Treatments that show promise in lowering the viral load in hepatitis C patients deserve attention. The disease affects many and has a growing global footprint. This story takes the promise of treatment too far, though, by calling a drug cocktail a “cure” and failing to back the claim up with any evidence.
New drugs to treat hepatitis C have the potential to more effectively eradicate the virus with fewer side effects than older drugs. But with so many people affected, and with costs on the order of $90,000 for a course of treatment, it will be a struggle to figure out how to deliver these new treatments without breaking the bank. Moreover, considering that most infected individuals likely will never develop symptoms of advanced liver disease and that these drugs may cause harm, some thought should be given to the risk of overtreating patients with hepatitis C.
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.
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.
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.
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.”
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.
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.
The story does mention several drug regimens that are available for treatment of hepatitis C and notes that they appear to take longer to achieve a response than the new drug. We’ll call this good enough for a satisfactory, but we’d note that there are other treatments for hepatitis C that have a long and detailed history in the medical literature. A good hepatitis C expert could have provided a nice summary for readers.
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?
Although we question the story’s definition of “cure,” the story does address novelty by describing how results for the new drug appear to improve upon findings with previous similar regimens.
The story takes a quote from this Achillion news release, but it alerts readers to the fact that the language came from “a statement.” Since no independent perspectives are offered, we can’t really be sure to what extent this story relied on the news release, so we’ll rate it Not Applicable.
Systematic, Criteria-Driven
@HealthNewsRevu @mcjaklevic HealthNewsReview once again revealing hype that far outstrips reality. I suspect that one day, AI will meaningfully contribute to good patient care. Whether that's in 10 years or 100, I couldn't say. What is clear is that we ain't there yet.
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