Are new hepatitis C drugs all they’re cracked up to be?

There has been some media coverage of a review by the Cochrane Collaboration, which casts doubt upon the effectiveness of new hepatitis C treatments, and indeed the BMJ has addressed some of the controversy that has followed in its article ‘Are new hepatitis C drugs all they’re cracked up to be?’ by Nigel Hawkes (21st June 2017).

The Hepatitis C Coalition would like to state that we believe the Cochrane analysis to have some considerable shortcomings. For their methodology, the Cochrane Collaboration has taken a number of clinical trials, which are by nature short term, and designed to measure the efficacy of antiviral treatment and used them to analyse the impact of the drugs on morbidity and mortality. This contravenes the fundamental principles of evidence-based medicine. The sole purpose of these clinical trials was to evaluate the virological efficacy of new direct acting antiviral medicines (DAAs); such registration trials are not designed to look at morbidity or mortality.

Regulatory authorities such as the National Institute of Health and Care Excellence (NICE) and clinicians all recognise that clearing hepatitis C virus reduces mortality. Current data from Public Health England reveal that there has already been an 11% reduction in mortality following the introduction of antiviral therapy. These data are supported by similar analyses worldwide.

The scientific errors in this manuscript have had some very unfortunate effects. The global media reported on this data as showing that curing hepatitis C has no effect on outcomes. Such inaccurate interpretation could lead to a host of unintended consequences for people living with hepatitis C, many of whom are among the most marginalised in our society. Due to this report, patients with hepatitis C may potentially be unable to access lifesaving therapy.

To have produced such a report that may put patients in danger by potentially stopping or not taking effective treatments does the scientific credibility of evidence-based medicine more harm than good. It might be more prudent for funding for studies such as these to be diverted to causes that improve health.

We urge the Cochrane Collaboration immediately to publish clarification of their findings emphasising that the studies, as structured, cannot possibly draw any conclusions as to morbidity and mortality or other hard end points due to their short-term nature. The fact of virological cure is there and a statement as to the substantial other body of evidence showing that successfully treating hepatitis C does change outcomes should be included. We are sure that the Cochrane Collaboration would wish to avoid the situation where their work could lead to enhanced morbidity and mortality from a curable disease and we would be happy to help draft such clarification and provide any supporting evidence required.

The Hepatitis C Coalition is a group of leading clinicians, patient organisations, professional groups, industry and other interested parties committed to the reduction of morbidity and mortality associated with hepatitis C and its eventual elimination. The Hepatitis C Coalition has funding from AbbVie, Gilead Sciences and Merck Sharp & Dohme. For more information, please visit http://www.hepc-coalition.uk/.

Members of the Hepatitis C Coalition

Addaction
AbbVie
British Association for the Study of the Liver (BASL)
British Association for the Study of the Liver (BASL) Nurse Forum
British Society of Gastroenterology
British Viral Hepatitis Group
Blenheim CDP
British Liver Trust
Change Grow Live (CGL)
Gilead Sciences
The Haemophilia Society
The Hepatitis C Trust
London Joint Working Group on Substance Use and Hepatitis C
London Drug and Alcohol Policy Forum
Liver4Life
Merck Sharp & Dohme
South Asian Health Foundation
Sickle Cell Society
Turning Point
TB Alert
UK Thalassaemia Society