Using a computer model of the hepatitis C disease, Stanford researchers have shown that two new drugs intended to target the virus are cost-effective for patients suffering from advanced hepatitis C, despite some significant side effects.
Hepatitis C, a virus that leads to swelling or inflammation of the liver, is now killing more Americans than the HIV virus. The majority of the 3.2 million people estimated to have chronic hepatitis C in the United States are baby-boomer adults, according to a Scientific American blog.
Jeremy Goldhaber-Fiebert, an assistant professor of medicine, and his research team examined treatments that involved pegylated interferon alongside ribavirin — collectively deemed the standard two-drug therapy — and compared it to a “triple therapy,” with either boceprevir (trade name Victrelis) or telaprevir (trade name Incivek) added to the standard two-drug therapy.
Both drugs entered the commercial market in the summer of 2011, and — though they decrease the chance of chronic hepatitis C — both have severe side effects.
The most common adverse drug reactions to Incivek, as listed by the Food and Drug Administration (FDA), include rash, pruritus, anemia, nausea, hemorrhoids and diarrhea. Victrelis is associated with an additional decrease in hemoglobin concentrations, resulting in fatigue, anemia, nausea, headache and dysgeusia.
The research team, which included graduate students Shan Liu and Lauren Cipriano M.S. ‘11 as well as Professors of Medicine Mark Holodniy and Douglas K. Owens, designed a model to comparatively examine the advantages and disadvantages of three treatment strategies: giving all hepatitis C patients the standard treatment, giving all of them a triple therapy and giving triple therapy only to the patients less likely to respond to standard treatments.
“The computer model we developed includes the health risks, quality of life changes and costs for patients who have genotype 1 chronic hepatitis C infection as well as the effectiveness, costs, side effects [and] quality-of-life changes of undergoing various treatments for chronic hepatitis C,” Goldhaber-Fiebert said. “An expensive treatment, even with some side effects, may be beneficial overall if it is more effective, thereby prolonging life, improving quality and/or averting costs compared to not undergoing treatment.”
Statistical and simulation analysis showed that the new triple therapies were cost-effective for chronic hepatitis C patients with advanced liver disease. For patients with a mild case of the disease, the model’s findings advised determining their IL-28B genotype — associated with gauging whether the standard two-drug treatment will be effective — before deciding on treatment.
“Protease inhibitors increase the effectiveness of standard therapy, but they are costly,” the team’s study states. “A genetic assay may identify patients most likely to benefit from this treatment advance.”
The study links how imminent the threat of severe disease is with justifying the costs and risks of the “triple therapy.”
“If the protease inhibitor costs $1,100 per week, universal triple therapy costs $102,600 per quality-adjusted life-year (QALY) for mild fibrosis or $51,500 per QALY for advanced fibrosis compared with IL-28B-guided triple therapy and $70,100 per QALY (mild fibrosis) and $36,300 per QALY (advanced fibrosis) compared with standard therapy,” the study states.
Despite the costs, universal triple therapy reduced the lifetime risk for liver carcinoma by 38 percent in cases of mild fibrosis and 28 percent in incidents of advanced fibrosis, increasing the quality-adjusted life expectancy by three percent and eight percent, respectively, compared with standard therapy, the study showed.
The study concluded that, “universal triple therapy and IL-28B guided triple therapy are cost-effective when the least-expensive protease inhibitor is used for patients with advanced fibrosis.”