Direct-acting antiviral treatment of patients with the hepatitis C virus is indisputably one of the most important medical advances of the 21st century. In only a few years, the therapy has saved untold lives in the U.S. and around the world.

But Johns Hopkins hepatologist Tinsay Woreta wonders what comes next for patients who, while cured of HCV, suffered liver damage while they still harbored the virus.

“It’s a new era,” she says. “But there are still plenty of questions.”

Woreta is studying the progression of liver fibrosis in patients who have been cleared of the hepatitis C infection. In the short history of combating the infection with direct-acting antiviral (DAA) therapy, studies have described changes in liver fibrosis in the context of interferon-based therapies or have examined the effects only during DAA therapy and through three months of post-treatment.

By the end of this one-year study, which ends in March, 2018, Woreta says she expects to understand more about the treatment of the condition and how long to monitor patients after successful DAA therapy.

“There is real concern that patients who achieve cure are still at risk for cirrhosis and liver cancer,” Woreta says, “particularly those with advanced fibrosis.”

The study looks at cases where physicians have used transient elastography (TE) to evaluate liver stiffness at various follow-up points after DAA therapy.

“TE is a noninvasive way to determine the degree of fibrosis,” says Woreta, noting that liver biopsy, long the gold standard, is imperfect, expensive and comes with significant patient risk. “This is a much better, more efficient way to learn what we need to know.”

Woreta and her co-principal investigator Carla Rodriguez of the Kaiser Permanente Research Institute are using data from electronic health records of hepatitis B and C patients who had TE at Johns Hopkins or Kaiser’s Mid-Atlantic facilities.

They’re measuring long-term changes in a diverse cohort, looking at factors such as fibrosis stage, sex, race, age, BMI and therapy status.

“We hope this research contributes to the way clinicians assess risk for liver cancer and other serious diseases,” says Woreta. “Looking at the rate of progression—or even regression—after therapy should teach us more about how and when to treat patients and should tell us
about the need and the frequency of follow-up TE.”