Hepatitis Cure Rates "Jarringly Low”
According to new data from the Centers for Disease Control and Prevention (CDC), only one in three adults in the U.S. infected with hepatitis C have been cured despite the introduction of direct-acting antivirals almost 10 years ago.
Hepatitis is an inflammation of the liver that can be caused by a group of viruses—hepatitis A, B, C, D and E. These viruses can damage liver cells and cause scar tissue. With fewer healthy liver cells, the body begins to show symptoms ranging from mild (such as fatigue) to more severe (such as mental confusion). In many cases hepatitis is not a serious threat to health and can resolve on its own. For some people, however, the disease can become chronic (long-lasting) and may lead to liver failure and death.
While all hepatitis viruses can be spread through sexual contact, hepatitis B is most associated with sexual activity (and there is a vaccine to prevent it). Hepatitis C, on the other hand, is primarily transmitted by direct contact with blood through sharing needles or other injecting equipment during intravenous drug use. According to the CDC, having an STI or HIV, having sex with multiple partners, or engaging in rough sex may increase a person’s risk for hepatitis C (HCV).
Until about 10 years ago, treatment for HCV involved versions of interferon, naturally occurring proteins in the body that mobilized the immune system to fight disease, which were sometimes combined antiviral medications. These treatments often came with unpleasant side effects and were not considered a cure as a significant percentage of patients relapsed.
In 2013, Gilead introduced Solvadi, a 12-week course of treatment that cured HCV in up to 96% of patients. While this was a major breakthrough, people were outraged by the $84,000 price tag which prompted a Congressional investigation. Today, there are a number of similar medications that are nearly 100% effective in curing HCV, including lower-priced generic versions but even these can cost over $20,000 without insurance.
A new study published in Morbidity and Mortality Weekly Report analyzed data from patients across the country who were tested for hepatitis C at Quest Diagnostic lab. An official diagnosis of HCV requires a positive antibody test followed by a positive nucleic acid test to confirm the presence of the virus.
Over 1.7 million patients who had received a positive HCV antibody test were included in the analysis. Of those, 88% (1.52 million) went back for viral testing. Among patients who had viral testing, 69% (1.03 million) were categorized as having an initial infection which would make them eligible for treatment. Subsequent testing found that 34% (356,807) of those with initial infection were cured (with medication) or cleared (spontaneously). Among this group, however, 7% (23,518) were later found to have a persistent infection or reinfection.
The researchers then looked at data by age, sex, and type of insurance a patient had. Not surprisingly, patients with other payor, unspecified payor/insurance, or Medicaid had lower viral clearance (23%, 33%, and 31%, respectively) than those with Medicare and commercial insurance (40% and 45%, respectively).
At a White House briefing on the topic, lead research Carolyn Wester called the cure rates “jarringly low” and suggested the high price of treatment and numerous restrictions put in place by insurance companies were partially to blame. She said, “Some payers limit which patients are eligible for treatment or require burdensome pre-authorization before treatment can begin, or even limit the types of providers who can prescribe treatment. All of these restrictions can delay or even prohibit access to this life-saving medication.”
Other experts pointed out that the testing process—which requires patients to get their results and then come for a second test to confirm the diagnosis—is cumbersome and can lead to delays in treatment for some people or no treatment for those who don’t follow up. (The CDC recommends one-time hepatitis C testing of all adults 18 years and older, and suggests that all pregnant women get tested during every pregnancy.)
Francis Collins, who is leading the White House National Hepatitis C Elimination Program, addressed this at the briefing. He argued that the U.S. needs rapid point-of-care tests like those already available in Europe and Australia. Collins suggested that initiating a rapid testing program could save the $44 billion over the next 20 years. “It’s rare to have both an opportunity to save lives and save money, but that’s what we have here. You can’t know this and just walk away,” he said.
The Viral Hepatitis National Strategic Plan calls for more than 80% of people with hepatitis C to achieve viral clearance by 2030. This study shows that we are still far from reaching that goal.