Asymptomatic COVID-19 Patients Left Viral RNA After Eye Exams

SARS-CoV-2 was detected on a minority of environmental samples from an exam room where asymptomatic patients underwent a routine ophthalmology exam, a small study from Turkey found.

Of the seven samples taken after examinations of patients who passed COVID-19 triage questions, two samples of seven — one from the slit lamp breath shield and one from the phoropter, tested positive for SARS-CoV-2, reported Hasan Aytoğan, MD, of İzmir Tepecik Training and Research Hospital in Turkey, and colleagues, writing in JAMA Ophthalmology.

However, the authors only measured detectable virus, and were unable to determine if it was infectious virus, they noted.

They examined two threads of research to conduct their study: how long the virus lasts on surfaces, as well as the role of asymptomatic transmission by looking at an examination day in an outpatient ophthalmology clinic “without interventions for patients who were asymptomatic.”

“Since we were examining patients who are asymptomatic during the pandemic, we wanted to know if we could detect COVID-19 viral material at the end of a day of examinations of patients who were asymptomatic and seen in an eye examination room,” they wrote.

The room was cleaned with a hydrogen peroxide solution and had no visitors for 18 hours after cleaning. Importantly, the authors noted the room was not cleaned between patients, but chin and forehead rests were wiped with isopropyl alcohol, 70%.

Researchers used real-time polymerase chain reaction (RT-PCR) testing to detect viral RNA in samples from the biomicroscope stage, slit lamp breath shield, phoropter, tonometer, and door handles.

A total of 31 people entered the exam room, including 22 patients who passed COVID-19 triage and nine companions. Mean examination time was about 9 minutes. Seven samples were taken prior to all examinations that day and seven samples were taken after the last patient left the room.

While all samples taken at the beginning of each visit were negative, two of seven were positive at the end of the day. The samples from the slit lamp breath shield and phoropter were within a few feet (within 1 meter) of the patient versus other zones that were further away.

Other than RT-PCR only measuring viral material, not infectious virus or even viral load, the authors also noted it was not known whether patients, companions, and healthcare workers developed symptoms.

Disclosures

The authors disclosed no conflicts of interest.

Primary Source

JAMA Ophthalmology

Source Reference: Aytoğan H, et al “Detection of coronavirus disease 2019 viral material on environmental surfaces of an ophthalmology examination room” JAMA Ophthalmol 2020; DOI: 10.1001/jamaophthalmol.2020.3154.

https://www.medpagetoday.com/infectiousdisease/covid19/87880

IL-1 Blockade: A Treatment at Last for Osteoarthritis?

The interleukin (IL)-1β inhibitor canakinumab (Ilaris) showed promise for preventing the need for hip or knee replacement among patients with osteoarthritis in an exploratory analysis of data from a randomized clinical trial, investigators reported.

Among patients enrolled in the Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS), the pooled incidence rate for total hip replacement/total knee replacement (THR/TKR) was 0.31 events per 100 person-years for those receiving the monoclonal antibody every 3 months for up to 5 years compared with 0.54 per 100 for those given placebo, according to Paul M. Ridker, MD, of Harvard Medical School in Boston, and colleagues.

Accordingly, the hazard ratio for THR/TKR with canakinumab treatment was 0.58 (95% CI 0.42-0.80, P=0.001), the researchers reported in Annals of Internal Medicine.

“The results of this exploratory trial are both unexpected and exciting,” stated Nancy Lane, MD, of University of California Davis Health, and David Felson, MD, of Boston University School of Medicine, in an editorial accompanying the study.

With the aging of the population, the prevalence of osteoarthritis has been on the rise in recent decades, but effective treatments have remained elusive.

The chronic joint inflammation associated with osteoarthritis typically is characterized by the presence of inflammatory mediators, including IL-1β, which can drive cartilage destruction through release of proteolytic enzymes. Whether targeting this cytokine could provide benefits in osteoarthritis has not been determined. Previous studies examining this possibility have been limited by short duration and a focus primarily on pain, and found no significant improvements.

To more fully explore the possibility that canakinumab might have structural-modifying rather than analgesic effects in osteoarthritis, Ridker and colleagues analyzed data from CANTOS, which included 10,061 patients with a history of myocardial infarction and elevated C-reactive protein (CRP), randomizing them to canakinumab in dosages of 50, 150, or 300 mg or placebo every 3 months. The study took place from 2011 to 2017 in 39 countries, and was sponsored by Novartis.

In the study’s main analysis, patients receiving the active treatment had fewer cardiovascular events but more serious infections and infection-related mortality. Canakinumab has therefore not been recommended for the secondary prevention of heart disease.

However, THR/TKR was considered a serious adverse event and was routinely reported, providing a large, long-term source of data on the effects of canakinumab on the most severe cases of osteoarthritis.

During a median follow-up of 3.7 years, the hazard ratios for THR/TKR compared with placebo for all three dose groups were reduced:

• 50 mg, HR 0.60 (95% CI 0.38-0.95)

• 150 mg, HR 0.53 (95% CI 0.33-0.84)

• 300 mg, HR 0.60 (95% CI 0.38-0.93)

Risks for THR/TKR also were reduced for both men (HR 0.54, 95% CI 0.36-0.81) and women (HR 0.66, 95% CI 0.38-1.12), the researchers reported.

In a subgroup analysis that excluded patients with gout or rheumatoid arthritis, similar significantly lower risks were again seen, and in a secondary analysis evaluating the effects of treatment on new or worsening arthritis symptoms, the incidence rates were 1.17 per 100 person-years in the pooled canakinumab groups compared with 1.63 per 100 in the placebo group (HR 0.73, 95% CI 0.61-0.87).

“These data thus provide support for the hypothesis that IL-1β inhibition might represent a novel pathway for future therapies targeting osteoarthritis,” Ridker and colleagues stated.

The finding that risk reductions were similar in the three dose groups suggests that the lower doses could provide similar efficacy while possibly minimizing risks, the researchers noted.

Limitations of the study, they said, included that CANTOS was not intended to evaluate canakinumab for osteoarthritis, so data on many aspects of the disease such as functional status and radiographic progression were not routinely collected. In addition, the number of women included was relatively small (approximately 25%), whereas knee osteoarthritis primarily afflicts older women.

In their editorial, Lane and Felson wrote, “Further studies should evaluate the importance of elevated CRP levels as a factor affecting response to treatment, include more women to better reflect the osteoarthritis population, explore how to minimize infections, and try to better define the duration of therapy needed to detect treatment effects.”

Disclosures

CANTOS was sponsored by Novartis.

The authors reported financial relationships with multiple companies, including Novartis, AbbVie, Bristol Myers Squibb, EMD Serono, Flexion, Galapagos, GlaxoSmithKline, Pfizer, Samumed, Stryker, Kowa, Amarin, Corvidia, Flame, Inflazome, Janssen, AstraZeneca, CiVi BioPharma, Livimplant, and Serenitas.

Felson reported having no potential conflicts of interest; Lane reported support from Novartis and the National Institutes of Health.

Primary Source

Annals of Internal Medicine

Source Reference: Schieker M, et al “Effects of interleukin-1β on incident hip and knee replacement: exploratory analyses from a randomized, double-blind, placebo-controlled trial” Ann Intern Med 2020; doi:10.7326/M20-0527.

Secondary Source

Annals of Internal Medicine

Source Reference: Lane N, Felson D “A promising treatment for osteoarthritis?” Ann Intern Med 2020; doi:10.7326/M20-4938.

https://www.medpagetoday.com/rheumatology/arthritis/87871

Ancestry relaunches DNA health offerings with Quest next-gen sequencing

The genomic family history company Ancestry is relaunching its health-focused service, using next-generation sequencing technology developed by Quest Diagnostics to provide customers with their risks of developing certain inheritable diseases.

The AncestryHealth program still plans to evaluate the genes behind different cancers, as well as heart disease and blood disorders, but with physician-ordered, next-generation sequencing tests replacing its previous microarray-based offerings.

This promises to be more accurate and provide more data by reading the portions of the genome typically left unanalyzed by microarrays—which have underpinned most consumer genetic testing products for the past several years, according to the company.

The upgrade can lead to higher detection rates for the risks of breast and ovarian cancer, for example, but they are not used as clinical diagnostic tests, nor have they been reviewed or approved by the FDA.

“As the market leader in consumer genomics for more than a decade, we are proud to make an important leap forward in democratizing access to comprehensive genetic health risk detection,” said Ancestry’s president and CEO, Margo Georgiadis.

“We are committed to our long-term vision of helping millions get on the path toward living longer, healthier lives through affordable personalized, preventive health screening in partnership with the healthcare ecosystem,” Georgiadis said.

In addition, AncestryHealth plans to provide remote access to genetic counselors, in partnership with PWNHealth, to add context to lab reports and provide resources for connecting consumers with providers for future healthcare decisions. It also aims to create a downloadable family health history record that can be delivered to clinicians and used to help fill out medical forms.

“This improvement in automating next generation sequencing will enable genetic screening faster and at much lower cost, and could have profound implications for healthcare in the future, truly empowering better health through actionable insights for millions of people who want to know more about their health risks,” said Quest’s chairman, president and CEO, Steve Rusckowski.

“It wasn’t long ago that genetic sequencing took months and cost thousands of dollars,” Rusckowski said. “Quest’s proprietary innovation enables sequencing insights in a fraction of the time at a fraction of the cost.”

For $179, AncestryHealth’s kit will be available in 47 states, outside of New York, New Jersey and Rhode Island.

https://www.fiercebiotech.com/medtech/ancestry-relaunches-dna-health-offerings-employing-quest-s-next-gen-sequencing

Sanofi faces manslaughter charges in France over yearslong Depakine probe

For years, Sanofi has faced a French probe into birth defects tied to epilepsy medicine Depakine, and now the investigation is moving forward on manslaughter charges.

Authorities in France are investigating those charges because of safety risks for babies when the medicine, known generically as valproate, is taken by pregnant women, Reuters reported.

Still, it’s unclear whether the drugmaker will face a trial. Prosecutors can still decide not to take the case if they determine the evidence is insufficient, according to reports.

France’s Le Monde newspaper first reported the charges, which Sanofi confirmed in a statement to FiercePharma. Sanofi will challenge the indictment, a spokeswoman said. Earlier this year, authorities charged the company with “aggravated deception” and “involuntary injuries” associated with Depakine.

“Sanofi Aventis France has complied with its disclosure obligations and is challenging the merits of these lawsuits,” the spokeswoman added.

Approved since 1967, Depakine treats epilepsy, migraines and bipolar disorder. The drug lost its patent in 1998 and is still prescribed in more than 100 countries, according to Reuters, including the U.S., where it was launched under the brand name Depakote.

Sanofi has been under investigation for four years over risks from the medicine. An agency of the French government concluded that 425 to 450 babies suffered birth defects or were stillborn between 2006 and 2014 after their mothers took Depakine, Reuters reported.

https://www.fiercepharma.com/pharma/sanofi-faces-manslaughter-charges-france-over-yearslong-depakine-probe

ViiV Healthcare infringement suit against Gilead to continue – judge

A Delaware district court judge has denied a motion from Gilead Sciences (GILD +3.4%) that HIV triple combo pill Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) does not infringe on a ViiV Healthcare patent covering rival HIV med Tivicay (dolutegravir).

Judge Colm Connolly said,”It is not clear from the claims or written description of the patent that a difluoro benzyl ring necessarily excludes a trifluoro benzyl ring.”

The case will continue with a seven-day jury trial set to begin on Monday, September 21.

ViiV sued Gilead in February 2018 claiming that Biktarvy’s integrase inhibitor bictegravir infringes its patent covering integrase strand transfer inhibitor dolutegravir and other compounds that include dolutegravir’s unique chemical scaffold.

ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (GSK +2.2%), Pfizer (PFE -0.2%) and Shionogi (OTCPK:SGIOY -2.0%).

https://seekingalpha.com/news/3599204-viiv-healthcare-infringement-suit-against-gilead-to-continue-judge

Neurocrine Biosciences EPS beats by $0.40, beats on revenue

Neurocrine Biosciences (NASDAQ:NBIX): Q2 Non-GAAP EPS of $1.42 beats by $0.40; GAAP EPS of $0.81 beats by $0.15.

Revenue of $302.4M (+64.7% Y/Y) beats by $40.74M.

Press Release

https://seekingalpha.com/news/3599230-neurocrine-biosciences-eps-beats-0_40-beats-on-revenue

Steris EPS beats by $0.33, beats on revenue

Steris (NYSE:STE): Q1 Non-GAAP EPS of $1.31 beats by $0.33; GAAP EPS of $1.03 beats by $0.18.

Revenue of $668.9M (-4.0% Y/Y) beats by $25.52M.

Press Release

https://seekingalpha.com/news/3599350-steris-eps-beats-0_33-beats-on-revenue