The Danish Medicines Agency does not recognise the conclusions from a CTU review of treatment for hepatitis
The authors of a recently published review from the Copenhagen Trial Unit (CTU) claim that a new method for the treatment of hepatitis C showed no particular effect when compared with placebo. The Danish Medicines Agency has evaluated the Cochrane review from the CTU and does not support in any way the conclusions or the basis on which they were made.
What did the CTU analyse?
DAA stands for Direct-acting Antiviral Agents, which is a new breakthrough treatment for patients suffering from hepatitis and secondary complications. Medical experts assess that up to 95% of patients may be cured by the new treatment. However, the treatment is far more expensive than any previous types of treatment, and since the treatment is relatively new, there are no adequate data on the long-term effects. The CTU included a large number of trials in the meta-analysis and draw the conclusion that DAAs do not seem to have any effects when compared with placebo treatment.
Why does the Danish Medicines Agency not recognise the conclusions of the CTU?
Our evaluation of the review reveals a number of methodological weaknesses that make the authors’ conclusions questionable. Overall, the weaknesses of the review can be summarised as follows:
- The review from the CTU is based on 138 trials with a total of around 25,000 trial subjects. However, the conclusions are based on the results of only 12 trials covering 3,000 patients.
- The objective of the CTU’s review was to assess the long-term effects of DAA treatment, but the trials included only covered short-term treatment and served a different purpose.
- The CTU’s review compares groups of trial subjects in different trials in a way that is not scientifically valid, in the opinion of the Danish Medicines Agency.
- The CTU’s review included trials irrespective of the duration of treatment or follow-up measures, which is unusual in a meta-analysis.
Overall, the Danish Medicines Agency evaluates that the conclusions of the CTU are based on inadequate scientific evidence and methodological stringency and therefore not valid. On the contrary, there is broad international consensus that the new DAA treatment is both effective and safe.
The thorough evaluation of the CTU’s conclusions are summarised in the memo below. The memo was prepared by medical experts with expert knowledge in this field. The evaluation of a meta-analysis, like this one made by the CTU, is relatively complex. Consequently, medical terminology is used in the memo, which is aimed at healthcare professionals with a knowledge of clinical terminology and meta-analyses.