Publications by authors named "Melanie Thompson"

Article Synopsis
  • - The text emphasizes that new antiretroviral drugs and formulations are continuously being developed for HIV prevention and treatment, highlighting the importance of updated strategies to manage the virus effectively.
  • - A panel of expert physician scientists has compiled updated recommendations for 2024 based on extensive literature reviews and data from scientific conferences, focusing on treatment protocols tailored to specific patient needs.
  • - Current recommendations advocate for antiretroviral therapy for all individuals with HIV, primarily using integrase strand transfer inhibitors, while also offering alternatives for those with unique circumstances, and suggesting both oral and injectable options for HIV prevention.
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Advances in antiretroviral therapy (ART) have made it possible for persons with human immunodeficiency virus (HIV) to live a lifespan approaching that of people without HIV, without progressing to AIDS or transmitting HIV to sexual partners or infants. There is, therefore, increasing emphasis on maintaining health throughout the lifespan. To receive optimal medical care and achieve desired outcomes, persons with HIV must be consistently engaged in care and able to access uninterrupted treatment, including ART.

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Objective: The purpose of this study was to examine the use of a nurse-driven plan to describe factors associated with delays in the 1st case on time start within the operating room.

Methods: A posttest-only quasi-experiment was conducted to examine the effect of designating specific time periods for steps in the preoperative process on 1st case operating delays. Rationale for delays was also examined.

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Article Synopsis
  • The US "Ending the HIV Epidemic" initiative targets four counties in the Atlanta area to significantly decrease HIV cases by 2030, necessitating a closer look at local resources and needs related to HIV services.
  • A mixed-methods study was conducted using 2021 data to identify disparities in HIV prevalence and service distribution, including an online survey of local health stakeholders to measure service availability and organizational readiness.
  • The results highlighted significant racial and geographic inequities, particularly in HIV testing and PrEP access, with several counties not prioritized by the initiative reporting high unmet needs for various HIV-related services.
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Importance: Recent advances in treatment and prevention of HIV warrant updated recommendations to guide optimal practice.

Objective: Based on a critical evaluation of new data, to provide clinicians with recommendations on use of antiretroviral drugs for the treatment and prevention of HIV, laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and new challenges in people with HIV, including COVID-19 and monkeypox virus infection.

Evidence Review: A panel of volunteer expert physician scientists were appointed to update the 2020 consensus recommendations.

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Background: Between May and November, 2022, global outbreaks of human monkeypox virus infection have been reported in more than 78 000 people worldwide, predominantly in men who have sex with men. We describe the epidemiological and clinical characteristics of monkeypox virus infection in cisgender (cis) and transgender (trans) women and non-binary individuals assigned female sex at birth to improve identification and understanding of risk factors.

Methods: International collaborators in geographical locations with high numbers of diagnoses of monkeypox virus infection were approached and invited to contribute data on women and non-binary individuals with confirmed monkeypox virus infection.

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Objectives: The aim of this study was to understand how demographic and treatment-related factors impact responses to fostemsavir-based regimens.

Design: BRIGHTE is an ongoing phase 3 study evaluating twice-daily fostemsavir 600 mg and optimized background therapy (OBT) in heavily treatment-experienced individuals failing antiretroviral therapy with limited treatment options (Randomized Cohort 1-2 and Nonrandomized Cohort 0 fully active antiretroviral classes).

Methods: Virologic response rates (HIV-1 RNA <40 copies/ml, Snapshot analysis) and CD4+ T-cell count increases in the Randomized Cohort were analysed by prespecified baseline characteristics (age, race, sex, region, HIV-1 RNA, CD4+ T-cell count) and viral susceptibility to OBT.

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Advances in antiretroviral therapy (ART) have made it possible for persons with human immunodeficiency virus (HIV) to live a near expected life span, without progressing to AIDS or transmitting HIV to sexual partners or infants. There is, therefore, increasing emphasis on maintaining health throughout the life span. To receive optimal medical care and achieve desired outcomes, persons with HIV must be consistently engaged in care and able to access uninterrupted treatment, including ART.

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Background: Fostemsavir, a prodrug of the first-in-class attachment inhibitor, temsavir, is indicated for heavily treatment-experienced individuals with multidrug-resistant HIV-1. We previously reported superior efficacy of fostemsavir versus placebo in the randomised cohort of the BRIGHTE study after 8-day functional monotherapy (primary endpoint); here we report planned interim analyses through week 96.

Methods: BRIGHTE (NCT02362503) is an ongoing multicentre, two-cohort, phase 3 trial, done at 108 centres in 22 countries.

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Importance: Data on the use of antiretroviral drugs, including new drugs and formulations, for the treatment and prevention of HIV infection continue to guide optimal practices.

Objective: To evaluate new data and incorporate them into current recommendations for initiating HIV therapy, monitoring individuals starting on therapy, changing regimens, preventing HIV infection for those at risk, and special considerations for older people with HIV.

Evidence Review: New evidence was collected since the previous International Antiviral (formerly AIDS) Society-USA recommendations in 2018, including data published or presented at peer-reviewed scientific conferences through August 22, 2020.

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Objective: To evaluate changes in weight and BMI in adults with HIV-1 at 1 and 2 years after starting an antiretroviral regimen that included doravirine, ritonavir-boosted darunavir, or efavirenz.

Design: Post-hoc analysis of pooled data from three randomized controlled trials.

Methods: We evaluated weight change from baseline, weight gain at least 10%, and increase in BMI after 48 and 96 weeks of treatment with doravirine, ritonavir-boosted darunavir, or efavirenz-based regimens.

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COVID-19 has caused devastating health consequences and social inequities globally and in the United States. Unfortunately, the US has not developed a comprehensive National COVID-19 Strategy. In this editorial, we briefly review lessons about the development, structure, implementation and evaluation of the National HIV/AIDS Strategy (NHAS) for the US, and use these lessons to inform an initial proposal for a timely, dynamic, evidence-based, participatory, comprehensive and impactful National COVID-19 Strategy.

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Background: Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention.

Methods: This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both.

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Article Synopsis
  • In a study analyzing the effectiveness and safety of two HIV treatment regimens over 144 weeks, a combination of bictegravir, emtricitabine, and tenofovir alafenamide was found to be as effective as a dolutegravir-based regimen for treatment-naive patients.
  • *The studies included 1,274 participants who were randomly assigned to receive either the bictegravir regimen or various dolutegravir regimens, with the primary endpoint showing non-inferiority at week 48.
  • *By week 144, the efficacy results showed that a high percentage of participants in both treatment groups maintained low plasma HIV-1 RNA levels, indicating continued effectiveness of the bictegravir regimen.*
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Background: People with human immunodeficiency virus (PWH) demonstrate increased atherosclerotic cardiovascular disease (ASCVD). Statins are being studied to prevent ASCVD in human immunodeficiency virus (HIV), but little is known regarding the effects of statins on a broad range of inflammatory and cardiovascular proteins in this population.

Methods: We used a highly specific discovery proteomic approach (Protein Extension Assay), to determine statin effects on over 350 plasma proteins in relevant ASCVD pathways among HIV and non-HIV groups.

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Background: Among some patients with human immunodeficiency virus type 1 (HIV-1) infection who have undergone multiple antiretroviral therapies and have limited options for treatment, new classes of antiretroviral drugs with novel mechanisms of action are needed. Fostemsavir is the prodrug of temsavir, a first-in-class investigational HIV-1 attachment inhibitor.

Methods: In this ongoing phase 3 trial in 23 countries, we enrolled patients with multidrug-resistant HIV-1 infection in two cohorts, according to their remaining treatment options.

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Purpose Of Review: Knowledge of HIV status is the gateway to HIV treatment and prevention, and optimizing this pillar is essential to bend the curve of the HIV epidemic toward zero new infections. This review will discuss the epidemiology of serostatus awareness, including disparities among key populations, and explore interventions and societal barriers.

Recent Findings: Rates of serostatus awareness have improved overall; however, progress is lagging in many regions, nations and populations, with substantial disparities seen among key populations.

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Background: The safety and efficacy of doravirine were compared with that of efavirenz as initial treatment of adults living with HIV-1 infection (NCT01632345).

Methods: A Phase IIb double-blind trial with participants stratified by screening HIV-1 RNA (≤ or >100,000 copies/ml) and randomized 1:1:1:1:1 to receive once-daily doravirine (25, 50, 100 or 200 mg) or efavirenz 600 mg (Part I) for up to 96 weeks, with open-label tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC). After dose selection at week 24, doravirine 100 mg was provided to participants receiving the other doses of doravirine and additional participants were randomized 1:1 to receive once-daily doravirine 100 mg or efavirenz 600 mg for 96 weeks with TDF/FTC (Part II).

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Background: A prespecified integrated safety analysis was conducted for 3 doravirine (DOR) double-blind trials (Phase IIb: P007 [NCT01632345]; Phase III: DRIVE-FORWARD [NCT02275780] and DRIVE-AHEAD [NCT02403674]).

Methods: DOR (100 mg) arms from these trials were compared with darunavir plus ritonavir (DRV+r) in DRIVE-FORWARD and efavirenz (EFV) in P007 and DRIVE-AHEAD. Background therapies were emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in P007; abacavir/lamivudine (ABC/3TC) or FTC/TDF in DRIVE-FORWARD; and 3TC/TDF for DOR and FTC/TDF for EFV in DRIVE-AHEAD.

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Article Synopsis
  • * It was a phase 3, randomized, double-blind trial conducted at 122 centers in nine countries with 631 HIV treatment-naive adults participating.
  • * Results indicated that both treatments were effective, with a focus on assessing the proportion of participants achieving an undetectable HIV viral load after 96 weeks, contributing valuable long-term data for future HIV treatment options.
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Background: People with HIV (PWH) demonstrate increased cardiovascular disease (CVD), due in part to increased immune activation, inflammation, and endothelial dysfunction.

Methods: In a randomized trial (INTREPID), 252 HIV-infected participants with dyslipidemia and no history of coronary artery disease were randomized (1:1) to pitavastatin 4 mg vs. pravastatin 40 mg for 52 weeks.

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Importance: Antiretroviral therapy (ART) is the cornerstone of prevention and management of HIV infection.

Objective: To evaluate new data and treatments and incorporate this information into updated recommendations for initiating therapy, monitoring individuals starting therapy, changing regimens, and preventing HIV infection for individuals at risk.

Evidence Review: New evidence collected since the International Antiviral Society-USA 2016 recommendations via monthly PubMed and EMBASE literature searches up to April 2018; data presented at peer-reviewed scientific conferences.

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