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By David Rowlands, Mar 24 2018 01:17PM

Hepatitis C is not a visible virus. It disproportionately affects disadvantaged and marginalised communities, with almost half of people who attend hospital for hepatitis C coming from the poorest fifth of society. People living with hepatitis C often experience few obvious symptoms, and 40-50% of the estimated 160,000 with hepatitis C in England are unaware they are infected, though the virus can lead to fatal liver cirrhosis and cancer. Those most at risk of transmission from blood-to-blood contact are already from marginalised groups less likely to have a strong voice, including people who inject drugs, men who have sex with men, and migrant communities from endemic countries. When compared to HIV, also a blood-borne virus with similar transmission routes, awareness of hepatitis C is exponentially lower.


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Today’s report by the All-Party Parliamentary Group on Liver Health makes bold recommendations designed to press forward towards achieving NHS England’s ambition to eliminate hepatitis C by 2025, five years before the World Health Organization’s global target. However, expert witnesses to the APPG’s inquiry agreed that unless the number of people getting diagnosed and treated is significantly increased, this ambition will not be met.


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By David Rowlands, Feb 22 2018 09:42AM

Gilead’s pan-genotypic treatment for hepatitis C Vosevi has won the National Institute for Health and Care Excellence’s seal of approval for use on the NHS.


Vosevi (sofosbuvir/velpatasvir/voxilaprevir; SOF/VEL/VOX) was cleared by European regulators in July last year as the first and only single tablet regimen for patients with any genotype of chronic hepatitis C virus infection.


The therapy was authorised as a 12-week treatment regimen, for patients without cirrhosis or with compensated cirrhosis, on the back of clinical data showing high cure rates.


Clinical data from two Phase III clinical trials, involving around 750 HCV patients without cirrhosis or with mild cirrhosis, showed that 96-97 percent of those who received Vosevi had no virus detected in the blood 12 weeks post treatment.


In final guidelines, NICE has approved NHS funding for the therapy to treat patients with hepatitis C genotypes 1-6 following prior treatment with direct-acting antivirals (DAA), and for DAA treatment-naïve patients with genotype 3.


Vosevi costs £14,942.33 per 28-day pack, but Gilead has agreed a nationally available price reduction on the therapy with the Commercial Medicines Unit, the level of which remains confidential.


HCV infection is considered a major public health challenge, with around 15 million people chronically infected across the UK and the disease representing the most common single cause of liver transplantation in the region.


Last month, NHS England laid out plans for England to become the first country to eliminate hepatitis C, at least five years earlier than the World Health Organisation’s target date of 2030.


February is set to see the single largest medicines procurement ever undertaken by the NHS, which will see new agreements drawn up with drug companies that will involve collaboration to identify more people who are living with hepatitis C who need to be treated, the organisation said.


By David Rowlands, Feb 19 2018 07:31AM

Organised jointly by EATG, AVAC, AIDSfonds, AIDES, AIDS Action Europe, NAM-AIDSMAP, NAT, Prepster, UNAIDS, WHO, the European PrEP Summit was organised in Amsterdam on 9-10 February 2018. The more than 120 participants included prescribers, doctors, activists, buyers’ clubs, community representatives and researchers all aligned to explore and discuss the situation of PrEP in Europe.


Access, the issue of generics, different solutions for mainstreaming PrEP in LGBT organisations and beyond, the situation of women, migrants, black people and other minorities that have even more difficult access were discussed, and some key finding were also shared.


All presentations from the conference are uploaded to the PrEP in Europe website. A report follows later.


Source of information www.eatg.org


By David Rowlands, Feb 8 2018 12:48PM

Gilead’s new combination therapy Biktarvy has been approved by the US Food and Drug Administration for the treatment of HIV.


The once-daily single tablet regimen combines the novel investigational integrase strand transfer inhibitor bictegravir with emtricitabine/tenofovir alafenamide (FTC/TAF; marketed as Descovy).


The therapy has shown high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials involving treatment-naïve adult patients and among virologically suppressed adults who switched regimens.


The application centered on data from four Phase III studies in which the regimen met its primary goal of non-inferiority to ViiV Healthcare’s flagship drug dolutegravir (DTG) at 48 weeks.


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By David Rowlands, Jan 31 2018 03:14PM

England could be the first country in the world to eliminate Hepatitis C, under ambitious plans announced by the NHS today.


NHS leaders today called on the pharmaceutical industry to work with them to provide best value for money for treatments so that in its 70th year, the NHS can commit to eliminating Hepatitis C in England at least five years earlier than the World Health Organisation goal of 2030.


Hepatitis C is currently a significant public health issue globally, accounting for around 400,000 deaths per year. Most recent figures show that Hepatitis C is affecting 160,000 people in England.


The NHS has invested in Hepatitis C treatment each year as new treatments became available to improve outcomes for people with the virus but doctors, patient groups and NHS leaders believe it is possible to go further and is encouraging pharma companies to work with them to meet this more ambitious target.


The next round of procurement, which launches in February, is the single largest medicines procurement ever done by the NHS, and NHS England expects to see more new treatments curing even more patients by October. Over 25,000 patients have already been treated to date and this number is expected to rise to 30,000 later this year, prioritising the sickest patients first.


Part of the new agreements between NHS England and drug companies will involve collaboration to identify more people who are living with Hepatitis C who need to be treated. Experts have predicted that this approach, combined with the NHS sustaining the same level of investment and the best new treatments being used could undoubtedly lead to Hepatitis C being eradicated as a major public health concern in the very near future.


England is one of few countries in Europe where numbers of patients receiving new oral treatments for Hepatitis C are already increasing year on year, enabled by deals previously agreed with industry. The deals, including ‘pay per cure’ where the NHS only pays when a patient is cured and a focus on prioritising the sickest patients, have led to a 10% reduction in the number of deaths and the numbers of patients needing a liver transplant have reduced by 50%.


Further progress to date in the treatment of Hepatitis C includes:


The creation of 22 ‘operational delivery networks’ in each area in England – driving improvements in treatment in local areas, ensuring all patients can access the treatment they need, regardless of where they live. This will enable improvements in areas with historically low service provision.

In 2017 a National Hepatitis C patient registry was established – making it possible to record and monitor treatment uptake, outcomes and increased diagnosis rates in real time.


Professor Graham Foster, National Clinical Chair for Hepatitis C, NHS England, said:


“The progress made in the treatment of Hepatitis C has transformed the lives of many of my patients and has been made possible by NHS England working closely with industry to bring prices down and expand treatment options. Yet we have the opportunity to do so much more. Over the last seven decades, the NHS has been at the forefront of medical innovation – to be able to commit to a world first in the year of the NHS’ 70th anniversary would be another remarkable and truly historic achievement.”


Peter Huskinson, National Commercial Director, NHS England, said:


“The NHS has made major headway in the last three years in the treatment of Hepatitis C, which has enabled a once in a generation opportunity to eliminate a major disease. With the right response from pharma companies in the coming months, we can strike the most competitive deal possible – improving the future for patients with Hep C alongside securing the best value for money for taxpayers.”


Charles Gore, CEO of The Hepatitis C Trust, the national Hepatitis C charity, said:


“This is wonderful news. It is exactly what is needed. The proposed deal will galvanise the action we must take to find all those living with Hepatitis C who have not yet been diagnosed so that we can cure them. It will prevent the liver cancer that Hepatitis C causes. It will save lives. In the current environment we applaud NHS England’s ambition to be a world leader.”


Judi Rhys, Chief Executive of the British Liver Trust, said:


“We are delighted that NHS England are playing a leading role in tackling Hepatitis C and eliminating this deadly virus. A key challenge will be the fact that hep C often has no symptoms in the early stages and it is thought that less than half of those living with the virus have been diagnosed. It is therefore vital that anyone who is at risk asks to be tested.”


By David Rowlands, Jan 12 2018 06:03PM

For the first time in 37 years, an end to new HIV transmissions is beginning to look achievable


The Mayor of London, Sadiq Khan, together with a Who’s Who in council politics, signed the Paris Declaration on Fast-Track Cities aiming to End the AIDS Epidemic. In an event held at City Hall, the Mayor and representatives from NHS England, Public Health England and London Councils, all pledged support for the initiative.


Their ambition is a bold one. Firstly, to cut rates of new HIV infection in the capital and secondly, and in many ways more importantly, to eliminate the discrimination and stigma associated with the condition.


Signing such a declaration poses two key questions: firstly, is this important? And secondly, is it achievable? The answer, in short, is definitely and maybe.


For the British HIV Association (BHIVA) and many other campaigning organisations this really is an incredibly important and courageous statement for the Mayor to make. It means he is putting the weight of City Hall behind the fight to halt the spread of HIV, and to end the discrimination and stigma associated with it.


He said: “As well as putting an end to new infections, I am clear that HIV-related stigma and discrimination must end too. Improving the quality of life and wellbeing of those living with HIV in London is a priority for me, which is why I’m proud to sign this commitment today.”


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Source of information www.huffingtonpost.co.uk


By David Rowlands, Dec 18 2017 11:08AM

The WHO Regional Office for Europe is seeking input on a United Nations (UN) common position paper on ending tuberculosis (TB), HIV and viral hepatitis through intersectoral collaboration, drafted in collaboration with sister UN agencies. The consultation survey will remain available until 11 January 2018 and can be accessed here.


The paper illustrates the factors outside the health sector that influence the ongoing epidemics of TB, HIV and viral hepatitis in the WHO European Region, and sets a vision for cross-sectoral actions, highlighting principles and directions. It also looks at possible and practical means of implementation and evaluation.


The five questions in the survey focus on the sections that concern shared principles, directions for action, and accountability and operationalization.


The survey will take approximately 10 minutes and is anonymous.


Source of infomration www.eatg.org

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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