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FDA release on hepatitis C drug informs on harms, benefits but is light on evidence


4 Star

FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

Our Review Summary

hepatitis CThis release announces the approval by the FDA of a new pill, Epclusa, for patients with chronic infections with Hepatitis C virus, also known as HCV. The tablet combines an existing drug, sofosbuvir, with a new drug, velpatasvir, and is the first single therapy for all six major forms of the virus. Patients can be infected with different forms and require different treatments.

The release informs on the novelty, harms and benefits of the drug but doesn’t give reporters — or lay readers — much background on the clinical trials that led to the approval.


Why This Matters

An estimated 120 million people have HCV infections worldwide, with an upper estimate of 3.9 million in the US alone, according to the Centers for Disease Control and Prevention (CDC).

This new treatment — Epclusa — has an estimated cost of about $74,800 per 12-week necessary therapy length — or about $900 per pill. But without treatment, many HCV patients may require years of treatment and suffer damage to their livers that require transplants and could ultimately be more expensive. The economics of new drugs is a vital part of any story about the drugs. We wish this release had included some context on the cost issues surrounding HCV infection for both patients and the society at large. A blogger with Bloomberg News focused a post about the drug pricing which has been controversial due to the millions of patients affected.


Does the news release adequately discuss the costs of the intervention?

Not Applicable

The release does not discuss cost. The FDA evaluates drugs without consideration of cost, so it’s understandable that they wouldn’t comment on it — and that’s why we’re rating this Not Applicable.

We look forward to the day when any news release about a new drug — even one from the FDA — includes some mention of cost in its message. After all, the value of a new drug is a function not just of how well it works, but its cost-effectiveness.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?


The release includes results from Phase III clinical trials in about 1,600 patients showing a benefit.

“Results demonstrated that 95–99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured.”

The release also notes that after 12 weeks, 94 percent of patients with more advanced disease who received Epclusa in combination with ribavirin showed no virus in their blood.

Does the news release adequately explain/quantify the harms of the intervention?


The release notes that the most common side effects of Epclusa are headache and fatigue. It also explains that Epclusa carries a warning that “serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral.” The FDA also warns that certain drugs may reduce the amount of Epclusa in the blood which would reduce its effectiveness.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release does not use the important words “randomized controlled” that would signal to the reader about the quality of the evidence. The release also does not give us the precise size of cohorts, or even tell us where to get further details with a journal citation, URL or a link.

The FDA also missed an opportunity to inform readers about limitations of these studies and gaps in our knowledge related to these medications. For example, these were short-term studies, and so we don’t yet know whether these patients will have fewer cases of liver cancer, liver failure, or need for liver transplants down the line. That’s an educated inference based on the drug’s ability to eradicate the virus — but not proven.

Does the news release commit disease-mongering?


There is no disease mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release did not identify funding sources or state whether there were any conflicts of interest.This release describes the approval of a new drug by a regulatory agency, but we’d still like to know who sponsored the study that’s the basis for the approval. It’s not enough to state who manufactures and markets the drug.

Does the news release compare the new approach with existing alternatives?


The release explains in some detail that different HCV patients may follow different drug regimens, depending on their particular strain of virus and other characteristics of their infection. A bit more explanation about how patients and providers may choose whether to use Epclusa or other alternatives and how they will compare would have been helpful.

Does the news release establish the availability of the treatment/test/product/procedure?


The release is announcing the approval of the drug which usually means it will be available in the near future.

Does the news release establish the true novelty of the approach?


The release states that this is a wholly new combination drug that has not been available until this approval by the FDA. It also states that it is the first drug that works for all six strains of the virus.

Total Score: 7 of 9 Satisfactory


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