Tag: 8/3/22

Categories : HIV Medical IndustryTags :

Generic Options for HIV Prophylactic Cabotegravir Locked Out, MSF Warns

On By ModernMedia
Image of a syring for vaccination
Photo by Mika Baumeister on Unsplash

Médecins Sans Frontières (MSF) has warned that pharmaceutical company ViiV’s recent decision not to pursue voluntary licensing for the long-acting HIV prophylactic cabotegravir (CAB-LA) means that lower cost generic production in low- and middle-income countries (LMICs) is effectively locked out for countries like South Africa.

CAB-LA was approved for the prevention of HIV infection by the USFDA in December 2021, and ViiV currently charges $3700 (R55 000) per vial in the US ($22 200/R333 000 annually per person). The Clinton Health Access Initiative (CHAI) has shown that generic manufacturers could produce this drug for around $2.60 (R39) per vial (less than $20/R3000 per person per year). Although ViiV has publicly said they would provide CAB-LA for their at-cost price in many LMICs, they have yet to announce what that price is.

According to MSF, generic manufacturer prices are often much lower than the patented drug – and they can even produce complicated formulations like CAB-LA.  The generic equivalent [PDF] of ViiV’s paediatric formulation of the HIV drug dolutegravir costs 22 times less.

Amanda Banda, Infectious Diseases Policy and Advocacy Advisor of the MSF Access Campaign, said: “What good is HIV prevention if the people who need it can’t afford it? This is the most effective form of HIV prevention for vulnerable and marginalised communities and yet ViiV is delaying the ability of generic manufacturers to supply the drug, meaning that many people across low- and middle-income countries who would benefit from the medicine to prevent HIV infection won’t be able to access it. CAB-LA will need to be available at a price that is comparable to currently available oral PrEP if country treatment programs and donors are expected to scale up its use to the levels needed – and it’s hard to imagine that ViiV will make CAB-LA available at less than $40 (R600) per year.  ViiV needs to immediately sign a licensing deal with the Medicines Patent Pool so that more affordable generics can be produced, and more lives can be saved.”

Dr Tom Ellman, Head of MSF’s South African Medical Unit said: “We want to urgently make this drug available for people at high risk of HIV infection in our programs in sub-Saharan Africa – we don’t want a donation with many strings attached from the corporation; it is not the role of ViiV to control the use of a drug that is approved by the USFDA. We want ViiV to sell us this drug at an affordable price.”

Source: MSF

Categories : Injury & TraumaTags :

Over 70% of TBI Patients Report More Symptoms a Year On

On By ModernMedia
Source: Pixabay

More than 70% of patients with traumatic brain injury (TBI) reported at least one problematic symptom at one year of follow-up that was new or worse than before injury according to a study published in the Journal of Neurotrauma. Half of the patients reported three or more such symptoms after a year.

Joan Machamer, from the University of Washington, Harborview Medical Center, and colleagues representing the TRACK-TBI Investigators, compared the frequency and persistence of symptoms in patients with TBI to two control groups: patients with orthopedic trauma and friend controls. The groups were evaluated at 2 weeks, and 3, 6, and 12 months after injury.

Physical symptoms such as headache, fatigue, and dizziness tended to occur earlier, according to the researchers, with cognitive symptoms becoming dominant later. While physical symptoms declined noticeably over time, cognitive symptoms remained more constant over time.

“Clinicians should inquire about symptoms in patients who have had a TBI, reassure them that experiencing symptoms is common, and direct them to seek treatment for symptoms that are disrupting their lives,” the researchers said.

Commenting on the study, David L. Brody, MD, PhD, Editor-in-Chief of Journal of Neurotrauma noted that is remarkable for several reasons. “First, it is among the largest studies of its type, with over 2,000 participants. Second, it confirms what many of us who practice brain injury medicine have observed for many years– a wide variety of symptoms can be very persistent and very troubling to our patients even after so-called ‘mild’ TBI. Third, the investigators used the right controls; people with orthopedic injury as well as friends of the patients with TBI. Symptoms in patients with TBI were substantially more common and more severe than in both control groups.”

Source: Mary Ann Liebert, Inc.

Categories : COVIDTags :

COVID Battle not Over as Many Countries Continue to Struggle

On By ModernMedia
Image by Quicknews

Two years into the pandemic, and the COVID battle is not over for much of the world, warns the International Federation of Red Cross and Red Crescent Societies (IFRC). Many countries lack the capacities to transition to ‘a new normal’: high vaccination coverage, strong healthcare systems or testing capacities. The crisis will not be over until everyone has the same access to these tools, the IFRC says.

Francesco Rocca, IFRC President, said: “’Living with the virus’ is a privilege that many countries and communities around the world cannot enjoy. Ensuring equitable access to vaccines, diagnostics and treatments will not only save lives, but will also protect the world against the emergence of new and more dangerous variants. It is the only path to normalcy. None of us is safe until we all are.”

Red Cross Red Crescent staff and volunteers are constantly working to close the equity gap, ensuring that vaccines make it to the vulnerable individuals and communities that desperately need them. Their role is crucial, not only in vaccination but in informing communities, building trust, and dispelling COVID vaccine misinformation. They have now reached over 300 million people through immunisation activities.

In countries like Zambia, where health systems are fragile and rumours around vaccines are spreading fast, vaccine supply is just one of numerous obstacles. The Zambia Red Cross Society’s mobile COVID vaccination campaign takes vaccines directly to people in hard-to-access areas. Volunteers mobilise communities for vaccination, raise awareness about the mobile vaccination centres, provide information about vaccines and engage local leaders as advocates for healthy behaviour change.

Afghanistan’s health system is struggling as a new wave of COVID infections hits. Afghan Red Crescent is ramping up services at its health clinics across the country and its COVID hospital in Kabul, while supporting nationwide vaccination efforts and running information campaigns on preventing the spread of the virus.

A record surge of infections in the Pacific region is threatening to overwhelm hospitals and health systems which, until now, have largely avoided the worst of the pandemic. In countries like Fiji and Vanuatu, with more than 165 inhabited islands, Red Cross volunteers have been travelling by car, boat and foot to reach remote communities to increase awareness about COVID and get people vaccinated.

COVID not only thrives on inequality but deepens it. Women, urban communities and migrants have been disproportionately affected by the devastating socioeconomic impacts. More than 5 million children have also lost a parent or another caregiver to COVID. Psychosocial support has been at the centre of Red Cross Red Crescent work, and volunteers are seeing a significant rise in mental health support needs.

Source: International Federation of Red Cross and Red Crescent Societies (IFRC)

Categories : Medical Research & TechnologyTags :

Study Implicates High Leptin Levels in Androgen Deficiencies

On By ModernMedia
Source: National Cancer Institute on Unsplash

Researchers have uncovered new clues about the cellular processes that can lead to androgen deficiencies, in which high leptin levels appear to play a role. The findings are published in the journal Cell Death & Disease.

Symptoms of testosterone deficiency include low sex drive, erectile dysfunction, depression, and fatigue. TD afflicts approximately 30% of men aged 40-79 years, with an increase in prevalence strongly associated with ageing and common medical conditions including obesity, diabetes, and hypertension.

“Although testosterone deficiency may be present in one in five men 40 years or older, the driving factors remain largely unknown,” said Himanshu Arora, PhD, assistant professor of urology.

Dr Arora’s lab examined the effect of different concentrations of leptin on the microenvironment of the testes. The research builds on prior studies of how Sertoli and peritubular myoid cells (PMC) in the testicular microenvironment help drive Leydig stem cell differentiation via the cellular desert hedgehog signalling pathway, which transmits information to embryonic cells that guides proper cell differentiation.

The researchers extracted cellular samples from men undergoing testes biopsies for sperm retrieval. When the testes microenvironment secreted leptin in low doses, they found that Leydig stem cells differentiated into adult Leydig cells producing normal levels of testosterone. Higher doses of leptin were observed to depress testosterone levels.

“Our findings identify leptin as a key factor within the testes microenvironment,” said Dr Arora, adding that the insight “holds important implications for androgen deficiency and could have further application in prostate cancer research.”

Noting that leptin is already used in treating patients for obesity, “Preclinical studies could indicate whether adjusting levels of this hormone would be helpful in patients with testosterone deficiency,” said Ranjith Ramasamy, MD, study co-author and associate professor and director of the Miller School’s Reproductive Urology Program.

Source: University of Miami Health System, Miller School of Medicine

Categories : Environmental EffectsTags :

Climate Change Will Increase Deaths Linked to Extreme Temperatures

On By ModernMedia
Heat cracked earth
Photo by Joshua Woroniecki on Unsplash

The death rate linked to extreme temperatures will increase significantly under global warming of 2°C, with even steeper rises for each degree of warming, finds a report published in Environmental Research Letters.

With a warming scenario of just 2°C from pre-industrial levels, temperature-related mortality in England and Wales during the hottest days of the year will increase by 42%. This means an increase from present-day levels of around 117 deaths per day, averaged over the 10 hottest days of the year, to around 166 deaths per day. The findings underline the importance of keeping global warming levels to below 2°C.

At current global warming levels of around 1.21°C there would be a slight decrease in temperature-related mortality in winter and a minimal net effect in summer, meaning that overall, at this level of warming we see a slight decrease in temperature-related mortality rate.

The researchers assessed the impact of climate change on mortality rates England and Wales, specifically risk from heat in summer and cold in winter. They found that as the global mean temperature increases, temperature-related mortality in summer will increase at a much faster, non-linear rate.

The rate of increase particularly speeds up at 2°C of warming, with a much higher risk appearing beyond 2.5°C. The researchers say that 3°C warming could lead to a 75% increase in mortality risk during heatwaves.

The relationship between temperature and mortality on a graph is roughly U-shaped, meaning that at extremely high temperatures, mortality risk increases sharply for each degree rise of daily mean temperature.

The rate in winter will continue to decrease, although this leaves out extreme weather events such as storms.

Lead author Dr Katty Huang said: “The increase in mortality risk under current warming levels is mainly notable during heatwaves, but with further warming, we would see risk rise on average summer days in addition to escalating risks during heatwaves. What this means is that we shouldn’t expect past trends of impact per degree of warming to apply in the future. One degree of global warming beyond 2°C would have a much more severe impact on health in England and Wales than one degree warming from pre-industrial levels, with implications for how the NHS can cope.”

In England and Wales, temperature is associated with around 9% of total population mortality, meaning that 9% of all deaths during 2021 could be associated with the temperature. Most of those deaths are related to the side effects of cold weather.

The team analysed the 2018 UK Climate Projections (UKCP18) with data on present-day temperature and mortality in order to predict changes in temperature-related mortality relative to degrees of global warming.

In order to isolate the effects of global warming on mortality risk, the researchers looked at the potential impact for the current population, and not attempting to predict future age distributions and medical conditions.

Project lead Professor Andrew Charlton-Perez said: “As the Intergovernmental Panel on Climate Change impacts report recently showed, it is increasingly common to examine how different levels of mean global warming raise the risk of significant harm to people and society. Our study shows that because death rates will go up significantly if countries experience very high temperatures, limiting the average global rise in temperatures is likely to have substantial benefits for the overall health of the population.”

Source: University College London