New Hepatitis C Treatment Options Emerging

More than 3 million individuals in the United States are affected by hepatitis C virus (HCV), according to the U.S. Centers for Disease Control and Prevention.

The CDC also notes that “most people” infected with hepatitis C are unaware of their infection, and between 75 percent and 85 percent of these individuals develop chronic infection.
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Given these figures, it seems more organizations and researchers are stepping up efforts to combat the disease and increase detection of HCV infection. In Wisconsin, for example, the state’s Division of Public Health has piloted a program that offered rapid HCV testing to clients of 4 agencies, according to the WDPH.

During a two-month testing period, 1,255 individuals were tested using a rapid HCV test, with 246 of the tests (20 percent) coming back positive. According to WDPH, most of the infections (72 percent) had not previously been reported to the agency.

On a broader scale, the World Health Organization recently issued its first-ever treatment guidelines for hepatitis C, which included 9 key recommendations, “based on a thorough review of the best and latest scientific evidence,” according to WHO. The organization’s recommendations included screening tests for those at high risk; advising those with chronic hepatitis C infection to undergo alcohol assessment; and suggestions on existing treatments based on interferon injections as well as new, oral medicine-only regimens.   

In issuing its guidelines, WHO also called for greater access to hepatitis C medications, recommending new drugs from Johnson & Johnson as well as Gilead Sciences, despite questioning the costs associated with the medications. (Indeed, U.S. lawmakers asked Gilead in March to justify the $84,000 price tag associated with its hepatitis C drug Sivaldi.)

In a statement, WHO noted that “modern drugs are transforming the ability to fight hepatitis C, because pills such as Gilead’s Sovaldi are far more effective and better-tolerated than older injection regiments, with cure rates well above 90 percent in many cases.”

In addition to drugs that are making progress in curing hepatitis C, new treatment options are emerging as well. For example, a recent University of Texas Health Science Center study found that an interferon-free combination of drugs was safe, well-tolerated, and cured more than 90 percent of 380 trial patients with liver cirrhosis in 12 weeks.

“For primary care, the implication of these emerging therapies is that they are safe and well-tolerated enough that primary care providers can not only screen and diagnose patients, but can now consider treating them as well,” says Fred Poordad, MD, professor of medicine at the University of Texas Health Science Center, and lead investigator of the study.

“The hope,” says Poordad, “is that with millions of Americans still not diagnosed, primary care will take a lead role in screening the birth cohort with the highest prevalence of infection, and then offer this simple 12-week therapy and eradicate more than 90 percent of cases of hepatitis C.”

A pair of recent multi-center clinical trials led by Beth Israel Deaconess Medical Center may show potential for another new option that researchers say could lead to an increase in the number of hepatitis C patients cured.

According to the researchers, who recently presented their findings at the European Association for the Study of the Liver, a new 12-week single tablet regimen of ledipasvir and sofosbuvir proved to be highly effective in treating a broad range of patients with HCV genotype 1, a form of the virus found in up to 75 percent of infections. In the study, between 94 percent and 99 percent of patients were cured of hepatitis C, with similar results seen in patients who had never been treated as well as those who had previously been treated with a combination of peginterferon and ribavirin.

“Eliminating interferon and ribavirin from treatment regimens is expected to reduce the incidence and severity of adverse events, to simplify the treatment of patients with HCV infection, and to provide an option for patients who are eligible for the current interferon-based treatments,” said Nezam Afdhal, MD, director of the Liver Center at Beth Israel Deaconess Medical Center, and senior author of both clinical studies.

—Mark McGraw

References

Stockman L, Guilfoyle S, et al. Rapid Hepatitis C Testing Among Persons at Increased Risk for Infection — Wisconsin, 2012–2013. MMWR. 2014.

Poordad F, Hezode C, et al. ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis. NEJM. 2014.