Adding a direct acting anti-viral drug to the standard treatment regimen for hepatitis C significantly increases the cure rate in the most difficult to treat patients, according to a research report published in the online edition of the journal The Lancet.
The research team, led by Paul Kwo, M.D., of Indiana University School of Medicine, reported that adding the drug nearly doubled the treatment's effectiveness when given for 48 weeks in one treatment arm of the study.
An estimated 3.2 million Americans and 170 million people worldwide are infected with the hepatitis C virus, but many do not know it. In the United States, 70 percent of affected individuals are infected with genotype 1 hepatitis C, the most difficult to treat. Although there may be no symptoms for years, long-term infection can cause cirrhosis and the disease is a leading cause of liver cancer and liver transplantation. Hepatitis C infections occur mainly through transmission of infected blood, such as via injection drug use, and there is no vaccine.
Currently fewer than half of patients with genotype 1 hepatitis C are treated effectively by the standard combination of two drugs, peginterferon alfa-2b plus ribavirin, which is typically given for 48 weeks. The treatment can be difficult for some patients due to anemia and other side effects.
Adding the drug boceprevir increased the cure rate to as high as 75 percent in those who received 48 weeks of the three-drug combination therapy, compared to 38 percent of those in the control group, who received the standard two-drug treatment for 48 weeks, said Dr. Kwo, associate professor of medicine at the IU School of Medicine. The two-year phase 2 trial was conducted at 67 sites with 520 patients in the U.S., Canada and Europe.
Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial.
Paul Y Kwo, MD, Eric J Lawitz, MD, Jonathan McCone, MD, Eugene R Schiff, MD, John M Vierling, MD, David Pound, MD, Mitchell N Davis,DO, Joseph S Galati, MD, Stuart C Gordon, MD, Natarajan Ravendhran, MD, Lorenzo Rossaro, MD, Frank H Anderson, MD, Ira M Jacobson, MD, Raymond Rubin, MD, Kenneth Koury,PhD, Lisa D Pedicone, PhD, Clifford A Brass, MD, Eirum Chaudhri, MD, Janice K Albrecht, PhD.
The Lancet, 2010; DOI: 10.1016/S0140-6736(10)60934-8
Link to The Lancet abstract