Major gaps in hepatitis C care identified as new drugs, screening efforts emerge

In the largest study of its kind, the team examined data culled from 10 studies between 2003 and 2013 and found that less than 10 percent of people infected with hepatitis C in the United States -- 330,000 of nearly 3.5 million people -- were cured (achieved viral suppression) with antiviral hepatitis C treatment. The researchers also found that only 50 percent of people were diagnosed and aware of their infection; 43 percent of those with the disease had access to outpatient care; and only 16 percent were prescribed treatment.

"This study puts forth a good baseline of hepatitis C care in the United States over the last 10 years -- which will be useful in monitoring the success and impact of new screening efforts and advances in antiviral therapy," said the study's first author, Baligh Yehia, MD, MPP, MSHP, an assistant professor of Medicine in Penn's division of Infectious Diseases. "There are many people who don't know that they have the infection, don't have access to hepatitis C care and medications, and who haven't been treated. With this data, we can see these gaps more clearly. This information will be useful for ensuring better access to hepatitis c care and treatment in the coming years."

In June, the Centers for Medicare and Medicaid Services began reimbursing for hepatitis C virus screenings for two target populations, including baby boomers (those born between 1945 through 1965) and those at high risk for the infection. Six months prior, the U.S. Food & Drug Administration (FDA) approved sofosbuvir, an oral medication shown to cure most cases of hepatitis C infection, with fewer side effects than the current treatment options. Other drugs -- which have shown success in clinical trials, some conducted at Penn Medicine -- are expected to gain FDA approval within the year.

"The new regimens will be game changers in the treatment of chronic hepatitis C," said senior author Vincent Lo Re III, MD, MSCE, assistant professor of Medicine and Epidemiology in the division of Infectious Diseases and department of Biostatistics and Epidemiology at Penn. "Given the high prevalence of this infection, particularly in baby boomers who didn't know they were infected, having new, highly-effective treatment options to eradicate the virus will be a tremendous benefit to patients that will ultimately help us to reduce liver-related complications and re-infection rates."

Such advances are expected to increase the number of patients treated for the disease. In the 1990s, HIV treatment turned a monumental corner with the advent of antiretroviral therapy. "It's a very similar situation that we can learn from," said Yehia. "With those advances, came challenges with access to and engagement in care. As hepatitis C therapy continues to advance, a focus on improving diagnosis, linkage to care, and insurance coverage will be more critical."

The team screened close to 10,000 articles before identifying 10 studies that address one or more steps in the cascade of care, ranging from diagnosis to viral suppression. Some of the data came from the National Health and Nutrition Examination Survey and the Chronic Hepatitis B and C Cohort study. The researchers addressed seven key steps along this cascade and estimated the following based off the data analyzed:

 Number of people with chronic hepatitis C infection -- 3.5 million

 Diagnosed and aware of their infection -- 1.7 million (50% of those with infection)

 Those with access to outpatient care -1.5 million (43% of those with infection)

 Hepatitis C RNA confirmed -- 950,000 (27% of those with infection)

 Disease staged by liver biopsy -- 580,000 (17% of those with infection)

 Prescribed treatment -- 550,000 (16% of those with infection)

 Achieved sustained virologic response -- 330,000 (9% of those with infection)

"The advent of new antiviral agents for hepatitis C will shorten treatment duration, likely increasing the number of people offered treatment, and improving cure rates, which are the final two steps of the hepatitis C treatment cascade," said Yehia. "However, educating providers and the general public about prevention, care, and treatment, ensuring access to providers skilled in the treatment of hepatitis C, and addressing the high cost of these agents will be critical to maximizing the benefits of these new therapies."