Faldaprevir and deleobuvir are part of effort to develop treatments that avoid harsh side effects
WebMD News from HealthDay
By Amy Norton
HealthDay Reporter
WEDNESDAY, Aug. 14 (HealthDay News) -- An experimental drug duo may cure some cases of the liver disease hepatitis C, without the severe side effects of standard therapy, a new clinical trial suggests.
The study, of 362 people with chronic hepatitis C, found that the new drugs -- combined with one older drug -- cleared the virus from up to 69 percent of patients. And that was without having to use interferon, a difficult-to-take injection drug that is part of the current therapy.
Experts said the findings, published in the Aug. 15 issue of the New England Journal of Medicine, are another step forward in vastly improving hepatitis C treatment.
Dozens of drugs are in development, and some are currently being considered for approval by the U.S. Food and Drug Administration (FDA).
"These are very exciting times in hepatitis C treatment," said Dr. Michael Saag, an infectious disease specialist at the University of Alabama at Birmingham who was not involved in the new study.
Hepatitis C is a liver infection usually passed through contact with infected blood. For most people, the infection becomes chronic, which can eventually lead to scarring of the liver (cirrhosis) or liver cancer years later.
That happens only in a minority of people. "But we have no way of knowing in advance who will develop cirrhosis or cancer," Saag said.
The current drug regimen for chronic hepatitis C includes interferon, plus an older oral drug called ribavirin, and either one of two drugs just approved in the last couple of years, called telaprevir and boceprevir. That combo cures about 68 percent to 75 percent of people with the most common strain of hepatitis C, called genotype 1.
The problem is, treatment lasts for months and almost always causes substantial side effects.
Interferon is especially hard to take, with side effects ranging from sleep problems and mood swings, to nausea and diarrhea, to muscle pain, fever and fatigue.
"There is a great desire to be able to cure hepatitis C without interferon," said Saag, who also serves on the Infectious Diseases Society of America's hepatitis task force.
In the new study, funded by drugmaker Boehringer Ingelheim, German researchers tested two experimental drugs called faldaprevir and deleobuvir against hepatitis C genotype 1.
The investigators randomly assigned 362 patients to one of five groups. Each group received the two new drugs. Four groups also took ribavirin, while the fifth did not.
In the end, the ribavirin proved necessary, Saag pointed out. Three months after their treatment ended, anywhere from 52 percent to 69 percent of patients on all three drugs were hepatitis free, depending on the dose and how long they took the medications.
In contrast, only 39 percent of patients who did not take ribavirin were free of the virus.
source : More Drugs Show Promise in Fighting Hepatitis C
