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Hopes of hepatitis C cure raised after antiviral drug treatment success.

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Sofosbuvir and ledipasvir stop virus replicating in 97% of patients in study reported in the Lancet journal

Hepatitis C virus seen through an electron microscope. Photograph: UIG/Getty

Scientists have reported the successful eradication of hepatitis C in patients using two new antiviral drugs, raising hopes of a possible cure.

In the trial, the virus was eliminated from almost all the patients involved, including those who had not previously responded to existing drugs.

Hepatitis C is caused by a virus that spreads via bodily fluids and ends up damaging the liver. Unlike other forms of hepatitis, there is no vaccine and the only treatments include powerful combinations of drugs known as interferons and protease inhibitors. But the treatments have many side-effects, are complex to administer and, in the common type of hepatitis C known as genotype 1, the drugs do not work. If an infection cannot be cured, it can lead to liver cancer.

The new treatment, reported in medical journal the Lancet on Tuesday , consists of the experimental drugs sofosbuvir and ledipasvir. In the trial, 100 patients with genotype 1 hepatitis C were split into groups and given the drugs in a single pill for either eight or 12 weeks. Forty of the participants had previously failed to respond to drugs and half of this group had cirrhotic livers.

After 12 weeks, 97% of the participants had what scientists called a “sustained virological response”, which meant that the hepatitis C virus was not replicating inside them. The patients suffered varying amounts of side-effects, including nausea, anaemia, respiratory tract infections and headaches, but none were considered to be serious.

Professor Eric Lawitz of the University of Texas, who led the study, said the results offered hope to people currently without treatment options: “The results of this trial suggest that the fixed-dose combination of sofosbuvir and ledipasvir could offer patients a short, all-oral treatment that might be highly effective and safe in patients who tend not to respond well to existing therapies, including individuals with cirrhosis, or black race, resistant strains of the virus.”

Charles Gore, chief executive of the Hepatitis C Trust, said the new drug combination was great news. “We were concerned that those with advanced hepatitis C would remain difficult to treat, but these new direct antivirals are incredibly potent. The results suggest that even the most difficult to treat people will in fact be extremely treatable. It now looks as if almost no one will be excluded from benefiting from treatment, which is an incredible achievement.

“There are a number of exciting new drugs on the horizon. However, of the 215,000 people estimated to be living with the virus in the UK, less than half have been diagnosed. In England, only 3% of hepatitis C patients receive treatment each year. There is no point having these treatments if we can’t use them, so we must ensure that we diagnose more people who can avail of them.”

In 2010, a total of 7,834 new hepatitis C cases were reported in England, though the true figure is probably much higher. Rates of infection are greater in people of African descent than in other ethnic groups.

The virus is present in the blood and, to a much lesser extent, the saliva and semen or vaginal fluid of an infected person.

It is most likely to be transmitted through blood-to-blood contact. Intravenous drug users who share their needles are known to be especially vulnerable.

Professor Margaret Hellard of the Burnet Institute in Melbourne, Australia, who co-authored a linked comment on the research published in the Lancet, said: “As a proof of concept study, [this] demonstrates very high response rates, regardless of the presence of cirrhosis, prior treatment failure, or [resistant] genotype.”

She cautioned, however, that the study was small, based at a single location and only had a short follow-up, which she said raised concerns about how representative the sample was and whether early clinical trial results could be generalised to real-world settings. “Whilst giving cause for optimism, the full implications of these results need to be tempered for now,” she wrote.

Growing cartilage with a 3D printer..

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A partnership between scientists at the University of Wollongong and St Vincent’s Hospital Melbourne has led to a breakthrough in tissue engineering, with researchers growing cartilage from stem cells to treat cancers, osteoarthritis and traumatic injury.

In work led by Associate Professor Damian Myers of St Vincent’s Hospital Melbourne – a node of the UOW-headquartered Australian Research Council Centre of Excellence for Electromaterials Science (ACES) – scaffolds fabricated on 3D printing equipment were used to grow cartilage over a 28-day period from stem cells that were extracted from tissue under the knee cap.

 

Professor Myers said this was the first time true cartilage had been grown, as compared to “fibrocartilage”, which does not work long-term.

“We are trying to create a tissue environment that can ‘self-repair’ over many years, meaning the repaired site will not deteriorate,” he said.

“It’s very exciting work, and we’ve done the hard yards to show that what we have cultured is what we want for use in surgery for cartilage repair.”

ACES Director Professor Gordon Wallace and his team developed customised fabrication equipment to deliver live cells inside a printed 3D structure. This cutting edge technology was utilised to deliver 3D printed scaffolds on which the cartilage was grown.

“ACES has established a biomedical 3D printing lab at St Vincent’s Hospital Melbourne in April this year. This has greatly accelerated progress by bringing clinicians and materials scientists face to face on a daily basis,” Professor Wallace said.

This research, which will soon move to pre-clinical trials to demonstrate repair of cartilage, is part of a wider limb regeneration project, involving Professor Wallace, Professor Mark Cook and Professor Peter Choong through the Aikenhead Centre for Medical Discovery. The aim is to eventually use a patient’s own stem cells to grow muscles, fat, bone and tendons.

Professor Wallace and his team are also working to develop custom-made 3D printed human organs.

“By 2025, it is feasible that we will be able to fabricate complete functional organs, tailored for an individual patient,” he said.

 

Source: http://www.sciencealert.com.au

 

 

Better asthma drugs on way.

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Wai-Meng-Woo_AsthmaCompound_FreshScience

Asthma inhalers could soon become much more effective, thanks to a clever new way of making the particles they deliver invented by a Melbourne chemical engineer and his team.

Current puffer designs and typical size ranges of particles mean a large portion of the medication propelled into a patient’s throat remains there. Only a fraction reaches the lungs.

 

But Monash University lecturer Dr Meng Wai Woo and his team have now developed a method of making ultra-fine particles, which will make drug delivery much more consistent and efficient. The new method, known as anti-solvent vapour precipitation, uses ethanol to dehydrate droplets, and results in super-small particles of uniform size.

“Ultrafine uniform particles will ensure that fewer drug particles get stuck in the throat while more can reach the lower regions of the lungs,” said Dr Woo. “Because we can now make the small particles more uniform, it means the inhalers will work better.”

The team’s work results in particles smaller than a micron (thousandth of a millimetre) in diameter – much smaller than those produced by conventional dehydrating mechanisms, which are limited by the size of the atomised droplet.

The team’s discovery was unveiled at the 18th International Drying Symposium in Xiamen, China, last year. It is likely to excite a lot of interest among pharmaceutical companies. Infusion devices and metered dose inhalers account for around $US20 billion in worldwide sales each year, with the key development aim being to balance improved efficiency against the cost of manufacture.

“From a drug manufacturer’s perspective, this new approach can maintain the uniformity of the particle and yet potentially maintain commercially viable production rate,” said Dr Woo.

Investigations into using ethanol as a means of producing ultrafine particles began in 2011, as part of Dr Woo’s ongoing research into manufacturing processes in the dairy industry.

Attempting to produce lactose crystals, his team decided to reject the traditional hot air drying method and use nitrogen laced with ethanol vapour as an alternative dehydrating agent.

To their surprise, the result was not the crystals they expected, but hundreds of very tiny, very uniform lactose particles. Further testing showed that the amount of alcohol absorbed into the initial droplets was a key variable in influencing the outcome.

Dr Woo’s method means that the pharmaceutical industry can now potentially deliver critical medicines via the airway direct into the lungs with much greater accuracy.

Assisted by a grant from the Australian Research Council, the Monash team is now testing its method on another dairy product – whey – researching the ultrafine particle delivery of protein-based medicines. They are also building a demonstration unit to showcase the anti-solvent vapour precipitation process, which will be completed later this year.

Dr Woo is one of 12 early-career scientists unveiling their research to the public for the first time thanks to Fresh Science, a national program sponsored by the Australian Government through the Inspiring Australia initiative.

Source: http://sciencealert.com.au

 

95th annual meeting of the Endocrine Society.

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Cognition and testosterone replacement therapy

 

Testosterone replacement therapy in postmenopausal women might preserve cognitive function according to results of a single-centre, double-blind, randomised, placebo-controlled trial presented by Susan Davis (Monash University, Melbourne, VIC, Australia). Women participating in the study were aged 55—65 years, not receiving other hormone replacement therapy, and had normal cognitive function. 92 participants were randomly assigned to receive 220 μg per day of transdermal testosterone gel or placebo for 26 weeks, and were assessed for cognitive function at 0, 12, and 26 weeks. Results of intention-to-treat analyses showed women receiving testosterone treatment scored 1·57 points higher on a 48-point scale for verbal learning and memory than did women in the placebo group, a change roughly equal to the cognitive decline reported over 1 year in a patient with Alzheimer’s disease. Other cognitive measures did not differ between treatment groups. These results suggest that normalising testosterone in postmenopausal women to concentrations found in younger women might help to preserve visual learning and memory abilities with age.

Medicine for a circadian disorder?

Sleep irregularities or restriction are increasingly associated with metabolic dysfunction. Blind individuals unable to perceive light frequently have sleep disorders, such as non-24-h sleep-wake disorder, due to dysregulation of light-regulated circadian rhythms. Steven Lockely (Harvard Medical School, Boston, MA, USA) presented the results of two phase 3 randomised, multicentre, double-blind, placebo-controlled trials that tested tasimelteon to treat individuals that have non-24-h sleep-wake disorder. Tasimelteon is a selective agonist for melatonin receptors MT1 and MT2 hypothesised to entrain the sleep cycles of blind individuals with non-24-h sleep-wake disorder. In the Safety and Efficacy of Tasimelteon (SET) study, 84 patients were randomly assigned to receive tasimelteon or placebo for up to 6 months. Significantly more patients receiving tasimelteon than those receiving placebo were entrained after 6 months of treatment (20% vs 3%, p=0·0171). In the Randomised-withdrawal Study of the Efficacy and Safety of Tasimelteon (RESET), 20 blind individuals with non-24-h sleep-wake disorder who had been entrained with tasimelteon treatment were randomly assigned to continue taking the drug, or switch to placebo, for 2 months. 90% taking the drug maintained entrainment versus 20% taking placebo (p=0·0026), suggesting that continuous treatment with tasimelteon is needed to maintain benefit. Tasimelteon was safe and well tolerated and caused a low incidence of minor adverse events such as nausea, headache, and sleepiness. This drug might also have a role for other indications such as delayed sleep phase disorder or jetlag.

Atorvastatin and paediatric type 1 diabetes

Preliminary results of a randomised controlled trial, presented by J Atilio Canas (Nemours Children’s Clinic, Jacksonville, FL, USA), showed that atorvastatin is safe and effective for reducing LDL cholesterol and other atherogenic lipoprotein particles in children with type 1 diabetes. Children with type 1 diabetes have a high risk of cardiometabolic complications later in life and thus early management of lipoprotein might prove beneficial. After a 3 month run-in period, 42 children with type 1 diabetes were randomly assigned to receive atorvastatin (n=21) or placebo (n=21) for 6 months. At baseline, all randomly assigned children had significantly higher concentrations of lipoprotein subfractions than a control group of healthy children. After 6 months, concentrations of atherogenic lipoproteins had decreased significantly in type 1 diabetic children receiving atorvastatin, whereas those in the placebo group stayed the same or increased. HbA1c concentrations remained the same in both groups. No severe adverse events related to atorvastatin were reported.

Puberty suppression in transgender adolescents

In some countries, adolescents with gender dysphoria can be treated with gonadotropic-releasing hormone analogues (GnRHa) to reversibly suppress puberty, lessening psychological difficulties. Whether such treatment affects the development of other systems, particularly bone, has been unclear. Henriette Delemarre-van de Waal (Leiden University Medical Center, Leiden, Netherlands) presented the results of a study done in the Netherlands in which 126 adolescents aged 12—14 years received GnRHa for up to 4 years, after which they began receiving cross-sex hormones involved in gender reassignment. GnRHa treatment for up to 4 years did not affect insulin sensitivity, or amounts of cholesterol, HDL, or LDL. Normal accumulation of bone mass was slowed with GnRHa treatment, but rapidly recovered to amounts seen in untreated individuals once treatment with cross-sex hormones was started. Studies in progress will address the effects of GnRH treatment on brain development and function.

Endoscopic ultrasound for pNETs

Pancreatic neuroendocrine tumours (pNETs) are the second most common tumour in patients with multiple endocrine neoplasia type 1 (MEN1), and the leading cause of MEN1-related death. Sophie van Asselt (University of Groningen, Groningen, Netherlands) presented results showing that endoscopic ultrasound (EUS) is better than CT or MRI for pNET yearly screening in patients with MEN1. In a prospective, multicentre, cross-sectional study, 41 patients with genetically confirmed MEN1 were screened by CT or MRI, EUS, and 11C-5-hydroxytryptophan PET (11C-5-HTP PET). 102 pancreatic lesions were reported in 35 patients. EUS was more sensitive than CT or MRI, both at the patient level (tumours detected in 97% vs51% of patients) and the lesion level (94% vs 30% of lesions detected). Screening by 11C-5-HTP PET contributed no added value. A limitation of the study was the absence of histological confirmation of the pNETs; follow-up studies will assess clinical outcomes.

Hypoparathyroidism survey reported

Bart Clarke (Mayo Clinic, Rochester, MN, USA) presented results of the PARADOX study, which aimed to characterise in detail the symptoms of individuals with hypoparathyroidism. 374 patients from the USA participated in an internet-based survey that included questions about clinical symptoms and quality of life. The results showed many patients had symptoms not previously thought to be associated with low calcium concentrations, such as mental confusion and exercise and heat intolerance. Despite supplementation with vitamin D and calcium, almost all patients that responded to the survey continued to have symptoms, and 69% had cormorbid disorders including arrhythmias (66%) and kidney stones (35%). Limitations of this study will be addressed in a long-term follow-up, the PARADIGM study, which will involve creating a registry of several thousand patients, not limited to the USA. Trials investigating a new drug for hypoparathyroidism, PTH(1—84), are in progress.

Hospital readmissions for paediatric DKA

US hospital readmissions for paediatric diabetic ketoacidosis (DKA) are frequent, despite being preventable. A retrospective study presented by Faisal Malik (University of Washington, Seattle, WA, USA) assessed data from 42 children’s hospitals: 12 488 patients aged 2—18 years were admitted between 2004 and 2007 and followed up for 5 years. 28·3% of children were readmitted for DKA one or more times within 1 year of a previous admission. Characteristics associated with risk of readmission were age 12 years or older, female sex, mental health disorder, non-hispanic black ethnicity, or having public health insurance. Because each readmission for paediatric DKA costs an average of US$7162, and DKA can be reduced by better education and disease management, scope exists to reduce the number of readmissions.

Androgen replacement for Klinefelter syndrome

Low-dose androgen improves quality of life in Klinefelter syndrome (47, XXY) according to Judith Ross (Alfred I duPont Hospital for Children, Philadelphia, PA, USA) who presented a subset of results from a randomised clinical trial. In addition to hypogonadism and reduced fertility, Klinefelter syndrome is associated with a range of cognitive, behavioural, and motor deficits, some of which might be due to androgen deficiency in childhood. 93 prepubertal boys aged 4—12 years were randomly assigned to receive oxandrolone (n=46) or placebo (n=47) for 2 years. Children were tested at baseline, 1 year, and 2 years with standard questionnaires to assess anxiety and depression; at the same timepoints, parents responded to questionnaires that assessed child behaviour. After 2 years, children that had received oxandrolone had more positive scores for anxiety and depression than at baseline, whereas those in the placebo group scored the same as at baseline. Parents of children in the oxandrolone group documented improvements in several child behavioural measures, whereas parents of children in the placebo group did not report changes. No major adverse events were noted.

Diabetes and mortality after lung transplant

Kathryn Hackman (The Alfred Hospital, Melbourne, VIC, Australia) presented results of a single-centre retrospective study showing that diabetes is a major contributor to mortality in patients who have had a lung transplant. In 367 patients that received a lung transplant between 2001 and 2010, diabetes increased the risk of mortality by five times—more than any other risk factor. Surprisingly, the commonest cause of death was chronic graft rejection rather than diabetic complications. Whether patients had diabetes before or after transplant did not affect outcomes. These results call for more focused efforts to screen and prevent diabetes in patients who have received a lung transplant. Outstanding questions are whether glycaemic control affects graft function, and whether tight glycaemic control might improve outcomes in transplant recipients.

Source: Lancet

In Melbourne, designing future bodies.

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Imagine you could take a pill that lets you sweat perfume; have an electronic tattoo that could be augmented by touch; or wear a dress that blushes and shivers with your emotions. No, this isn’t the stuff of sci-fi dreams, it’s the far-future designs of Melbourne body architect Lucy McRae.

McRae imagines new ways to merge biology and technology into our own bodies. Her visualizations are fascinating and often unnerving possibilities of what our bodies might look like in the future.

A current TED Fellow, McRae regards the body as a blank canvas for her investigations, a core which she builds layers and concepts on top of. She is driven by an insatiable curiosity and desire to change the way we think about our bodies.

“As a body architect, I find ways of extending the body beyond its physical and biological edge, manipulating the natural silhouette with materials that are draped, injected or bathed over the skin,” she explains.“The outcome can sometimes be surprisingly morbid, imperfect or grotesque, each time I’m never anticipating the final result.”

So what exactly is a body architect? McRae says she is the first and only ‘body architect’ in the world, and gave herself the title to convince HR at Philips FutureLab to hire her. And it worked.

This elusiveness of an understandable job title has allowed her to create a unique specialization based on her diverse background and training.

As a teenager McRae was an athlete, competing in 100-meter hurdle events at State level. She also trained in classical ballet from the age of four until the time she left high school.

“The more projects I complete, the more I understand the influence my ballet training has. I developed a conscious awareness and periphery of understanding people’s body movements and behavior,” she says.

McRae quit ballet because she knew a career in dance was going to be short lived. She went on to design school, and later worked in architecture firms, with a brief stint in the fashion industry.

Today she is based in Amsterdam, returning home to Melbourne on occasion to work on commissioned works. Within the Philips Design Probes team, she examines how technology could impact the human body in 15 to 20 years (known in the industry as ‘far-future’ design).

“Most projects are motivated by the relationship technology has with the human body, inventing and speculating ways of merging the two closer together,” she says.

She has explored this concept in a number of projects, including her low-fi, confronting experiments with friend and Dutch artist Bart Hess.The two work under the moniker LucyandBart.

McRae’s commissioned works has also produced some curious results. The most well known is the liquid textile dress she made for Swedish pop star Robyn on the ‘Indestructible’ music video clip.

More recently, McRae unveiled the film Morphe – a collaboration with the Melbourne skincare brand Aesop.

Morphe is set in a future laboratory in which a scientist administers an assortment of gels, liquids and other beauty treatments to a sleeping muse.

“My work is seeded from instinct. My process is primitive, driven and inspired by my immediate surroundings. I think Aesop has subliminal effects on people. I feel we are both creating alternate worlds which are sincere and unafraid,” she says.

The film has obvious references to both Mary Shelley’s Frankenstein and Charles Perrault’s Sleeping Beauty. But McRae says that the inspiration for the narrative came from the nineteenth-century physicist and philosopher Hermann Ludwig Helmholtz and his observation on human perception, that “everything is an event on the skin.”

She has also finished directing a film for an Australian art patron and restaurant owner which links food and the body in a macabre setting.

“In the film I create an alternative world where we see a lone woman meticulously concocting substances in a morgue-type laboratory. Reproducing ‘life’, she clones humans, mixes genders, and fuses man and woman, like a chef composes food.”

“Each clone has slightly different sensory enhancements in taste or sight which she makes according to her mathematical matrix.”

“I use film as a way of experimenting and testing these ideas, creating alternative worlds where science, technology, architecture and fashion co-exist.

McRae also cites gene mutations as a source of inspiration. And she enthuses over the work of Professor Gregory Sporton, who has developed a vibrating suit used for training elite Olympic gymnasts.

“I like thinking about how this perfecting technology could affect fashion or dance. Imagine having people walking down the street performing obscured alien movements while wearing this vibrational suit,” she says.

It is this ‘what if?’ exploration of the crossover between technology and the body that continues to inform her work.

“The body is soaked in information and I find ways of harnessing that knowledge to innovate and evolve the body. My work blurs and disrupts the physical edges of the human silhouette and its effects on behaviour and communication.”

Source: smart planet

 

Sleeping in Space.

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How do astronauts sleep in space? A visiting sleep researcher is shedding light on the effects of spaceflight on astronauts’ sleeping patterns.

Dr Laura Barger, an instructor at Harvard Medical School’s Division of Sleep Medicine and an Associate Physiologist at Brigham and the Women’s Hospital in Boston, investigated the sleep of astronauts on Space Shuttle and International Space Station missions over the past decade, and is bringing her expertise to Melbourne.

A former Air Force Lieutenant Colonel, Dr Barger’s research interests have focused on the health and safety risks associated with unusual and extended work hours. As part of the Harvard Work Hours, Health and Safety Group, she has also studied medical residents, police officers, firefighters, federal air marshals, and mission controllers supporting the Phoenix Mars Lander mission.

Dr Barger said astronauts face a number of challenges when trying to sleep in space including unusual shift patterns, which could have similar effects observed in some shift workers on earth, a 90-minute light-dark cycle for every time astronauts orbit the earth and the physical ‘free-fall’ sleeping environment.

“We studied sleep aboard Space Shuttle and International Space Station Missions and found there is a vast amount of sleep deficiency among astronauts and a widespread use of sleep promoting medications during spaceflight,” Dr Barger said.

Dr Barger is in Melbourne with the support of the Harvard Club of Australia Foundation. She will work with Monash University sleep researchers, including Associate Professor Shantha Rajaratnam, also a member of the Harvard Work Hours, Health, and Safety Group, on the association between work hours, sleep deficiency and motor vehicle crashes.

“Across all occupations, one safety outcome we measure is the incidence of motor vehicle crashes. One goal of the Harvard Work Hours Health and Safety Group is to come up with a strategy for future research examining drowsy driving,” Dr Barger said.

In addition to undertaking research, Dr Barger will conduct a series of lectures and seminars at Monash, sharing her insight into the effects of spaceflight on sleep and the circadian timing system and the effects of extended work hours and sleep loss on health and safety.

Credit: http://www.monash.edu.au