A recent phase 2 clinical trial published in Arthritis & Rheumatologyhas reported promising results for deucravacitinib, an oral inhibitor tyrosine kinase 2 (TYK2) inhibitor, in patients with active lupus.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterised by the presence of antinuclear autoantibodies and diverse clinical manifestations. Treatment often lacks efficacy for SLE patients, and current therapies are associated with undesirable side effects.
TYK2 is an intracellular kinase that mediates signalling of key cytokines involved in the pathogenesis of SLE. A biologic agent targeting the type I interferon (IFN) receptor has been approved in SLE. Deucravacitinib is an oral, selective, allosteric inhibitor of TYK2 that binds the regulatory domain and locks the enzyme in an inactive state distinguishing it from JAK inhibitors that bind the highly conserved active domain
For the trial, adults with active SLE were enrolled from 162 sites in 17 countries. Patients (n = 363) were randomised 1:1:1:1 to receive deucravacitinib 3mg twice daily, 6mg twice daily, 12mg once daily, or placebo. The primary endpoint was SRI-4 and secondary outcomes were assessed on a variety of disease activity measures.
At week 32, the percentage of patients experiencing benefits was 34% with placebo compared with 58%, 50%, and 45% with the respective deucravacitinib regimens.
Rates of adverse events were similar across groups, except higher rates of infections and cutaneous events, including rash and acne, with deucravacitinib treatment. Rates of serious adverse events were comparable, with no deaths, opportunistic infections, tuberculosis infections, major adverse cardiovascular events, or thrombotic events reported.
Some cases of tuberculosis (TB) can be successfully treated in as little as two months – a third of the current standard of six months in South Africa and most other countries. This is according to early findings from the landmark TRUNCATE TB trial presented at last week’s Union World Conference on Lung Health.
Nick Paton, a professor of Infectious Diseases at the National University of Singapore and the chief investigator of the TRUNCATE trial, explains that the standard six-month treatment for drug-susceptible TB (DS-TB) is actually overtreating a lot of people who have the disease. The reason for the six-month mark for TB treatment is that a minority of TB patients need the long treatment regimen to avoid relapse, but the majority would be cured before the six-month mark.
Essentially, it’s a blunt, but generally, effective instrument used to protect a minority of TB patients.
The TRUNCATE trial set out to see if a two-month (eight weeks) novel combination of TB regimens would be feasible when compared to the standard six-month (24 weeks) treatment regimen. According to Paton, trial participants in the experimental arms of the study were initially given eight weeks of treatment, with the option of extending treatment to 10 to 12 weeks if they had persistent clinical disease after the eight-week treatment. If there was still active TB after that, participants were switched to the standard six-month treatment.
Study participants were monitored regularly through follow-up visits, which included TB symptom screening once a month and sputum smear tests every one to three months.
“The core [of the strategy] is it’s a very short period of initial treatment, plus you then do the monitoring and pick up people [who relapsed] early,” Paton says.
A total of 674 trial participants were recruited from March 2018 to March 2022 across 18 sites in Thailand, Indonesia, the Philippines, Uganda, and India. Four patients withdrew from the trial and 10 participants died during the trial.
Paton tells Spotlight that the overall death rate was low and there was no difference in the death rate between the standard treatment arm and the TRUNCATE strategy arms. The causes of death were mixed, he adds, and often the precise cause was unknown
For the final results, 660 participants were evaluated at week 96. In other words, about two years of follow-up occurred.
Encouraging results
Paton explains that the trial used the TRUNCATE strategy, which initially involved using four treatment arms containing a novel combination of TB drugs and comparing the results to a control arm consisting of the standard six-month treatment. Later, two TRUNCATE strategy arms were selected to complete the latter half of the study. He notes that it was a pragmatic decision to stop two of the arms, to ensure better data.
“You do substantially cut down the amount of time on treatment overall.”
Professor Nick Paton, chief investigator of the TRUNCATE trial.
In the first of the two remaining experimental arms, 184 study participants received a regimen consisting of high-dose rifampicin (35mg per kg, reduced to 20mg per kg as a precaution following a liver injury-related death), isoniazid, pyrazinamide, ethambutol, and linezolid (600mg). In the second, 189 study participants received a regimen consisting of bedaquiline (400mg/d for two weeks then 200mg three times a week), isoniazid, pyrazinamide, ethambutol, and linezolid (600mg). The standard treatment arm had 181 participants.
In the standard treatment arm, 98% completed treatment and 3% had to be re-treated before week 96.
In the TRUNCATE strategy arms, overall, 91% completed the eight-week treatment and stopped treatment by week 12. 17%, (ranging from 13 to 23% by arm) had re-treatment, and 2% of participants did not complete initial treatment due to withdrawing from the trial, death, or defaulting on treatment.
A comparison of the two experimental TRUNCATE arms with the standard treatment arm showed that the TRUNCATE arm with bedaquiline and linezolid was non-inferior to the standard treatment arm, while the high dose rifampicin and linezolid arm fell just short of meeting the non-inferiority criteria. Efficacy was calculated based on the proportion of unsatisfactory outcomes at week 96. Unsatisfactory outcomes were classified as death, still having active TB, or still being on TB treatment at week 96.
“The idea was that if we added those [unsatisfactory outcomes] up and that was the same in the standard treatment arm as the TRUNCATE strategy arm then that shows that this strategy in principle, can work,” Paton tells Spotlight.
The mean total days on treatment were reduced in the TRUNCATE strategy arms when compared to the standard treatment arm, which was 180 days. For high-dose rifampicin-linezolid, the average total days on treatment was 106 days, and in the bedaquiline-linezolid arm, it was 85 days.
“So, clearly the net effect is to decrease the average time on treatment,” Paton says. “You do substantially cut down the amount of time on treatment overall.”
He adds that the proportion of participants that had Grade 3 or 4 adverse events, serious adverse events, or who died did not differ between the standard treatment arm and the TRUNCATE strategy arm. The proportion of participants with respiratory disability at week 96 also did not differ.
The only cases of acquired drug resistance were two cases observed in the bedaquiline and linezolid arm. This is a frequency of 1.1% according to Paton. One of these participants missed several treatment doses, while the other did not miss any doses. Both were successfully re-treated.
Initially, they wanted to enroll participants who were co-infected with HIV in the later stages of the trial, but none could be enrolled in time, so currently there is no data on how well it works in people living with HIV who also have TB, says Paton.
“The trial has shown that alternatives to systematically over-treating the large majority of people with TB can be successful. This is an important new research direction which has the promise to improve outcomes for patients and programmes,” Paton says. “The strategy may be refined in future to improve outcomes using alternative drug regimens or alternative approaches to monitoring. Ongoing analysis from the trial will further enhance our understanding.”
PK and safety data
At last week’s conference, Christopher Cousins, project leader of the TRUNCATE trial presented the first level of pharmacokinetic (PK) analysis from the trial. The PK results were taken from week eight of the study.
AUC for the high-dose rifampicin was four to six times higher than in the standard dose and exceeded the proposed efficacy targets in the majority of patients.
After fasting overnight, participants took an observed dose of their medication at the trial site and had blood sampling done over a 12-hour period. The data is based on 96 participants in the two experimental arms.
He says the AUC (which represents total drug exposure over time – AUC = area under the curve) for the high-dose rifampicin was four to six times higher than in the standard dose and exceeded the proposed efficacy targets in the majority of patients. This supports the hypothesis that high-dose rifampicin would enhance treatment sterilisation in the eight-week regimen.
The data also showed what seems to be a drug-drug interaction between rifampicin and linezolid, but this didn’t appear to be significant enough to abolish anti-mycobacterial efficacy.
According to Cousins, the bedaquiline concentrations at the end of week eight in the bedaquiline and linezolid arm were comparable to the concentrations seen after 24 weeks of treatment for drug-resistant TB (currently both bedaquiline and linezolid are part of the standard treatment for DR-TB, but not for DS-TB).
When asked how well monitoring participants in the TRUNCATE arms after they stopped treatment was able to detect those who still had active TB disease, Paton tells Spotlight that further analysis of the sputum smears samples will be able to tell us more. The trial used a relatively low-technology approach where a symptom screening and a sputum smear test were used to determine if a participant still had active TB and needed to be re-treated.
“We need to run additional biomarkers, interrogate the data set in more detail to figure out who was cured, who wasn’t cured, over what duration and how well do these other things [sputum smear test and symptom screening] pick it [TB] up,” he says.
He adds that this was a starting point, “but we are likely to be able to do better if we use some of the new biomarker technologies for monitoring”.
Implications of findings
“These results are very exciting as proof of concept – they show it’s possible to shorten treatment for drug-sensitive TB even further,” says Lindsay McKenna, TB Project Co-Director at New York-based Treatment Action Group (TAG). “But we need to optimise the regimen and study this treatment strategy in broader populations, including people living with HIV – none were enrolled in the study – and [in] programme contexts,” she says.
“There are other trials that are being planned that look to proactively (for example, at time of treatment initiation) determine who might benefit from shorter versus longer treatment based on available indicators or risk factors known to be correlated with treatment outcomes, such as disease severity, BMI, and HIV status (called a stratified medicine approach), and to tailor the duration of treatment accordingly,” she adds. “If the latter stratified medicine approach is proven, it will be very interesting to see how these two approaches compare and are viewed by programmes and affected communities.”
Feasibility of shortened regimens
Nerissa Donato the site co-investigator for the Truncate TB trial from the Lung Centre in the Philippines outlined the feasibility and acceptability of the TRUNCATE strategy at last week’s conference. This was based on participant questionnaires, clinician surveys, description data from the trial, and observations from Donato.
“The TRUNCATE strategies were acceptable and feasible in the context of the clinical trial. It can be successfully implemented provided that it is supported by the NTP (national treatment programme) and embraced by trained clinicians,” she says.
She explains the main challenges to implementing the strategy were patients’ concerns about potential side effects and the greater pill burden, but after some discussion participants were comfortable with the regimen due to the possibility of a much shorter treatment regimen. The close following up of participants and follow-up visits required was different from the normal procedure of treating for six months and being discharged from care. But she says participants were generally happy to come back for the follow-up visits.
Clinicians who participated were initially sceptical of whether the regimen was safe and would work but after the trial, they had a more positive view, according to Donato.
She says that in order to implement the strategy in the real world, it would need to be adopted by the NTPs, which will likely require more data on cost-effectiveness.
Need better treatment approaches and regimens
Paton tells Spotlight that somewhere between the two extremes of overtreating TB patients and personalised medicine as seen in high-income countries, there can lie a better treatment option for TB patients. An approach that is less monolithic and instead based on reacting to individual patient needs and responses.
“We need to look at how do we personalise it [TB treatment], but in a way that’s not so high tech so it becomes impossible for programmes,” he says. “At least if you’re monitoring [patients] you’ve got a safety net. If you get it wrong, you just make sure you pick the person up early and re-treat and there shouldn’t be serious harm from that.”
Additional data from the trial will be released in the coming months.
A smartwatch ECG can accurately detect heart failure (HF) in nonclinical environments, according to a study published in Nature Medicine. Researchers analysed Apple Watch ECG recordings with AI to identify patients with ventricular dysfunction. Study participants were able to remotely record their smartwatch ECGs at any time, with the data automatically and securely uploaded to their electronic health records via a smartphone app.
“Currently, we diagnose ventricular dysfunction – a weak heart pump – through an echocardiogram, CT scan or an MRI, but these are expensive, time consuming and at times inaccessible. The ability to diagnose a weak heart pump remotely, from an ECG that a person records using a consumer device, such as a smartwatch, allows a timely identification of this potentially life-threatening disease at massive scale,” says senior study author Paul Friedman, MD, chair of the Department of Cardiovascular Medicine at Mayo Clinic.
Ventricular dysfunction might not cause symptoms, but affects about 2% of the population and 9% of people over 60. Symptoms may develop with a low ejection fraction, including shortness of breath, a rapid heart rate and swelling in the legs. Early diagnosis is important because once identified, there are numerous treatments to improve quality of life and decrease the risks of heart failure and death.
Mayo researchers interpreted Apple Watch single-lead ECGs by modifying an earlier algorithm developed for 12-lead ECGs that is proven to detect a low ejection fraction.
While the data are early, the modified AI algorithm using single-lead ECG data had an area under the curve of 0.88 to detect low ejection fraction. By comparison, this measure of accuracy is as good as or slightly better than a medical treadmill diagnostic test.
“These data are encouraging because they show that digital tools allow convenient, inexpensive, scalable screening for important conditions. Through technology, we can remotely gather useful information about a patient’s heart in an accessible way that can meet the needs of people where they are,” says first author Zachi Attia, PhD, the lead AI scientist in the Department of Cardiovascular Medicine at Mayo Clinic.
“Building the capability to ingest data from wearable consumer electronics and provide analytic capabilities to prevent disease or improve health remotely in the manner demonstrated by this study can revolutionize health care. Solutions like this not only enable prediction and prevention of problems, but also will eventually help diminish health disparities and the burden on health systems and clinicians,” says co-author Bradley Leibovich, MD, the medical director for the Mayo Clinic Center for Digital Health.
Approximately 420 of the 2454 participants had an echocardiogram within 30 days of logging an Apple Watch ECG in the app. Of those, 16 patients had low ejection fraction confirmed by the echocardiogram, which provided a comparison for accuracy.
WHO today launched new guidelines to improve survival and health outcomes for babies born preterm (< 37 weeks) or small (< 2.5kg). In a significant departure from common clinical practice, the guidelines advise that caregiver skin to skin contact with a caregiver – aka kangaroo mother care – should start immediately after birth, without incubator stabilisation. This reflects the immense health benefits of ensuring caregivers and their preterm babies can stay close, without being separated, after birth.
The guidelines also provide recommendations to ensure emotional, financial and workplace support for families of very small and preterm babies, who can face extraordinary stress and hardship because of intensive caregiving demands and anxieties around their babies’ health.
“Preterm babies can survive, thrive, and change the world – but each baby must be given that chance,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “These guidelines show that improving outcomes for these tiny babies is not always about providing the most high-tech solutions, but rather ensuring access to essential healthcare that is centred around the needs of families.”
Depending on where they are born, there remain significant disparities in a preterm baby’s chances of surviving. While most born at or after 28 weeks in high-income countries go on to survive, in poorer countries survival rates can be as low as 10%.
Most preterm babies can be saved through feasible, cost-effective measures including quality care before, during and after childbirth, prevention and management of common infections, and kangaroo mother care – combining skin to skin contact in a special sling or wrap for as many hours as possible with a primary caregiver, usually the mother, and exclusive breastfeeding.
Previous recommendations for preterm babies were for an initial period of separation from their primary caregiver, with 3–7 days of initial stabilisation in an incubator or warmer. However, research has now shown that starting kangaroo mother care immediately after birth reduces mortality, infections and hypothermia, and improves feeding.
Breastfeeding is also strongly recommended to improve health outcomes for preterm and low birthweight babies, with evidence showing it reduces infection risks compared to infant formula. Where mother’s milk is not available, donor human milk is the best alternative, though fortified ‘preterm formula’ may be used if there are no donor milk banks.
Integrating feedback from families gathered through over 200 studies, the guidelines also advocate for increased emotional and financial support for caregivers. Parental leave is needed to help families care for the infant, the guidelines state, while government and regulatory policies and entitlements should ensure families of preterm and low birthweight babies receive sufficient financial and workplace support.
Earlier this year, WHO released related recommendations on antenatal treatments for women with a high likelihood of a preterm birth. These include antenatal corticosteroids, which can prevent breathing difficulties and reduce health risks for preterm babies, as well as tocolytic treatments to delay labour and allow time for a course of corticosteroids to be completed. Together, these are the first updates to WHO’s preterm and low birth weight guidelines since 2015.
The guidelines were released ahead of World Prematurity Day, which is marked every year on 17th November.
For patients with anxiety disorders, a guided mindfulness-based stress reduction program was as effective as use of the gold-standard drug escitalopram, according to results of a first-of-its-kind, randomised clinical trial published in JAMA Psychiatry.
“Our study provides evidence for clinicians, insurers, and healthcare systems to recommend, include and provide reimbursement for mindfulness-based stress reduction as an effective treatment for anxiety disorders because mindfulness meditation currently is reimbursed by very few providers,” says Elizabeth Hoge, MD, director of the Anxiety Disorders Research Program and associate professor of psychiatry at Georgetown and first author. “A big advantage of mindfulness meditation is that it doesn’t require a clinical degree to train someone to become a mindfulness facilitator. Additionally, sessions can be done outside of a medical setting, such as at a school or community centre.”
Anxiety disorders can be highly distressing; they include generalised anxiety, social anxiety, panic disorder and fear of certain places or situations, including crowds and public transportation, all of which can lead to an increased risk for suicide, disability and distress and therefore are commonly treated in psychiatric clinics. Drugs that are currently prescribed for the disorders can be very effective, but many patients either have difficulty getting them, do not respond to them, or find the side effects (e.g., nausea, sexual dysfunction and drowsiness) as a barrier to consistent treatment. Standardized mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), can decrease anxiety, but prior to this study, the interventions had not been studied in comparison to effective anti-anxiety drugs. Of note, approximately 15% of the U.S. population tried some form of meditation in 2017.
The clinicians recruited 276 patients between June 2018 and February 2020 from three hospitals in Boston, New York City and Washington, D.C., and randomly assigned people to either MBSR or escitalopram. MBSR was offered weekly for eight weeks via two and a half-hour in-person classes, a day-long retreat weekend class during the 5th or 6th week, and 45-minute daily home practice exercises. Patients’ anxiety symptoms were assessed upon enrolment and again at completion of the intervention at 8 weeks, along with post-treatment assessments at 12 and 24 weeks after enrolment. The assessments were conducted in a blinded manner — the trained clinical evaluators did not know whether the patients they were assessing received the drug or MBSR.
At the end of the trial, 102 patients had completed MBSR and 106 had completed their medication course. The patients were relatively young, with a mean age of 33 and included 156 women, which comprised 75% of the enrolees, mirroring the disease prevalence in the U.S.
The researchers used a validated assessment measure to rate the severity of symptoms of anxiety across all of the disorders using a scale of 1 to 7 (with 7 being severe anxiety). Both groups saw a reduction in their anxiety symptoms (a 1.35 point mean reduction for MBSR and 1.43 point mean reduction for the drug, which was a statistically equivalent outcome), dropping from a mean of about 4.5 for both, which translates to a significant 30% or so drop in the severity of peoples’ anxiety.
Olga Cannistraro, 52, says she uses her MBSR techniques as needed, but more than a decade ago, the practice transformed her life. She was selected for an MBSR study after responding to advertisement asking, “Do you worry?”
“I didn’t think of myself as anxious – I just thought my life was stressful because I had taken on too much,” she recalls. “But I thought ‘yeah, I do worry.’ There was something excessive about the way I responded to my environment.”
After participating in an earlier study led by Hoge, she learned two key MBSR techniques. “It gave me the tools to spy on myself. Once you have awareness of an anxious reaction, then you can make a choice for how to deal with it. It’s not like a magic cure, but it was a life-long kind of training. Instead of my anxiety progressing, it went in the other direction and I’m very grateful for that.”
“It is important to note that although mindfulness meditation works, not everyone is willing to invest the time and effort to successfully complete all of the necessary sessions and do regular home practice which enhances the effect,” Hoge said. “Also, virtual delivery via videoconference is likely to be effective, so long as the ‘live’ components are retained, such as question-and-answer periods and group discussion.”
Hoge points out that there are many phone apps that offer guided meditation, however researchers don’t know how apps compare with the full in-person, weekly group class experience.
Trial enrollment was wrapping up as the COVID pandemic started in early 2020 but most enrollees completed their eight-week course of treatment before the pandemic started. Additionally, the researchers conducted a second phase of the study during the pandemic that involved moving the treatments to an online, videoconference, and that will be the focus of future analyses. The researchers also hope to explore the effects of MBSR on sleep and depression.
With few solutions available, treatment of knee osteoarthritis is challenging, but a randomised control trial published in Arthritis and Rheumatology has found that, at least for short-term relief, ultrasound-guided genicular nerve block (GNB) was effective.
The global prevalence of knee osteoarthritis (OA) is ~22.9% of over-40s. Knee OA is a significant cause disability and potentially loss of independence. Treatment remains challenging, with nonsurgical management options such as education, weight loss, exercise therapy, and walking aids. Few recommended pharmacotherapeutic options exist for knee OA, with surgical joint replacement being a definitive treatment strategy for patients with severe disease who are unresponsive to conservative care. For many patients, such as people who are frail or elderly or people with complex comorbidities, surgical intervention may not be suitable.
In a 12-week parallel-group, placebo-controlled randomised trial of GNB, patients in the active arm received 3 injections of 5.7 mg celestone chronodose (1ml) and 0.5% bupivacaine (3ml) to the inferomedial, superomedial, and superolateral genicular nerves. Patients in the placebo arm received saline injections. An experienced radiologist or rheumatologist with the assistance of a senior sonographer used ultrasound to locate the nerves.
At baseline and at weeks 2, 4, 8, and 12, patients recorded their pain and disability on self-report scales. Patients in the active group reported improvements in pain scores at 2, 4, 8, and 12 weeks with a diminution of the effect over time.
These results reflect comparator groups, which also reported an effect reduction at 12 weeks.
“This study demonstrates that genicular nerve block is an effective short-term therapy for pain management in people with knee osteoarthritis,” said corresponding author Ernst M. Shanahan, BMBS, MPH, MHPE, PhD, FAFOEM, FRACP, of Flinders University. “We think it may be a useful treatment option for this group of people, in particular those waiting for, or wishing to defer surgery.”
Researchers report in Cell Systems that they have discovered another difference between cancer cells and normal cells besides mutations: the X chromosome, typically only inactivated in XX female cells, can also be inactivated across different male-derived cancers.
“To balance the expression of genes between the sexes, in normal development, one copy of the female X chromosome is inactivated at random across the human body. We wanted to know if this process that occurs in normal development goes awry in genetically unstable male or female cancer cells,” says senior author Srinivas Viswanathan, a cancer geneticist and medical oncologist at the Dana-Farber Cancer Institute.
By using publicly available datasets comprising of thousands of DNA samples from cancer patients around the world, the team of researchers stumbled upon the high expression of XIST – the gene responsible for shutting down gene expression on the X chromosome – in about 4% of the male cancer samples analysed.
While XIST may be expressed in very early development in all sexes, X inactivation is thought to be a female-specific process later in development. It was previously shown that some female cancer cells may lose the ability to turn off one of the X chromosomes, leading to increased X-linked gene expression, but this ability of X inactivation had still only been studied primarily in female cells.
Within the 4% of anomalous male cancer samples identified, 74% were from reproductive cancers already shown to inactivate the X chromosome, but that left 26% of samples from other cancer types. These included liver, brain, skin, heart, lung, and thyroid cancers.
“We were very surprised by this result since XIST is a transcript typically used to classify female cancers, and so we wanted to ensure that this was not merely a result of mis-annotation. Yet, we do in fact see that some male cancers of diverse subtypes activate XIST and display features of X inactivation,” says Viswanathan.
“We have to be aware of the caveats of working with these types of datasets. These samples have been in many people’s hands, and there is more room for human error,” said co-corresponding author Cheng-Zhong Zhang, cancer biologist at the Dana-Farber Cancer Institute. “This is the biggest source of uncertainty for us; we have to be creative in how we look at the data and find controls.”
One possible explanation for why this phenomenon is occurring is genetic instability. Cancers often have multiple copies of chromosomes, and if two X chromosomes happen to be in one cell, then it may be necessary to inactivate one of them by activating XIST, regardless of whether that cell is in a female or male individual.
“Another possibility is there are some important genes on the X chromosome that, when silenced, enable the cancer to grow. We will investigate this in future studies,” says Viswanathan.
“In some ways, sex is the ultimate biomarker in that it subdivides the human population, but we often don’t think about how genetic differences between the sexes may inform cancer prognosis or response to therapy,” says Viswanathan.
Daily COVID vaccinations have more or less plateaued since July. At the peak of the vaccination drive, South Africa was administering up to 240 000 vaccine doses a day. But this number has dropped to just over 5000 a day. Less than half of these are first doses and a third are booster shots.
The government still hasn’t reached its target of 67% adult vaccination, which it wanted to achieve by the end of 2021. Half of the adult population in South Africa is currently vaccinated. Among adults 60 years or older, nearly 73% have been fully vaccinated.
GroundUp visited the District Six Community Day Centre, a government clinic, in Cape Town. We asked for a COVID vaccine and were directed to a small room on the first floor, where one of us waited over 1.5 hours to get a vaccine (though two of us were vaccinated considerably quicker – about 30 minutes). This wasn’t because there was a long queue.
The nurse administering the vaccines was busy treating patients elsewhere in the clinic. The person logging the vaccines on the computer system told GroundUp that on average, 12 people a day come to the clinic for vaccines.
GroundUp visited a Clicks store in Cape Town where, three months ago, vaccines were still being administered. But they no longer do COVID vaccines.
The government’s dedicated Coronavirus website has a list of “active vaccination sites”, many of which are no longer active, and the “Find My Jab” page has completely different information.
Meanwhile, people are still getting ill from the virus. About 2000 new cases are reported each week, but according to the National Institute for Communicable Diseases (NICD) only 16% of cases are being detected. Testing sites are also few and far between.
Professor Glenda Gray says that the vaccine has done a good job at reducing deaths, serious illness and hospitalisations. Official daily deaths and hospitalisation rates are low in relation to previous waves. In the past four weeks, 125 deaths from COVID were reported.
The real number of deaths is likely much more than this. A weekly report published by the Medical Research Council and the University of Cape Town calculates the number of excess deaths – the deaths above the historical average before COVID: there have been close to 50 000 excess deaths so far this year. While in earlier waves the researchers were able to estimate that 85% to 95% of these excess deaths were due to COVID, the changing nature of the epidemic has made it much harder to estimate how many of this year’s excess deaths are due to COVID.
More than 85% of COVID infections in the country are from the Omicron BA.5 variant, which is widespread and infectious but usually causes very mild illness.
To prevent serious illness and death, getting the vaccine and booster shots are still recommended. Gray says that it is especially important for immunocompromised people, such as people living with HIV, to get vaccinated.
“Sadly, the virus has done a far better job of generating immunity than our government, which continues to be maddeningly slow at getting the vaccine out,” says Professor Francois Venter, infectious diseases clinician and head of Ezintsha at Wits University.
Although being infected by and recovering from the virus does provide a level of immunity, getting a vaccine still greatly improves one’s protection against the virus.
“I think we were all hoping once we had immunity from either infection or a vaccine or two, it would be enough. But from what we are seeing internationally, new waves of COVID, while not killing people in the numbers we saw in 2020 and 2021, are still making people very sick,” Venter says.
Dr Nicholas Crisp, Deputy Director-General of the National Department of Health, is the coordinator of the national vaccination drive. He agrees the current status of the vaccination drive is “very disappointing”.
He says the vaccination program is being integrated into primary health care, targeting areas geographically where communities or segments of a community are not vaccinated.
To monitor and manage the pandemic, Crisp says the government is continuing with daily testing, gene sequencing and wastewater sampling. Crisp says that the government is preparing for the future of COVID as well as other potential pandemics.
Future variants of the virus could be more dangerous. “As long as there is transmission, there is going to be mutation,” Gray told GroundUp. How the virus mutates in the future is yet to be seen.
In the US, new bivalent vaccines designed to target the Omicron variant are already available. But, Gray says, there is not yet sufficient evidence that these work better than the current vaccines.
According to Crisp, the government is not considering any new vaccines. “We are not buying vaccines this year and may not buy vaccines next year,” he says.
South Africa still has 8 million doses of the Pfizer vaccine and 10 million doses of the Johnson and Johnson vaccine. He says paediatric Pfizer vaccines will be purchased with some of the credit that South Africa has with the Covax facility. These will be given to children who are immunocompromised.
A systematic review has revealed that plant-based or plant-heavy diets may offer a level of protection against prostate cancer and other male sexual health issues according.
The analysis included 23 studies, 12 of which included prostate cancer, and suggested a link between a plant-based diet and reduced prostate cancer risk. Some evidence also suggested benefits for erectile dysfunction and benign prostate hyperplasia. The findings were reported at the Sexual Medicine Society of North America (SMSNA) annual meeting.
“Medicine has moved to a more holistic approach overall, and with that, more researchers have started to look into [the question of] ‘Can we use these plant-based diets to help manage and prevent conditions like prostate cancer, erectile dysfunction [ED], and benign prostate hyperplasia [BPH]?’ Nathan Feiertag, MD, a medical student at Albert Einstein College of Medicine in New York City, told MedPage Today. “There were relatively few studies that we were able to find for this literature review, but that’s the current state.”
With the growing popularity of plant-based diets, studies have shown their benefits for patients with hypertension or diabetes. Dr Feirtag said that less is known about their effect on prostate cancer, ED and BPH.
Dr Feiertag told MedPage Today that “Urologists can maybe consider our review as an opportunity to incorporate or modify existing diet counselling for their patients, especially the ones who are eager to implement lifestyle changes, particularly as it pertains to prostate hyperplasia, ED, and prostate cancer.”
The review mostly consisted of cohort studies, along with cross-sectional studies, and a handful of randomised controlled trials. Studies included those on vegan diets, vegetarian diets, and plant-heavy diets, such as the Mediterranean diet. In a number small cohort studies, there was a significant decrease in prostate cancer velocity, though not sustained at six months, Dr Feiertag said.
Two of the five ED studies found a link between plant-based diets and improved International Index of Erectile Function scores, though one reported worsening scores. The two studies included on ED reported a reduced relative risk of ED for patients on plant-based diets. For BPH, five of six studies reported an inverse relationship between plant-based diets and developing BPH.
Limitations including not being generalisable due to the number of observational and cohort studies that relied on patient-reported evaluations of diet. Additional high-quality studies are needed to confirm the link between diet and urological conditions.
Fortunately, the studies all reported no non-association or no harmful effects of following a plant-based or plant-forward diet. “For the patients who want to change their diet, this is useful for them. It definitely won’t hurt,” Dr Feiertag told MedPage Today.
Smartphones are nowadays ubiquitous and repeatedly checked throughout the day, making them potential receptacles for environmental hazards such as allergens. A new study being presented at this year’s American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting in Louisville, KY, showed elevated levels of cat and dog allergens, as well as β-D glucans (BDG) and endotoxin on simulated phone models.
“Smartphones showed elevated and variable levels of BDG and endotoxin, and cat and dog allergens were found on smartphones of pet owners” says Hana Ruran, lead author on the study. “BDGs are found in fungal cell walls and have been found in many environments and surfaces causing chronic airway and irritant symptoms – making BDGs a consistent marker to study problematic mould. Endotoxin is a potent inflammatory agent and a marker of exposure to Gram negative bacteria.”
The researchers created phone models that had a similar size and surface to a real phone and the front surface of the phone model was wiped as part of the test. Electrostatic wipes (ESW) were used to sample simulated phone models of 15 volunteers and the “phones” were then measured for allergens, BDG and endotoxin levels.
The chemicals used in the mixture solutions for cleaning (chlorhexidine, cetylpyridinium chloride, tannic acid and benzyl benzoate) can be purchased through laboratory or chemical suppliers but are not commercially available in the same concentrations as used in the study. Isopropyl alcohol wipes were also tested for their cleaning properties.
“Combination chlorhexidine/cetylpyridinium was the most effective in reducing BDG and endotoxin and combination benzyl benzoate/tannic acid most effectively reduced cat and dog allergens on smartphones,” says Peter Thorne, PhD, professor in the University of Iowa Department of Public Health and co-author of the study. “The study demonstrates exposure to inhalant allergens and molecules that trigger innate immune reactions from a source most people haven’t considered. If you have allergies or asthma, you may want to think about cleaning your smartphone more often to minimise exposure to these allergens and asthma triggers.”
