New Hepatitis C Treatment Improves Cure Rate
Hepatitis C can be a difficult disease to treat, but researchers at Indiana University School of Medicine have found a way to improve the cure rate. The addition of an anti-viral drug to the standard treatment program has shown promising results in difficult-to-treat patients.
Hepatitis C is an infection of the liver caused by the hepatitis C virus (HCV). About 15 percent of cases are acute, which means the immune system is able to destroy the virus. In about 85 percent of people with the disease, the immune system is unable to fight the infection, and these individuals end up with long-term liver infection, or chronic hepatitis C.
According to the Centers for Disease Control and Prevention (CDC), an estimated 3.2 million people in the United States have chronic hepatitis C, although some sources state a higher figure of 3.9 million. About 17,000 new cases of hepatitis C are reported each year. In the United States, 70 percent of people with the disease have the genotype 1 form, which is the most difficult to treat.
Although the genotype 1 form of the disease often displays no symptoms for many years, presence of the infection over the years can cause cirrhosis and eventually result in liver cancer or the need for a liver transplant.
New Treatment for Hepatitis C
Fewer than half of patients who have genotype 1 hepatitis C get an effective response from the standard treatment, which includes peginterferon alfa-2b plus ribavirin, which patients usually take for 48 weeks. Use of these two drugs is associated with anemia and other significant side effects, including headache, anxiety, depression, hair loss, muscle pain, joint pain, insomnia, nausea, vomiting, fever, and fatigue.
In the current study, researchers found that adding the antiviral drug boceprevir to the standard two-drug, 48-week treatment increased the cure rate up to 75 percent, compared to 38 percent in those who took the standard treatment. A total of 520 patients from 67 sites around the United States, Canada, and Europe participated in the study.
The investigators tried several different treatment options to better identify the effectiveness of the combination therapy. For example, they gave some patients the three-drug combination for 28 weeks while others took it for 48 weeks. They also tested whether starting patients on the standard two-drug combination before adding boceprevir improved the response rate. They also evaluated whether reducing the dose of ribavirin could lower the anemia side effects while still treating the virus.
Overall, both the 28- and the 48-week boceprevir treatments significantly increased the response rates when compared with the two-drug, 48-week control group. Researchers also found that a 48-week treatment program that started with four weeks of the standard two-drug program resulted in the largest improvement over the control group: 75 percent of these patients tested negative for the hepatitis C virus six months after they ended treatment.
Among the patients who took the three-drug treatment for 48 weeks without a four-week lead-in, the success rate was 67 percent. Patients who received the three-drug treatment for 28 weeks with no lead-in achieved a 54 percent success rate.
Based on the results of this study, Paul Kwo, MD, associate professor of medicine at Indiana University School of Medicine, noted that if boceprevir is granted final approval, “approximately two-third of patients will be able to be treated successfully with 28 weeks of treatment and one-third will need 48 weeks of treatment.” Additional studies are needed, however, to confirm the cure rates for hepatitis C found in this study.
Centers for Disease Control and Prevention
Indiana University School of Medicine