Olayemi Osiyemi
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View article: The Effects of Cobicistat and Voriconazole on the Safety, Pharmacokinetics, and Pharmacodynamics of the TLR7 Agonist Vesatolimod in People with HIV
The Effects of Cobicistat and Voriconazole on the Safety, Pharmacokinetics, and Pharmacodynamics of the TLR7 Agonist Vesatolimod in People with HIV Open
View article: Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in Black and Hispanic/Latine adults with <scp>HIV</scp>‐1 initiating first‐line therapy: 5‐year follow‐up from two phase III studies
Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in Black and Hispanic/Latine adults with <span>HIV</span>‐1 initiating first‐line therapy: 5‐year follow‐up from two phase III studies Open
Introduction Black and Hispanic/Latine people are disproportionately affected by HIV‐1 and may have a greater risk of comorbidities than non‐Black and non‐Hispanic/Latine people with HIV. However, they have historically been underrepresent…
View article: 155. Long-Acting Subcutaneous Lenacapavir in People with Multi-Drug Resistant HIV-1: 3-Year Results of the CAPELLA Study
155. Long-Acting Subcutaneous Lenacapavir in People with Multi-Drug Resistant HIV-1: 3-Year Results of the CAPELLA Study Open
Background Lenacapavir (LEN) is a highly potent, long-acting HIV-1 capsid inhibitor approved in combination with other antiretrovirals (ARVs), for the treatment of heavily treatment-experienced (HTE) people with HIV-1 (PWH) with multidrug …
View article: Bictegravir/emtricitabine/tenofovir alafenamide in adults with HIV‐1 and end‐stage kidney disease on chronic haemodialysis
Bictegravir/emtricitabine/tenofovir alafenamide in adults with HIV‐1 and end‐stage kidney disease on chronic haemodialysis Open
INTRODUCTION: Treatment for people with HIV-1 and end-stage kidney disease (ESKD) on haemodialysis (HD) has previously required complex dose-adjusted regimens, with limited data on the use of a single-tablet regimen in this population. Our…
View article: Bictegravir/emtricitabine/tenofovir alafenamide in adults with <scp>HIV</scp>‐1 and end‐stage kidney disease on chronic haemodialysis
Bictegravir/emtricitabine/tenofovir alafenamide in adults with <span>HIV</span>‐1 and end‐stage kidney disease on chronic haemodialysis Open
Introduction Treatment for people with HIV‐1 and end‐stage kidney disease (ESKD) on haemodialysis (HD) has previously required complex dose‐adjusted regimens, with limited data on the use of a single‐tablet regimen in this population. Our …
View article: Durable Efficacy of Switching From a 3- or 4-Drug Tenofovir Alafenamide–Based Regimen to the 2-Drug Regimen Dolutegravir/Lamivudine in the TANGO Study Through Week 196
Durable Efficacy of Switching From a 3- or 4-Drug Tenofovir Alafenamide–Based Regimen to the 2-Drug Regimen Dolutegravir/Lamivudine in the TANGO Study Through Week 196 Open
Background: Switching to the 2-drug regimen dolutegravir (DTG)/lamivudine (3TC) demonstrated durable noninferior efficacy vs continuing 3- or 4-drug tenofovir alafenamide–based regimens for maintaining virologic suppression in people with …
View article: Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial
Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial Open
The ACTIV-2 platform study is funded by the NIH. Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1 AI068634, UM1 AI0…
View article: Poster Abstracts
Poster Abstracts Open
Background: Biktarvy use is currently approved for HIV-1 infection in treatment-naïve and treatmentexperienced individuals after a series of successful investigator-sponsored phase III trials.However, studies on real-world evidence of its …
View article: 1586. Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race
1586. Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race Open
Background Long-acting cabotegravir + rilpivirine (CAB + RPV LA) administered monthly or every 2 months is the first and only complete LA regimen recommended by treatment guidelines for the maintenance of HIV-1 virologic suppression. This …
View article: 1251. 5-year outcomes of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment of HIV-1 in adults with high baseline HIV-1 RNA and/or low CD4 count in two Phase 3 randomized clinical trials
1251. 5-year outcomes of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment of HIV-1 in adults with high baseline HIV-1 RNA and/or low CD4 count in two Phase 3 randomized clinical trials Open
Background People with HIV (PWH) who are initiated on guidelines-recommended first-line INSTI-based antiretroviral therapy routinely achieve rapid virologic suppression; however, those with a high baseline (BL) HIV-1 RNA and/or low CD4 cou…
View article: Ibrutinib for Hospitalized Adults With Severe Coronavirus Disease 2019 Infection: Results of the Randomized, Double-Blind, Placebo-Controlled iNSPIRE Study
Ibrutinib for Hospitalized Adults With Severe Coronavirus Disease 2019 Infection: Results of the Randomized, Double-Blind, Placebo-Controlled iNSPIRE Study Open
Background Few therapies are approved for hospitalized patients with severe coronavirus disease 2019 (COVID-19). Ibrutinib, a once-daily Bruton tyrosine kinase inhibitor, may mitigate COVID-19–induced lung damage by reducing inflammatory c…
View article: Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial
Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial Open
Background In TANGO, switching to dolutegravir/lamivudine (DTG/3TC) demonstrated long-term noninferior efficacy vs continuing tenofovir alafenamide–based regimens in treatment-experienced adults with HIV-1. The phase 3 SALSA study evaluate…
View article: Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide–Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 From the Phase 3, Noninferiority TANGO Randomized Trial
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide–Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 From the Phase 3, Noninferiority TANGO Randomized Trial Open
Background Switching to dolutegravir/lamivudine (DTG/3TC) was noninferior to continuing tenofovir alafenamide (TAF)–based regimens for maintaining virologic suppression at week 48 of the TANGO study. Here we present week 144 outcomes (effi…
View article: TROCA PARA UM REGIME COM 2 MEDICAMENTOS DOLUTEGRAVIR / LAMIVUDINA (DTG / 3TC) EM DOSE FIXA COMBINADA É NÃO INFERIOR A CONTINUAR COM UM REGIME DE 3 MEDICAMENTOS POR 48 SEMANAS EM UM ENSAIO CLÍNICO RANDOMIZADO (SALSA)
TROCA PARA UM REGIME COM 2 MEDICAMENTOS DOLUTEGRAVIR / LAMIVUDINA (DTG / 3TC) EM DOSE FIXA COMBINADA É NÃO INFERIOR A CONTINUAR COM UM REGIME DE 3 MEDICAMENTOS POR 48 SEMANAS EM UM ENSAIO CLÍNICO RANDOMIZADO (SALSA) Open
A eficácia não inferior a longo prazo do regime de 2 medicamentos foi demonstrada em estudos de 144 semanas em virgens de tratamento e pacientes experimentados com um bom perfil de segurança e uma alta barreira à resistência. Avaliamos a e…
View article: TROCA PARA A COMBINAÇÃO DE DOSE FIXA DE DOLUTEGRAVIR/LAMIVUDINA É NÃO INFERIOR A UM REGIME BASEADO EM TENOFOVIR ALAFENAMIDA NA MANUTENÇÃO DA SUPRESSÃO VIROLÓGICA POR 144 SEMANAS (ESTUDO TANGO)
TROCA PARA A COMBINAÇÃO DE DOSE FIXA DE DOLUTEGRAVIR/LAMIVUDINA É NÃO INFERIOR A UM REGIME BASEADO EM TENOFOVIR ALAFENAMIDA NA MANUTENÇÃO DA SUPRESSÃO VIROLÓGICA POR 144 SEMANAS (ESTUDO TANGO) Open
View article: Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients
Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients Open
Among nonhospitalized patients who were at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo. (Funded by Gilead Scie…
View article: Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV
Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV Open
Objectives: To evaluate safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F], followed by 23-valent pneumococcal polysaccha…
View article: 900. Switching to DTG/3TC Fixed-Dose Combination (FDC) Is Non-inferior to Continuing a TAF-Based Regimen (TBR) in Maintaining Virologic Suppression Through 144 Weeks (TANGO Study)
900. Switching to DTG/3TC Fixed-Dose Combination (FDC) Is Non-inferior to Continuing a TAF-Based Regimen (TBR) in Maintaining Virologic Suppression Through 144 Weeks (TANGO Study) Open
Background DTG/3TC is a complete 2-drug regimen (2DR) for the treatment of HIV-1 infection. Non-inferior virologic efficacy has been proven over 3 years in treatment-naive people living with HIV (PLWH) and 2 years in a stable switch settin…
View article: Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy
Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy Open
Objectives: Long-acting formulations of cabotegravir (CAB) and rilpivirine (RPV) have demonstrated efficacy in Phase 3 studies. POLAR (NCT03639311) assessed antiviral activity and safety of CAB+RPV long-acting administered every 2 months (…
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: Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study
Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study Open
Background: With the highest rates of HIV/AIDS in the United States, Black Americans are still underrepresented in HIV medical research. Setting: BRAAVE (NCT03631732) is a randomized, phase 3b, multicenter, open-label US study. Methods: Ad…
View article: 1046. Week 48 Outcomes from the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African American Adults with HIV
1046. Week 48 Outcomes from the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African American Adults with HIV Open
Background Black Americans are disproportionately impacted by HIV. The BRAAVE 2020 study, evaluated the safety and efficacy of switching to the guidelines-recommended single-tablet regimen bictegravir, emtricitabine, tenofovir alafenamide …
View article: 1002. A Daily Single Tablet Regimen (STR) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically-Suppressed Adults Living with HIV and End Stage Renal Disease on Chronic Hemodialysis
1002. A Daily Single Tablet Regimen (STR) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically-Suppressed Adults Living with HIV and End Stage Renal Disease on Chronic Hemodialysis Open
Background Treatment for people living with HIV (PLWH) and end stage renal disease (ESRD) on hemodialysis (HD) has previously required complex dose-adjusted regimens. We evaluated a daily regimen of elvitegravir/cobicistat/emtricitabine/te…
View article: 116. Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Hiv-positive Subjects: Results from the POLAR Study
116. Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Hiv-positive Subjects: Results from the POLAR Study Open
Background Long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) injectable suspensions have demonstrated efficacy in phase III studies. POLAR assessed antiviral activity and safety of CAB LA+RPV LA, administered every 2 mos (Q2M), in …
View article: Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide–Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide–Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study Open
Background The 2-drug regimen dolutegravir (DTG) + lamivudine (3TC) is indicated for treatment-naive adults with human immunodeficiency virus type 1 (HIV-1). We present efficacy and safety of switching to DTG/3TC in virologically suppresse…
View article: Reduced exposure to darunavir and cobicistat in <scp>HIV</scp>‐1‐infected pregnant women receiving a darunavir/cobicistat‐based regimen
Reduced exposure to darunavir and cobicistat in <span>HIV</span>‐1‐infected pregnant women receiving a darunavir/cobicistat‐based regimen Open
Objectives The aim of the study was to evaluate darunavir and cobicistat pharmacokinetics in pregnant women with HIV ‐1 infection. Methods This phase 3b, open‐label study enrolled HIV ‐1‐infected pregnant women (18–26 weeks of gestation) r…
View article: Switching to coformulated rilpivirine (<scp>RPV</scp>), emtricitabine (<scp>FTC</scp>) and tenofovir alafenamide from either <scp>RPV</scp>,<scp> FTC</scp> and tenofovir disoproxil fumarate (<scp>TDF</scp>) or efavirenz, <scp>FTC</scp> and <scp>TDF</scp>: 96‐week results from two randomized clinical trials
Switching to coformulated rilpivirine (<span>RPV</span>), emtricitabine (<span>FTC</span>) and tenofovir alafenamide from either <span>RPV</span>,<span> FTC</span> and tenofovir disoproxil fumarate (<span>TDF</span>) or efavirenz, <span>FTC</span> and <span>TDF</span>: 96‐week results from two randomized clinical trials Open
Objectives The single‐tablet regimen rilpivirine, emtricitabine and tenofovir alafenamide ( RPV / FTC / TAF ) for treatment of HIV ‐1‐infected adults was approved based on bioequivalence. We assessed the clinical efficacy, safety and toler…
View article: Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies
Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies Open
Oritavancin is a lipoglycopeptide with bactericidal activity against Gram-positive organisms. Its rapid concentration-dependent bactericidal activity and long elimination half-life allow single-dose treatment of acute bacterial skin and sk…
View article: Pharmacokinetics, Antiviral Activity, and Safety of Rilpivirine in Pregnant Women with HIV-1 Infection: Results of a Phase 3b, Multicenter, Open-Label Study
Pharmacokinetics, Antiviral Activity, and Safety of Rilpivirine in Pregnant Women with HIV-1 Infection: Results of a Phase 3b, Multicenter, Open-Label Study Open
Introduction Physiologic changes during pregnancy may impact the pharmacokinetics of drugs. In addition, efficacy and safety/tolerability concerns have been identified for some antiretroviral agents. Methods Human immunodeficiency virus (H…
View article: Brief Report
Brief Report Open
This open-label, multinational, pilot study randomized (1:2 ratio) adults with HIV-1 RNA <40 copies per milliliter and nucleos(t)ide-related safety/tolerability issues to switch to ritonavir-boosted atazanavir (ATV/r) plus tenofovir disopr…