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| Version 0 | Version 1 |
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| Hepatitis C antiviral drugs are effective | Hepatitis C antiviral drugs are effective |
| (7 months later) | |
| The Cochrane analysis casting doubt on this life-saving therapy is flawed and may deter patients from seeking it, say clinicians and scientists | |
| Letters | |
| Tue 13 Jun 2017 20.03 BST | |
| Last modified on Mon 27 Nov 2017 22.43 GMT | |
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| We are clinicians and scientists who have studied and treated patients with chronic hepatitis C virus infection over many years and patient groups that represent those affected by hepatitis C. We write in response to your article on the effectiveness of antiviral therapy (Hepatitis ‘wonder drug’ may be clinically ineffective, say experts, 9 June). The Cochrane review that you highlight analysed clinical trials, which are by nature short term, where the sole purpose was to evaluate the virological efficacy of new antiviral drugs. The trials were neither designed, nor powered, to assess mortality, so it is hardly surprising that the Cochrane review was unable to identify any impact on mortality. | We are clinicians and scientists who have studied and treated patients with chronic hepatitis C virus infection over many years and patient groups that represent those affected by hepatitis C. We write in response to your article on the effectiveness of antiviral therapy (Hepatitis ‘wonder drug’ may be clinically ineffective, say experts, 9 June). The Cochrane review that you highlight analysed clinical trials, which are by nature short term, where the sole purpose was to evaluate the virological efficacy of new antiviral drugs. The trials were neither designed, nor powered, to assess mortality, so it is hardly surprising that the Cochrane review was unable to identify any impact on mortality. |
| Regulatory authorities and clinicians all recognise that clearing hepatitis C virus reduces mortality. Indeed, UK-based research demonstrates that oral antiviral treatment for patients with hepatitis C who also have cirrhosis substantially decreases mortality and morbidity (Cheung et al Journal of Hepatology 2016). | Regulatory authorities and clinicians all recognise that clearing hepatitis C virus reduces mortality. Indeed, UK-based research demonstrates that oral antiviral treatment for patients with hepatitis C who also have cirrhosis substantially decreases mortality and morbidity (Cheung et al Journal of Hepatology 2016). |
| Current data from Public Health England reveal that there has already been an 11% reduction in mortality following the introduction of antiviral therapy, as well as a 50% reduction in a need for liver transplantation for chronic hepatitis C infection, with the added benefit that more donor organs will now be available for patients without viral hepatitis. | Current data from Public Health England reveal that there has already been an 11% reduction in mortality following the introduction of antiviral therapy, as well as a 50% reduction in a need for liver transplantation for chronic hepatitis C infection, with the added benefit that more donor organs will now be available for patients without viral hepatitis. |
| These data are supported by similar analyses worldwide. The Cochrane analysis is fundamentally flawed, does not reflect international experience of the benefits of antiviral therapy, and has the potential to deter patients with hepatitis C from seeking life-saving antiviral therapy. | These data are supported by similar analyses worldwide. The Cochrane analysis is fundamentally flawed, does not reflect international experience of the benefits of antiviral therapy, and has the potential to deter patients with hepatitis C from seeking life-saving antiviral therapy. |
| The real story is one of remarkable, if surprising, success over just a decade, transforming an unpleasant and sometimes fatal disease into one that is readily cured.Graham R Foster Professor of hepatology, Queen Mary University of London, William Irving Professor of virology, University of Nottingham, John McLauchlan Professor of viral hepatitis, University of Glasgow, Charles Gore CEO, The Hepatitis C Trust and president, World Hepatitis Alliance, Graeme JA Alexander President, British Association for the Study of The Liver | The real story is one of remarkable, if surprising, success over just a decade, transforming an unpleasant and sometimes fatal disease into one that is readily cured.Graham R Foster Professor of hepatology, Queen Mary University of London, William Irving Professor of virology, University of Nottingham, John McLauchlan Professor of viral hepatitis, University of Glasgow, Charles Gore CEO, The Hepatitis C Trust and president, World Hepatitis Alliance, Graeme JA Alexander President, British Association for the Study of The Liver |
| • It can take decades for a person to realise that they are infected with hepatitis C, by which time their liver may have been significantly damaged. As such, the objective of clinical trials is to demonstrate clearance of the virus in the blood (SVRs) to predict the effectiveness of treatment, rather than studying mortality, which would require studies to run over periods of up to 30 years. This objective measure, along with other “surrogate markers”, is an internationally recognised and accepted benchmark used by medicines regulators, clinicians and researchers alike. | • It can take decades for a person to realise that they are infected with hepatitis C, by which time their liver may have been significantly damaged. As such, the objective of clinical trials is to demonstrate clearance of the virus in the blood (SVRs) to predict the effectiveness of treatment, rather than studying mortality, which would require studies to run over periods of up to 30 years. This objective measure, along with other “surrogate markers”, is an internationally recognised and accepted benchmark used by medicines regulators, clinicians and researchers alike. |
| There is also a wealth of evidence that demonstrates the impact of being infected with the hepatitis virus on progression – from early cirrhosis of the liver through to end-stage liver failure and liver transplant or liver cancer. This is why the markers that measure how much virus a patient is carrying, and whether the virus has been eradicated, are of crucial importance. | There is also a wealth of evidence that demonstrates the impact of being infected with the hepatitis virus on progression – from early cirrhosis of the liver through to end-stage liver failure and liver transplant or liver cancer. This is why the markers that measure how much virus a patient is carrying, and whether the virus has been eradicated, are of crucial importance. |
| All of this is taken into account by Nice as part of its strict assessment process. | All of this is taken into account by Nice as part of its strict assessment process. |
| Our concern is that the Cochrane Collaboration research has been reported in a way that only tells half of this story, which is unhelpful for patients who are currently living through the pain of progressive liver disease or end-stage liver failure.Dr Paul Catchpole Value and access director, Association of the British Pharmaceutical Industry (ABPI) | Our concern is that the Cochrane Collaboration research has been reported in a way that only tells half of this story, which is unhelpful for patients who are currently living through the pain of progressive liver disease or end-stage liver failure.Dr Paul Catchpole Value and access director, Association of the British Pharmaceutical Industry (ABPI) |
| • Having contracted hepatitis C from blood transfusions in 1978 and thought I was permanently depressed, I was shocked to read a lengthy, negative report in the Guardian. | • Having contracted hepatitis C from blood transfusions in 1978 and thought I was permanently depressed, I was shocked to read a lengthy, negative report in the Guardian. |
| Having qualified to be treated with one of the new drugs last summer, clearing the virus, to my joy I found this depression, with which I’d lived half my life, was due to this pernicious and largely underreported virus. This has enabled me to deal with other incurable medical conditions with great optimism and, at the age of 76, given me a new perspective on life. There is more joy.Jan MortimerLewes, East Sussex | Having qualified to be treated with one of the new drugs last summer, clearing the virus, to my joy I found this depression, with which I’d lived half my life, was due to this pernicious and largely underreported virus. This has enabled me to deal with other incurable medical conditions with great optimism and, at the age of 76, given me a new perspective on life. There is more joy.Jan MortimerLewes, East Sussex |
| • Join the debate – email guardian.letters@theguardian.com | • Join the debate – email guardian.letters@theguardian.com |
| • Read more Guardian letters – click here to visit gu.com/letters | • Read more Guardian letters – click here to visit gu.com/letters |
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