Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.

BACKGROUND: Severe coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known. METHODS: We conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15. RESULTS: A total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003). CONCLUSIONS: Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).

Qualitative Evaluation of a Program to Integrate Hepatitis C Care Into HIV Care Inclusive of Task Shifting to Nonspecialist Providers.

The treatment and cure of hepatitis C (HCV) in people with HIV is particularly important as progression of their liver disease is quicker compared with those who have HCV monoinfection. Innovative approaches are needed to maximize access to curative HCV treatment. Integration of HCV care into HIV primary care with education and support of nonspecialist providers via telementoring offers a solution to specialist workforce shortages. Using focus group qualitative methodology, health care workers' perspectives regarding this approach, particularly with the Extension for Community Healthcare Outcomes (ECHO) telementoring model, were obtained and are described. Successful integration of HCV care into HIV primary care has demonstrated benefits to patients, including allowing them to remain in their medical home for care. Factors beyond disease that influence their health and wellbeing must also be considered.

Lack of virologic suppression is associated with lower HIV-related disclosure stigma in people living with HIV.

Stigma remains a leading barrier to HIV care. To determine the influence of disclosure stigma (DS), fear of disclosing one's serostatus, on virologic suppression, a cross-sectional study was performed at the largest publicly-funded HIV clinic in South Texas. A survey was administered to participants who were: ≥18 years old, living with HIV, and receiving antiretroviral therapy. Surveys included demographics, adherence questionnaire, and a validated HIV-stigma scale with DS as the sum of 10 items ranked 0-3, with score of 30 indicating highest stigma. The primary outcome was lack of virologic suppression (LOVS): most recent HIV-1 RNA > 20 copies/ml. A bivariate analyses examined predictors of DS, dichotomized at the median. Depression score, perceived stress, and lack of friend/family support were associated with DS. Logistic regression models examined the relationship between DS, as a continuous variable, and LOVS. For 275 participants (69% Hispanic), median DS score was 18.5. DS was significantly inversely associated with LOVS (aOR 0.94 per 1 scale point; CI 0.89, 0.99) after adjustment for age, gender/sexual orientation, race/ethnicity, and drug use. The unanticipated inverse association between DS and LOVS highlights the complexity of this relationship. However, the balance of data in this cohort demonstrate an overall negative impact of DS.

Low Adherence to Post Emergency Department Follow-Up Among Hypertensive Patients With Medical Insurance.

BACKGROUND: Improvement in hypertension control in the insured, adult population could improve morbidity and mortality associated with hypertension in the United States. The emergency department (ED) is a potential site of intervention, where individuals are diagnosed with asymptomatic hypertension and referred to primary care. OBJECTIVE: To inform intervention strategies, we identified risk factors of nonadherence to primary care follow-up among individuals aged 18-60 years with a primary discharge diagnosis of asymptomatic hypertension in the ED. METHODS: Data were obtained from a commercial claims database for January 2012-September 2015. A total of 84,929 individuals were included. Rate of nonadherence to primary care follow-up was determined for individuals billed for a primary discharge diagnosis of essential hypertension. Multivariate logistic regression was used to calculate adjusted odds ratios. The relationships between demographic and clinical variables with nonadherence to follow-up were assessed. RESULTS: Two-thirds of the study population did not adhere to follow-up within 30 days of ED discharge. Risk factors for nonadherence included no history of recent visit with primary care (odds ratio [OR] 1.87; 95% confidence interval [CI] 1.81-1.93) and multiple prior ED visits (OR 1.65; 95% CI 1.57-1.73). Protective characteristics included history of filling antihypertensive prescriptions in the last year (OR 0.42; 95% CI 0.40-0.43); or history of filling a 30-day antihypertensive prescription on day of diagnosis (OR 0.83; 95% CI 0.80-0.87). CONCLUSIONS: Individuals without a recent primary care visit or who visit the ED frequently are at higher risk of nonadherence to follow-up for hypertension, despite medical insurance. Insurance status may not overcome individual level barriers to follow-up.

Prescription Opioid Use is Associated with Virologic Failure in People Living with HIV.

Prescription opioid misuse is a rising epidemic in the U.S., and people living with HIV are at increased risk. We assessed the association between prescription opioid use and virologic failure in HIV+ patients in the South Texas HIV Cohort. We found prescription opioid use was significantly associated with virologic failure, after adjustment for age, race, gender, insurance status, years living with HIV, reported HIV risk factor, chronic hepatitis C virus infection, current substance abuse, and care engagement. These findings suggest that opioid analgesic use may have negative consequences beyond misuse in people living with HIV.

High priority for hepatitis C screening in safety net hospitals: Results from a prospective cohort of 4582 hospitalized baby boomers.

UNLABELLED: Low-income populations are disproportionately affected by hepatitis C virus (HCV) infection. Thus, implementing baby boomer screening (born 1945-1965) for HCV may be a high priority for safety net hospitals. We report the prevalence and predictors of HCV infection and advanced fibrosis or cirrhosis based on the Fibrosis-4 score plus imaging for a baby boomer cohort admitted to a safety net hospital over a 21-month interval with >9 months of follow-up. Anti-HCV antibody testing was performed for 4582, or 90%, of all never-screened patients, of whom 312 (6.7%) tested positive. Adjusted odds ratios of testing anti-HCV-positive were 2.66 for men versus women (P<0.001), 1.25 for uninsured versus insured (P=0.06), 0.70 for Hispanics versus non-Hispanic whites (P=0.005), and 0.93 per year of age (P<0.001). Among 287 patients tested for HCV RNA (91% of all anti-HCV-positive cases), 175 (61%) were viremic (3.8% overall prevalence in cohort), which was 5% less likely per year of age (P<0.03). Noninvasive staging of 148 (84.6%) chronic HCV patients identified advanced fibrosis or cirrhosis in 50 (33.8%), with higher adjusted odds ratios of 3.21 for Hispanics versus non-Hispanic whites/Asians (P=0.02) and 1.18 per year of age (P=0.001). Other factors associated with significantly higher adjusted odds ratios of advanced fibrosis or cirrhosis were alcohol abuse/dependence, obesity, and being uninsured. CONCLUSION: In this low-income, hospitalized cohort, 4% of 4582 screened baby boomers were diagnosed with chronic HCV, nearly twice the rate in the community; one-third had noninvasive testing that indicated advanced fibrosis or cirrhosis, which was significantly more likely for Hispanics, those of older age, those with obesity, those with alcohol abuse/dependence, and those who lacked insurance.

A Call for Youth Voice to Support Engagement in Care for 18- to 29-Year Olds Living with HIV in the US South.

Youth with HIV (YWH) face challenges in achieving viral suppression, particularly in the Southern United States, and welcome novel interventions responsive to community needs. The Theory of Planned Behavior (TPB) describes factors that influence behavior change, and the Positive Youth Development (PYD) supports youth-focused program design. We applied TPB and PYD to explore factors supporting care engagement and challenges for YWH in South Texas. We conducted 14 semi-structured interviews with YWH and 7 focus groups with 26 stakeholders informed by TPB, PYD, and themes from a youth advisory board (YAB). The research team and YAB reviewed emerging themes, and feedback-aided iterative revision of interview guides and codebook. Thematic analysis compared code families by respondent type, TPB, and PYD. All study methods were reviewed by the UT Health San Antonio and University Health Institutional Review Boards. Emerging themes associated with care engagement included: varied reactions to HIV diagnosis from acceptance to fear/grief; financial, insurance, and mental health challenges; history of trauma; high self-efficacy; desire for independence; and desire for engagement with clinic staff from their age group. Stakeholders perceived YWH lifestyle, including partying and substance use, as care barriers. In contrast, YWH viewed "partying" as an unwelcome stereotype, and barriers to care included multiple jobs and family responsibilities. Two key themes captured in PYD but not in TPB were the importance of youth voice in program design and structural barriers to care (e.g., insurance, transportation). Based on these findings, we provide critical and relevant guidance for those seeking to design more effective youth-centered HIV care engagement interventions. By considering the perspectives of YWH in program design and incorporating the PYD framework, stakeholders can better align with YWHs' desire for representation and agency. Our findings provide important and relevant guidance for those seeking to design more effective HIV care engagement interventions for YWH.

CROI 2023: Advances in Antiviral Therapy in HIV and Viral Hepatitis.

Several innovative methods were presented at the 2023 Conference on Retroviruses and Opportunistic Infections (CROI) targeting different aspects of the HIV care continuum to improve testing, linkage to care, and viral suppression. Some of these approaches were directed at more vulnerable groups, such as pregnant women, adolescents, and individuals who inject drugs. In contrast was the devastating impact of the COVID-19 pandemic, with negative outcomes on HIV viral load suppression and retention in care. Data were presented on hepatitis B virus (HBV) suppression showing that tenofovir alafenamide (TAF)/emtricitabine (FTC)/bictegravir (BIC) may be superior to tenofovir disoproxil fumarate/FTC plus dolutegravir in suppressing HBV in HIV/HBV-coinfected individuals. A pilot study examining a 4-week trial of direct-acting antiviral therapy to treat hepatitis C in recently infected individuals showed lower rates of sustained virologic response at 12 weeks than longer courses. Additional data were presented on the use of long-acting cabotegravir/rilpivirine, comparing this regimen with oral TAF/FTC/BIC and the use of long-acting cabotegravir/rilpivirine in those with viremia. Data were presented on a novel strategy of lenacapavir with 2 broadly neutralizing antibodies given every 6 months as maintenance antiretroviral therapy (ART). Data were presented on improving HIV care outcomes in adolescents, interventions to prevent mother-to-child transmission, and HIV reservoirs in children and adolescents. Data were also presented on interactions between ART and hormonal contraception, as well as ART-related weight gain and impact on pregnancy. A study examining BIC pharmacokinetics in pregnancy was presented, as well as retrospective data on outcomes of adolescents receiving TAF/FTC/BIC.

Who Is at Risk for New Hepatitis B Infections Among People With HIV?

Hepatitis B virus (HBV) increases morbidity and mortality among people with HIV (PWH). We retrospectively analyzed HBV incidence among 5785 PWH. Fourteen had newly positive hepatitis B s antigen (mean 5.2 person-years of follow-up, 46.4/100 000 infections/year). These data show gaps in HBV vaccination and in the preventative efficacy of HBV-specific antiretroviral therapy.