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Clinical Outcomes of Mpox Disease in Patients Treated with Tecovirimat

Leocadio, Ciarra; Garcia, Elizabeth; Lash, Maura; Berardi, Jonathan; Chan, Justin; Chasan, Rachel; Esquivel, Blanca; Foote, Mary; Glesby, Marshall J; Guerra, Amiyah; Harris, Alexander B; Knutsen, Dorothy; Mannheimer, Sharon; Mazo, Dana; McLean, Jacob; McPherson, Tristan; Meyerowitz, Eric; Mgbako, Ofole; Patel, Gopi; Pagán Pirallo, Patricia M; Radix, Asa E; Riska, Paul; Sayegh, Mark; Seifu, Leah; Shaw, Raphael; Zingman, Barry; Zomorodi, Rustin; Zucker, Jason; Wong, Marcia
BACKGROUND:There is emerging literature describing clinical characteristics and outcomes in patients with mpox treated with tecovirimat. METHODS:We analyzed retrospective deidentified data from healthcare systems in New York City with the highest number of tecovirimat prescriptions. Individuals with probable or confirmed mpox initiating tecovirimat from May-December 2022 were included. A chart abstraction instrument was used to extract demographic and clinical data from medical records. We examined factors associated with delay in treatment and hospitalization. RESULTS:A total of 708 individuals prescribed tecovirimat for mpox were included in the analysis; median age was 36 years (IQR 31-43); 566 (80%) were cisgender men who have sex with men; and 399 (56%) were living with HIV. Side effects (100, 14%) and severe adverse events (7, 1%) were rare. The most common long-term sequela was scarring (69, 10%). One hundred and one (14%) were hospitalized. Median time from symptom onset to treatment initiation was 8 days (IQR 6-11). Non-Hispanic Black patients had higher risk of initiating tecovirimat ≥8 days after symptom onset (relative risk [RR]=1.3, 95%CI: 1.2-1.7) and being hospitalized (adjusted relative risk [aRR]=2.2, 95%CI: 1.4-3.5) compared with Hispanic patients, after adjusting for HIV and insurance status. CONCLUSIONS:We described common reasons for tecovirimat initiation and hospitalization. There were racial inequities in hospitalization and treatment delays. More research and focused efforts to mitigate these inequities are needed. These findings may better inform decisions for treatment initiation and hospitalization for mpox.
PMID: 40974008
ISSN: 1537-6591
CID: 5935702

A Just Appraisal: Co-creating a New Health Equity Framework with Learners through Journal Club to Evaluate the Literature

Mgbako, Ofole; Gonzalez, Cristina M; Olagun-Samuel, Christine; Torres, Christian; Richardson, Safiya; Williams, Renee; Greene, Richard E; Ortiz, Robin
BACKGROUND:Health equity is receiving increased attention in medical education. However, guidance is often lacking on how to integrate health equity into routine medical education. Journal club presents an opportunity to deepen medical educators' and learners' understanding of health equity principles and use it as a lens through which to critically appraise the literature. AIM/OBJECTIVE:We present a health equity framework, iteratively co-created by faculty and learners, that can be applied in a journal club setting. SETTING/METHODS:Academic medical center in New York City, USA. PARTICIPANTS/METHODS:Faculty, residency program directors, medical students, and residents. PROGRAM DESCRIPTION/METHODS:Authors developed the health equity journal club framework during a medical student selective course. Learner and faculty applied the framework to journal club articles; their feedback informed revisions. Framework domains included authorship, ethics, methodology, language, peer review, and references. PROGRAM EVALUATION/RESULTS:Learner evaluations were overall positive, and 86% (n = 13) of responding residency program directors (n = 15) across 15 departments who were surveyed plan to use the framework moving forward. DISCUSSION/CONCLUSIONS:A health equity journal club framework applied to critical appraisal of the literature may facilitate health equity as a routine part of medical education. Co-creating the framework proved vital to inclusion of learner voices.
PMID: 40760378
ISSN: 1525-1497
CID: 5904892

Health insurance status and severe mpox disease outcomes among sexual minority men in NYC: a retrospective cohort study

Mgbako, Ofole; Castellano, Cecilia; Jano, Kathryn; Piccolo, Anthony Lo; DiLorenzo, Madeline A; Knutsen, Dorothy; Shah, Yusra; Pressley, Joyce C; Duncan, Dustin T; Felder, Jason; Mazo, Dana
BACKGROUND:The 2022-2023 global mpox outbreak predominantly affected sexual minority men, with notable racial/ethnic disparities in the USA. While the current literature has established the clinical predictors of severe mpox disease, little is known about the role of insurance status on clinical outcomes. We sought to characterize patients diagnosed with mpox in New York City (NYC) and examine associations between insurance status and mpox severity score (mpox-SS). METHODS:), prior vaccination with JYNNEOS or a smallpox vaccine, presence of a sexually transmitted infection (STI), and CDC Social Vulnerability Index. RESULTS:The mean age (SD) was 38.3 (10.2) years with 53 (37.1%) identifying as non-Hispanic White, 44 (30.8%) as Hispanic/Latino, and 30 (20.9%) as non-Hispanic Black. Over 90% were male sex at birth or identified as cisgender men and approximately 80% were sexual minority men. Ninety-six (67.1%) had private insurance, 6 (4.2%) Medicare, 35 (24.5%) Medicaid, and 4 were (2.8%) uninsured. Sixty-three (44.1%) had a confirmed HIV diagnosis, 25 (17.4%) patients had prior JYNNEOS vaccination, and 31 (21.7%) had a high-risk condition. Thirty-eight (26.6%) patients received tecovirimat; 21 (14.7%) patients were hospitalized, with 4 (2.8%) of those admitted to the ICU. The mean (SD) mpox-SS was 6.85 (3.36). In univariate analysis, lack of insurance or Medicaid status was associated significantly with more severe mpox-SS. Insurance status remained significant (p = 0.03) in multivariable models. CONCLUSIONS:Being uninsured or on Medicaid was significantly associated with a higher mpox-SS in this diverse cohort of predominantly cisgender sexual minority men in NYC. High-risk status and lack of prior vaccination were associated with higher mpox-SS. Further studies are needed to assess the relationship between insurance, delays in access to care, or other socioeconomic inequities with severe mpox to understand the inequities beyond insurance access to prevent disparities in future outbreaks.
PMCID:12239370
PMID: 40629412
ISSN: 1741-7015
CID: 5890732

The Role of the Multidisciplinary HIV Care Center in Mitigating Social Isolation Among Patients with HIV During the Early COVID-19 Pandemic

Mgbako, Ofole; Loughran, Claire; Vaughn, Michael P; Felder, Jason; Augustin, Ashley; Gordon, Peter; Remien, Robert H; Olender, Susan
As the COVID-19 pandemic began in 2020, significant public health mitigation efforts were vital to combat an unprecedented health crisis. These efforts, which involved social distancing and self-quarantine, likely worsened a public health crisis of social isolation and loneliness in the U.S., particularly among people with HIV (PWH). Multidisciplinary HIV care centers, which served as the main source of clinical care for PWH and in some cases the only point of social contact, faced evolving dynamics of in-person visits during the COVID-19 pandemic, as well as a shift to telehealth services. Using in-depth interviews, we explored the role that multidisciplinary HIV care centers and providers played in the experience of social isolation among PWH in New York City. We recruited participants (n = 30) from a multidisciplinary HIV care center in NYC between October 2020 and June 2021. We conducted semi-structured interviews to understand the specific domains of social isolation that were mitigated. In this cohort, the major theme that drove both in-person and telehealth care continuity was the strength of the patient-provider relationship. We found that participants saw members of the HIV care center as part of their social network, and providers served both as a source of emotional support and provided important social resources and benefits. Thus, in times of heightened social isolation, HIV care centers can play a critical role in providing social support in addition to clinical care.
PMID: 38856843
ISSN: 1573-3254
CID: 5668822

Severe Mpox Among People With Advanced Human Immunodeficiency Virus Receiving Prolonged Tecovirimat in New York City

Garcia, Elizabeth A; Foote, Mary M K; McPherson, Tristan D; Lash, Maura K; Bosompem, Amma N; Bouscaren, Alyssa; Chan, Justin; DiLorenzo, Madeline A; Feihel, Dennis; Fowler, Randal C; Gandhi, Vani; Jenny-Avital, Elizabeth R; Kopping, Erik J; Mazo, Dana; McLean, Jacob; Mgbako, Ofole; Sayegh, Mark N; Shaw, Raphael N; Su, Michelle; Meissner, Jeanne Sullivan; Wang, Jade C; Wen, Wendy; Winters, John C; Zeana, Cosmina B; Zucker, Jason; Wong, Marcia
Severe mpox has been observed in people with advanced human immunodeficiency virus (HIV). We describe clinical outcomes of 13 patients with advanced HIV (CD4 <200 cells/μL), severe mpox, and multiorgan involvement. Despite extended tecovirimat courses and additional agents, including vaccinia immune globulin, cidofovir, and brincidofovir, this group experienced prolonged hospitalizations and high mortality.
PMCID:11168585
PMID: 38868307
ISSN: 2328-8957
CID: 5668382

Acceptability and Feasibility of Providing Adherence Feedback Based on Tenofovir Diphosphate in Dried Blood Spots: Results from a Pilot Study Among Patients and Providers in Cape Town, South Africa

Ferraris, Christopher M; D'avanzo, Paul A; Jennings, Lauren; Robbins, Reuben N; Nguyen, Nadia; Leu, Cheng-Shiun; Dolezal, Curtis; Mgbako, Ofole; Hsiao, Nei-Yuan; Joska, John; Castillo-Mancilla, Jose R; Myer, Landon; Anderson, Peter L; Belaunzarán-Zamudio, Pablo F; Mellins, Claude A; Orrell, Catherine; Remien, Robert H
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) predict viral breakthrough, but their use remains understudied in real-world clinic settings. This pilot study examined acceptability, feasibility, and initial adherence outcomes of providing adherence feedback using TFV-DP concentrations on patient- and provider-levels in Cape Town, South Africa. We enrolled 60 persons with HIV (PWH) receiving tenofovir-containing ART attending a primary health clinic. They were randomized 1:1 to an intervention receiving TFV-DP concentration feedback by research staff vs. no feedback at monthly visits for 4 months. Acceptability among medical providers and level of clinical follow-up of TFV-DP results was examined. Patient acceptability was assessed descriptively. Mean electronic adherence (EA), as measured by WisePill device, and TFV-DP in DBS were compared between the two arms. All participants in the intervention group (100%) reported finding TFV-DP feedback helpful and 86% reported changing adherence behaviors. Medical providers indicated high acceptability of incorporating TFV-DP concentration feedback into the clinic, yet among 29 results < 1000 fmol/punch, only 2 were reviewed with no follow-up actions performed. In the intervention arm, mean TFV-DP concentrations were significantly higher (t = 2.5, p < .01) during follow-up and EA in upper quartile (96-100%) was greater compared to controls (x2 = 7.8, p ≤ .05). This study found high acceptability among patients for receiving adherence feedback based on TFV-DP concentrations. TFV-DP and EA data demonstrated greater adherence in the intervention group. Providers indicated high acceptability of incorporating TFV-DP feedback into the clinic, but few providers reviewed results, which could impact clinic-level feasibility.
PMID: 37043053
ISSN: 1573-3254
CID: 5590632

Implementation and early outcomes of a telehealth visit model to deliver tecovirimat for mpox infection in New York City

Chan, Justin; DiTullio, David J; Pagan Pirallo, Patricia; Foote, Mary; Knutsen, Dorothy; Kottkamp, Angelica Cifuentes; McPherson, Tristan D; Mukherjee, Vikramjit; Pitts, Robert; Wallach, Andrew; Wong, Marcia; Mazo, Dana; Mgbako, Ofole
The 2022 mpox outbreak in New York City posed challenges to rapidly scaling up treatment capacity. We describe a telehealth treatment model launched during this outbreak that facilitated healthcare provider treatment capacity, and was able to adhere to a Centers for Disease Control and Prevention (CDC)-sponsored expanded access investigational new drug (EA-IND) protocol for tecovirimat. Sixty-nine patients were evaluated and prescribed tecovirimat for mpox through telehealth visits at NYC Health + Hospitals/Bellevue and NYU Langone Health from June to August 2022. Thirty-two (46.4%) were previously diagnosed with HIV. Forty-four (63.8%) reported full recovery, with the remainder lost to follow-up. Most patients (n = 60, 87.0%) attended at least one follow-up visit (either in person or through telehealth) after starting treatment. We observed favorable treatment outcomes, with no serious adverse events, hospitalizations, or deaths related to mpox. While equitable access to telehealth remains a limitation that needs to be addressed, this telehealth model enabled a rapid scale-up of tecovirimat prescription during the mpox outbreak, and should be considered as an important tool used to respond to future infectious disease outbreaks.
PMID: 37632124
ISSN: 1758-1109
CID: 5598892

Comparing Predictive Ability of Two Objective Adherence Measures in a Community-Based Cohort on Antiretroviral Therapy in South Africa: Tenofovir Diphosphate Concentrations and Electronic Adherence Monitors

Jennings, Lauren; Ferraris, Christopher M; Castillo-Mancilla, Jose R; Robbins, Reuben N; Nguyen, Nadia; Leu, Cheng-Shiun; Dolezal, Curtis; Hsiao, Nei-Yuan; Mgbako, Ofole; Joska, John; Myer, Landon; Anderson, Peter L; Remien, Robert H; Orrell, Catherine
BACKGROUND:Electronic adherence (EA) and tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) are objective measures of antiretroviral therapy (ART) adherence. We characterized the association between these measures in a prospective cohort of persons with HIV (PWH) on ART. SETTING:Four primary health clinics in Cape Town, South Africa. METHODS:We enrolled 250 virally suppressed PWH receiving tenofovir-based ART. We collected EA data, monthly viral load, and TFV-DP in DBS for 12 months. We used logistic regression to estimate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) for future viral breakthrough (VB) (>400 copies/mL) for each adherence measure. Receiver operating characteristics (ROCs) provided the predictive power of these measures. RESULTS:Participants had a median (IQR) age of 34 (27-42); 78% were women. Twenty-one (8%) developed VB. Logistic regression showed that when percent EA and TFV-DP concentrations increased, the odds of VB decreased. This relationship was consistent at the time of VB (aOR of 0.41 [95% CI: 0.25 to 0.66] for TFV-DP and aOR of 0.64 [95% CI: 0.54 to 0.76] for EA) and for up to 2 months before VB. Both adherence measures predicted future VB at both 1 month and 2 months before viral load measurement. CONCLUSION:We established that 2 objective adherence measures, EA and TFV-DP in DBS, have a positive association with, and are both strongly predictive of, VB in a community-based South African cohort on ART. Future research is needed to determine the feasibility of implementing these adherence measures in resource-limited settings to facilitate adherence interventions.
PMCID:10287050
PMID: 36976520
ISSN: 1944-7884
CID: 5538132

An Equity-Focused Care Continuum Framework for Mpox and Future Infectious Disease Outbreaks: A Public Health of Consequence, July 2023 [Comment]

Pitts, Robert A; Cifuentes Kottkamp, Angelica; Mgbako, Ofole
PMID: 37285568
ISSN: 1541-0048
CID: 5541292

Critical Elements of an Mpox Vaccination Model at the Largest Public Health Hospital System in the United States

Piccolo, Anthony J Lo; Chan, Justin; Cohen, Gabriel M; Mgbako, Ofole; Pitts, Robert A; Postelnicu, Radu; Wallach, Andrew; Mukherjee, Vikramjit
In the spring of 2022, mpox spread to non-endemic countries, including the United States. In New York City (NYC), vaccine demand grew as quickly as case counts. With the leadership of the Regional Emerging Special Pathogens Treatment Center (RESPTC) at NYC Health and Hospitals/Bellevue (NYC H+H)-part of the largest public hospital system in the United States-an innovative vaccination model was established that overcame challenges involving health inequities, inadequate access, and lack of vaccine uptake, to successfully administer JYNNEOS vaccines to over 12,000 patients. Transmission has slowed since its peak in August 2022, which has been attributed to successful vaccination campaigns, infection-induced immunity, and behavioral changes among those at highest risk; however, a Centers for Disease Control and Prevention (CDC) assessment released on 4 April 2023 suggests jurisdictions with low vaccination levels (<35%) remain at risk for an mpox resurgence. Here, we summarize the critical aspects of our mpox vaccination model in NYC, which include integration into routine clinical care, prioritization of health equity, and reutilization of COVID-19 vaccination systems, to provide valuable insights for healthcare institutions as we move into the next stage of this ongoing outbreak.
PMCID:10385008
PMID: 37514954
ISSN: 2076-393x
CID: 5591792