March 30, 2011 -- Two highly anticipated hepatitis C drugs are poised to usher in a new era in the treatment of the viral disease as early as this summer, experts say.
The Merck drug boceprevir and Vertex Pharmaceutical’s similar drug telaprevir are expected to win FDA approval within months, following phase III trials showing that both drugs boosted cure rates to around 70% when used with standard therapy.
The drugs will be used in patients with HCV genotype 1 -- the hardest to treat form of the viral infection.
Adding one of the drugs to the current two-drug regimen of peginterferon and ribavirin will make the treatment of hepatitis C more complex, but it will also cure a lot more people, hepatitis C specialist Donald M. Jensen, MD, of the University of Chicago Medical Center, tells WebMD.
“Triple-drug therapy represents a major advance in the treatment of hepatitis C for patients,” he says.
Results from two phase III boceprevir trials are published in the New England Journal of Medicine.
In one trial, 66% of previously untreated patients treated with the three-drug regimen of boceprevir, peginterferon, and ribavirin cleared the virus for good, compared to 38% of patients treated with peginterferon and ribavirin alone.
Patients who show no evidence of hepatitis C virus (HCV) infection in the blood for six months are considered cured because the likelihood that the virus will reappear is very small. This is known medically as sustained viral clearance.
In another study, just over half of patients who did not respond to the initial two-drug treatment achieved sustained viral clearance when boceprevir was added to a second, 44-week course of treatment. Only 7% of patients treated for a second time with standard therapy cleared the virus for good.
Responses to the triple-drug therapy were even better in patients who initially responded to standard treatment but then relapsed. Seventy-five percent of these patients treated for 44 weeks achieved sustained viral clearances, compared to 29% of patients who got a second round of peginterferon and ribavirin.
The outcomes were similar to those seen in phase III trials of telaprevir.
“Triple therapy is coming soon,” veteran HCV researcher Bruce R. Bacon, MD, of St. Louis University School of Medicine, tells WebMD. “The only question is will it be triple-drug therapy with boceprevir or triple drug therapy with telaprevir?”
How the Drug Combo Works
About 3 million Americans are infected with HCV, and the CDC says more than 12,000 people in the U.S. die each year of liver disease and liver cancer caused by the virus. It is also the leading cause of liver transplants.
Most people show no symptoms of infection with hepatitis C for years, or even decades. Because of this, few people even know they are infected until they develop liver disease or have significant liver scarring, known as cirrhosis.