New drugs offer easier, more effective hepatitis C treatment

If you are a baby boomer, the U.S. Centers for Disease Control and Prevention (CDC) recommends that you be tested for infection with the hepatitis C virus. The virus can live in the liver for decades, often causing silent damage that leads to liver failure or liver cancer.

But wide-scale testing has proved to be a hard sell. One reason is that treatments to eliminate HCV infection have required weekly injections of one drug and oral doses of others. Treatment could take up to a year. Typical side effects of the injected drug required to clear the virus, called peginterferon, include depression, anxiety, irritability, anemia, and fatigue.

"The existing therapies were almost as feared as the disease itself," says Dr. Raymond Chung, a hepatitis expert at Massachusetts General Hospital and an associate professor of medicine at Harvard Medical School.

Two drug studies published today in The New England Journal of Medicine mark the latest advance in making treatment for HCV easier and more effective. Researchers report that combining several oral antivirals—drugs taken in pill form, not as injections—clear the virus from the liver in more than 95% of people in just 12 weeks.

These latest reports follow FDA approvals of two oral HCV drugs in late 2011: simeprevir (Olysio) and sofosbuvir (Sovaldi). When either of these drugs is combined with injected peginterferon and an oral drug called ribavirin (Rebetol), HCV can be cleared from the liver in up to 90% of cases of the most common form of the virus (genotype 1).

The case for HCV testing

The CDC estimates that between 3 and 4 million people in the United States are chronically infected with HCV. Half may not be aware of it. The longer that HCV remains in the liver, the more likely that it will cause liver disease. One sign of this is the development of scar tissue in the liver, known as cirrhosis. An HCV infection can also lead to liver failure (requiring a transplant) or liver cancer.

Testing people born between 1945 and 1964 targets those people who have been infected long enough to be at highest risk for progression to liver disease, cirrhosis or cancer during their lifetimes, says Dr. Chung, who wrote an editorial that accompanies the New England Journal of Medicine articles.

HCV is transmitted via exposure to blood or blood products. Those most at risk of HCV infection include anyone who

• currently uses or has ever used injected drugs
• received a transfusion of blood, blood components or an organ transplant before July 1992
• received clotting factor concentrates produced before 1987
• has ever been on long-term kidney dialysis

Others at risk include healthcare, emergency medical, and public safety workers who were potentially exposed to HCV from needle sticks, sharps, or blood, and children born to HCV-positive women.

Screening pros and cons

Wide scale testing of Baby Boomers will increase the pool of people who can benefit from with new oral drugs. "This strategy will really home in on those who are at greatest risk of disease," Dr. Chung says. "If fully implemented, it might be able to identify another million people previously undiagnosed with hepatitis C."

Not everyone with chronic HCV infection develops liver disease or liver cancer. But they can still spread the infection to others. Also, once a person develops cirrhosis or significant liver damage, successful antiviral treatment may not eliminate the lifetime risk of premature death from liver disease or cancer as much as treating it earlier in the course of disease.

Price remains an obstacle

In an era of safe, highly effective antivirals and a treatment time that may shrink to 8 weeks with tolerable side effects, many barriers to HCV treatment are falling.

Except for one: cost. Currently the cost of oral therapy tops $80,000. "The irony is that we have solved the scientific challenge of HCV, but now the bottleneck lies in getting those pills into the patient," Dr. Chung says. "That's where cost enters the room."

With even more oral drugs expected to be approved by the end of 2014, Dr. Chung says, there is hope that competition for a growing pool of HCV-infected people will help to drive costs down.

"Now that we have a treatment that would succeed in vast majority of people with few side effects and a shorter treatment time, it would be a shame to miss out on curing someone who might later present with advanced disease," Dr. Chung says.