Widespread screening for hepatitis C – a recommendation that has been aggressively pushed by public health officials, with the advent of new, expensive drugs to cure the viral infection and prevent liver-disease deaths – may be premature, a group of scientists is arguing.
In a paper published Tuesday in the British Medical Journal, the scientists say there’s little concrete evidence that screening all Baby Boomers for hepatitis C – a policy endorsed by the U.S. Centers for Disease Control and Prevention and other public health agencies – will save lives. Plus screening and treatment could cause unnecessary harm to millions of people who test positive for the virus but never experience any ill effects from it, they say.
“The question is whether these aggressive screening policies are justified and whether they would result in more benefit than harm,” said Dr. John Ioannidis, a Stanford epidemiologist and an author of the paper. “We know very little about the potential harms of these drugs, especially in the long-term. And we don’t know how they will translate into long-term benefits.”
Ioannidis and his colleagues suggest that instead of rolling out widespread screening programs, researchers, as soon as possible, start a randomized trial to test the usefulness of screening and who may benefit from it.
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Their argument comes amid a massive push to screen and treat the estimated 2.7 million people thought to have hepatitis C in the United States. Most of those people were born between 1945 and 1965, epidemiologists say, and the vast majority don’t know they carry the virus.
In the past two to three years, new drugs have become available that can cure the most common type of hepatitis C in more than 90 percent of patients. Those drugs are expensive – costing up to $84,000 for a standard 12-week course of treatment – but they’re a vast improvement over earlier therapies that had severe side effects and often didn’t work.
The earlier drugs were similar to those used to treat cancer and commonly caused nausea, fatigue, anemia and flu-like symptoms. The new drugs also can cause side effects, including fatigue and anemia, but they’re milder.
Hepatitis C is caused by a virus that typically is spread through contact with infected blood. Baby Boomers are a large reservoir of illness because they could have become infected from intravenous drug use, unsafe tattoos or contaminated blood transfusions in the decades before safer practices were introduced. Plus, they’re now reaching an age when the negative effects of chronic infection may be catching up with them.
Up to a third of people who contract hepatitis C are able to clear the virus without treatment. Everyone else develops chronic hepatitis C infection. People often live with a chronic infection for two or more decades without obvious symptoms – meaning that Baby Boomers who were infected in the ‘60s or ‘70s may be feeling the effects only now.
Of the chronic cases, only about 20 percent will develop severe liver disease that can lead to cancer, severe scarring that requires a liver transplant, or death. About 16,000 people a year are thought to die from hepatitis C in the United States.
The new drugs offer the first hope that the virus can be cured in most patients and have propelled efforts to screen people who may be infected, although doctors have been slow to adopt those policies and most people still haven’t been tested.
In addition to the CDC, the World Health Organization and the U.S. Preventive Services Task Force recommend screening for anyone in the Baby Boomer demographic, whether they think they were exposed to the virus or not.
That’s the right tactic, said Emalie Huriaux, director of federal and state affairs for Project Inform in San Francisco, an HIV and hepatitis C patient advocacy group.
“The landscape is right for eliminating the disease, and that’s where we should be putting our efforts,” Huriaux said. “To me, the question isn’t should we be screening all the Baby Boomers. It really is how do we screen all the Baby Boomers.”
Huriaux said that she appreciated that the scientists were right to call for caution about widespread screening, but she’s reluctant to back off from programs that could provide enormous health benefits to people who may not know they are sick.
She noted that people who never get severe liver disease may still suffer fatigue or other vague, subtle symptoms of chronic infection that aren’t deadly but can affect their quality of life.
But the scientists questioning widespread screening and treatment said that while they too are enthusiastic about the new drugs and the potential to save lives, there are too many uncertainties about the therapies to justify such aggressive action at this time.
“Our concern is that the screening strategy is based on a number of assumptions that haven’t been adequately tested,” said Dr. Kenneth Lin, a Georgetown University associate professor of family medicine who was also an author of the paper. “Screening is likely to cast a wide net, and a lot of people will be treated unnecessarily.”
Dr. Joanna Ready, chief of gastroenterology at Kaiser Santa Clara and a longtime expert in hepatitis C, said it’s easy to get caught up in the excitement over the new drugs and the possibility of curing a deadly infection. Widespread screening, she said, is critical – “you can’t treat what you don’t diagnose,” she said.
But she agreed that more study needs to be done to better understand who will benefit from the new therapies.
“Twelve weeks after you stop therapy, in patients who have no detectable virus, we think that translates into a permanent cure. We think – but we don’t know,” Ready said. “It’s going to be years before we know if we’re impacting the actual natural history.”