The objective of this study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of hepatitis C treatment. A period of time without alerts will be compared to a period of time with alerts.

开始日期2023-01-16

申办/合作机构

Epividian, Inc.

[+1]

NCT05710120 / CompletedN/A

Hepatitis C Screening: HCV Risk Score Alerts in CHORUS™

The objective of this study is to evaluate whether alerts that identify patients without hepatitis C infection to healthcare providers and clinic staff can increase the uptake of screening for hepatitis C. A period of time without alerts will be compared to a period of time with alerts.

开始日期2023-01-16

申办/合作机构

Epividian, Inc.

[+1]

NCT05495204 / CompletedN/A

External Comparison of Effectiveness of Ibalizumab in Clinical Trials vs. Other HTE Regimens in OPERA

Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.

开始日期2022-08-05

申办/合作机构

Epividian, Inc.

[+1]

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0 项与 Epividian, Inc. 相关的专利（医药）

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项与 Epividian, Inc. 相关的文献（医药）

2024-07-01·AIDS Research and Human Retroviruses

Incident HIV-Associated Wasting/Low Weight Is Associated with Nearly Doubled Mortality Risk in the Modern ART Era

Article

作者: Wohlfeiler, Michael B ; Harbour, Michael ; Siddiqui, Javeed ; Fusco, Gregory P ; Hsu, Ricky K ; Fusco, Jennifer S ; Brunet, Laurence ; Hayward, Brooke ; Weber, Rachel Palmieri ; Phillips, Amy L

HIV-associated wasting (HIVAW) is an underappreciated AIDS-defining illness, despite highly effective antiretroviral therapy (ART). We (a) assessed the association between incident HIVAW/low weight and all-cause mortality and (b) described virologic outcomes after people with HIV (PWH) experienced HIVAW/low weight while on ART. In the Observational Pharmaco-Epidemiology Research & Analysis (OPERA^®) cohort, PWH without prior HIVAW/low weight who were active in care in 2016-2020 were followed through the first of the following censoring events: death, loss to follow-up, or study end (October 31, 2021). HIVAW/low weight was a diagnosis of wasting or low body mass index (BMI)/underweight or a BMI measurement <20 kg/m². Hazard ratios (HRs) and 95% confidence intervals (CIs) for the association between time-dependent HIVAW/low weight and mortality were estimated with extended Cox regression models. Over a median follow-up of 45 months (interquartile range: 27, 65), there were 4,755 (8%) cases of HIVAW/low weight and 1,354 (2%) deaths among 62,314 PWH. PWH who experienced HIVAW/low weight had a significantly higher risk of death than those who did not (HR: 1.96; 95% CI: 1.68, 2.27) after adjusting for age, race, ethnicity, and changes in viral load (VL) and Veterans Aging Cohort Study Mortality Index scores over follow-up. Among 4,572 PWH on ART at HIVAW/low weight, 68% were suppressed (VL of <200 copies/mL); subsequent virologic failure was uncommon (7%). Among viremic PWH, 70% and 60% achieved suppression and undetectability (VL of <50 copies/mL), respectively, over follow-up. HIVAW remains a challenge for some PWH. Particular attention needs to be paid to HIVAW/low weight and virologic control to restore health and potentially reduce the risk of death.

2023-12-01·AIDS Research and Human Retroviruses

Definition, Burden, and Predictors of HIV-Associated Wasting and Low Weight in the OPERA Cohort

Article

We aimed to describe the prevalence, incidence, and predictors of HIV-associated wasting (HIVAW)/low weight among people with HIV (PWH) in the United States. We conducted an observational, clinical cohort analysis, utilizing prospectively collected electronic health record data obtained from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA^®) cohort. HIVAW/low weight included a wasting or low body-mass index (BMI)/underweight diagnosis (ICD codes and title search) or BMI <20 kg/m². Prevalence was estimated among adult PWH in care from 2012 to 2015 and 2016 to 2020. Incidence from January 1, 2016, to October 31, 2021, was estimated using univariate Poisson regression among eligible PWH without prior HIVAW/low weight. Demographic and clinical predictors of incident HIVAW/low weight were included in multivariable logistic regression models, stratified by antiretroviral therapy (ART) experience. The period prevalence of HIVAW/low weight was 12% in both 2012-2015 and 2016-2020. Among 67,119 PWH without any prior HIVAW/low weight, 7% experienced incident HIVAW/low weight a median 64 months from HIV diagnosis. In multivariable regression models, similar predictor patterns were observed among ART-naïve and ART-experienced PWH without any prior HIVAW/low weight: lower odds of HIVAW/low weight with older age, female sex, Black race, and Hispanic ethnicity and higher odds with Medicaid. Notably, there was a dose-response relationship between increasing Veterans Aging Cohort Study Mortality Index scores and incident HIVAW/low weight in both groups. Wasting/low weight remains a challenge for PWH and may be underappreciated by providers. Advanced HIV and comorbidities significantly predict incident HIVAW/low weight. Increasing awareness of HIVAW, especially among frailer PWH, could improve the care of affected PWH.

2023-11-27·Open Forum Infectious Diseases

1608. Real-World Effectiveness of Long-Acting Cabotegravir + Rilpivirine in Virologically Suppressed Treatment-Experienced Individuals: Two Years of Data from the OPERA® Cohort

作者: van Wyk, Jean A ; Cochran, Quateka ; Vannappagari, Vani ; Wohlfeiler, Michael B ; Brunet, Laurence ; Fusco, Gregory P ; Fusco, Jennifer S ; Sridhar, Gayathri ; Hsu, Ricky K ; Sension, Michael

AbstractBackgroundCabotegravir + rilpivirine (CAB+RPV) injections, the first complete long-acting (LA) antiretroviral therapy (ART) regimen, was approved by the FDA in January 2021 for ART-experienced people with HIV (PWH) who are virologically suppressed (viral load [VL] < 50 copies/mL). We assessed the virologic effectiveness of CAB+RPV LA among ART-experienced individuals with VL < 50 copies/mL at initiation in the first 2 years of use in the OPERA® Cohort, stratified by body mass index (BMI).MethodsAll ART-experienced adults with VL< 50 copies/mL at initiation who received ≥ 1 CAB+RPV LA injection for the first time between 21Jan2021 and 28Feb2023 were followed until 25Mar2023. Individuals on either monthly or every 2-month injection schedules were included. Discontinuation was defined as a regimen switch or 2 consecutive missed injections. VLs were monitored from first injection until CAB+RPV discontinuation, death, or study end. Confirmed virologic failure (CVF) was defined as 2 consecutive VLs ≥ 200 copies/mL or 1 VL ≥ 200 copies/mL followed by discontinuation. Results were stratified by BMI at first injection (< 30 vs. ≥ 30 kg/m2).ResultsAll 1843 PWH who received CAB+RPV injections were ART-experienced at start and 1578 (86%) had VL < 50 copies/mL at initiation. Of the 1578 suppressed, 267 (17%) were women, 654 (41%) were Black, 451 (29%) were Hispanic, and 469 (30%) had a BMI of ≥ 30; median age was 40 (IQR: 32, 53) years (Table 1). Among those with CAB+RPV dose available, 1297 (84%) remained on CAB+RPV LA over a median follow-up of 7.4 (IQR: 3.9, 10.9) months at study end. Among 1323 with VLs after first injection, the last VL measured was < 200 copies/mL in 99% (n=1305) and < 50 copies/mL in 94% (n=1237) (Table 2); all follow-up VLs were < 200 copies/mL in 96% (n=1272), and < 50 copies/mL in 84% (n=1115). Regardless of BMI, virologic suppression was maintained by ≥ 98% of individuals and only 1% experienced CVF over follow-up (Table 2).ConclusionIn this real-world cohort of PWH in the United States who received CAB+RPV LA injections, observations from the first 2 years suggest that this regimen is effective among individuals virologically suppressed at initiation. Furthermore, the regimen is consistently effective among those with high BMI.DisclosuresMichael Sension, MD, Gilead: Advisor/Consultant|Gilead: Honoraria|Viiv: Advisor/Consultant|Viiv: Grant/Research Support|Viiv: Honoraria Ricky K. Hsu, MD, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Gilead Sciences: Honoraria|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Janssen: Honoraria|Merck: Advisor/Consultant|Merck: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Honoraria Jennifer S. Fusco, BS, Epividian, Inc.: Salary|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds Laurence Brunet, PhD, Epividian, Inc.: Salary|Epividian, Inc.: Stocks/Bonds Gayathri Sridhar, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Full Time Employee Vani Vannappagari, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee Jean A. van Wyk, MBChB, MFPM, ViiV Healthcare Ltd: Stocks/Bonds Michael B. Wohlfeiler, JD, MD, AAHIVS, ViiV Healthcare: Serves as a PI on clinical trials, but does not receive personal compensation for this work (it goes directly to AIDS Healthcare Foundation) Gregory P. Fusco, MD, MPH, Epividian, Inc.: Board Member|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds

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