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By David Rowlands, Dec 12 2017 11:11AM

The National Institute for Health and Care Excellence (NICE) published guidance in the form of a Final Appraisal Determination (FAD), confirming that AbbVie’s Maviret®, a once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A inhibitor and pibrentasvir (40mg), an NS5A inhibitor (glecaprevir/pibrentasvir), is recommended within its marketing authorisation, as an option for treating chronic hepatitis C infection in adults.


Maviret® is licensed as a treatment in the EU for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). It is also licensed for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 (GT3) chronic HCV infection.


Chronic HCV is a silent, progressive disease that can lead to liver damage (fibrosis or cirrhosis), liver cancer and death. More than 200,000 people in the UK are estimated to be chronically infected with hepatitis C. Of those chronically infected, only an estimated three percent receive treatment each year, despite the advent of treatments that can offer viral elimination.


David Rowlands, HCV patient champion for the Leicester Operational Delivery Network explains: “This is great news. People living with hepatitis C have been eagerly awaiting these new pan-genotypic treatments and it is now vital that NHS England ensures patients have access to them as quickly and widely as possible. These drugs are cost effective and allow patients to be cured in as little as 8 weeks, so the UK government should now seize the opportunity in front of it to make good on its publically stated commitment to eliminate hepatitis C as a public health threat by the World Health Organization’s target of 2030. As a minimum, we need to work together to develop community outreach clinics to find people who are not yet engaged in treatment. As a minimum, we need to work together to develop community outreach clinics to find people who are not yet engaged in treatment.”


Dr Alice Butler, UK Medical Director, AbbVie said: “We welcome the NICE decision as we believe that treatments, like MAVIRET®, have an important role to play in not only helping people clear the hepatitis C virus and move on with their lives, but also in opening up new approaches to how and where patients can be treated. Rather than traditionally focusing on treating within hospital settings, once-daily, pan-genotypic options enable treatment to be delivered to patients more locally, within their own communities. This could be an important strategy to reach patients who don’t typically engage with healthcare services.


We look forward to seeing NHS England implementing the NICE guidance swiftly and in full as soon as possible to benefit all eligible patients”, Dr Butler concluded.


Read the full press release...

By David Rowlands, Dec 12 2017 10:55AM

Even a scrap of old DNA can yield vital clues about the history of a disease. So when Oliver Pybus, an evolutionary biologist at Oxford University, heard about the short sequence of viral genome extracted from blood kept frozen for more than 60 years, he had to have it. With that genetic sliver, Pybus thought he could add a vital chapter to a story he has long sought to complete: the history of the hepatitis C virus.


Scientists have amassed a wealth of knowledge about hepatitis C since its discovery in 1989. The virus currently infects about 150 million people worldwide and exists in several variations, or genotypes. Roughly 3 million people are infected in the U.S., mostly as a result of blood transfusions before the mid-1970s, when paid blood donations were stopped. (People infected with hepatitis C, often through contaminated needles from injection drug use, accounted for a large swath of paid donors.)


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By David Rowlands, Dec 11 2017 10:24AM

An essay published in PLOS Medicine, building on the emerging HIV cure research ethics, identifies key ethical and implementation issues at each stage of the translational research continuum that are distinctive to HIV cure research. It highlights key potential ethical and implementation issues for HIV cure research developers, regulators, and policy makers.


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By David Rowlands, Nov 9 2017 12:33PM

HIV incidence among the HIV-negative gay men in the PARTNER 1 and 2 studies, due to sex with partners outside the main relationship, was high, and very high in partners who admitted having condomless anal sex with non-primary partners, the 16th European AIDS Conference (EACS 2017) heard recently.


The conference heard that even now, in the latest data from the PARTNER 2 study, only 5% of HIV-negative participants are taking pre-exposure prophylaxis (PrEP), even though over a third have had condomless anal sex with non-primary partners.


The data were presented by Valentina Cambiano of University College London, who is one of the investigators in the PARTNER studies.


PARTNER is arguably one of the most significant HIV prevention studies ever conducted. It studies couples where one partner has HIV and the other does not and its primary aim is to try to quantify the risk of transmission from a person on HIV treatment who has a fully suppressed viral load. While enrolment of heterosexual couples stopped at the end of PARTNER 1 in 2014, it was decided more data on gay men was needed so PARTNER 2, for gay couples only, is still underway.


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Source of information www.aidsmap.com

By David Rowlands, Oct 27 2017 12:38PM

AbbVie, a global research and development based biopharmaceutical company, today announced that its pan-genotypic hepatitis C regimen, Maviret®, has been recommended for use within NHS Wales, following an assessment by the All Wales Medicines Strategy Group (AWMSG). Maviret® is recommended for use for the treatment of chronic hepatitis C virus (HCV) infection in adults.


Chronic hepatitis C is a silent, progressive disease that can lead to liver damage, scarring of the liver (cirrhosis), liver cancer and death . It is estimated that in Wales 12,000 people are living with chronic hepatitis C .


“New treatments, such as Maviret®, offer patients with all the major genotypes of hepatitis C a chance of clearing the virus with as little as 8 weeks of treatment. This is good news for patients who now have a number of treatment choices that can benefit their quality of life and health. Treatment is cost effective and can also make a positive impact on overall public health as the pool of disease is reduced through treatment. It will also help Wales achieve targets in relation to the World Health Organization’s (WHO) elimination agenda,” said Dr Brendan Healy, Consultant in Infectious Diseases & Microbiology, University Hospital of Wales.


Charles Gore, Chief Executive of The Hepatitis C Trust comments, “This is good news for Wales but we now need to see England and Scotland following Wales’s lead quickly if we are to achieve the WHO goal of eliminating hepatitis C as a public health threat by 2030.”


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By David Rowlands, Oct 27 2017 12:29PM

Scaling up HIV testing to reduce undiagnosed HIV infection requires a fundamental re-ordering of HIV testing services to make them more attractive to people at risk, and doing so can bring about enormous changes in HIV incidence and treatment uptake, delegates heard on the opening day of the 16th European AIDS Conference (EACS 2017) in Milan.


Over the past three years, one clinic in London has seen recent HIV infections among gay and bisexual men using its services fall by around 90%. The experience of the 56 Dean Street clinic, in the heart of London’s West End, illustrates how services may need to change to improve rates of HIV diagnosis, increase the numbers of people on treatment and reduce new HIV infections among key populations, especially men who have sex with men.


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Source of infomation www.AIDSmap.com

By David Rowlands, Oct 3 2017 06:59AM

At last February’s Conference on Retroviruses and Opportunistic Infections (CROI), Dutch clinicians presented a so-far unique case of a man who had apparently become infected with non-drug-resistant HIV while taking pre-exposure prophylaxis (PrEP) consistently. Two previous cases of PrEP failure had been reported, but in both cases, the men concerned had been infected with multidrug-resistant HIV. This case, therefore, raised concerns that PrEP may not be 100% effective.


The case has now been published as a paper in The Lancet HIV journal. The report confirms the details presented at CROI but adds interesting data on an unusual course of seroconversion. Although there is no direct evidence for this, the researchers hypothesise that the PrEP might have stopped a localised HIV infection in rectal tissue spreading through the body, and the infection only became a typical, systemic infection when PrEP was stopped.


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Source of information aidsmap.com

By David Rowlands, Sep 28 2017 08:03AM

The majority of HIV-positive people in the UK are not receiving recommended monitoring of cardiovascular risk, according to the results of an audit conducted by the British HIV Association (BHIVA) published in BMC Infectious Diseases.


The audit also showed that only a small minority of people are receiving appropriate monitoring of bone mineral density and fracture risk. There was wide variation between clinics in monitoring rates for some conditions. But the survey also revealed some excellent practice, with monitoring of viral load and adherence to antiretrovirals exceeding national targets.


“There was high participation in the national audit and the data showed good practice in some areas,” comment the authors. “However, low recorded rates of monitoring of cardiovascular risk were noted and smoking status was not reported for one in seven patients, and less than half of current smokers were offered cessation support.”


Improvements in treatment and care means that HIV is now a chronic, manageable condition with many HIV-positive people having a normal or near-normal life expectancy.


Cardiovascular, liver, kidney and bone disease are now important causes of illness in HIV-positive individuals. The prompt identification of these conditions is important so that appropriate therapy can be initiated.


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Source of information www.aidsmap.com

By David Rowlands, Sep 13 2017 10:58AM

The cash-strapped NHS has struck up a 'pay as you cure' deal for a hepatitis C drug as it desperately attempts to save money.


Under the new deal, which is the first of its kind, the National Health Service will only pay for the medication if a patient is successfully cured.


For those who aren't cured by taking the medication, its manufacturer, who hasn't been identified, will cough up and pay the fee.


If it proves successful, the move by NHS England could be adopted for other costly treatments to reduce the nation's drug bill.


Currently, the health service spends more than £15 billion on the range of drugs it provides every year, according to official figures.


It comes amid repeated cuts to the NHS, which has seen various services scrapped in recent months, creating a 'postcode lottery' for many.


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By David Rowlands, Aug 17 2017 08:09AM

Work has begun to develop a digital value proposition tool for a novel rapid sexually transmitted infection (STI) test


Aquarius Population Health, a leading independent health economics consultancy, has recently been awarded an 18-month Innovate UK grant in collaboration with Atlas Genetics Ltd and the Applied Diagnostic Research and Evaluation Unit at St George’s University of London (total £2,000,000). The funding will be used to develop evidence for health services to support the introduction of a new rapid diagnostic test. In 30-minutes the test can diagnose multiple sexually transmitted infections including chlamydia and gonorrhoea – infections which could take up to a week to diagnose using the current laboratory testing systems.


Dr Mike Harvey and Dr Susie Huntington from Aquarius Population Health will be leading the work from Aquarius Population Health - mapping patient pathways within sexual health clinics and building a digital value proposition tool. Understanding the patient pathway facilitates thinking about new and better ways of delivering care and optimising resources for clinics. The digital value proposition tool will enable UK-based sexual health services to anticipate the potential benefits, costs and cost-effectiveness of adopting the new test. It will also quantify the impact on patients, sexual health services and on public health more broadly.


Dr Elisabeth Adams, Managing Director of Aquarius Population Health, comments:


“We are very excited to collaborate on this Innovate UK funded project. We’re convinced that our innovative digital value proposition tool will help sexual health clinics in their commissioning and adoption of this new technology.”


Dr John Clarkson, Chief Executive Officer of Atlas Genetics, comments:


“We are delighted to have been selected for this substantial follow-on contract. The work being done by this collaboration will enable us to better understand how best to integrate our io® system into UK sexual health clinical practice. Innovate UK’s commitment to introducing new, pioneering approaches to healthcare validates both our technology and our leading role in molecular diagnostics.”


Dr Tariq Sadiq, Director of The Applied Diagnostic Research & Evaluation Unit (ADREU), at St George’s University of London (SGUL), comments:


“This is a highly exciting and innovative approach to overcoming the substantial challenges to getting great technology adopted into the NHS by shedding light on potential routes through the complex landscape of factors and obstacles in our health systems.”


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