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Earlier this month, a pooled analysis by the prestigious Cochrane Collaboration questioned whether sofosbuvir and other direct-acting antivirals (DAAs) can actually save lives in the long run — a finding that could deal a massive blow to hepatitis C patients and drug companies alike.
The problem is that it’s simply not true, according to a chorus of experts who have called the Cochrane review “outdated,” “fundamentally flawed,” and “absurd.”
In an extraordinary show of unity, hepatitis C researchers, clinicians, and advocates have denounced the Cochrane analysis and its implications, pointing to clear-cut evidence that current DAAs not only cure hepatitis C, but also reduce the risk of liver transplant, cancer, and other complications later in life.
Cochrane, meanwhile, stands by its analysis and has declined a request by the World Hepatitis Alliance to clarify its results.
DAAs “are marketed as a revolution,” so it’s “natural” that Cochrane would be interested, said first author Janus Jakobsen, MD, PhD, chief physician at the Copenhagen Trial Unit at Rigshospitalet in Denmark.
In the 744-page meta-analysis, Jakobsen and his group reviewed 138 trials assessing the effects of 51 different DAAs. They disputed the value of SVR as a clinically meaningful endpoint, and noted that all studies had a “high risk of bias” because of industry funding.
In sum, “the results indicated that [DAAs] do not have any clinical effect,” said Jakobsen. “Regarding the long-term effects, we are totally in the dark,” he added.
Jakobsen’s results sparked backlash from hepatitis C experts and advocates, including the World Hepatitis Alliance, the Hepatitis C Trust, the American Association for the Study of Liver Diseases (AASLD), and the Infectious Diseases Society of America (IDSA).
Critics of the Cochrane review argue that SVR is a proven surrogate endpoint, that the studies included were not designed to determine long-term benefits and that the analysis should not have included drugs that have since been withdrawn from the market, including boceprevir (Victrelis) and telaprevir (Incivek).
It is an “irresponsible interpretation of the data” that carries “so-called evidence based medicine to an illogical extreme,” said Douglas Dieterich, MD, of Mount Sinai Hospital in New York.
Read the rest of this very good article here: https://www.medpagetoday.com/infectiousdisease/hepatitis/66284