Cochrane study on direct-acting antivirals is 'fundamentally flawed', says Hepatitis C Trust
The Hepatitis C Trust has criticised a study carried out by the Cochrane Hepato-Biliary Group that cast doubt on the effectiveness of direct-acting antivirals (DAAs) against hepatitis C, saying it is “fundamentally flawed”.
The trust, which is a national patient-led charity for hepatitis C, sent a letter to The Guardian, in response to an article it published on the study, expressing its concerns.
“The Cochrane review analysed clinical trials, which are by nature short term, where the sole purpose was to evaluate the virological efficacy of new antiviral drugs,” says the trust. “The trials were neither designed, nor powered, to assess mortality, so it is not at all surprising that the Cochrane review was unable to identify any impact on mortality.”
In its response, the trust highlights that regulatory authorities and clinicians all recognise that clearing hepatitis C virus reduces mortality and UK-based research has demonstrated that oral antiviral treatment substantially decreases mortality and morbidity in patients with cirrhosis.
It also refers to current data from Public Health England showing 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.
“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,” it says.
The study has also generated comment on Hep Forums, a discussion area for people who have hepatitis, their friends and family or others with questions about hepatitis and liver health. Forum users criticised the failure of the study to consider long-term natural history data as well as looking at the short-term results in clinical trials, with one respondent describing the study as “pointless”.
“[The study] objective was ‘To assess the benefits and harms of DAAs in people with chronic HCV’ as written in the abstract,” says the respondent. “The report most definitely does not do that. It places the blame on biased, overly short studies; we might place it on the limits the Cochrane Collaboration adopted on which studies got included.”
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202957
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