Public Health

Taylor, P.C., Adams, A.C., Hufford, M.M., de la Torre, I., Winthrop, K. and Gottlieb, R.L. (2021). “Neutralizing monoclonal antibodies for treatment of COVID-19.” Nat Rev Immunol: 1-12.

Full text of this article.

Several neutralizing monoclonal antibodies (mAbs) to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed and are now under evaluation in clinical trials. With the US Food and Drug Administration recently granting emergency use authorizations for neutralizing mAbs in non-hospitalized patients with mild-to-moderate COVID-19, there is an urgent need to discuss the broader potential of these novel therapies and to develop strategies to deploy them effectively in clinical practice, given limited initial availability. Here, we review the precedent for passive immunization and lessons learned from using antibody therapies for viral infections such as respiratory syncytial virus, Ebola virus and SARS-CoV infections. We then focus on the deployment of convalescent plasma and neutralizing mAbs for treatment of SARS-CoV-2. We review specific clinical questions, including the rationale for stratification of patients, potential biomarkers, known risk factors and temporal considerations for optimal clinical use. To answer these questions, there is a need to understand factors such as the kinetics of viral load and its correlation with clinical outcomes, endogenous antibody responses, pharmacokinetic properties of neutralizing mAbs and the potential benefit of combining antibodies to defend against emerging viral variants.

McCullough, P.A. and Vijay, K. (2021). “SARS-CoV-2 infection and the COVID-19 pandemic: a call to action for therapy and interventions to resolve the crisis of hospitalization, death, and handle the aftermath.” Rev Cardiovasc Med 22(1): 9-10.

Full text of this article.

In this bold issue of Reviews in Cardiovascular Medicine, we present the most comprehensive and scalable early ambulatory treatment program for high-risk patients who have contracted SARS-CoV-2. No such published regimen has received so much acclaim and the concepts embodied in this paper have been responsible for saving hundreds of thousands of lives and sparing millions of hospitalization. Since it took months for the large body of information to congeal on the pathophysiology and rationale for treatment, we cannot go back in time and estimate avoidable losses [6]. Going forward, available sources of data from Zelenko and Procter, suggest available drugs used in combination can reduce hospitalizations and death by 85% and that no high-risk patient with COVID-19 should go untreated at home. Lack of home treatment can only lead to long durations of illness, more intense symptoms, and increases the risk of hospitalization, death, and potentially post-COVID-19 syndromes. At this point in time, there is no justification in any part of the world for denial of available, appropriately prescribed off label intracellular anti-infectives, corticosteroids/colchicine, and antithrombotics. [No abstract; excerpt from article].

Alshehri, A.M., Barner, J.C., Wong, S.L., Ibrahim, K.R. and Qureshi, S. (2021). “Perceptions among Muslims regarding fasting, medication use and provider engagement during Ramadan in the United States.” Int J Health Plann Manage Mar 12. [Epub ahead of print].

Full text of this article.

BACKGROUND: Muslims with chronic diseases tend to fast during Ramadan, although Islam allows them not to fast. Therefore, understanding their perceptions and how they manage their health, especially as a minority population, is very important. OBJECTIVE: To examine Muslims’ (1) perceptions of fasting exemptions, (2) medication usage behaviour, (3) perceptions of relationships with healthcare providers and (4) factors impacting health management during Ramadan. METHOD: This was a qualitative study employing four focus groups (two groups of women and two groups of men). Adult Muslims (aged 18 years or more) with chronic diseases were invited to participate. Participants were asked open-ended questions about their fasting ability, medication usage behaviours, healthcare access and collaboration with providers during Ramadan. Trained researchers conducted the focus groups interviews in both English and Arabic. Each focus group was recorded, and three investigators independently transcribed the data and extracted themes and categories. Coding terminology issues were resolved through discussion. RESULTS: Twenty-five Muslims with chronic diseases (e.g., diabetes, hypertension, renal failure and anaemia) participated. The most prominent themes/subthemes were as follows: (1) fasting exemption (e.g., uncontrolled medical conditions), (2) fasting nonexemption (e.g., controlled medical conditions), (3) nonoral medication use during Ramadan, (4) healthcare provider involvement during Ramadan, and (5) factors impacting health management during Ramadan. CONCLUSION: Muslim patients perceive fasting as an important religious practice, so they tend to self-modify their medication-taking behaviours. Educating pharmacists and other healthcare providers about Muslim culture, especially their strong desire to fast, may lead to Muslims better managing their medications and viewing pharmacists and other healthcare providers as knowledgeable healthcare providers.

Wolk, C.B., Alter, C.L., Kishton, R., Rado, J., Atlas, J.A., Press, M.J., Jordan, N., Grant, M., Livesey, C., Rosenthal, L.J. and Smith, J.D. (2021). “Improving Payment for Collaborative Mental Health Care in Primary Care.” Med Care 59(4): 324-326.

Full text of this article.

BACKGROUND: There is strong evidence supporting implementation of the Collaborative Care Model within primary care. Fee-for-service payment codes, published by Current Procedural Terminology in 2018, have made collaborative care separately reimbursable for the first time. These codes (ie, 99492-99494) reimburse for time spent per month by any member of the care team engaged in Collaborative Care, including behavioral care managers, primary care providers, and consulting psychiatrists. Time-based billing for these codes presents challenges for providers delivering Collaborative Care services. OBJECTIVES: Based on experience from multiple health care organizations, we reflect on these challenges and provide suggestions for implementation and future refinement of the codes. CONCLUSIONS: Further refinements to the codes are encouraged, including moving from a calendar month to a 30-day reimbursement cycle. In addition, we recommend payers adopt the new code proposed by the Centers for Medicare and Medicaid Services to account for smaller increments of time.

Lundgren, J.D., Grund, B., Barkauskas, C.E., Holland, T.L., Gottlieb, R.L., Sandkovsky, U., Brown, S.M., Knowlton, K.U., Self, W.H., Files, D.C., Jain, M.K., Benfield, T., Bowdish, M.E., Leshnower, B.G., Baker, J.V., Jensen, J.U., Gardner, E.M., Ginde, A.A., Harris, E.S., Johansen, I.S., Markowitz, N., Matthay, M.A., Østergaard, L., Chang, C.C., Davey, V.J., Goodman, A., Higgs, E.S., Murray, D.D., Murray, T.A., Paredes, R., Parmar, M.K.B., Phillips, A.N., Reilly, C., Sharma, S., Dewar, R.L., Teitelbaum, M., Wentworth, D., Cao, H., Klekotka, P., Babiker, A.G., Gelijns, A.C., Kan, V.L., Polizzotto, M.N., Thompson, B.T., Lane, H.C. and Neaton, J.D. (2020). “A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19.” N Engl J Med Dec 22;NEJMoa2033130. [Epub ahead of print].

Full text of this article.

BACKGROUND: LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19. METHODS: In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5. RESULTS: On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P = 0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47). CONCLUSIONS: Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.).