Should the New Hep C Drugs Be Used Sooner?

Over the past few years, the timing of the initiation of treatment of hepatitis C has taken a number of twists and turns. Now, there seems to be one more. Earlier treatment is being recommended.

Prior to 2011 there were no specific antiviral therapies available to treat the infection. A combination of interferon and ribavirin was the only option, and it was a poor option. The cure rate was as low as 20 percent (depending on the strain of the virus), the side effects were awful, and the duration of therapy ranged from 6-24 months.

When Incivek (Vertex) was approved in 2011, it came roaring out of the gate with sales of more than $450 million in its first quarter alone. Patients who had been avoiding treatment came forward in droves. But, this didn't last long. Late stage trials of drugs from other companies one of which would become Gilead's game-changing Sovaldi were so promising that doctors advised their patients to wait 6-12 months. Sales of Incivek fell off a cliff, and Vertex was forced to get rid of 370 employees.

With new, highly effective (and also highly expensive) drugs available, essentially all hep C patients wanted them, and in many instances it was not clear who should get them, and when, with the exception of patients on the verge of liver failure, who got them first.

Sovaldi alone put considerable stress on the budgets of state and federal agencies, and although there was no consensus at the time, it was not uncommon for patients, some of whom had been living with the infection for as long as 40 years, to wait a bit longer.

But now, a new report in JAMA Internal Medicine is suggesting that sooner is better: Treatment of patients who did not yet have severe liver fibrosis was more cost-effective than waiting until they did.

Lead author, James G. Kahn, MD, MPH, of the University of California San Francisco, and colleagues used a patient simulation model to predict cost-effectiveness, as measured by quality-adjusted life-years (QALYs) gained, and, although the total costs from earlier treatment would be higher, it was none-the-less a better option.

Additionally, determining the stage of fibrosis is not trivial, as pointed out by Dr. Steven D. Lidofsky of the University of Vermont College of Medicine: "There is a current shortage of health professionals who are equipped to deal with the nuances of fibrosis staging, surveillance for disease-related complications... consequently, factors that exacerbate inequities in access to HVC treatment are likely to be amplified in economically disadvantaged areas and rural regions."

The group performed a 5-year estimate, which projected:

• Treating 50% of all eligible HCV genotype 1 patients in the U.S. would cost $53 billion(at full price)
• The cost of treating only advanced patients during this same time would be $30 billion?
• Costs could be partially be offset by $3 billion in savings in the management of chronic HCV and advanced liver disease
• 26% of liver transplant cases could be avoided

Clearly, the unparalleled success of these long-awaited drugs has created secondary issues, mostly cost. But, a research-based solution like this comes along perhaps once per generation. Finding the drugs comes first. Figuring out how to pay for them comes later.