We’re told a 12-week regimen costs $54,600. However, we’re not clued in as to how much a 16-week treatment costs and that’s important since some of the trials lasted 16 weeks. Generally, according to the NIH, treatments take anywhere from 24 to 48 weeks. It’s unclear if this is true of Zepatier, although the results seem to indicate one round of treatment is all you need. There’s also a notable addition in this release in regard to cost: Financial assistance that brings the cost down to “as little as $5 for each prescription” for private insurance plans that aren’t generous when it comes to drugs. As the recent HealthNewsReview.org post by Lieberman might suggest, this is part of a growing trend to conceal the true cost of expensive drugs to the consumer, forcing those with more substantial insurance plans to foot the bill. “Do we want the health system to work for a few or for everyone?” Lieberman wrote. “That should guide our reporting when the next news release touting the newest specialty drug shows up.” After 12 to 16 weeks of treatment, Merck claims its drug can cure two types of hepatitis C in 94% of people. This includes people who had cirrhosis, HIV or kidney impairment. However, it should have been explained that the response or “cure” refers only to the reduction of viral load, which does not address long-term effects or adverse effects of the drug. The benefits are given in absolute terms, but viral loads are not reported and the response or viral loads in the placebo group are not reported at all in the release. This would be a critical element to be adequately reported in describing the results of studies on the efficacy of a particular drug. Finally, since some of the patients already had cirrhosis, there is no way the drug can prevent this outcome, and the needed study outcome should be reduction in the rate of liver or other GI cancers. The discussion on harms includes a long list of drugs to avoid mixing with Zepatier as well as common side effects and adverse reactions including headaches, fatigue, nausea, and anemia in about 5% of people who took the drug. Although we wouldn’t expect harms from placebo to be severe, we expected to see at least a mention of them since the drug was compared against placebo. And, since the minor harms were listed so extensively, we would have liked to see a mention of the risks for more rare but serious side effects due to the drug. In its news release on the approval, the FDA writes, “Zepatier carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants, generally at or after treatment week eight.” Drugs must pass high bars to achieve FDA approval, and here we’re given the detailed results in five randomized, double-blind clinical trials for one form of hepatitis C (GT1 HCV) and one trial for another — GT4 HCV. Each of the trials used a few different populations with different pre-existing conditions. Despite the exhaustive accounting of study results, we’ll ding the release here for not acknowledging that the studies were all designed to find the “disease oriented” and not “patient oriented” outcomes. This means that the trial looked at the reduction in viral load, not the prevention of specific conditions like cirrhosis, an outcome that is supposed to be prevented by the use of these drugs. Patients care most about conditions that affect them and not how many virus particles are in their blood, so this was an important omission. There are no harrowing, overly dramatic details here. Merck is clearly labeled as the sponsor of the release. In the clinical trials section, some alternative treatments are named, including “IFN or PegIFN ± RBV” and “boceprevir, simeprevir, or telaprevir in combination with PegIFN + RBV.”  We’ll award a Satisfactory on that basis, although the trials mentioned are all compared against placebo and not these drugs. It would have helped to know what those treatments are, and their effectiveness. We will note, however, that highly successful curative hepatitis C treatments are very new — basically, within the past few years. The alternatives prior to that were liver transplants, which can cost $300,000, and viral interferon treatments, which were less than 50% effective. Merck’s release states the drug will start shipping to wholesalers within 7 days of Jan. 28, 2016. This is the second one-pill, once-a-day option for hepatitis C. We don’t think the release demonstrates novelty. “Multiple therapeutic tools” to treat hepatitis C are mentioned in a quote by the executive director of the Hepatitis Education Project, but we’re not clued in to what those are or where Zepatier fits in. Alternative drugs have similar, albeit slightly lower, cure rates in the high-80% to low-90% range. We see the word “cure” four times in the release. The release defines its use of the term cure early on in the release as “Sustained virologic response is defined as HCV RNA levels measuring less than the lower limit of quantification at 12 weeks after the cessation of treatment (SVR12), indicating that a patient’s HCV infection has been cured.”  We disagree because there’s no indication that these “sustained” responses are prolonged for a long period after the drug is discontinued.
Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review