Publications by authors named "Parul Patel"

Background: Modest weight and lipid changes have been observed in cabotegravir plus rilpivirine long-acting (CAB+RPV LA) Phase 3/3b studies. The SOLAR study included standardized evaluations of weight and metabolic changes in people living with HIV switching to CAB+RPV LA dosed every 2 months (Q2M) vs. continuing bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF).

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Lowering viral load during pregnancy is regarded as the most important method of reducing human immunodeficiency virus 1 (HIV-1) vertical transmission risk, and minimizing fetal exposure to drugs is a guiding principle during pregnancy. Dolutegravir/lamivudine (DTG/3TC) has demonstrated high efficacy, a high barrier to resistance, and a good safety profile in non-pregnant individuals; however, DTG/3TC is not recommended by perinatal HIV treatment guidelines for initial therapy in pregnant people living with HIV-1 because of limited data on use of the 2-drug regimen during pregnancy. Efficacy and pharmacokinetic data from pregnant individuals using DTG and/or 3TC are reviewed and used to extrapolate anticipated DTG/3TC efficacy in pregnancy.

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  • Taste dysfunction is a common symptom in individuals with long COVID, with 20-25% experiencing persistent issues, particularly with bitter taste perception.
  • The study found that people with long COVID had significantly lower levels of salivary gustin, a protein that affects taste, which correlated with a reduced ability to taste bitterness.
  • Sonic hedgehog (SHH) and other specific cell markers were identified in saliva, indicating potential mechanisms behind taste dysfunction in long COVID patients.
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  • This study (NCT05769764) focused on analyzing the expression of HER3 in non-small cell lung cancer (NSCLC) using archived tissue samples from patients with advanced stages of the disease.
  • Out of 203 samples evaluated, HER3 was found in 98.5%, showing high expression across different tumor types and regardless of previous treatments.
  • With a median H-score of 140 and 70.4% of samples showing high intensity (3+), the findings suggest that HER3-targeted therapies could be effective for a wide range of NSCLC patients.
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  • Cabotegravir plus rilpivirine (CAB + RPV) is an effective long-acting injectable treatment for maintaining HIV-1 virologic suppression, and this analysis looked at its effects based on participants' body mass index (BMI).
  • Data was collected from various trials over periods ranging from 48 to 152 weeks, focusing on virologic outcomes, confirmed failures, and safety across different BMI categories.
  • Results showed similar efficacy and tolerability for CAB + RPV LA in both lower and higher BMI groups, with high rates of HIV-1 RNA suppression and comparable safety profiles.
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Background: Mouse double minute-2 homolog (MDM2) plays a key role in downregulating p53 activity in hematologic malignancies, and its overexpression is associated with poor outcomes.

Methods: This phase 1 study assessed the safety and efficacy of different dosing regimens of the MDM2 inhibitor milademetan as monotherapy and in combination with azacitidine (AZA) in patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.

Results: Seventy-four patients (monotherapy, n = 57; milademetan-AZA combination, n = 17) were treated.

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  • - The study examines the safety and outcomes of a long-acting HIV treatment regimen, Cabotegravir (CAB) + Rilpivirine (RPV), focusing on injection site reactions (ISRs) experienced by participants across several trials.
  • - Analysis of injection techniques from healthcare providers revealed that practices such as slow injection speed and bringing the medication to room temperature helped minimize discomfort for patients during the injection process.
  • - Overall, the injections showed good tolerability, with most ISRs being mild to moderate and lasting only a few days, indicating that the CAB + RPV regimen is a viable option for long-term HIV maintenance therapy.
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Unlabelled: Long-acting cabotegravir is approved for pre-exposure prophylaxis and combination HIV treatment, both initiated with optional short-term oral lead-in (OLI). We evaluated the impact of OLI on long-acting cabotegravir pharmacokinetics. Cabotegravir plasma concentrations were compared between HIV-positive participants initiating injections with ( = 278) or without ( = 110) OLI in phase III treatment study FLAIR and in HIV-negative participants using OLI ( = 263) in pivotal pre-exposure prophylaxis studies HPTN 083 and HPTN 084.

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The virulence of methicillin-resistant (MRSA) and its potentially fatal outcome necessitate rapid and accurate detection of patients colonized with MRSA in healthcare settings. Using the BD Kiestra Total Lab Automation (TLA) System in conjunction with the MRSA Application (MRSA App), an imaging application that uses artificial intelligence to interpret colorimetric information (mauve-colored colonies) indicative of MRSA pathogen presence on CHROMagar chromogenic media, anterior nares specimens from three sites were evaluated for the presence of mauve-colored colonies. Results obtained with the MRSA App were compared to manual reading of agar plate images by proficient laboratory technologists.

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Introduction Dental therapists (DTs) are members of the dental team with a wide scope of practice, who support the provision of dental care to patient groups including those with vulnerabilities. One such group are older patients who are often unable to attend general dental practices to access their dental care. A domiciliary or 'home visit' may be required to deliver this care in a non-clinical setting.

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Objectives: Cabotegravir + rilpivirine (CAB + RPV) dosed monthly or every 2 months is the first complete long-acting (LA) regimen recommended by treatment guidelines for the maintenance of HIV-1 virological suppression. This post hoc analysis summarizes outcomes for Asian participants through week 96.

Methods: Data from Asian participants naive to CAB + RPV randomized to receive dosing every 4 weeks (Q4W) or every 8 weeks (Q8W) in the FLAIR (NCT02938520) and ATLAS-2M (NCT03299049) phase 3/3b studies were pooled.

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  • * This method improves patient satisfaction by reducing concerns about stigma, adherence anxiety, and the daily reminder of their status, as it's administered by healthcare professionals.
  • * The review provides practical guidance on starting the treatment, handling missed doses, and transitioning to other medications, with case scenarios to illustrate real-life situations faced by clinicians.
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Purpose: Human epidermal growth factor receptor 3 (HER3) is broadly expressed in breast cancer; high expression is associated with an adverse prognosis. Patritumab deruxtecan (HER3-DXd) is an investigational HER3-targeted antibody-drug conjugate that is being evaluated as a novel treatment in HER3-expressing advanced breast cancer in the U31402-A-J101 study.

Methods: Adults with disease progression on previous therapies were eligible.

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Currently, the capacity to provide buprenorphine treatment (BT) is not sufficient to treat the growing number of people in the United States with opioid use disorder (OUD). We sought to examine participant retention in care rates of primary care delivered BT programs and to describe factors associated with retention/attrition for participants receiving BT in this setting. A PRISMA-guided search of various databases was performed to identify the articles focusing on efficacy of BT treatment and OUD.

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Purpose: Patritumab deruxtecan, or HER3-DXd, is an antibody-drug conjugate consisting of a fully human monoclonal antibody to human epidermal growth factor receptor 3 (HER3) attached to a topoisomerase I inhibitor payload via a stable tetrapeptide-based cleavable linker. We assessed the efficacy and safety of HER3-DXd in patients with epidermal growth factor receptor ()-mutated non-small-cell lung cancer (NSCLC).

Methods: This phase II study (ClinicalTrials.

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  • Cabotegravir plus rilpivirine is the only approved long-acting treatment for HIV-1, administered every 2 months, and the SOLAR study compares its effectiveness to daily oral therapy with bictegravir, emtricitabine, and tenofovir alafenamide.
  • This phase 3b study involved 687 participants across 118 centers in 14 countries and aimed to assess if the long-acting regimen could maintain HIV virological suppression similarly to the daily regimen.
  • The study found that 67% of participants switched to long-acting therapy, demonstrating significant interest in alternatives to daily medications for maintaining HIV suppression.
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  • Expanded analysis of predictors of confirmed virologic failure (CVF) in 1651 participants taking cabotegravir + rilpivirine long-acting (CAB + RPV LA) included data beyond 48 weeks and considered various demographic and viral factors.
  • Results showed that 1.4% of participants experienced CVF, with risks increasing for those with mutations associated with rilpivirine resistance, specific HIV subtypes, and higher body mass index.
  • The study concluded that having two or more of these baseline factors has a significant impact on the risk of CVF, indicating the importance of these factors in effectively managing treatment with CAB + RPV LA.
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A pragmatic, multiphase prospective quality improvement initiative was performed to determine whether a positive displacement connector (PD) causes reduction of central line-associated bloodstream infection (CLABSI), occlusion, and catheter hub colonization when compared with a neutral displacement connector with alcohol disinfecting cap (AC). Patients with an active central vascular access device (CVAD) were enrolled March 2018 to February 2019 (P2) and compared to the prior year (P1). Two hospitals were randomized to use PD without AC (Hospital A) and with AC (Hospital B).

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Purpose: This study evaluated the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of milademetan, a small-molecule murine double minute-2 (MDM2) inhibitor, in patients with advanced cancers.

Patients And Methods: In this first-in-human phase I study, patients with advanced solid tumors or lymphomas received milademetan orally once daily as extended/continuous (days 1-21 or 1-28 every 28 days) or intermittent (days 1-7, or days 1-3 and 15-17 every 28 days) schedules. The primary objective was to determine the recommended phase II dose and schedule.

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Background: Increases in fatal synthetic opioid overdoses over the past 8 years have left states scrambling for effective means to curtail these deaths. Many states have implemented policies and increased service capacity to address this rise. To better understand the effectiveness of policy level interventions we estimated the impact of the presence of naloxone access laws (NALs) on synthetic opioid fatalities at the state level.

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  • Limited data on the effects of cabotegravir + rilpivirine (CAB + RPV) in pregnant women living with HIV showed 25 pregnancies after exposure, with diverse outcomes including 10 live births.
  • The study involved women who had taken CAB + RPV and then transitioned to other antiretroviral medications when they became pregnant, with ongoing monitoring of drug levels post-exposure.
  • Results indicated that drug concentrations during pregnancy were comparable to those in non-pregnant women, but there was one reported case of congenital anomaly among the live births, prompting further investigation into pregnancy safety and outcomes.
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  • - Cabotegravir + rilpivirine is a new long-acting antiretroviral therapy given monthly or every two months, but the COVID-19 pandemic disrupted many patients' clinic visits for injections.
  • - A study evaluated how well the treatment was maintained during the pandemic across various clinical trials, finding that 94% of participants continued their planned dosing without major issues despite some visits being affected.
  • - Most of the 130 affected participants switched to oral therapy to ensure continued treatment, with 98% maintaining effective viral suppression, highlighting the flexibility of the treatment approach during the pandemic.
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  • The study aimed to analyze the pharmacokinetics of cabotegravir, focusing on how different factors (both intrinsic and extrinsic) affect the drug's variability in the body using data from various clinical trials.
  • Researchers utilized advanced statistical tools like NONMEM and R to evaluate a large dataset of plasma concentrations from HIV-1-infected and uninfected subjects, testing different dosing methods and identifying trends related to demographics and health metrics.
  • The findings suggest a population pharmacokinetic model that can guide dosing strategies without necessitating adjustments based on individual factors like race or age, highlighting certain influences from smoking and body metrics on drug absorption and clearance.
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  • - A phase 3 study called FLAIR evaluated the effectiveness of switching HIV-1 suppressed participants from daily oral medication to long-acting intramuscular injections of cabotegravir plus rilpivirine over 124 weeks.
  • - Participants were randomly assigned to either continue with their standard oral therapy or switch to the long-acting regimen, with the option to choose a four-week oral lead-in before the first injection.
  • - Key outcomes measured included viral load levels, confirmed treatment failures, and overall safety, with results showing the non-inferiority of the new long-acting treatment compared to standard therapy.
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