Devi SenGupta
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View article: Predictors of virological outcomes after analytical interruption of antiretroviral therapy following immune interventions with HTI vaccines in early-treated people with HIV: a pooled analysis from the AELIX-002 and AELIX-003 clinical trials
Predictors of virological outcomes after analytical interruption of antiretroviral therapy following immune interventions with HTI vaccines in early-treated people with HIV: a pooled analysis from the AELIX-002 and AELIX-003 clinical trials Open
Randomized, placebo-controlled clinical trials (RCTs) incorporating analytical treatment interruptions (ATI) are the gold standard in HIV cure research. Two independent RCTs, AELIX-002 and AELIX-003, evaluated HTI immunogen-based vaccines …
View article: Combination immunotherapy induces post-intervention control of HIV
Combination immunotherapy induces post-intervention control of HIV Open
The identification of therapeutic strategies to induce sustained antiretroviral therapy (ART)-free control of HIV infection is a major priority. Combination immunotherapy including HIV vaccination, immune stimulation/latency reversal, and …
View article: Safety, immunogenicity and effect on viral rebound of HTI vaccines combined with a TLR7 agonist in early-treated HIV-1 infection: a randomized, placebo-controlled phase 2a trial
Safety, immunogenicity and effect on viral rebound of HTI vaccines combined with a TLR7 agonist in early-treated HIV-1 infection: a randomized, placebo-controlled phase 2a trial Open
Building on results from the AELIX-002 trial with HIVACAT T-cell immunogen (HTI)-based vaccines, the AELIX-003 (NCT04364035) trial tested the safety of the combination of ChAdOx1.HTI (C) and MVA.HTI (M), with the TLR7 agonist vesatolimod (…
View article: Differential shaping of T cell responses elicited by heterologous ChAd68/self-amplifying mRNA SIV vaccine in macaques in combination with αCTLA4, αPD-1, or FLT3R agonist
Differential shaping of T cell responses elicited by heterologous ChAd68/self-amplifying mRNA SIV vaccine in macaques in combination with αCTLA4, αPD-1, or FLT3R agonist Open
While therapeutic vaccines are a promising strategy for inducing human immunodeficiency virus (HIV) control, HIV vaccines tested to date have offered limited benefit to people living with HIV. The barriers to success may include the use of…
View article: Early Viral Dynamics Predict Human Immunodeficiency Virus Posttreatment Control After Analytic Treatment Interruption
Early Viral Dynamics Predict Human Immunodeficiency Virus Posttreatment Control After Analytic Treatment Interruption Open
Background A key research priority for developing a human immunodeficiency virus (HIV) cure strategy is to define the viral dynamics and biomarkers associated with sustained posttreatment control. The ability to predict the likelihood of s…
View article: Time to HIV viral rebound and frequency of post-treatment control after analytical interruption of antiretroviral therapy: An individual data-based meta-analysis of 24 prospective studies
Time to HIV viral rebound and frequency of post-treatment control after analytical interruption of antiretroviral therapy: An individual data-based meta-analysis of 24 prospective studies Open
Background: There is a global need to explore novel interventions conferring sustained HIV control without antiretroviral therapy (ART). The only current strategy to test efficacy is through an analytical treatment interruption (ATI). Incl…
View article: A Pooled Analysis of Eight Clinical Studies Suggests a Link Between Influenza-Like Symptoms and Pharmacodynamics of the Toll-Like Receptor-7 Agonist Vesatolimod
A Pooled Analysis of Eight Clinical Studies Suggests a Link Between Influenza-Like Symptoms and Pharmacodynamics of the Toll-Like Receptor-7 Agonist Vesatolimod Open
Flu-like AEIs associated with vesatolimod administration were typically mild but increased with exposure, which may be predicted by the response to initial doses. The data suggest that adaptive clinical monitoring could help maximize pharm…
View article: Circulating immune and plasma biomarkers of time to HIV rebound in HIV controllers treated with vesatolimod
Circulating immune and plasma biomarkers of time to HIV rebound in HIV controllers treated with vesatolimod Open
Background Antiretroviral therapy (ART) for HIV-1 treatment has improved lifespan but requires lifelong adherence for people living with HIV (PLWH), highlighting the need for a cure. Evaluation of potential cure strategies requires analyti…
View article: HIV rebound in HIV controllers is associated with a specific fecal microbiome profile
HIV rebound in HIV controllers is associated with a specific fecal microbiome profile Open
HIV infection is associated with gut dysbiosis, and microbiome variability may affect HIV control when antiretroviral therapy (ART) is stopped. The TLR7 agonist, vesatolimod, was previously associated with a modest delay in viral rebound f…
View article: Multi-stakeholder consensus on a target product profile for an HIV cure
Multi-stakeholder consensus on a target product profile for an HIV cure Open
Developing a cure for HIV is a global priority. Target product profiles are a tool commonly used throughout the drug development process to align interested parties around a clear set of goals or requirements for a potential product. Three…
View article: Vesatolimod, a Toll-like Receptor 7 Agonist, Induces Immune Activation in Virally Suppressed Adults Living With Human Immunodeficiency Virus–1
Vesatolimod, a Toll-like Receptor 7 Agonist, Induces Immune Activation in Virally Suppressed Adults Living With Human Immunodeficiency Virus–1 Open
Background Treatment with vesatolimod, an investigational, oral, toll-like receptor 7 (TLR7) agonist, leads to sustained viral remission in some non-human primates when combined with anti-envelope antibodies or therapeutic vaccines. We rep…
View article: 548. Baseline characteristics associated with clinical improvement and mortality in hospitalized patients with moderate COVID-19
548. Baseline characteristics associated with clinical improvement and mortality in hospitalized patients with moderate COVID-19 Open
Background Remdesivir (RDV) has been shown to shorten recovery time and was well tolerated in patients with severe COVID-19. Here we report baseline characteristics associated with clinical improvement at day (d) 14. Methods We enrolled ho…
View article: 557. Impact of Concomitant Hydroxychloroquine Use on Safety and Efficacy of Remdesivir in Moderate COVID-19 Patients
557. Impact of Concomitant Hydroxychloroquine Use on Safety and Efficacy of Remdesivir in Moderate COVID-19 Patients Open
Background Remdesivir (RDV) has been shown to shorten recovery time and was well tolerated in patients with severe COVID-19. Hydroxychloroquine (HQN) is an experimental treatment for COVID-19. Effects of coadministration of HQN with RDV ha…
View article: 72. Remdesivir vs Standard Care in Patients with Moderate covid-19
72. Remdesivir vs Standard Care in Patients with Moderate covid-19 Open
Background Remdesivir (RDV) shortens time to recovery time in patients with severe COVID-19. Its effect in patients with moderate COVID-19 remains unclear. Methods We conducted an open-label, phase 3 trial (NCT04252664) involving hospitali…
View article: 561. Safety of Remdesivir vs Standard Care in Patients with Moderate Covid-19
561. Safety of Remdesivir vs Standard Care in Patients with Moderate Covid-19 Open
Background Remdesivir (RDV) has been shown to shorten recovery time and was well tolerated in patients with severe COVID-19. Here we report safety of RDV in patients with moderate COVID-19. Methods We conducted an open-label, phase 3 trial…
View article: 73. Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated with Remdesivir
73. Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated with Remdesivir Open
Background Remdesivir (RDV), a RNA polymerase inhibitor with potent in vitro activity against SARS-CoV-2, is the only treatment with demonstrated efficacy in shortening the duration of COVID-19. Here we report regional differences in clini…
View article: Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19
Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19 Open
ClinicalTrials.gov Identifier: NCT04292730.
View article: Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: A pooled analysis of 26 clinical trials
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: A pooled analysis of 26 clinical trials Open
Objective:Compared with tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF) has been associated with improvement in markers of renal dysfunction in individual randomized trials; however, the comparative incidence of clinically…
View article: Remdesivir for 5 or 10 Days in Patients with Severe Covid-19
Remdesivir for 5 or 10 Days in Patients with Severe Covid-19 Open
In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit can…
View article: 2490. Longer-Term Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed Adults Living With HIV and End-Stage Renal Disease on Chronic Hemodialysis
2490. Longer-Term Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed Adults Living With HIV and End-Stage Renal Disease on Chronic Hemodialysis Open
Background HIV treatment for individuals with end-stage renal disease (ESRD) on hemodialysis (HD) has previously required complex dose-adjusted regimens. We evaluated the safety and efficacy of single-tablet, once-daily elvitegravir/cobici…
View article: Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate Open
These pooled data from 26 studies, with over 12 500 person-years of follow-up in children and adults, support the comparative renal safety of TAF over TDF.
View article: Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks
Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks Open
In clinical studies GS-US-380-1489 (study 1489) and GS-US-380-1490 (study 1490), bictegravir-emtricitabine-tenofovir alafenamide (B-F-TAF), dolutegravir-abacavir-lamivudine (DTG-ABC-3TC), and dolutegravir plus emtricitabine-tenofovir alafe…