Tuesday, August 5, 2014

FDA - Faster, Easier Cures for Hepatitis C

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products

Faster, Easier Cures for Hepatitis C

A Preventable and Curable Disease

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.

Get Updates
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.

Helpful Links
Complex debate on the decision to treat HCV with currently available therapies or wait for more options.

Podcast August 2014: Evolution of Hepatitis C Virus Treatment



New FDA process speeds approval of high-priced breakthrough drugs

Gilead's Sovaldi prescribed more than all other hepatitis C drugs combined

Why Hepatitis C Still Kills 16,000 Americans Per Year, and What We Can Do About It

Baby boomers targeted for Hepatitis C testing
If you’re age 50 or older, ask your doctor to be screened for Hepatitis C

The diagnosis was a surprise for Claudia Dionne: testing during her yearly check-up revealed hepatitis C. The liver-damaging virus was not causing symptoms but for the 4 million people in the United States with hepatitis C it can lead to liver cirrhosis, liver cancer and is the most common reason people need a liver transplant.

But research is changing what comes next for those who learn their diagnosis early. Four new drugs – Victrelis, Incivek, Olysio and Sovaldi — approved in the past three years make treatment easier and more effective. Additional medicines are expected to be approved this year.

Without injections or side effects, treatments have become so simple that 12 weeks of pills alone have a 90 to 95 percent success rate for most people — provided they are diagnosed early. All it takes is a simple blood test.
Who is at risk for Hepatitis C?

Anyone who received a blood transfusion before 1990 is at risk for infection. Widespread screening of the blood supply for hepatitis C began in 1991, so anyone who was transfused before then could have been exposed to the virus.

Another source of infection is infected needles used for acupuncture or tattoos performed at unlicensed locations that do not meet federal safety guidelines.

You should be tested if:
• Your mother had Hepatitis C when you were born
• You were born between 1945 and 1965
• You used injection drugs in the past even if it was just one time many years ago
• You had a blood transfusion before 1990
What you should know about testing?

The only way to tell if you are infected is to have a blood test for the hepatitis C virus. If you have your blood tested regularly by your primary care doctor, you shouldn’t assume you have been tested for Hepatitis C. You should specifically ask to have a screening test, which tests for the virus antibody. If the hepatitis C antibody is detected, a confirmation PCR (polymerase chain reaction) test for the virus RNA (genetic material) is recommended.

The CDC recommends testing, regardless of exposure, if you were born between 1945 and 1965. It’s possible to have a risk factor but to have forgotten about it. Requesting a screening based on your age also bypasses the discomfort of having to talk to your doctor about potentially embarrassing things such as admitting to taking drugs and sharing needles.

The CDC estimates that people born in this period are five times more likely to test positive than people who are younger or older. This group accounts for 70 percent of people with Hepatitis C so screening becomes a very efficient way to detect and treat.
Why should you be tested?

If you are treated and your body responds, you can get rid of the virus before liver damage and liver failure. You stop the progression of liver disease. As long we have people who are infected, they are a source of infection for other people. With every patient we treat, we diminish the pool of people who can become ill or can infect others.

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