Study APV20002: Safety and Efficacy Results Through Week 684 for Pediatric Participants Living with HIV-1 Treated with Ritonavir-Boosted Fosamprenavir Oral Solution-Based Antiretroviral Therapy.

APV20002 was a multicenter, international, open-label study that began in 2003 investigating the pharmacokinetics, efficacy, and safety of ritonavir-boosted fosamprenavir (FPV/r) oral solution (OS) in combination with nucleoside reverse transcriptase inhibitor-based antiretroviral therapy (ART) in participants living with HIV-1 aged 4 weeks to <2 years with a primary endpoint at Week 48 (48W). Participants in APV20002 could continue in the study post-48W until FPV OS was locally available in their countries. Children were required to discontinue after reaching >39 kg or if FPV OS had no clinical benefit.

Neonatal morbidity and mortality in birth centers in the United States 2018-2021: An observational study of low-risk birthing individuals.

Background: Many studies reporting neonatal outcomes in birth centers include births with risk factors not acceptable for birth center care using the evidence-based CABC criteria. Accurate comparisons of outcomes by birth setting for low-risk patients are needed.

Methods: Data from the public Natality Detailed File from 2018 to 2021 were used.

Distress, Social Support, and Self-Compassion: Relationships With Mental Health Among College Students.

This study investigated how distress, conceptualized as an interaction between hassles and stress perceptions, related to mental health, whether the type of distress (social or nonsocial) was consequential, and whether perceived support and self-compassion attenuated these relationships. Students ( = 185) from a mid-sized university in the southeast completed a survey. Survey questions pertained to hassles and stress perceptions, mental health (i.

Strong Start Innovation: Equitable Outcomes Across Public and Privately Insured Clients Receiving Birth Center Care.

Introduction: The Birth Center model of care is a health care delivery innovation in its fourth decade of demonstration across the United States. The purpose of this research was to evaluate the model's potential for decreasing poverty-related health disparities among childbearing families.

Methods: Between 2013 and 2017, 26,259 childbearing people received care within the 45 Center for Medicare and Medicaid Innovation Strong Start birth center sites.

Family Unpredictability and Sense of Coherence: Relationships With Anxiety and Depression in Two Samples.

Sense of coherence (SOC) refers to beliefs about how comprehensible, manageable, and meaningful one's life is. We investigated how SOC relates to family of origin unpredictability and psychological functioning in two samples. College students (=172, 78% female; =18.

Salary and Workload of Midwives Across Birth Center Practice Types and State Regulatory Structures.

Introduction: Expansion of the midwifery-led birth center model of care is one pathway to improving maternal and newborn health. There are a variety of practice types among birth centers and a range of state regulatory structures of midwifery practice across the United States. This study investigated how those variations relate to pay and workload for midwives at birth centers.

Humility, Personality, and Psychological Functioning.

As part of the shift to a more positive psychology, researchers have demonstrated a relatively new and intense fascination with humility. Following a discussion of this construct and its correlates, we investigate how humility relates to personality dimensions, anxiety and depression, love of life and happiness, and self-efficacy in two samples-college students and adult Mturk workers. In both studies, we used the Dual Dimension Humility Scale, a measure that does not conflate the construct with honesty.

A Case of Brainstem Anesthesia after Retrobulbar Block for Globe Rupture Repair.

Purpose: To present a rare case of brainstem anesthesia from retrobulbar block and discuss evidence-based methods for reducing the incidence of this complication.

Case: A 72-year-old female, was given a retrobulbar block of 5 mL of bupivacaine 0.5% for postoperative pain management, after a globe rupture repair under general anesthesia.

Improving adult coping with social isolation during COVID-19 in the community through nurse-led patient-centered telehealth teaching and listening interventions.

Background: The coronavirus disease 2019 (COVID-19) pandemic led to social isolation which both threatens mental health and has been shown to increase the risk for early death by 50%, and to contribute to increased rates of heart disease, hypertension, stroke, and inflammation.

Local Problem: No identified special programs to address loneliness related to social isolation were in place. This project aimed to improve adult coping with COVID-19 in the community to 80% over 8 weeks.

Changes over time in creatinine clearance and comparison of emergent adverse events for HIV-positive adults receiving standard doses (300 mg/day) of lamivudine-containing antiretroviral therapy with baseline creatinine clearance of 30-49 vs ≥50 mL/min.

A retrospective analysis of the randomized controlled DART (Development of AntiRetroviral Therapy in Africa; ISRCTN13968779) trial in HIV-1-positive adults initiating antiretroviral therapy with co-formulated zidovudine/lamivudine plus either tenofovir, abacavir, or nevirapine was conducted to evaluate the safety of initiating standard lamivudine dosing in patients with impaired creatinine clearance (CLcr). Safety data collected through 96 weeks were analyzed after stratification by baseline CLcr (estimated using Cockcroft-Gault) of 30-49 mL/min (n = 168) versus ≥50 mL/min (n = 3,132) and treatment regimen. The Grade 3-4 adverse events (AEs) and serious AEs (for hematological, hepatic and gastrointestinal events), maximal toxicities for liver enzymes, serum creatinine and bilirubin and maximum treatment-emergent hematology toxicities were comparable for groups with baseline CLcr 30-49 versus CLcr≥50 mL/min.

Assessment of drug interaction potential between the HCV direct-acting antiviral agents elbasvir/grazoprevir and the HIV integrase inhibitors raltegravir and dolutegravir.

Background: Elbasvir/grazoprevir is a once-daily fixed-dose combination therapy for the treatment of chronic HCV infection, including HCV/HIV coinfection.

Objectives: To evaluate the pharmacokinetic interaction of elbasvir and grazoprevir with raltegravir or dolutegravir.

Methods: Three open-label trials in healthy adult participants were conducted.

Similar neurocognitive outcomes after 48 weeks in HIV-1-infected participants randomized to continue tenofovir/emtricitabine + atazanavir/ritonavir or simplify to abacavir/lamivudine + atazanavir.

Human immunodeficiency virus (HIV)-associated neurocognitive disorders can persist in many patients despite achieving viral suppression while on antiretroviral therapy (ART). Neurocognitive function over 48 weeks was evaluated using a Cogstate test battery assessing psychomotor function, attention, learning, and working memory in 293 HIV-1-infected, ART-experienced, and virologically suppressed adults. The ASSURE study randomized participants 1:2 to remain on tenofovir/emtricitabine (TDF/FTC) and ritonavir-boosted atazanavir (ATV/r) or simplify to abacavir/lamivudine + atazanavir (ABC/3TC + ATV).

Changes from 2000 to 2009 in the Prevalence of HIV-1 Containing Drug Resistance-Associated Mutations from Antiretroviral Therapy-Naive, HIV-1-Infected Patients in the United States.

Pre-existing HIV drug resistance can jeopardize first-line antiretroviral therapy (ART) success. Changes in the prevalence of drug resistance-associated mutations (DRMs) were analyzed from HIV-infected, ART-naive, U.S.

The genomic road to invasion-examining the similarities and differences in the genomes of associated oral pre-cancer and cancer samples.

Background: It is frequently assumed that pre-invasive lesions are simpler precursors of cancer and will contain a limited subset of the genomic changes seen in their associated invasive disease. Driver mutations are thought to occur early, but it is not known how many of these are present in pre-invasive lesions. These assumptions need to be tested with the increasing focus on both personalised cancer treatments and early detection methodologies.

Response by gender of HIV-1-infected subjects treated with abacavir/lamivudine plus atazanavir, with or without ritonavir, for 144 weeks.

Purpose: The 144-week results of the open-label, multicenter Atazanavir/Ritonavir Induction with Epzicom Study (ARIES) were stratified by gender to compare treatment responses.

Methods: A total of 369 HIV-infected, antiretroviral-naïve subjects receiving once-daily abacavir/lamivudine + atazanavir/ritonavir (ATV/r) whose HIV-1 RNA was <50 copies/mL by week 30 were randomized 1:1 at week 36 to maintain or discontinue ritonavir for 108 subsequent weeks. Between- and within-treatment gender-related efficacy and safety differences were analyzed.

HLA-B*57:01 allele prevalence in HIV-infected North American subjects and the impact of allele testing on the incidence of abacavir-associated hypersensitivity reaction in HLA-B*57:01-negative subjects.

Background: The presence of the HLA-B*57:01 allele in HIV-infected subjects is associated with a higher risk of abacavir-associated hypersensitivity reaction (ABC HSR). HLA-B*57:01 allele prevalence varies in different populations, but HLA-B*57:01 testing with immunological confirmation has had a negative predictive value for ABC HSR between 97 and 100%.

Methods: In the ASSURE study (EPZ113734), the HLA-B*57:01 prevalence in virologically suppressed, antiretroviral treatment-experienced, HIV-infected subjects from the United States, including Puerto Rico, was assessed.

A systematic multidisciplinary initiative for reducing the risk of complications in adult scoliosis surgery.

OBJECTIVE Systematic multidisciplinary approaches to improving quality and safety in complex surgical care have shown promise. Complication rates from complex spine surgery range from 10% to 90% for all surgeries, and the overall mortality rate is 1%-4%. These rates suggest the need for improved perioperative complex spine surgery processes designed to minimize risk and improve quality.

Use of Tablet Devices in the Management of Agitation Among Inpatients with Dementia: An Open-Label Study.

Objective: To investigate the feasibility, safety, and utility of tablet devices as novel nonpharmacologic tools in managing older psychiatric inpatients with agitation and dementia.

Methods: Thirty-six patients at a geriatric psychiatry inpatient unit were provided with tablets when agitated and used various apps on the tablet related to communication, games, music, web browser, and photography during their stay. Study staff documented the frequency, duration, and app usage history and rated the extent to which agitation improved after tablet use.

Scale of Unpredictability Beliefs: Reliability and Validity.

Experiencing unpredictability in the environment has a variety of negative outcomes. However, these are difficult to ascertain due to the lack of a psychometrically sound measure of unpredictability beliefs. This article summarizes the development of the Scale of Unpredictability Beliefs (SUB), which assesses perceptions about unpredictability in one's life, in other people, and in the world.

A Two-Way Steady-State Pharmacokinetic Interaction Study of Doravirine (MK-1439) and Dolutegravir.

Introduction: Doravirine, a non-nucleoside reverse-transcriptase inhibitor in development for the treatment of patients with human immunodeficiency virus-1 infection, has potential to be used concomitantly in antiretroviral therapy with dolutegravir, an integrase strand transfer inhibitor. The pharmacokinetic interactions between these drugs were therefore assessed.

Methods: Oral formulations of doravirine and dolutegravir were dosed both individually and concomitantly once daily in healthy adults.

No clinically significant pharmacokinetic interactions between dolutegravir and daclatasvir in healthy adult subjects.

Background: Daclatasvir (DCV) is an NS5A replication complex inhibitor recently approved for chronic hepatitis C virus treatment.

Methods: To assess drug interactions between the HIV integrase strand transfer inhibitor dolutegravir (DTG) and DCV, subjects were randomized into 1 of 2 sequences in an open-label, 3-period, crossover study. Subjects received either DTG 50 mg once daily or DCV 60 mg once daily for 5 days in periods 1 and 2 and DTG 50 mg plus DCV 60 mg once daily for 5 days in period 3, with no washout between periods 2 and 3.

Elucidating drivers of oral epithelial dysplasia formation and malignant transformation to cancer using RNAseq.

Oral squamous cell carcinoma (OSCC) is a prevalent cancer with poor prognosis. Most OSCC progresses via a non-malignant stage called dysplasia. Effective treatment of dysplasia prior to potential malignant transformation is an unmet clinical need.

Treatment-Emergent Mutations and Resistance in HIV-Infected Children Treated with Fosamprenavir-Containing Antiretroviral Regimens.

Treatment-emergent mutations and drug resistance were analyzed in virus from HIV-infected children meeting virologic failure (VF) criteria over 48 weeks following treatment with unboosted fosamprenavir or fosamprenavir/ritonavir-containing regimens in studies APV20002 and APV29005. Both antiretroviral therapy (ART)-naïve and ART-experienced patients were enrolled. Patients met VF criteria by either failing to suppress HIV-RNA to <400 copies/mL through week 24 or after confirmed viral rebound (≥400 copies/mL) anytime through week 48.