Coverage From ID Week 2020

Ken reports on medical innovations and advances in practice and edits presentations for news and professional education publications. He previously taught and mentored pharmacy and medical students, and provided and managed pharmacy care and drug information services. He regularly contributes to Contagion Live, HCP Live, Neurology Live, and Pain Medicine News.

Four months of treatment with a rifapentine-moxifloxacin based anti-tuberculosis regimen produced the same survival rate with absence of

at 12 months as the conventional half-year regimen with rifampin-based treatment, in a phase 3 

 evaluating rifapentine based regimens with and without the fluoroquinolone in over 2000 patients in 34 sites around the world.

Susan Dorman, MD, the Medical University of South Carolina, Charleston, and colleagues of the AIDS Clinical Trials Group and the Tuberculosis Trials Consortium conducted the trial comparing 2 rifapentine-based experimental regimens against conventional treatment in patients newly diagnosed with 

 not resistant to isoniazid, rifampin, or fluoroquinolones.

The participants were randomly assigned in equal numbers to receive either a conventional regimen consisting of rifampin, isoniazid, pyrazinamide and ethambutol; or with rifampin replaced with either rifapentine or with rifapentine and moxifloxacin.

The investigators chose rifapentine, a cyclopentyl derivative of rifampin, as an alternative to rifampin following preclinical models that suggest that increasing exposure to rifamycins could shorten the time course for treating tuberculosis.

, and its longer half-life makes the drug an attractive option for increasing the duration of exposure to rifamycins while maintaining the once-daily dosing schedule that facilitates the completion of treatment," Dorman and colleagues explained.

The investigators also noted evidence that moxifloxacin exerts activity against 

, and that its addition to anti-tuberculosis regimens has accelerated sputum-culture conversion to negative status, albeit without yet shortening the requirement for 6 months of treatment.

Rifapentine was administered at a daily dose of 1200mg and moxifloxacin 400mg daily; with other drugs administered at standard doses adjusted for body weight. The medications in each regimen were administered 7 days per week, with the study protocol specifying direct observation of medications being taken at least 5 days per week. As food affects the absorption of rifapentine and rifampin differently, rifapentine was administered within 1 hour after ingesting food, while rifampin was taken on an empty stomach.

Dorman and colleagues reported that 4 months of treatment with the rifapentine with moxifloxacin based regimen (but not without moxifloxacin) was noninferior (within margin of 6.6 percentage points) to 6 months of the conventional rifampin-based treatment.In the microbiologically eligible populations, 15.5% of those on the rifapentine with moxifloxacin based regimen had an unfavorable outcome, compared to 14.6% on the longer rifampin-based regimen. Adverse events of grade 3 or higher occurred in 18.8% of the riapentine with moxifloxacin group, and 19.3% of those receiving the rifampin-based treatment.

The results were welcomed in an accompanying editorial,

"Shortening the Short Course of Tuberculosis Treatment"

, by Valerie Mizrahi, PhD, Institute of Infectious Diseases and Molecular Medicine and the Department of Pathology, Wellcome Center for Infectious Diseases Research in Africa, University of Cape Town, Cape Town, South Africa, and Editor in Chief of 

Eric Rubin, MD, PhD, an infectious disease specialist.

"It was almost as though 6 months represented some strict limit—that is, until now," Mizrahi and Rubin enthused.

That this development has been long awaited is reflected in the years since Mizrahi's previous editorial in the 

"Shortening Treatment for Tuberculosis—Back to Basics,"

 in which she reviewed failure of 3 separate trials to achieve this outcome, and called for a closer look at the characteristics and potential susceptibility of 

Although they welcome the prospect of a shortened course of treatment, Mizrahi and Rubin offer some concerns about this regimen, including the need to take rifapentine after meals to maximize absorption. They also suggest that the conventional rifampin-based regimen has an advantage of comprising drugs that are not generally used for other infections.In addition to necessitating rapid drug-susceptibility testing for moxifloxacin, they note, the widespread use of the antibiotic for tuberculosis could promote resistance to fluoroquinolones in other bacteria.

"This trial does, however, establish an important principle: there is no magic 6 months of therapy," Mizrahi and Rubin declare.

"This trial not only proves that we can have a shorter short-course treatment, but also suggests that an even shorter short-course treatment might one day be feasible," they conclude.

Articles

Rifapentine-moxifloxacin based anti-tuberculosis regimen shortened the conventional six-month course of treatment to four.

New Anti-Tuberculosis Regimen Cures 2 Months Earlier

Brian P. Dunleavy has been covering health and medical research for more than 25 years, for United Press International and EverydayHealth.com, among other outlets. He is also the former editor of Infectious Disease Special Edition. In addition, he has written on other subjects for Biography.com, History.com, the 

, among others. He holds a master’s degree from the University of Missouri School of Journalism.

That researchers are still trying to work out the durability of immunity gleaned from prior SARS-CoV-2 infection some 15 months into the pandemic is a testament to the dynamic nature of the virus (and all viruses), as opposed to any shortcomings of studies to date.

So far, we have heard that prior infection itself provides immunity lasting for anywhere from 3 to 6 months—maybe more, maybe less. The duration of protection offered by currently available vaccines is, at this point, anyone’s guess.

One of the more recent attempts to quantify and qualified the immunity derived from SARS-CoV-2 antibodies comes in the form of a 

 authored by researchers from the Infectious Disease Clinical Research Program at the Uniformed Services University of the Health Sciences.

Among active-duty service members in the US military with confirmed COVID-19, 95% (183/192) of outpatients and 100% of inpatients (58/58) remained seropositive at 6 months, and 9 of 11 outpatients and 8 of 8 inpatients remained seropositive at 12 months after symptom onset. For all patients in the study, anti-SARS-CoV-2 binding-Immunoglobulin G (IgG) responses had a half-life of >1000 days following symptom onset, according to the researchers.

Generally, neutralizing antibodies levels (geometric mean titer: 378 in inpatients vs 83 in outpatients) and durability (65 in inpatients vs 33 in outpatients) were based on COVID-19 severity, the researchers said. However, notably, older patients generally had both higher IgG binding and neutralizing antibody there were “no significant relationships” between antibody responses and COVID-19 clinical outcomes, they said. All instances of seroreversion occurring 6 to 12 months following symptom onset involved outpatient participants <65 years old (median age: 30 years).

Although the findings suggest that humoral responses to SARS-CoV-2 infection are robust on “longer time-scales,” even following milder disease, “the magnitude and durability of the antibody response after natural infection was lower and more variable in younger participants who did not require hospitalization for COVID-19,” according to the researchers, who would not comment on their work while it is being evaluated for peer-reviewed publication.

Given these findings, in their concluding remarks, they noted that they “support vaccination against SARS-CoV-2 in all suitable populations, including those individuals that have recovered from natural infection.”

David O. Freedman, MD, Professor Emeritus of Infectious Diseases at the University of Alabama-Birmingham, agreed, although he emphasized that the study involved “military population, so the young folks are very fit, active-duty people and the older folks are still a selected group who were more fit than most to get into the military in their younger days.”

Still, “either older age or how severe your initial infection was predicts how long and strong your immune response is,” Freedman told 

. “Younger patients [seem to] lose antibodies at 1 year, which speaks to the need for vaccination in this population.”

Protection from “natural infection” may last longer in older adults, authors say.

Public Health Watch: Military Study Suggests SARS-CoV-2 Immunity May Last Up to 1 Year in Some

, joined the MJH Life Sciences team in November 2020. He graduated from William Paterson University with a degree in liberal studies, and concentrations in history and psychology. He enjoys film, reading, and pretending he is a good cook. Follow him on Twitter 

 has discovered that exercise may improve long lasting symptoms of 

 including respiratory symptoms, fatigue and cognition issues.

The research was conducted by investigators from the National Institute for Health Research (NIHR) Leicester Biomedical Research Center, which is a collaboration between Leicester's Hospitals, the University of Leicester and Loughborough University.

"We know that COVID-19 survivors present with a wide variety of symptoms and that a one-size-fits-all approach to managing these would not be appropriate,” Enya Daynes, a lead author on the study said. “However, there are some overlap between the needs of COVID-19 survivors and patients who have accessed pulmonary rehabilitation or other conditions, such as COPD. So, we modified our well-established PR course for COVID-19 survivors and measured their symptoms to assess whether the program could be of potential benefit.”

For the study, the team of investigators followed 30 patients who participated in a 6 week rehabilitation course, which included exercise classes 2 times a week. In the program, participants did aerobic exercises, strength training and educational discussions.

Of the participants, 87% were admitted to a hospital with a COVID-19 infection, with an average stay of 10 days. 14% required mechanical ventilation and were treated in an intensive care unit. 4 of the participants had a pre-existing respiratory condition, such as asthma or chronic obstructive pulmonary disease.

Findings from the study showed that participants had a statistically significant improvement in exercise capacity and an improvement in their overall wellbeing and cognition.

"There has been concern that rehabilitation may worsen or trigger symptoms of post-viral fatigue and that exercise therapy may exacerbate fatigue. The exercise element of this program is progressed by staff experienced in delivering pulmonary and cardiac rehabilitation programs in line with patient's symptoms throughout the program,” Sally Singh, a senior author on the study said. “Our results did not show that fatigue worsened among the group of patients on the study, and that many of their symptoms improved. This suggests an adapted pulmonary rehabilitation course can be part of a spectrum of patient-centered and holistic approaches to treating the many different presentations of lasting COVID symptoms."

Patients who completed a 6 week rehabilitation program showed statistically significant improvement in exercise capacity, overall wellbeing and cognition.

Exercise May Aid in Recovery of Long Lasting COVID-19 Symptoms

This week, the biotechnology company Novavax has announced that it has finalized an agreement with the vaccine alliance Gavi, for purchase of its recombinant protein-based COVID-19 vaccine candidate to the COVAX Facility.

COVAX is worldwide initiative aimed at equitable access to COVID-19 vaccines directed by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization.

As part of the agreement, Novavax will manufacture and distribute 350 million doses of its vaccine to countries who are participating in the alliance.

Under a separate agreement, the Serum Institute of India will manufacture and deliver the balance of the 1.1 billion doses of the Novavax vaccine.

"This is a tremendous opportunity to partner with global organizations focused on accelerating equitable access to safe and effective COVID-19 vaccines, particularly in countries where vaccination rates are currently low," President and Chief Executive Officer of Novavax Stanley C. Erck, said. "This arrangement is the culmination of a collaboration among CEPI, Gavi, Serum Institute and Novavax, who are partnering in our urgent mission to deliver significant amounts of vaccines to all countries, regardless of income level. Novavax thanks CEPI for its longstanding support and tireless work with Gavi as the curators of the COVAX Facility."

Novavax and The Serum Institute plan to deliver the doses during the third quarter of 2021. Additionally, Novavax has stated that they will deliver doses if the Serum Institute cannot deliver their expected doses.

"Today's agreement with Novavax marks a major step towards COVAX's objective of building the world's largest and most diverse portfolio of COVID-19 vaccines, and a major step towards our goal of delivering 2 billion doses of safe and effective vaccines in 2021," CEO of Gavi Seth Berkley, said. "Novavax' commitment not only to support COVAX directly, but also through technology transfer via other manufacturers, shines a light on the end-to-end nature of COVAX and the kind of collaboration needed to bring this pandemic under control."

Novavax plans to deliver approximately 350 million doses to COVAX during the third quarter of 2021.

Novavax and Gavi Announce Purchase Agreement for COVAX Facility

On Friday, the World Health Organization approved China’s Sinopharm 

 vaccine for emergency use, in an effort to aid many poorer nations who are currently undergoing surges of the pandemic and don’t have wide access to other vaccines.

The vaccine will now be included in WHO’s COVID-19 Vaccines Global Access (COVAX) initiative, a worldwide effort aimed at providing equitable access to vaccines.

Access to vaccines has been a running issue since the start of the COVID-19 pandemic, as richer countries with more resources have been hoarding doses.

Prior to the announcement, the WHO was granted access to Phase 3 clinical trial data of the vaccine to independently assess. Sinopharm has not yet released this data to the public.

 showing the vaccine to have a 79% efficacy against COVID-19.

The vaccine is the first from China to be deemed both safe and effective by the WHO.

Next week, access could improve even further as the WHO will consider another Chinese vaccine created by the company Sinovac.

“The situation right now is just so desperate for low- and lower-middle-income countries that any doses we can get out are worth mobilizing,” Andrea Taylor, a global data vaccine analyst at the Duke Global Health Institutesaid. “Having potentially two options coming from China could really change the landscape of what’s possible over the next few months.”

The vaccine will now be included in WHO’s COVAX initiative, which is providing greater and more equitable access to vaccines around the world.

China’s Sinopharm COVID-19 Vaccine Approved by WHO

Reaching a vaccination rate of 50% by July of 2021 could prevent 5.8 million cases and 215,790 hospitalizations.

High COVID-19 Vaccine Coverage by Summer Could Prevent Millions of Cases

. Prior to joining MJH Life Sciences in 2020, he has covered a variety of fields and markets including diabetes, oncology, ophthalmology, IT, travel, and local news. You can email him at 

The companies are seeking approval for anyone aged 16 and above.

Pfizer-BioNTech Applying for FDA BLA for Their COVID-19 Vaccine

Machine learning improves prediction of bacterial sepsis among immunocompromised recipients of stem cell transplant.

Machine Learning Improves Prediction of Sepsis after Stem Cell Transplant

Company plans to initiate a rolling submission for US Food and Drug Administration (FDA) Biologics License Application (BLA) this month for the vaccine.

Moderna COVID-19 Vaccine is 96% Efficacious in Pediatric Population

While the majority of COVID-19 patients made a full recovery, some still showed signs of reduced lung functioning during the study period.

One Third of Hospitalized COVID-19 Patients Have Changes in Lungs a Year After Infection

Niclosamide, a common therapy for tapeworm infestation, has shown in lab studies to be highly effective against SARS-CoV-2.

Long-Acting Injectable May be Potential Therapy for COVID-19

Moderna reports data demonstrating a single 50 µg shot of its mRNA-1273 or mRNA-1273.351 booster shot increased neutralizing titers against SARS-CoV-2, as well as the South African and Brazilian variants.  





COVID-19 Vaccine Booster Dose Increases Immune Response to SARS-CoV-2, 2 Variants 

Kevin Kunzmann is the managing editor for 

. Prior to joining parent company MJH Life Sciences in 2017, he worked as a health care and government reporter for The Pocono Record, and as a freelance writer for NJ Advance Media, The Express-Times, The Daily Journal, and more. He graduated from Rowan University with a degree in journalism in 2015. In his spare time, he enjoys reading, cooking, running his dog, and complaining about the Mets. Follow him on Twitter 

New real-world research suggest the vaccine may help provide control of the pandemic virus.

Pfizer-BioNTech COVID-19 Vaccine Significantly Prevents Infection, Severe Disease in Israel

Amongst HIV negative participants, the vaccine demonstrated a 51% efficaciousness against B.1.351.

Novavax Reports Effectiveness of its COVID-19 Vaccine Against South African Variant

As countries like India and those in South America continue to struggle, the loosening of protections will help in their fight against the virus.

Top Medical News

New Anti-Tuberculosis Regimen Cures 2 Months Earlier

Public Health Watch: Military Study Suggests SARS-CoV-2 Immunity May Last Up to 1 Year in Some

Exercise May Aid in Recovery of Long Lasting COVID-19 Symptoms

Novavax and Gavi Announce Purchase Agreement for COVAX Facility

China’s Sinopharm COVID-19 Vaccine Approved by WHO

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