 and January 2023. Selected articles described self-reported disruptions to PrEP service access associated with the COVID-19 pandemic or its responses. Pooled effect sizes were computed using a random-effects model.</p><p><strong>Results: </strong>Thirteen studies involving 12,652 PrEP users were included in our analysis. The proportion of participants reporting a disruption in access to PrEP services during the COVID-19 pandemic ranged from 3% to 56%, with a pooled proportion of 21% (95% confidence intervals: 8% to 38%). Social restrictions, financial constraints, and limited health insurance coverage were key factors affecting access to PrEP services during the pandemic.</p><p><strong>Conclusions: </strong>To our knowledge, this is the first meta-analysis to quantify the extent of disruptions to accessing PrEP services because of the COVID-19 pandemic. To increase the ability of primary care services to maintain PrEP services during public health crises, a mixture of strategies is worth considering. These include multi-month PrEP prescriptions, telehealth services, deployment of peer support groups to provide a community-based service or home delivery, and provision of financial support interventions.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"97 3","pages":"208-215"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11458105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-10-07DOI: 10.1097/QAI.0000000000003496
Trudy D Leong, Jeremy Nel, Lise Jamieson, Regina Osih, Halima Dawood, Hasina Subedar, Michael McCaul, Leigh F Johnson, Karen Cohen
Background: South Africa has a high HIV incidence and oral pre-exposure prophylaxis (PrEP) is available as public-sector standard of care. Access to alternative prevention methods for women may further reduce HIV acquisition.
Setting: South African public sector.
Methods: We performed a systematic search for high-quality up-to-date guidelines recommending dapivirine rings as PrEP using the Grading of Recommendations Assessment, Development, and Evaluation -Adolopment process. We appraised the systematic review and randomized controlled trial (RCT) evidence underpinning the selected guideline's recommendations and conducted a cost-effectiveness analysis. The Grading of Recommendations Assessment, Development, and Evaluation evidence-to-decision framework guided the adaptation of source guideline recommendations, according to our local context.
Results: We identified the 2021 World Health Organization PrEP Guidelines, informed by 2 placebo-controlled RCTs, which were included in a contemporaneous systematic review. There were 23 fewer HIV acquisitions per 1000 clients with dapivirine ring vs placebo (95% confidence interval: 10 to 34), with no increase in adverse events (moderate certainty evidence). We found no RCTs comparing dapivirine to oral PrEP or among adolescent/pregnant/breastfeeding clients. Dapivirine is less cost-effective than oral PrEP at $14.59/ring, at the current price.
Conclusions: The source guideline recommendation was adapted for the local context. Dapivirine ring seems to be less efficacious than oral PrEP, although comparative studies are lacking. Data on adolescents and pregnancy are also lacking, currently limiting the use of dapivirine as an alternative for women unable to take oral PrEP. At the current price, dapivirine is not cost-effective and unaffordable for inclusion in the South African Essential Medicines List.
{"title":"A Review and Economic Analysis of the Dapivirine Vaginal Ring as HIV Pre-Exposure Prophylaxis for Women, to Inform South African Public-Sector Guidelines.","authors":"Trudy D Leong, Jeremy Nel, Lise Jamieson, Regina Osih, Halima Dawood, Hasina Subedar, Michael McCaul, Leigh F Johnson, Karen Cohen","doi":"10.1097/QAI.0000000000003496","DOIUrl":"10.1097/QAI.0000000000003496","url":null,"abstract":"<p><strong>Background: </strong>South Africa has a high HIV incidence and oral pre-exposure prophylaxis (PrEP) is available as public-sector standard of care. Access to alternative prevention methods for women may further reduce HIV acquisition.</p><p><strong>Setting: </strong>South African public sector.</p><p><strong>Methods: </strong>We performed a systematic search for high-quality up-to-date guidelines recommending dapivirine rings as PrEP using the Grading of Recommendations Assessment, Development, and Evaluation -Adolopment process. We appraised the systematic review and randomized controlled trial (RCT) evidence underpinning the selected guideline's recommendations and conducted a cost-effectiveness analysis. The Grading of Recommendations Assessment, Development, and Evaluation evidence-to-decision framework guided the adaptation of source guideline recommendations, according to our local context.</p><p><strong>Results: </strong>We identified the 2021 World Health Organization PrEP Guidelines, informed by 2 placebo-controlled RCTs, which were included in a contemporaneous systematic review. There were 23 fewer HIV acquisitions per 1000 clients with dapivirine ring vs placebo (95% confidence interval: 10 to 34), with no increase in adverse events (moderate certainty evidence). We found no RCTs comparing dapivirine to oral PrEP or among adolescent/pregnant/breastfeeding clients. Dapivirine is less cost-effective than oral PrEP at $14.59/ring, at the current price.</p><p><strong>Conclusions: </strong>The source guideline recommendation was adapted for the local context. Dapivirine ring seems to be less efficacious than oral PrEP, although comparative studies are lacking. Data on adolescents and pregnancy are also lacking, currently limiting the use of dapivirine as an alternative for women unable to take oral PrEP. At the current price, dapivirine is not cost-effective and unaffordable for inclusion in the South African Essential Medicines List.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"261-272"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11458098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1097/QAI.0000000000003484
Maganizo B Chagomerana, Carlee B Moser, Minhee Kang, Triin Umbleja, Michael D Hughes, Thomas B Campbell, Susan E Krown, Margaret Z Borok, Wadzanai Samaneka, McNeil Ngongondo, Mulinda Nyirenda, Deborah C Langat, Brenda Hoagland, Henriette Burger, Naftali Busakhala, Evangeline Njiru, Noluthando Mwelase, Rosie Mngqibisa, Mina C Hosseinipour
Background: AIDS-related Kaposi sarcoma (AIDS-KS) remains a leading cause of morbidity and mortality among people living with HIV in Africa. Mortality among people with AIDS-KS on antiretroviral therapy remains high compared with people on antiretroviral therapy who do not have AIDS-KS.
Setting: People living with HIV with Kaposi sarcoma (KS) who participated in 2 randomized trials (A5263/AMC066 [advanced stage] and A5264/AMC067 [mild-to-moderate stage]) conducted by AIDS Clinical Trials Group/AIDS Malignancy Consortium in low- and middle-income countries.
Methods: We estimated mortality rates over the trial period. Cox proportional hazards regressions were used to identify baseline characteristics associated with mortality and compared mortality rates between participants who had KS progression within 12 weeks of treatment initiation (early progression of KS [KS-PD]) and those who did not.
Results: Of the 329 and 189 eligible participants in A5263/AMC066 and A5264/AMC067, 71 (21.6%) and 24 (12.7%) died, respectively. In both trials, hypoalbuminemia was associated with increased hazards of death compared with normal albumin; A5263/AMC066: mild hypoalbuminemia (adjusted hazard ratio [aHR] = 3.01; 95% CI: 1.42 to 6.29), moderate hypoalbuminemia (aHR = 5.11; 95% CI: 2.54 to 10.29), and severe hypoalbuminemia (aHR = 14.58; 95% CI: 6.32 to 35.60), and A5264/AMC067: mild hypoalbuminemia (aHR = 5.66; 95% CI: 1.90 to 16.93) and moderate hypoalbuminemia (aHR = 7.02; 95% CI: 2.57 to 19.15). The rate of death was higher among participants who had early KS-PD than those without early KS-PD in A5263/AMC066 (HR = 5.09; 95% CI: 1.71 to 15.19) but not in A5264/AMC067 (HR = 1.74; 95% CI: 0.66 to 4.62).
Conclusions: Albumin measurements may be used to identify individuals at higher risk of death after initiating KS treatment and for evaluation of interventions that can reduce AIDS-KS mortality.
{"title":"Mortality and Associated Risk Factors Among People Living With HIV With Kaposi Sarcoma: A5263/AMC066 and A5264/AMC067.","authors":"Maganizo B Chagomerana, Carlee B Moser, Minhee Kang, Triin Umbleja, Michael D Hughes, Thomas B Campbell, Susan E Krown, Margaret Z Borok, Wadzanai Samaneka, McNeil Ngongondo, Mulinda Nyirenda, Deborah C Langat, Brenda Hoagland, Henriette Burger, Naftali Busakhala, Evangeline Njiru, Noluthando Mwelase, Rosie Mngqibisa, Mina C Hosseinipour","doi":"10.1097/QAI.0000000000003484","DOIUrl":"10.1097/QAI.0000000000003484","url":null,"abstract":"<p><strong>Background: </strong>AIDS-related Kaposi sarcoma (AIDS-KS) remains a leading cause of morbidity and mortality among people living with HIV in Africa. Mortality among people with AIDS-KS on antiretroviral therapy remains high compared with people on antiretroviral therapy who do not have AIDS-KS.</p><p><strong>Setting: </strong>People living with HIV with Kaposi sarcoma (KS) who participated in 2 randomized trials (A5263/AMC066 [advanced stage] and A5264/AMC067 [mild-to-moderate stage]) conducted by AIDS Clinical Trials Group/AIDS Malignancy Consortium in low- and middle-income countries.</p><p><strong>Methods: </strong>We estimated mortality rates over the trial period. Cox proportional hazards regressions were used to identify baseline characteristics associated with mortality and compared mortality rates between participants who had KS progression within 12 weeks of treatment initiation (early progression of KS [KS-PD]) and those who did not.</p><p><strong>Results: </strong>Of the 329 and 189 eligible participants in A5263/AMC066 and A5264/AMC067, 71 (21.6%) and 24 (12.7%) died, respectively. In both trials, hypoalbuminemia was associated with increased hazards of death compared with normal albumin; A5263/AMC066: mild hypoalbuminemia (adjusted hazard ratio [aHR] = 3.01; 95% CI: 1.42 to 6.29), moderate hypoalbuminemia (aHR = 5.11; 95% CI: 2.54 to 10.29), and severe hypoalbuminemia (aHR = 14.58; 95% CI: 6.32 to 35.60), and A5264/AMC067: mild hypoalbuminemia (aHR = 5.66; 95% CI: 1.90 to 16.93) and moderate hypoalbuminemia (aHR = 7.02; 95% CI: 2.57 to 19.15). The rate of death was higher among participants who had early KS-PD than those without early KS-PD in A5263/AMC066 (HR = 5.09; 95% CI: 1.71 to 15.19) but not in A5264/AMC067 (HR = 1.74; 95% CI: 0.66 to 4.62).</p><p><strong>Conclusions: </strong>Albumin measurements may be used to identify individuals at higher risk of death after initiating KS treatment and for evaluation of interventions that can reduce AIDS-KS mortality.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"97 3","pages":"216-225"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11494148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1097/qai.0000000000003472
Bradley E Aouizerat,Josephine N Garcia,Carlos V Domingues,Ke Xu,Bryan C Quach,Grier P Page,Deborah Konkle-Parker,Hector H Bolivar,Cecile D Lahiri,Elizabeth T Golub,Mardge H Cohen,Seble G Kassaye,Jack DeHovitz,Mark H Kuniholm,Nancie M Archin,Phyllis C Tien,Dana B Hancock,Eric Otto Johnson
BACKGROUNDCocaine-one of the most frequently abused illicit drugs among persons living with HIV [people living with HIV (PLWH)]-slows the decline of viral production after antiretroviral therapy and is associated with higher HIV viral load, more rapid HIV progression, and increased mortality.SETTINGWe examined the impact of cocaine use on the CD4+ T-cell HIV latent reservoir (HLR) in virally suppressed PLWH participating in a national, longitudinal cohort study of the natural and treated history of HIV in the United States.METHODSCD4+ T-cell genomic DNA from 434 women of diverse ancestry (ie, 75% Black, 14% Hispanic, 12% White) who self-reported cocaine use (ie, 160 cocaine users, 59 prior users, 215 non-users) was analyzed using the Intact Proviral HIV DNA Assay, measuring intact provirus per 106 CD4+ T cells.FINDINGSHIV latent reservoir size differed by cocaine use (ie, median [interquartile range]: 72 [14-193] for never users, 165 [63-387] for prior users, 184 [28-502] for current users), which was statistically significantly larger in both prior (P = 0.023) and current (P = 0.001) cocaine users compared with never users.CONCLUSIONSCocaine use may contribute to a larger replication competent HLR in CD4+ T cells among virologically suppressed women living with HIV. Our findings are important because women are underrepresented in HIV reservoir studies and in studies of the impact of cocaine use on outcomes among PLWH.
背景可卡因是艾滋病病毒感染者(PLWH)中最常滥用的非法药物之一,它能减缓抗逆转录病毒治疗后病毒产量的下降,并与更高的艾滋病病毒载量、更快的艾滋病进展和更高的死亡率有关。设置我们研究了使用可卡因对CD4+ T细胞HIV潜伏库(HLR)的影响,研究对象是参与美国HIV自然史和治疗史全国纵向队列研究的病毒已被抑制的艾滋病毒感染者。方法使用完整病毒 HIV DNA 检测法对 434 名不同血统(即 75% 黑人、14% 西班牙人、12% 白人)、自我报告使用过可卡因的女性(即 160 名可卡因使用者、59 名先前使用者、215 名非使用者)的 CD4+ T 细胞基因组 DNA 进行分析,测量每 106 个 CD4+ T 细胞中的完整病毒数量。结果艾滋病毒潜伏库的大小因使用可卡因而异(即,中位数[四分位数间距]:从未使用者 72 [14-193],既往使用者 165 [63-387],当前使用者 184 [28-502]),在统计学上,既往使用者(P = 0.结论可卡因的使用可能导致病毒学抑制的女性艾滋病毒感染者的 CD4+ T 细胞中 HLR 复制能力增强。我们的研究结果非常重要,因为在艾滋病毒储库研究以及可卡因使用对艾滋病毒感染者预后影响的研究中,女性所占比例较低。
{"title":"Frequent Cocaine Use is Associated With Larger HIV Latent Reservoir Size.","authors":"Bradley E Aouizerat,Josephine N Garcia,Carlos V Domingues,Ke Xu,Bryan C Quach,Grier P Page,Deborah Konkle-Parker,Hector H Bolivar,Cecile D Lahiri,Elizabeth T Golub,Mardge H Cohen,Seble G Kassaye,Jack DeHovitz,Mark H Kuniholm,Nancie M Archin,Phyllis C Tien,Dana B Hancock,Eric Otto Johnson","doi":"10.1097/qai.0000000000003472","DOIUrl":"https://doi.org/10.1097/qai.0000000000003472","url":null,"abstract":"BACKGROUNDCocaine-one of the most frequently abused illicit drugs among persons living with HIV [people living with HIV (PLWH)]-slows the decline of viral production after antiretroviral therapy and is associated with higher HIV viral load, more rapid HIV progression, and increased mortality.SETTINGWe examined the impact of cocaine use on the CD4+ T-cell HIV latent reservoir (HLR) in virally suppressed PLWH participating in a national, longitudinal cohort study of the natural and treated history of HIV in the United States.METHODSCD4+ T-cell genomic DNA from 434 women of diverse ancestry (ie, 75% Black, 14% Hispanic, 12% White) who self-reported cocaine use (ie, 160 cocaine users, 59 prior users, 215 non-users) was analyzed using the Intact Proviral HIV DNA Assay, measuring intact provirus per 106 CD4+ T cells.FINDINGSHIV latent reservoir size differed by cocaine use (ie, median [interquartile range]: 72 [14-193] for never users, 165 [63-387] for prior users, 184 [28-502] for current users), which was statistically significantly larger in both prior (P = 0.023) and current (P = 0.001) cocaine users compared with never users.CONCLUSIONSCocaine use may contribute to a larger replication competent HLR in CD4+ T cells among virologically suppressed women living with HIV. Our findings are important because women are underrepresented in HIV reservoir studies and in studies of the impact of cocaine use on outcomes among PLWH.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"40 1","pages":"156-164"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1097/qai.0000000000003494
{"title":"Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Initiating Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate: A Subanalysis of ALLIANCE Data: Erratum.","authors":"","doi":"10.1097/qai.0000000000003494","DOIUrl":"https://doi.org/10.1097/qai.0000000000003494","url":null,"abstract":"","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"4 1","pages":"202"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BACKGROUNDSafety data from randomized trials of antiretrovirals in pregnancy are scarce. We evaluated maternal bone and renal data from the International Maternal Pediatric Adolescent AIDS Clinical Trials Network 2010 trial, which compared the safety and efficacy of 3 antiretroviral therapy regimens started in pregnancy: dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF), dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF), and efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF).METHODSA subset of participants underwent dual-energy X-ray absorptiometry scans at postpartum week 50 only. Maternal bone mineral density (BMD) Z-scores were compared between arms. Maternal creatinine was measured at enrolment and periodically through week 50 postpartum, and by-arm differences in average weekly change in estimated creatinine clearance were compared.RESULTSSix hundred forty-three participants were randomized to DTG + FTC/TAF (N = 217) or DTG + FTC/TDF (N = 215) or EFV/FTC/TDF (N = 211). Median age = 27 years (IQR 23, 32), median CD4 count = 466 cells/mm3 (IQR 308, 624); 564 (88%) women enrolled in Africa and 479 (74%) breastfed. Week 50 postpartum dual-energy X-ray absorptiometry results from 154 women were included in the analysis. Hip and spine BMD was on average higher in women in the DTG + FTC/TAF and lower in the DTG + FTC/TDF and EFV/FTC/TDF arms, but no significant differences in BMD Z-scores were observed between treatment groups. The weekly rate of change in estimated creatinine clearance differed among treatment groups during the antepartum period, but not over the full study follow-up.CONCLUSIONSMarkers of bone and renal toxicity did not differ significantly through week 50 postpartum among women randomized to start DTG + FTC/TAF or DTG + FTC/TDF or EFV/FTC/TDF in pregnancy.
{"title":"Markers of Maternal Bone and Renal Toxicity Through 50 Weeks Postpartum: IMPAACT 2010 (VESTED) Trial.","authors":"Gaerolwe Masheto,Sean S Brummel,Lauren Ziemba,John Shepherd,Tapiwa Mbengeranwa,Laarni Igawa,Anne Coletti,Dorinda Mukura,Lindie Rossouw,Gerhard Theron,Chelsea Krotje,Patrick Jean-Philippe,Nahida Chakhtoura,Haseena Cassim,Sisinyana Ruth Mathiba,Joel Maena,William Murtaugh,Lee Fairlie,Judith Currier,Risa Hoffman,Lameck Chinula,Paul E Sax,Lynda Stranix-Chibanda,Shahin Lockman,","doi":"10.1097/qai.0000000000003478","DOIUrl":"https://doi.org/10.1097/qai.0000000000003478","url":null,"abstract":"BACKGROUNDSafety data from randomized trials of antiretrovirals in pregnancy are scarce. We evaluated maternal bone and renal data from the International Maternal Pediatric Adolescent AIDS Clinical Trials Network 2010 trial, which compared the safety and efficacy of 3 antiretroviral therapy regimens started in pregnancy: dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF), dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF), and efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF).METHODSA subset of participants underwent dual-energy X-ray absorptiometry scans at postpartum week 50 only. Maternal bone mineral density (BMD) Z-scores were compared between arms. Maternal creatinine was measured at enrolment and periodically through week 50 postpartum, and by-arm differences in average weekly change in estimated creatinine clearance were compared.RESULTSSix hundred forty-three participants were randomized to DTG + FTC/TAF (N = 217) or DTG + FTC/TDF (N = 215) or EFV/FTC/TDF (N = 211). Median age = 27 years (IQR 23, 32), median CD4 count = 466 cells/mm3 (IQR 308, 624); 564 (88%) women enrolled in Africa and 479 (74%) breastfed. Week 50 postpartum dual-energy X-ray absorptiometry results from 154 women were included in the analysis. Hip and spine BMD was on average higher in women in the DTG + FTC/TAF and lower in the DTG + FTC/TDF and EFV/FTC/TDF arms, but no significant differences in BMD Z-scores were observed between treatment groups. The weekly rate of change in estimated creatinine clearance differed among treatment groups during the antepartum period, but not over the full study follow-up.CONCLUSIONSMarkers of bone and renal toxicity did not differ significantly through week 50 postpartum among women randomized to start DTG + FTC/TAF or DTG + FTC/TDF or EFV/FTC/TDF in pregnancy.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"29 1","pages":"172-179"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BACKGROUNDThe pathogenesis of HIV-associated neurocognitive (NC) impairment is multifactorial, and antiretroviral (ARV) neurotoxicity may contribute. However, interventional pharmacological studies are limited.METHODSSingle-blind, randomized (1:1), controlled trial to assess the change of NC performance (Global Deficit Score, GDS, and domain scores) in PLWH with NC impairment randomized to continue their standard of care treatment or to switch to a less neurotoxic ARV regimen: darunavir/cobicistat, maraviroc, emtricitabine (MARAND-X). Participants had plasma and cerebrospinal fluid HIV RNA< 50 copies/mL, R5-tropic HIV, and were on ARV regimens that did not include efavirenz and darunavir. The change of resting-state electroencephalography was also evaluated. The outcomes were assessed at week 24 of the intervention through tests for longitudinal paired data and mixed-effect models.RESULTSThirty-eight participants were enrolled and 28 completed the follow-up. Global Deficit Score improved over time but with no difference between arms in longitudinal adjusted models. Perceptual functions improved in the MARAND-X, while long-term memory improved only in participants within the MARAND-X for whom the central nervous system penetration-effectiveness (CNS penetration effectiveness) score increased by ≥3. No significant changes in resting-state electroencephalography were observed.CONCLUSIONSIn this small but well-controlled study, the use of less neurotoxic ARV showed no major beneficial effect over an unchanged regimen. The beneficial effects on the memory domain of increasing CNS penetration effectiveness score suggest that ARV neuropenetration may have a role in cognitive function.
{"title":"Switching to Low Neurotoxic Antiretrovirals to Improve Neurocognition Among People Living With HIV-1-Associated Neurocognitive Disorder: The MARAND-X Randomized Clinical Trial.","authors":"Alessandro Lazzaro,Daniela Vai,Ambra Barco,Giacomo Stroffolini,Veronica Pirriatore,Giulia Guastamacchia,Marco Nigra,Valeria Ghisetti,Maria Cristina Tettoni,Giuseppe Noce,Claudia Giaccone,Mattia Trunfio,Alice Trentalange,Stefano Bonora,Giovanni Di Perri,Andrea Calcagno","doi":"10.1097/qai.0000000000003480","DOIUrl":"https://doi.org/10.1097/qai.0000000000003480","url":null,"abstract":"BACKGROUNDThe pathogenesis of HIV-associated neurocognitive (NC) impairment is multifactorial, and antiretroviral (ARV) neurotoxicity may contribute. However, interventional pharmacological studies are limited.METHODSSingle-blind, randomized (1:1), controlled trial to assess the change of NC performance (Global Deficit Score, GDS, and domain scores) in PLWH with NC impairment randomized to continue their standard of care treatment or to switch to a less neurotoxic ARV regimen: darunavir/cobicistat, maraviroc, emtricitabine (MARAND-X). Participants had plasma and cerebrospinal fluid HIV RNA< 50 copies/mL, R5-tropic HIV, and were on ARV regimens that did not include efavirenz and darunavir. The change of resting-state electroencephalography was also evaluated. The outcomes were assessed at week 24 of the intervention through tests for longitudinal paired data and mixed-effect models.RESULTSThirty-eight participants were enrolled and 28 completed the follow-up. Global Deficit Score improved over time but with no difference between arms in longitudinal adjusted models. Perceptual functions improved in the MARAND-X, while long-term memory improved only in participants within the MARAND-X for whom the central nervous system penetration-effectiveness (CNS penetration effectiveness) score increased by ≥3. No significant changes in resting-state electroencephalography were observed.CONCLUSIONSIn this small but well-controlled study, the use of less neurotoxic ARV showed no major beneficial effect over an unchanged regimen. The beneficial effects on the memory domain of increasing CNS penetration effectiveness score suggest that ARV neuropenetration may have a role in cognitive function.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"60 1","pages":"180-191"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1097/qai.0000000000003481
Jeremy E Orr,Jazmin Velazquez,Christopher N Schmickl,Naa-Oye Bosompra,Pamela N DeYoung,Dillon Gilbertson,Atul Malhotra,Igor Grant,Sonia Ancoli-Israel,Maile Young Karris,Robert L Owens
BACKGROUNDPeople living with HIV (PLWH) often report fatigue even when viral load is suppressed. Obstructive sleep apnea (OSA), which is often associated with fatigue, is common in PLWH, but whether OSA explains fatigue in this population is unknown.SETTINGAcademic university-affiliated HIV and Sleep Medicine Clinics.METHODSPLWH, aged 18-65 years, with a body mass index of 20-35 kg/m2 and viral suppression (RNA <200 copies per mL), were recruited to undergo daytime questionnaires, including the Functional Assessment of Chronic Illness Therapy Fatigue Scale and Epworth Sleepiness Scale, 7 days of actigraphy (to determine daily sleep duration and activity amplitude and rhythms), and an in-laboratory polysomnography to assess for the presence and severity of OSA.RESULTSOf 120 subjects with evaluable data, 90 (75%) had OSA using the American Academy of Sleep Medicine 3% desaturation or arousal criteria, with an apnea-hypopnea index >5/h. There was no difference in Functional Assessment of Chronic Illness Therapy scores between those with and without OSA, although those with OSA did report more daytime sleepiness as measured using the Epworth Sleepiness Scale. In a multivariable model, predictors of fatigue included more variable daily sleep durations and decreased mean activity counts. Sleepiness was predicted by the presence of OSA.CONCLUSIONOSA was very common in our cohort of PLWH, with those with OSA reporting more sleepiness but not more fatigue. Variability in sleep duration was associated with increased fatigue. Further study is needed to determine if treatment of OSA, or an emphasis on sleep consistency and timing, improves symptoms of fatigue in PLWH.
背景艾滋病病毒感染者(PLWH)即使在病毒载量得到抑制的情况下也经常报告疲劳。阻塞性睡眠呼吸暂停(OSA)通常与疲劳有关,在艾滋病病毒感染者中很常见,但 OSA 是否能解释这一人群的疲劳问题尚不清楚。患有和未患有 OSA 的患者在慢性疾病治疗功能评估得分上没有差异,但使用 Epworth 嗜睡量表测量,患有 OSA 的患者白天嗜睡程度更高。在一个多变量模型中,疲劳的预测因素包括每日睡眠时间更长和平均活动次数减少。结论 在我们的 PLWH 群体中,OSA 非常常见,OSA 患者嗜睡程度更高,但疲劳程度并不更高。睡眠时间的不稳定性与疲劳的增加有关。需要进一步研究以确定治疗 OSA 或强调睡眠的连贯性和时间安排是否能改善 PLWH 的疲劳症状。
{"title":"Sleep, Sleep Apnea, and Fatigue in People Living With HIV.","authors":"Jeremy E Orr,Jazmin Velazquez,Christopher N Schmickl,Naa-Oye Bosompra,Pamela N DeYoung,Dillon Gilbertson,Atul Malhotra,Igor Grant,Sonia Ancoli-Israel,Maile Young Karris,Robert L Owens","doi":"10.1097/qai.0000000000003481","DOIUrl":"https://doi.org/10.1097/qai.0000000000003481","url":null,"abstract":"BACKGROUNDPeople living with HIV (PLWH) often report fatigue even when viral load is suppressed. Obstructive sleep apnea (OSA), which is often associated with fatigue, is common in PLWH, but whether OSA explains fatigue in this population is unknown.SETTINGAcademic university-affiliated HIV and Sleep Medicine Clinics.METHODSPLWH, aged 18-65 years, with a body mass index of 20-35 kg/m2 and viral suppression (RNA <200 copies per mL), were recruited to undergo daytime questionnaires, including the Functional Assessment of Chronic Illness Therapy Fatigue Scale and Epworth Sleepiness Scale, 7 days of actigraphy (to determine daily sleep duration and activity amplitude and rhythms), and an in-laboratory polysomnography to assess for the presence and severity of OSA.RESULTSOf 120 subjects with evaluable data, 90 (75%) had OSA using the American Academy of Sleep Medicine 3% desaturation or arousal criteria, with an apnea-hypopnea index >5/h. There was no difference in Functional Assessment of Chronic Illness Therapy scores between those with and without OSA, although those with OSA did report more daytime sleepiness as measured using the Epworth Sleepiness Scale. In a multivariable model, predictors of fatigue included more variable daily sleep durations and decreased mean activity counts. Sleepiness was predicted by the presence of OSA.CONCLUSIONOSA was very common in our cohort of PLWH, with those with OSA reporting more sleepiness but not more fatigue. Variability in sleep duration was associated with increased fatigue. Further study is needed to determine if treatment of OSA, or an emphasis on sleep consistency and timing, improves symptoms of fatigue in PLWH.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"60 1","pages":"192-201"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1097/qai.0000000000003470
Raiza M Beltran,Lauren A Hunter,Laura J Packel,Loriann De Martini,Ian W Holloway,Betty J Dong,Jerika Lam,Sandra I McCoy,Ayako Miyashita Ochoa
BACKGROUNDPre-exposure prophylaxis (PrEP) uptake remains low among people who could benefit, some of whom may prefer alternatives to oral PrEP, such as long-acting injectable pre-exposure prophylaxis (LAI-PrEP). We evaluated the potential for LAI-PrEP provision in pharmacies through a mixed methods study of pharmacists in California, where Senate Bill 159 enables pharmacists to independently provide oral PrEP.METHODSIn 2022-2023, we conducted an online cross-sectional survey of California pharmacists and pharmacy students (n = 919) and in-depth interviews with pharmacists (n = 30), both of which included modules assessing attitudes about PrEP provision. Using log-binomial regression, we estimated prevalence ratios (PRs) comparing survey participants' willingness to provide LAI-PrEP by pharmacy- and individual-level characteristics. Qualitative interview data were analyzed using Rapid Qualitative Analysis to identify factors that may affect pharmacists' provision of LAI-PrEP.RESULTSHalf of the survey participants (53%) indicated that they would be willing to administer LAI-PrEP using gluteal injection in their pharmacy. Willingness was higher among participants who worked in pharmacies that provided vaccinations or other injections (56% vs. 46%; PR: 1.2; 95% confidence interval: 1.0-1.4) and/or oral PrEP under Senate Bill 159 (65% vs. 51%; PR: 1.3; 95% confidence interval: 1.1-1.5) than among participants whose pharmacies did not. Interviewed participants reported barriers to LAI-PrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services.CONCLUSIONPharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible.
{"title":"A Mixed Methods Evaluation of Pharmacists' Readiness to Provide Long-Acting Injectable HIV Pre-exposure Prophylaxis in California.","authors":"Raiza M Beltran,Lauren A Hunter,Laura J Packel,Loriann De Martini,Ian W Holloway,Betty J Dong,Jerika Lam,Sandra I McCoy,Ayako Miyashita Ochoa","doi":"10.1097/qai.0000000000003470","DOIUrl":"https://doi.org/10.1097/qai.0000000000003470","url":null,"abstract":"BACKGROUNDPre-exposure prophylaxis (PrEP) uptake remains low among people who could benefit, some of whom may prefer alternatives to oral PrEP, such as long-acting injectable pre-exposure prophylaxis (LAI-PrEP). We evaluated the potential for LAI-PrEP provision in pharmacies through a mixed methods study of pharmacists in California, where Senate Bill 159 enables pharmacists to independently provide oral PrEP.METHODSIn 2022-2023, we conducted an online cross-sectional survey of California pharmacists and pharmacy students (n = 919) and in-depth interviews with pharmacists (n = 30), both of which included modules assessing attitudes about PrEP provision. Using log-binomial regression, we estimated prevalence ratios (PRs) comparing survey participants' willingness to provide LAI-PrEP by pharmacy- and individual-level characteristics. Qualitative interview data were analyzed using Rapid Qualitative Analysis to identify factors that may affect pharmacists' provision of LAI-PrEP.RESULTSHalf of the survey participants (53%) indicated that they would be willing to administer LAI-PrEP using gluteal injection in their pharmacy. Willingness was higher among participants who worked in pharmacies that provided vaccinations or other injections (56% vs. 46%; PR: 1.2; 95% confidence interval: 1.0-1.4) and/or oral PrEP under Senate Bill 159 (65% vs. 51%; PR: 1.3; 95% confidence interval: 1.1-1.5) than among participants whose pharmacies did not. Interviewed participants reported barriers to LAI-PrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services.CONCLUSIONPharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"113 1","pages":"142-149"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1097/qai.0000000000003471
Andrew Mujugira,Beyonce Karungi,Agnes Nakyanzi,Monica Bagaya,Rogers Nsubuga,Timothy Sebuliba,Olivia Nampewo,Faith Naddunga,Juliet E Birungi,Oliver Sapiri,Kikulwe R Nyanzi,Felix Bambia,Timothy Muwonge,Monica Gandhi,Jessica E Haberer
BACKGROUNDPeer-delivered HIV self-testing (HIVST) and sexually transmitted infection self-sampling (STISS) may promote adherence to oral pre-exposure prophylaxis (PrEP), but no studies have analyzed this approach among transgender women (TGW) in sub-Saharan Africa.SETTINGThe Peer study was a cluster randomized trial in Uganda (October 2020-July 2022; NCT04328025).METHODSTen TGW peer groups, each with 1 TGW peer and 8 TGW, were randomized 1:1 to receive quarterly in-clinic HIV testing with PrEP refills as standard-of-care (SOC) or SOC plus monthly peer delivery of oral-fluid HIVST, STISS, and PrEP refills (intervention). Participants were followed for 12 months. The primary outcome was PrEP adherence.RESULTSWe screened 85 TGW and enrolled 82 (41 per arm). The median age was 22 years (interquartile range [IQR] 20-24). Twelve-month retention was 88% (72/82). At the 3, 6, 9, and 12-month clinic visits, 10%, 5%, 5%, and 0% of TGW in the intervention arm had TFV-DP levels ≥700 fmol/punch, versus 7%, 15%, 7%, and 2% in the SOC arm, respectively (P = 0.18). At all visits, any detectable TFV-DP levels were significantly higher in SOC than the peer delivery group (P < 0.04). PrEP adherence was associated with sex work (incidence rate ratio 6.93; 95% CI: 2.33 to 20.60) and >10 years of schooling (incidence rate ratio 2.35; 95% CI: 1.14 to 4.84). There was a strong correlation between tenofovir detection in dried blood spots and urine (P < 0.001). No HIV seroconversions occurred.CONCLUSIONSPeer-delivered HIVST and STISS did not increase low levels of oral PrEP adherence among TGW in Uganda. Long-acting PrEP formulations should be considered for this population.
{"title":"Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial.","authors":"Andrew Mujugira,Beyonce Karungi,Agnes Nakyanzi,Monica Bagaya,Rogers Nsubuga,Timothy Sebuliba,Olivia Nampewo,Faith Naddunga,Juliet E Birungi,Oliver Sapiri,Kikulwe R Nyanzi,Felix Bambia,Timothy Muwonge,Monica Gandhi,Jessica E Haberer","doi":"10.1097/qai.0000000000003471","DOIUrl":"https://doi.org/10.1097/qai.0000000000003471","url":null,"abstract":"BACKGROUNDPeer-delivered HIV self-testing (HIVST) and sexually transmitted infection self-sampling (STISS) may promote adherence to oral pre-exposure prophylaxis (PrEP), but no studies have analyzed this approach among transgender women (TGW) in sub-Saharan Africa.SETTINGThe Peer study was a cluster randomized trial in Uganda (October 2020-July 2022; NCT04328025).METHODSTen TGW peer groups, each with 1 TGW peer and 8 TGW, were randomized 1:1 to receive quarterly in-clinic HIV testing with PrEP refills as standard-of-care (SOC) or SOC plus monthly peer delivery of oral-fluid HIVST, STISS, and PrEP refills (intervention). Participants were followed for 12 months. The primary outcome was PrEP adherence.RESULTSWe screened 85 TGW and enrolled 82 (41 per arm). The median age was 22 years (interquartile range [IQR] 20-24). Twelve-month retention was 88% (72/82). At the 3, 6, 9, and 12-month clinic visits, 10%, 5%, 5%, and 0% of TGW in the intervention arm had TFV-DP levels ≥700 fmol/punch, versus 7%, 15%, 7%, and 2% in the SOC arm, respectively (P = 0.18). At all visits, any detectable TFV-DP levels were significantly higher in SOC than the peer delivery group (P < 0.04). PrEP adherence was associated with sex work (incidence rate ratio 6.93; 95% CI: 2.33 to 20.60) and >10 years of schooling (incidence rate ratio 2.35; 95% CI: 1.14 to 4.84). There was a strong correlation between tenofovir detection in dried blood spots and urine (P < 0.001). No HIV seroconversions occurred.CONCLUSIONSPeer-delivered HIVST and STISS did not increase low levels of oral PrEP adherence among TGW in Uganda. Long-acting PrEP formulations should be considered for this population.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"40 1","pages":"125-132"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}