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Transformative advances in drug treatments approved by the Food and Drug Administration are giving the 3.2 million Americans with chronic hepatitis C a chance for a longer, healthier life without the virus. That’s welcome news for baby boomers—who make up three of four adults with the hepatitis C virus—and millions of other Americans, many of whom don’t yet know they are infected and carriers.
Hepatitis C can be cured, and today’s drug therapies are very effective and easier for patients to take, says Jeffrey S. Murray, M.D., the deputy director of the Division of Antiviral Products in FDA’s Center for Drug Evaluation and Research. Murray is an internist who specializes in infectious diseases.
Hepatitis (inflammation of the liver) refers to a group of viral infections that affect the liver. The most common types are hepatitis A, hepatitis B and hepatitis C. Each is caused by a different virus.
Hepatitis C is the most common chronic blood-borne infection in the United States. There is no vaccine for this disease, but hepatitis C can be prevented by avoiding behaviors that can spread the virus—including sharing needles, syringes or other equipment to inject drugs.
A diagnosis of hepatitis C no longer means months and months of painful drug injections, which for decades were the only option. Science is making strides in therapies, giving patients new alternatives.
“Interferon-based injections often make patients feel ill and give them flulike symptoms,” Murray says. The treatment by interferon also lasts six months to a year, and cures only 40% to 50% of hepatitis C patients.
“Patients with very advanced liver disease couldn’t take the traditional treatment because often those injections could make them worse,” he adds. “Now, patients can treat their hepatitis C with only pills– drug combinations that are faster and have a higher cure rate.”
Today’s pills have double the viral cure rates—90% to 100%—in just in 12 weeks’ time. Reducing the treatment from a year to three months is a huge advantage for people with hepatitis C, especially because it’s easier to swallow a pill than to get an injection, Murray says.
The new regimens include Sovaldi (sofosbuvir), which is the first drug approved to treat certain types of hepatitis C infection without the need to co-administer interferon. In recent years, FDA has also approved three protease inhibitors—Olysio (simeprevir), Victrelis (boceprevir) and Incivek (telaprevir)—to treat chronic hepatitis C virus infection. Olysio is a protease inhibitor that blocks a specific protein the hepatitis C virus needs to replicate. The drug is a component of a combination antiviral treatment regimen.
FDA provides information through a Hepatitis e-mails list, along with notices of upcoming public events, such as advisory committee meetings, and opportunities to comment on policies and issues that affect people with hepatitis B or C.
For most people, hepatitis is a silent disease until it causes substantial damage to the liver. That process may take several years, and can lead to liver failure, liver transplantation and liver cancer.
“Hepatitis C is a bit like smoking, the longer you’ve had it, the higher your risk of developing complications—in this case, liver cancer and end-stage liver disease. It’s a progressive disease that takes years, even decades, before the patient develops cirrhosis or cancer,” Murray says. “The good news is that when you cure hepatitis C, you also lower its risks, though you don’t completely erase the years of damage to your liver.”
Once infected with the hepatitis C virus, nearly 8 in 10 untreated people remain infected for life, according to the Centers for Disease Control and Prevention (CDC). Three in four patients with chronic hepatitis C are baby boomers (people born from 1945 to 1965), and many became infected before the virus was identified and the blood supply was tested for the disease. That’s why it’s important for baby boomers—there are 76.4 million of them, according to the U.S. Census Bureau—to take a simple blood test for hepatitis C.
“When it comes to hepatitis C, the outlook for the future is better, but the past is catching up with us—especially if you are a baby boomer,” Murray says. “Still, this is a fortuitous time because better hepatitis C treatments are becoming available just as the patient population at risk of long-term complications is about to peak. There are treatments for chronic hepatitis and many reasons to get tested now more than ever because of the availability of safe and effective therapies.”
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
July 28, 2014