The Guardian newspaper reported on Thursday 8th June 2017 on a new study extremely critical of the efficacy of the Direct-acting antiviral (DAA) drugs rolled-out to treat chronic Hepatitis C. The report was later picked up by other media outlets and journals.
Our results indicate the drugs may have no clinical effect
The study, published in the Cochrane Databse of Systematic Reviews (online, 6 June 2017) states that Direct-acting antivirals (DAA’s) for chronic hepatitis C (HCV), do not seem to have any effect on the risk of hepatitis C-related morbidity or all-cause mortality. The researchers found that while it appears that DAA’s are successful in clearing the HCV from the blood, there is no evidence that they prevent harm from the disease or save lives because the virus can still reside elsewhere in the body (organ tissues for example).
The study’s background introduction says:
Millions of people worldwide suffer from hepatitis C, which can lead to severe liver disease, liver cancer, and death. Numerous previous interventions have been used for hepatitis C, but none of these interventions have proven effective on patient-centred outcomes. DAAs are relatively new but expensive interventions for hepatitis C, and preliminary results have shown that DAAs seem to eradicate hepatitis C virus from the blood (sustained virological response). However, it is questionable if an eradication of hepatitis C virus in the blood leads no hepatitis C in the body and improved survival and fewer complications. In this Cochrane Review, the authors assessed the evidence on the clinical effects of DAAs for hepatitis C.
The study was carried out by the respected and independent Cochrane Collaboration (Cochrane Hepato-Biliary Group), which assessed all the drug company trials of the breakthrough hepatitis C treatments. It examined the results from 138 randomised clinical trials conducted between 2004 and 2016 of DAA’s either on the market or under development (84 trials), or those that had been withdrawn from the market (57 trials). The trials featured both treatment-experienced and treatment-naïve patients and in total they looked at 25,232 participants.
Janus Christian Jakobsen, chief physician at a clinical trial unit in Copenhagen and deputy co-ordinating editor of the Cochrane Hepato-Biliary Group said
“It is never possible to show that something does not work, but there is no evidence [that they do]. Our results indicate [the drugs] may have no clinical effect”
“From a patient perspective, it does not matter if the virus cannot be detected in the blood if DAAs do not improve survival or lead to fewer hepatitis C complications”.
The claims centre around the drug companies definition of ‘cure’. They state that a cure in relation to hepatitis C is defined as
the virus being undetectable in the blood for 12 weeks after completing treatment.
At a member meeting in March we also presented our concerns over the use and connotations of the word ‘cure’ in relation to these new drugs.
This subject was also raised and discussed at the Joint meeting with Haemophilia Scotland members, extract below:
We noted that the available information shows that the medical community is torn on declaring a sustained viral response (SVR) to be an absolute care:
The quality of the evidence was very low
Returning to the new review report, what was notable, and what the reviewers describe as ‘startling’, was they found that all the trials were funded by the manufacturers of the drugs themselves and therefore were “at high risk of bias”. Because of this they also clearly state “so our results presumably overestimate benefit and underestimate harm” and that “the quality of the evidence was very low”.
As we had noted in a previous post from March, pharmaceutical companies are no strangers to allegations of profiteering. Some observors seeing the latest developments from the Danish review may suspect there is more going on than an innocent mistake or good intentions gone awry. With a hefty price-tag of £30,000 per treatment it may seem more than disingenous to make claims that infected people can be ‘cured’ based on the narrow definition proferred by the pharmaceutical companies. Most people who see the word ‘cure’ rightly think the condition is gone and they will get better. This review makes clear there are concerns around the use of the ‘C’ word in this respect.
The full comprehensive report can be download from here
Officials form the Scottish Government had previously suggested to the Forum that timescales are too short to have a definitive answer at the moment. Many clinicians routinely use the ‘cure’ claim in relation to these DAA drugs and it was hailed as a big headline for infected people, drug companies and governements who purchased the drugs.
Drugs companies who responded to the media say they do not recognise the new study or its suggestions and understandably stick by their definition of ‘cure’.
“We do not recognize the conclusions of this report, as both controlled trials and real world experience contradict its findings”
The report authors further state
The lack of valid evidence and the possibility of potentially harming people with chronic hepatitis ought to be considered before treating people with hepatitis C with DAAs.
This in iteself is a very troubling statement. The debate continues, and from the polarised positions above, it needs to continue, for the sake of HCV infected people so clarity can be obtained.
The review authors could not be difinitive in their report and used words like ‘seem’ and ‘may’. The pharmaceutical companies are sticking to their position and do not ‘recognise’ the report’s conculsions.
With that being said, as always, follow the advice of your GP, consultants and medical staff, while raising honest questions or concerns if you have them.