Vertex drug shows promise against hepatitis C
LOS ANGELES - An experimental drug greatly increased the number of people who appear to be cured of hepatitis C infection, according to results of midstage testing.
The findings also suggest that the drug, telaprevir, made by Vertex Pharmaceuticals Inc., which sponsored the two studies, can cut treatment time from one year to six months. However, those taking the drug reported more side effects, including severe rash, nausea, and anemia, than those on standard treatment alone.
Still, telaprevir and similar drugs that other companies are testing offer hope of a major advance against the disease, which afflicts about 3.2 million Americans and 180 million people worldwide. It is caused by a bloodborne virus that can lead to liver scarring or liver cancer.
Treatment is aimed at helping the immune system eliminate the virus. Current therapy combines the drugs peginterferon and ribavirin, but fewer than half of the patients on them are cured. Telaprevir and similar drugs under development are a potential game-changer because they specifically attack the hepatitis C virus.
In the two studies, roughly two-thirds given telaprevir with standard therapy for six months showed no signs of the virus after six months, which doctors considered being cured of the disease. That's compared to 40 to 50 percent on standard treatment alone. "We can now sit down with our patients and tell them that two of three patients can be cured with a 24-week course of therapy," said Dr. John McHutchison, a Duke University doctor who led one study and has consulted for Cambridge, Mass.-based Vertex.
Telaprevir is in late-stage testing and is not available commercially; the company plans to seek government approval next year.
Results were published in today's New England Journal of Medicine.
Hepatitis C is a huge and growing problem because for years there was no way to screen the blood supply for the virus. Infection often doesn't produce symptoms for many years, so many of these cases are just now being recognized, even though they may stem from transfusions a decade or more ago.
The virus is mainly spread through contact with the blood of an infected person.
About one-quarter of people exposed to hepatitis C clear it out of their bodies without treatment. But the rest develop a lifelong infection that attacks their livers. There is no vaccine.
In one US study of 250 people with chronic hepatitis C, 61 percent who took telaprevir with standard therapy for six months cleared the virus, compared with 41 percent on standard therapy alone. Among those who took the drug and standard therapy for a year, 67 percent had no signs of infection. However, twice as many on telaprevir stopped treatment because of side effects.