Achillion, Gilead drug cocktail cures hepatitis C in six weeks

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

This is a business story, and the early post of this story included a lot of financial information, such as company share prices, the size of the market for hepatitis C drugs, and the total sales for the drugs being studied. But it didn’t include costs.

[Later in the day, the story was updated to include a price for the drug combination being reported on and other available treatments. It estimated a cost for the new drug combination of about $35,000 per patient per year, assuming a 55 percent discount. Other drug combinations were said to cost $83,000 to $93,000. We applaud the addition of extra information, but that wasn’t the story we reviewed.]

It’s also possible — but not discussed — that these drugs could end up paying for themselves in the long run if they reduce the need for liver transplants. Such benefits haven’t been established.

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

Not Satisfactory

The story does not quantify the benefits of the drug, even as it is presenting the findings as proof of a “cure.” The story says the drug “eradicated signs of the virus,” but there is nothing about who the patients were, how sick they were, or how many there were. It may be easier to eradicate the virus in individuals whose disease is not very advanced. Would patients with longstanding disease respond as favorably? We can’t answer any of these questions because the details simply aren’t provided.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story makes no mention of harms from the drug. What were the drop out rates and adverse drug reaction rates? What was the severity of the reactions? The story does not address these issues.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The main problem with this story starts with the headline and continues with the absence of information to support the headline. The headline says “Achillion, Gilead drug cocktail cures hepatitis C in six weeks.” [Note: After our review was completed, the headline of this story was changed to, “Promising data bodes well for all-Achillion hep C treatment.”] It does not explain how many people were studied to draw this conclusion, how long the study lasted, under what conditions the study was conducted and where the findings were published, if at all. Then there is the question of definitions. The story says that a cure is a “sustained virological response, 12 weeks after the completion of therapy.” It also talks about the drug cocktail “eradicating” the virus after just six weeks of treatment. Both of these statements are misleading. The term “cure” in hepatitis C circles generally considered to mean signs that the virus has been eliminated from the blood, or a sustained virological response, for 24 weeks after treatment. You can find that definition throughout the medical literature:

There even is some debate about whether 24 weeks of sustained virologic response is enough to say the disease has been cured.

But let’s stick with the most prevalent view for now. Given that view, it’s a bit of an overstatement to say that the drug cocktail in this case eradicated the disease after six weeks or cured the disease after only 12 weeks. There is push by drugmakers to shift toward using the 12-week endpoint as the new sign of success, but it’s far from a consensus view. Six weeks is definitely not the standard. Until that time, reporters would serve their readers better to provide more context for the term “cure.”

Does the story commit disease-mongering?

Not Satisfactory

The story seems to accept the commonly held premise that all with hepatitis C face doom if they are not treated. There was nothing about the natural history of the disease, or the fact that most people infected with this “liver-destroying virus” never develop symptomatic liver disease. The story does not raise the possibility of mass overtreatment of people with hepatitis C.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Even though this is a business story focused on the market prospects for the drug, the actual efficacy of the drug is key. To that end, an independent expert in hepatitis would have been a welcome addition.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story calls the new drug “experimental,” suggesting it’s not yet available. But the story doesn’t really address what will be the major obstacle to availability should the drug make it to approval: the cost and who will pay for it. What will be the limitations put on coverage by insurance companies looking at a huge potential total cost?