In the past, the decision whether to treat patients with hepatitis C (HCV) could be a complicated one.
Today, with a number of good treatment options and increasing evidence of the benefits associated with treatment, the decisions lie more in type of treatment, according to experts who spoke at the Postgraduate Course on Challenges in Management of Common Liver Diseases yesterday.
“In looking at hepatitis C treatment, there are several endpoints that we can consider: the clinical, the patient-reported outcomes, and, of course, economic outcomes,” said Norah Terrault, MD, MPH, FAASLD of the University of California, San Francisco.
She discussed a theoretical case involving a 50-year-old black male with genotype 1A and stage 1 fibrosis. “Individuals with low-stage fibrosis have a very low rate of liver-related events in the short term,” Dr. Terrault said. In one study of four large integrated healthcare systems in the United States, the five-year risk of developing such complications was 2.3% in patients with F0-F1 fibrosis at baseline.
Based on those data and a desire to prevent liver-related complications, one could argue that there is little justification for treatment in those with low fibrosis. However, hepatocellular carcinoma (HCC) remains a risk in patients who achieve a sustained virologic response (SVR). In one study of 642 patients who achieved SVR after treatment with pegylated interferon and ribavirin, those without cirrhosis had a 3.2% rate of HCC through 10 years. Those with cirrhosis had slightly higher rates, and there was an increasing incidence of HCC with increasing fibrosis stage at entry biopsy.
There are other clinical endpoints to consider as well. Several studies have shown that achieving an SVR can reduce the rate of de novo insulin resistance and of type 2 diabetes. Another showed an 85% reduction in the incidence of end-stage renal disease among treated patients who achieved SVR compared to untreated HCV controls.
Another important consideration is the prevention of transmission to others, which Dr. Terrault noted is of particular concern for women of child-bearing age, those who inject drugs, and men who have sex with men.
There is also accumulating evidence that achieving SVR can improve neurocognitive function, and studies also suggest that treating HCV in these patients is a cost-effective approach. In one analysis, the benefits of treatment, including increases in work productivity, resulted in a net economic gain of $2.28 billion per year.
A further argument in favor of treatment as early as possible is the availability of six good treatment combinations. SVR is achieved in 92-100% of patients across most subgroups with the available direct-acting antiviral (DAA) therapy combinations, Dr. Terrault said, and some patients are candidates for an eight-week course of therapy rather than the usual 12 or 16 weeks.
Karen F. Murray, MD, of Seattle Children’s Hospital, spoke about treating HCV in the pediatric setting, and pointed out that the rich set of treatment options for adults is not available for children. “Needless to say, the opportunity to avail all of our patients of these medications is very exciting,” she said, though they are not yet approved in children and are fairly expensive. Still, treating patients with available therapies does confer substantial benefits.
Though spontaneous clearance does occur in children, the likelihood of this happening drops as they age, Dr. Murray said. And because the virus has been shown to have detrimental effects on physical function, among other impacts, treatment is important in this population. “We firmly believe that all children should be treated,” she said.
Though approved options remain limited in the pediatric setting, she noted that there is some potential to augment available treatment. One option may be vitamin D supplementation; in one study, children who received vitamin D along with pegylated interferon/ribavarin were more likely to achieve SVR.
“Provide patients with hope for the future,” Dr. Terrault said. “There are more new drugs coming, and those drugs offer the opportunity to be treated with high SVR rates and short duration.”