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2.
JAMA ; 2022 Jan 14.
Article in English | MEDLINE | ID: covidwho-1625201
3.
Clin Infect Dis ; 2021 Feb 04.
Article in English | MEDLINE | ID: covidwho-1592484
4.
Clin Infect Dis ; 73(11): e4175-e4178, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1561500
5.
Ann Intern Med ; 174(7): 1037, 2021 07.
Article in English | MEDLINE | ID: covidwho-1526991

Subject(s)
COVID-19 , SARS-CoV-2 , Humans
6.
Clin Infect Dis ; 73(9): e3009-e3012, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1501016
7.
Clin Infect Dis ; 2021 Oct 20.
Article in English | MEDLINE | ID: covidwho-1475782

ABSTRACT

Despite the challenges of the pandemic, there has been substantial progress with COVID-19 therapies. Pivotal COVID-19 trials like SOLIDARITY, RECOVERY and ACCT-1 were rapidly conducted and data disseminated to support effective therapies.. However, critical shortcomings remain on trial conduct, dissemination and interpretation of study results, and regulatory guidance in pandemic settings. The lessons we learned have implications for both the current pandemic and future emerging infectious diseases. There is a need for establishing and standardizing clinical meaningful outcomes in therapeutic trials and for targeting defined populations and phenotypes that will most benefit from specific therapies. Standardized processes should be established for rapid and critical data review and dissemination to ensure scientific integrity. Clarity around the evidence standards needed for issuance of both Emergency Use Authorization (EUA) and Biologic License Application (BLA) should be established and an infrastructure for executing rapid trials in epidemic settings maintained.

8.
Clin Infect Dis ; 2021 Oct 20.
Article in English | MEDLINE | ID: covidwho-1475781

ABSTRACT

Given the urgent need for treatments during the COVID-19 pandemic, the US Food and Drug Administration (FDA) issued emergency use authorizations (EUAs) for multiple therapies. In several instances, however, these EUAs were issued before sufficient evidence of a given therapy's efficacy and safety were available, potentially promoting ineffective or even harmful therapies and undermining the generation of definitive evidence. We describe the strengths and weaknesses of the different therapeutic EUAs issued during this pandemic. We also contrast them to the vaccine EUAs and suggest a framework and criteria for an evidence-based, trustworthy, and publicly transparent therapeutic EUA process for future pandemics.

11.
South Afr J HIV Med ; 22(1): 1281, 2021.
Article in English | MEDLINE | ID: covidwho-1406830

ABSTRACT

In many ways, the coronavirus disease 2019 (COVID-19) pandemic mirrors the challenges, lessons and opportunities of the HIV pandemic. In this article, we argue that global pandemics such as COVID-19 and HIV require a global response. We highlight the HIV Online Provider Education (HOPE) programme as an example of the importance of global communication when combating a pandemic. From both the COVID-19 and HIV pandemics, we have learned that to optimise health worldwide, it is necessary to have effective and efficient means of swiftly sharing experiences, expertise, best practices and guidelines. To prepare for the next public health emergency, clinicians and researchers must put in place and promote effective programmes for global communication.

13.
Ann Intern Med ; 174(1): 69-79, 2021 01.
Article in English | MEDLINE | ID: covidwho-1067970

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the etiologic agent of coronavirus disease 2019 (COVID-19), has spread globally in a few short months. Substantial evidence now supports preliminary conclusions about transmission that can inform rational, evidence-based policies and reduce misinformation on this critical topic. This article presents a comprehensive review of the evidence on transmission of this virus. Although several experimental studies have cultured live virus from aerosols and surfaces hours after inoculation, the real-world studies that detect viral RNA in the environment report very low levels, and few have isolated viable virus. Strong evidence from case and cluster reports indicates that respiratory transmission is dominant, with proximity and ventilation being key determinants of transmission risk. In the few cases where direct contact or fomite transmission is presumed, respiratory transmission has not been completely excluded. Infectiousness peaks around a day before symptom onset and declines within a week of symptom onset, and no late linked transmissions (after a patient has had symptoms for about a week) have been documented. The virus has heterogeneous transmission dynamics: Most persons do not transmit virus, whereas some cause many secondary cases in transmission clusters called "superspreading events." Evidence-based policies and practices should incorporate the accumulating knowledge about transmission of SARS-CoV-2 to help educate the public and slow the spread of this virus.


Subject(s)
COVID-19/transmission , SARS-CoV-2/isolation & purification , Aerosols , Equipment Contamination , Fomites/virology , Humans , RNA, Viral/analysis , Risk Factors
14.
Clin Infect Dis ; 2021 Feb 04.
Article in English | MEDLINE | ID: covidwho-1066281
16.
JAMA ; 324(16): 1651-1669, 2020 10 27.
Article in English | MEDLINE | ID: covidwho-865967

ABSTRACT

Importance: Data on the use of antiretroviral drugs, including new drugs and formulations, for the treatment and prevention of HIV infection continue to guide optimal practices. Objective: To evaluate new data and incorporate them into current recommendations for initiating HIV therapy, monitoring individuals starting on therapy, changing regimens, preventing HIV infection for those at risk, and special considerations for older people with HIV. Evidence Review: New evidence was collected since the previous International Antiviral (formerly AIDS) Society-USA recommendations in 2018, including data published or presented at peer-reviewed scientific conferences through August 22, 2020. A volunteer panel of 15 experts in HIV research and patient care considered these data and updated previous recommendations. Findings: From 5316 citations about antiretroviral drugs identified, 549 were included to form the evidence basis for these recommendations. Antiretroviral therapy is recommended as soon as possible for all individuals with HIV who have detectable viremia. Most patients can start with a 3-drug regimen or now a 2-drug regimen, which includes an integrase strand transfer inhibitor. Effective options are available for patients who may be pregnant, those who have specific clinical conditions, such as kidney, liver, or cardiovascular disease, those who have opportunistic diseases, or those who have health care access issues. Recommended for the first time, a long-acting antiretroviral regimen injected once every 4 weeks for treatment or every 8 weeks pending approval by regulatory bodies and availability. For individuals at risk for HIV, preexposure prophylaxis with an oral regimen is recommended or, pending approval by regulatory bodies and availability, with a long-acting injection given every 8 weeks. Monitoring before and during therapy for effectiveness and safety is recommended. Switching therapy for virological failure is relatively rare at this time, and the recommendations for switching therapies for convenience and for other reasons are included. With the survival benefits provided by therapy, recommendations are made for older individuals with HIV. The current coronavirus disease 2019 pandemic poses particular challenges for HIV research, care, and efforts to end the HIV epidemic. Conclusion and Relevance: Advances in HIV prevention and management with antiretroviral drugs continue to improve clinical care and outcomes among individuals at risk for and with HIV.


Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/prevention & control , AIDS-Related Opportunistic Infections/drug therapy , Age Factors , Anti-Retroviral Agents/economics , Betacoronavirus , COVID-19 , Comorbidity , Coronavirus Infections/epidemiology , Drug Administration Schedule , Drug Costs , Drug Resistance, Viral/genetics , Drug Substitution/standards , Drug Therapy, Combination/methods , Female , HIV Infections/blood , HIV Infections/diagnosis , Humans , International Agencies , Male , Pandemics , Pneumonia, Viral/epidemiology , Polypharmacy , Pre-Exposure Prophylaxis/methods , Pregnancy , Pregnancy Complications, Infectious/drug therapy , RNA, Viral/blood , SARS-CoV-2 , Societies, Medical , United States , Viral Load/genetics
17.
AIDS ; 34(12): 1781-1787, 2020 10 01.
Article in English | MEDLINE | ID: covidwho-772526

ABSTRACT

BACKGROUND: Many people living with HIV (PLWH) have comorbidities which are risk factors for severe coronavirus disease 2019 (COVID-19) or have exposures that may lead to acquisition of severe acute respiratory distress syndrome coronavirus 2. There are few studies, however, on the demographics, comorbidities, clinical presentation, or outcomes of COVID-19 in people with HIV. OBJECTIVE: To evaluate risk factors, clinical manifestations, and outcomes in a large cohort of PLWH with COVID-19. METHODS: We systematically identified all PLWH who were diagnosed with COVID-19 at a large hospital from 3 March to 26 April 2020 during an outbreak in Massachusetts. We analyzed each of the cases to extract information including demographics, medical comorbidities, clinical presentation, and illness course after COVID-19 diagnosis. RESULTS: We describe a cohort of 36 PLWH with confirmed COVID-19 and another 11 patients with probable COVID-19. Almost 85% of PLWH with confirmed COVID-19 had a comorbidity associated with severe disease, including obesity, cardiovascular disease, or hypertension. Approximately 77% of PLWH with COVID-19 were non-Hispanic Black or Latinx whereas only 40% of the PLWH in our clinic were Black or Latinx. Nearly half of PLWH with COVID-19 had exposure to congregate settings. In addition to people with confirmed COVID-19, we identified another 11 individuals with probable COVID-19, almost all of whom had negative PCR testing. CONCLUSION: In the largest cohort to date of PLWH and confirmed COVID-19, almost all had a comorbidity associated with severe disease, highlighting the importance of non-HIV risk factors in this population. The racial disparities and frequent link to congregate settings in PLWH and COVID-19 need to be explored urgently.


Subject(s)
Coronavirus Infections/epidemiology , HIV Infections/epidemiology , Pneumonia, Viral/epidemiology , Adult , African Americans/statistics & numerical data , Aged , Betacoronavirus , COVID-19 , Cohort Studies , Comorbidity , Coronavirus Infections/ethnology , Cost of Illness , Female , HIV Infections/ethnology , Humans , Male , Massachusetts/epidemiology , Middle Aged , Pandemics , Pneumonia, Viral/ethnology , Risk Factors , SARS-CoV-2
18.
Clin Infect Dis ; 72(7): 1265-1267, 2021 04 08.
Article in English | MEDLINE | ID: covidwho-637619

ABSTRACT

Recently, results from at least six major randomized clinical trials studying management of COVID-19 have been announced via press release. Given the unique nature of the pandemic, results of such trials often have immediate and worldwide relevance. Yet, while press releases serve the important purpose of disseminating top-level results quickly, they are inherently limited in scope, and rarely include sufficient data to inform practice. Herein, we propose a minimum set of trial characteristics and results to be released simultaneously with clinical trial announcements. This practice will ensure data related to the management of COVID-19 can be used to appropriately impact care, while responding to the needs of diverse stakeholders in the scientific and publishing communities, as well as the public at large.


Subject(s)
COVID-19 , Pandemics , Humans , Pandemics/prevention & control , Publishing , Randomized Controlled Trials as Topic , SARS-CoV-2
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