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1.
Trials ; 22(1): 931, 2021 Dec 18.
Article in English | MEDLINE | ID: covidwho-1765462

ABSTRACT

BACKGROUND: Second-line treatment of HIV-2 in resource-limited settings (RLS) is complicated by a lack of controlled trial data, limited availability of HIV-2-active antiretroviral drugs, and inadequate access to drug resistance testing. We conducted an implementation trial of a dried blood spot- (DBS) based, drug resistance genotype-informed antiretroviral therapy (ART) switching algorithm for HIV-2-infected patients in Senegal. METHODS: HIV-2-infected adults initiating or receiving ART through the Senegalese national AIDS program were invited to participate in this single-arm trial. DBS from participants with virologic failure (defined as viral load (VL) > 250 copies/mL after > 6 months on the current ART regimen) were shipped to Seattle for genotypic drug resistance testing. Participants with evidence of drug resistance in protease or reverse transcriptase were switched to new regimens according to a pre-specified algorithm. Participant clinical and immuno-virologic outcomes were assessed, as were implementation challenges. RESULTS: We enrolled 152 participants. Ten were initiating ART. The remainder were ART-experienced, with 91.0% virologically suppressed (< 50 copies/mL). Problems with viral load testing capability resulted in obtaining VL results for only 227 of 613 (37.0%) participant-visits. Six of 115 participants (5.2%) with VL available after > 6 months on current ART regimen experienced virologic failure, with per-protocol genotypic testing attempted. One additional test was performed for a participant with a VL of 222 copies/mL. Genotypes from three participants showed no evidence of major drug resistance mutations, two showed nucleoside reverse transcriptase inhibitor (NRTI) resistance, one showed both NRTI and protease inhibitor resistance, and one test failed. No integrase inhibitor resistance was observed. Five of six successfully-tested participants switched to the correct regimen or received additional adherence counseling according to the algorithm; the sixth was lost to follow-up. Follow-up VL testing was available for two participants; both of these were virally suppressed (< 10 copies/mL). The trial was terminated early due to the COVID-19 pandemic (which prevented further VL and genotypic testing), planned rollout of dolutegravir-based 1st-line ART, and funding. CONCLUSIONS: The RESIST-2 trial demonstrated that a DBS-based genotypic test can be used to help inform second-line ART decisions as part of a programmatic algorithm in RLS, albeit with significant implementation challenges. TRIAL REGISTRATION: ClinicalTrials.gov NCT03394196 . Registered on January 9, 2018.


Subject(s)
COVID-19 , HIV Infections , Drug Resistance , Genotype , HIV Infections/diagnosis , HIV Infections/drug therapy , HIV-2 , Humans , Pandemics , SARS-CoV-2 , Senegal
2.
Cancer Med ; 11(2): 530-538, 2022 01.
Article in English | MEDLINE | ID: covidwho-1606588

ABSTRACT

BACKGROUND: An ASCO taskforce comprised of representatives of oncology clinicians, the American Cancer Society National Lung Cancer Roundtable (NLCRT), LUNGevity, the GO2 Foundation for Lung Cancer, and the ROS1ders sought to: characterize U.S. oncologists' biomarker ordering and treatment practices for advanced non-small-cell lung cancer (NSCLC); ascertain barriers to biomarker testing; and understand the impact of delays on treatment decisions. METHODS: We deployed a survey to 2374 ASCO members, targeting U.S. thoracic and general oncologists. RESULTS: We analyzed 170 eligible responses. For non-squamous NSCLC, 97% of respondents reported ordering tests for EGFR, ALK, ROS1, and BRAF. Testing for MET, RET, and NTRK was reported to be higher among academic versus community providers and higher among thoracic oncologists than generalists. Most respondents considered 1 (46%) or 2 weeks (52%) an acceptable turnaround time, yet 37% usually waited three or more weeks to receive results. Respondents who waited ≥3 weeks were more likely to defer treatment until results were reviewed (63%). Community and generalist respondents who waited ≥3 weeks were more likely to initiate non-targeted treatment while awaiting results. Respondents <5 years out of training were more likely to cite their concerns about waiting for results as a reason for not ordering biomarker testing (42%, vs. 19% with ≥6 years of experience). CONCLUSIONS: Respondents reported high biomarker testing rates in patients with NSCLC. Treatment decisions were impacted by test turnaround time and associated with practice setting and physician specialization and experience.


Subject(s)
Biomarkers, Tumor , Carcinoma, Non-Small-Cell Lung/diagnosis , Clinical Decision-Making , Lung Neoplasms/diagnosis , Oncologists , Carcinoma, Non-Small-Cell Lung/therapy , Humans , Lung Neoplasms/therapy , Surveys and Questionnaires , United States
3.
Cancer ; 128(4): 737-745, 2022 02 15.
Article in English | MEDLINE | ID: covidwho-1505935

ABSTRACT

BACKGROUND: During the coronavirus disease 2019 pandemic, US unemployment rates rose to historic highs, and they remain nearly double those of prepandemic levels. Employers are the most common source of health insurance among nonelderly adults. Thus, job loss may lead to a loss of health insurance and reduce access to cancer screening. This study examined associations between unemployment, health insurance, and cancer screening to inform the pandemic's potential impacts on early cancer detection. METHODS: Up-to-date and past-year breast, cervical, colorectal, and prostate cancer screening prevalences were computed for nonelderly respondents (aged <65 years) with 2000-2018 National Health Interview Survey data. Multivariable logistic regression models with marginal probabilities were used to estimate unemployed-versus-employed unadjusted and adjusted prevalence ratios. RESULTS: Unemployed adults (2000-2018) were 4 times more likely to lack insurance than employed adults (41.4% vs 10.0%; P < .001). Unemployed adults had a significantly lower up-to-date prevalence of screening for cervical cancer (78.5% vs 86.2%; P < .001), breast cancer (67.8% vs 77.5%; P < .001), colorectal cancer (41.9 vs 48.5%; P < .001), and prostate cancer (25.4% vs 36.4%; P < .001). These differences were eliminated after accounting for health insurance coverage. CONCLUSIONS: Unemployment was adversely associated with up-to-date cancer screening, and this was fully explained by a lack of health insurance. Ensuring the continuation of health insurance coverage after job loss may mitigate the pandemic's economic distress and future economic downturns' impact on cancer screening.


Subject(s)
COVID-19 , Early Detection of Cancer , Insurance, Health , Unemployment , Adult , Early Detection of Cancer/statistics & numerical data , Health Services Accessibility , Humans , United States/epidemiology
5.
Prev Med ; 151: 106642, 2021 10.
Article in English | MEDLINE | ID: covidwho-1294330

ABSTRACT

Screening can decrease the burden of breast, cervical, and colorectal cancers. The COVID-19 pandemic led many countries to suspend cancer screening services as part of their response to the pandemic. The International Cancer Screening Network (ICSN) carried out an online survey to assess the effects of the first wave of the COVID-19 pandemic on cancer screening. A 33-item survey was distributed to 834 email addresses to gather information about settings and assess decision-making processes that led to cancer screening suspension. Information about communication, impact on resources, and patient follow-up was collected. Quantitative data was analyzed as frequencies overall and by setting, while a comment section under each survey item captured nuanced details. Responses were recategorized into 66 settings, representing 35 countries. Most settings suspended cancer screening services (n = 60, 90.9%) in March 2020 (n = 45, 68.2%), guided by a government decision (n = 51, 77.3%). Few settings made the decision whether to suspend services based on a preparedness plan (n = 17, 25.8%). In most settings, professionals were reassigned (n = 41, 62.1%) and infrastructure repurposed (n = 35, 53.0%). The first wave of the COVID-19 pandemic has had profound effects on cancer screening worldwide, including the suspension of services in almost all settings. Most settings were unprepared to deal with the scale of the pandemic but demonstrated flexibility in the response. These results contribute to inform, through experiences and lessons learned, the next steps for the global cancer screening community to further evaluate the impact of COVID-19 and prepare for future disruptions.


Subject(s)
COVID-19 , Neoplasms , Early Detection of Cancer , Humans , Neoplasms/diagnosis , Pandemics , SARS-CoV-2 , Surveys and Questionnaires
6.
Journal of the Endocrine Society ; 5(Supplement_1):A346-A346, 2021.
Article in English | PMC | ID: covidwho-1221792

ABSTRACT

Introduction: Evidence establishes that COVID-19 patients with DM2 are at increased risk for severe disease and worse outcomes. Peer reviewed data is sparse comparing glycemic control and clinical outcomes among COVID-19 patients with vs. without DM2, and thus we sought to address this gap. Methods: We selected patients at least 18 years old who expired or were discharged between March 16, 2020 through September 15, 2020. Principal analysis compared glycemic patterns among patients with DM2 vs. non-DM2. Median, coefficient of variation (CV), maximum and minimum glucose parameters were computed to characterize longitudinal glycemic patterns. Logistic regression modeling identified significant (p&lt;.05) associations between composite outcome vs. glycemic parameters and putative risks for progression to severe COVID-19. Receiver operating characteristic (ROC) curve identified cut points for glycemic parameters. Cox regression models were employed to control for significant confounders. Continuous data summarized as median was compared using Kruskal-Wallis test. Discrete data were compared with Pearson’s chi-square test. Two-tailed p&lt;.05 was significant. Results: Among 494 patients, 157 (32%) had DM2 with no intergroup differences in age (68 [56–79]), sex (52% male, 48% female), or race (68% Caucasian, 19% Other, 13% African American). Insulin was administered to DM2 (93%) and non-DM2 (54%) patients (p&lt;.0001). Comorbidities were more prevalent in DM2, including cardiovascular (68% vs. 54%, p=.003), renal (72% vs. 52%, p&lt;.0001) and obesity (51% vs. 38%, p&lt;.0001). Markers including D-dimer (0.98 [0.61–1.95] mg/L), lactate dehydrogenase (308 [230–392] U/L), ferritin (436 [174–856] ng/mL), and triglycerides (172 [109–239] mg/dL), were not different in DM2 vs. non-DM2 (p&gt;.05). CRP was greater in patients with (8.6 [3.6–14.6]) vs. without (6.1 [2.0–12.6]) DM2 (p=.005). Baseline glucose in DM2 (163 [121–253] mg/dL) vs. non-DM2 (107 [96–124] mg/dL) was significantly greater, with former an independent predictor of composite outcome (p=.0005). Cox modeling of other glucose parameters in DM2 vs. non-DM2 demonstrated various impact regarding risk for composite outcome including median (155 [128–209], p=.46) vs. (103 [94–118], p=.09);coefficient of variation (28 [19–38], p=.08) vs. (15 [9–20], p=.002);maximum (252 [187–362], p=.0005) vs. (129 [110–156], p=.002);and minimum (99 [79–128], p=.95) vs. (89 [81–98], p=.02). The unified baseline glucose cut point for composite outcome risk controlled for significant covariates was 138 gm/dL (p&lt;.0001), which included respectively 20% and 10% of patients with and without DM2. Conclusion: Glycemic dysregulation in COVID-19 patients is independently associated with ICU admission and/or hospital mortality. Presence of DM2 amplifies glycemic dysregulation, but risk stratification appears warranted in all COVID-19 patients.

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