Moupali Das
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View article: HIV-1 infection kinetics, drug resistance, and long-term safety of pre-exposure prophylaxis with emtricitabine plus tenofovir alafenamide (DISCOVER): week 144 open-label extension of a randomised, controlled, phase 3 trial
HIV-1 infection kinetics, drug resistance, and long-term safety of pre-exposure prophylaxis with emtricitabine plus tenofovir alafenamide (DISCOVER): week 144 open-label extension of a randomised, controlled, phase 3 trial Open
BACKGROUND: Data characterising the long-term use and safety of emtricitabine plus tenofovir disoproxil fumarate as daily oral pre-exposure prophylaxis (PrEP) are scarce and there are uncertainties regarding the value of routine HIV-1 RNA …
View article: Type 1 Human Immunodeficiency Virus (HIV-1) Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-exposure Prophylaxis: Pooled Analysis From 72 Global Studies
Type 1 Human Immunodeficiency Virus (HIV-1) Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-exposure Prophylaxis: Pooled Analysis From 72 Global Studies Open
Background Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1…
View article: HIV Preexposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women
HIV Preexposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women Open
Importance Emtricitabine and tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP) is highly effective in cisgender men who have sex with men (MSM) when adherence is high (>4 doses/week). Real-world effectiven…
View article: 1556. Increase in New HIV Diagnoses Following Decrease in Use of Pre-Exposure Prophylaxis (PrEP) During the COVID-19 Pandemic
1556. Increase in New HIV Diagnoses Following Decrease in Use of Pre-Exposure Prophylaxis (PrEP) During the COVID-19 Pandemic Open
Background Population-level longitudinal data evaluating trends in new HIV diagnoses and use of pre-exposure prophylaxis (PrEP) to assess the impact of COVID-19 on HIV prevention efforts are limited. Here, we evaluated changes in new HIV d…
View article: HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo
HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo Open
BACKGROUND: While noninferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has been shown, interest remains in its efficacy relative to p…
View article: HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo
HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo Open
Background While noninferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has been shown, interest remains in its efficacy relative to pl…
View article: Facilitating Next‐Generation Pre‐Exposure Prophylaxis Clinical Trials Using <scp>HIV</scp> Recent Infection Assays: A Consensus Statement from the Forum <scp>HIV</scp> Prevention Trial Design Project
Facilitating Next‐Generation Pre‐Exposure Prophylaxis Clinical Trials Using <span>HIV</span> Recent Infection Assays: A Consensus Statement from the Forum <span>HIV</span> Prevention Trial Design Project Open
Standard‐of‐care HIV pre‐exposure prophylaxis (PrEP) is highly efficacious, but uptake of and persistence on a daily oral pill is low in many settings. Evaluation of alternate PrEP products will require innovation to avoid the unpracticall…
View article: 2088. Real-World Geographic Variations of HIV Diagnosis Rates among Individuals Prescribed and not Prescribed Oral HIV Pre-Exposure Prophylaxis (PrEP) Regimens in the United States
2088. Real-World Geographic Variations of HIV Diagnosis Rates among Individuals Prescribed and not Prescribed Oral HIV Pre-Exposure Prophylaxis (PrEP) Regimens in the United States Open
Background Declines in the diagnoses of new HIV infections have been reported in geographic areas with higher uptake of PrEP among persons who would benefit from PrEP (PWBP). In the present analysis, we examined the rate of new HIV diagnos…
View article: 2079. Comparison of Recency Assays to Estimate HIV Incidence in the SIENA (eStimating hIv incidEnce amoNg Agyw) Study in Uganda
2079. Comparison of Recency Assays to Estimate HIV Incidence in the SIENA (eStimating hIv incidEnce amoNg Agyw) Study in Uganda Open
Background HIV-1 recent infection testing algorithms (RITAs) use recency assays to estimate population level HIV incidence rates (IRs), and are currently being employed in PrEP trials to estimate background HIV incidence rates (bHIV-IR). T…
View article: 2059. Estimated Background HIV Diagnosis Rates among People Who Could Benefit from Pre-Exposure Prophylaxis (PrEP) at the Metropolitan Statistical Area (MSA) level in the United States, 2012-2019
2059. Estimated Background HIV Diagnosis Rates among People Who Could Benefit from Pre-Exposure Prophylaxis (PrEP) at the Metropolitan Statistical Area (MSA) level in the United States, 2012-2019 Open
Background Identifying areas of high background HIV diagnosis rates (bHIV) is critical for future PrEP trials using counterfactual study designs to estimate efficacy and to facilitate effective implementation of HIV prevention intervention…
View article: Gender Affirming Hormones Do Not Affect the Exposure and Efficacy of F/TDF or F/TAF for HIV Preexposure Prophylaxis: A Subgroup Analysis from the DISCOVER Trial
Gender Affirming Hormones Do Not Affect the Exposure and Efficacy of F/TDF or F/TAF for HIV Preexposure Prophylaxis: A Subgroup Analysis from the DISCOVER Trial Open
Clinicaltrials.gov registration number: NCT02842086.
View article: Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP)
Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP) Open
Introduction Black and Hispanic/Latinx cisgender men who have sex with men (MSM), transgender women, transgender men, and gender nonbinary (TGNB) individuals have been historically underrepresented in HIV pre-exposure prophylaxis (PrEP) cl…
View article: 848. Approaches to Optimize Recruitment of Historically Underrepresented Black and Hispanic/LatinX MSM, Transgender, and Gender Non-binary Individuals into the Lenacapavir for PrEP (PURPOSE 2) Trial
848. Approaches to Optimize Recruitment of Historically Underrepresented Black and Hispanic/LatinX MSM, Transgender, and Gender Non-binary Individuals into the Lenacapavir for PrEP (PURPOSE 2) Trial Open
Background Black and Hispanic/Latinx gay and other men who have sex with men (MSM), transgender women (TGW), transgender men (TGM), and gender nonbinary individuals (GNB) have been historically underrepresented in HIV prevention trials des…
View article: 855. Persistence on F/TAF versus F/TDF for HIV Pre-Exposure Prophylaxis: A Real-World Evidence Analysis in the United States
855. Persistence on F/TAF versus F/TDF for HIV Pre-Exposure Prophylaxis: A Real-World Evidence Analysis in the United States Open
Background Persistence to preexposure prophylaxis (PrEP) is an important determinant of its efficacy, but evidence on real-world persistence is lacking. This study assesses adherence to F/TDF and F/TAF for PrEP both in terms of discontinua…
View article: 854. Long-term Outcomes of Participants on F/TAF for Pre-Exposure Prophylaxis: Results for 144 Weeks of Follow-Up in the DISCOVER Trial
854. Long-term Outcomes of Participants on F/TAF for Pre-Exposure Prophylaxis: Results for 144 Weeks of Follow-Up in the DISCOVER Trial Open
Background In DISCOVER, a multinational randomized controlled trial, F/TAF demonstrated noninferior efficacy compared to F/TDF for HIV prevention with improved bone mineral density and renal safety biomarkers at the primary endpoint (when …
View article: 866. Adherence to F/TDF for PrEP in Dried Blood Spots and HIV Infection Rates: A Pooled Analysis of Global PrEP Studies
866. Adherence to F/TDF for PrEP in Dried Blood Spots and HIV Infection Rates: A Pooled Analysis of Global PrEP Studies Open
Background The use of daily F/TDF for HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV acquisition. Dried blood spot (DBS) tenofovir-diphosphate (TFV-DP) levels reflect TDF use over the past 6-8 weeks, providing an objective m…
View article: Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial
Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial Open
View article: Weight Change Following Antiretroviral Therapy Switch in People With Viral Suppression: Pooled Data from Randomized Clinical Trials
Weight Change Following Antiretroviral Therapy Switch in People With Viral Suppression: Pooled Data from Randomized Clinical Trials Open
Background We sought to identify factors associated with weight gain in randomized clinical trials of antiretroviral therapy (ART) switch. Methods We explored the effects of demographic factors, clinical characteristics, and ART on weight …
View article: Using the adherence‐efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background HIV incidence: a secondary analysis of a randomized, controlled trial
Using the adherence‐efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background HIV incidence: a secondary analysis of a randomized, controlled trial Open
Introduction Randomized trials of new agents for HIV pre‐exposure prophylaxis (PrEP) compare against emtricitabine and tenofovir disoproxil fumarate (F/TDF), without a placebo group. We used the well‐characterized adherence‐efficacy relati…
View article: Longer-Term Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide Versus Emtricitabine and Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis: Week 96 Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial
Longer-Term Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide Versus Emtricitabine and Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis: Week 96 Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial Open
View article: Two-dose emtricitabine/tenofovir alafenamide plus bictegravir prophylaxis protects macaques against SHIV infection
Two-dose emtricitabine/tenofovir alafenamide plus bictegravir prophylaxis protects macaques against SHIV infection Open
Objectives Current prophylaxis options for people at risk for HIV infection include two US FDA-approved daily pre-exposure prophylaxis (PrEP) regimens and guidelines for a 2-1-1 event-driven course specifically for men who have sex with me…
View article: 103. Persistence on F/TDF for HIV Pre-exposure Prophylaxis: Insights from Real-world Evidence
103. Persistence on F/TDF for HIV Pre-exposure Prophylaxis: Insights from Real-world Evidence Open
Background Background: Daily F/TDF is highly effective for HIV pre-exposure prophylaxis (PrEP). Prior studies have found that women and people of younger age have lower adherence and lower persistence on PrEP, yet real-world evidence descr…
View article: 995. Safety and Efficacy of F/TAF and F/TDF for PrEP in DISCOVER Participants Taking F/TDF for PrEP at Baseline
995. Safety and Efficacy of F/TAF and F/TDF for PrEP in DISCOVER Participants Taking F/TDF for PrEP at Baseline Open
Background DISCOVER is an ongoing trial comparing emtricitabine plus tenofovir alafenamide (F/TAF) or tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis (PrEP). DISCOVER included some participants already taking F/TDF f…
View article: 999. Using the F/TDF Adherence-Efficacy Relationship to Calculate Background HIV incidence: Results from the DISCOVER trial
999. Using the F/TDF Adherence-Efficacy Relationship to Calculate Background HIV incidence: Results from the DISCOVER trial Open
Background RRandomized trials of new PrEP agents compare to oral emtricitabine+tenofovir disoproxil fumarate (F/TDF) and do not have a placebo arm. We used the well-characterized adherence-efficacy relationship for F/TDF from iPrEX OLE, to…
View article: 985. Impact of Age and Medical Comorbidities on Renal Outcomes in the DISCOVER Trial
985. Impact of Age and Medical Comorbidities on Renal Outcomes in the DISCOVER Trial Open
Background In DISCOVER, emtricitabine/tenofovir alafenamide (F/TAF) was noninferior to F/tenofovir disoproxil fumarate (TDF) for preexposure prophylaxis (PrEP) in men who have sex with men and transgender women, with a superior renal labor…
View article: Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019
Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019 Open
Background Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivi…
View article: Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial
Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial Open
View article: Lack of an association between clinical INSTI-related body weight gain and direct interference with MC4 receptor (MC4R), a key central regulator of body weight
Lack of an association between clinical INSTI-related body weight gain and direct interference with MC4 receptor (MC4R), a key central regulator of body weight Open
An increasing prevalence of overweight and obesity in people living with HIV has been associated with initiation of antiretroviral therapy with integrase strand transfer inhibitors (INSTIs). An off-target inhibition of the endogenous ligan…
HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens Open
View article: Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate
Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate Open
We found no biomarker evidence of CNS injury when switching from TDF to TAF. It is unclear whether the small decrease in plasma NfL found after switch to TAF is of any clinical relevance, particularly with plasma NfL levels in both arms re…