Experimental Hepatitis C Drug Improves Outcome In Phase 3 Clinical Trials
An experimental drug manufactured by Vertex Pharmaceuticals has shown extremely promising results in a Phase 3 clinical trial, increasing the cure rate and decreasing the duration of treatment of Hepatitis C virus (HCV), a disease experts believe infects about 170 million people around the world.
Hepatitis C
HCV is a virus transmitted by blood and other bodily fluids. It causes inflammation of the liver and many who become infected don’t know until years later. The virus can cause the liver to become permanently scarred, a condition known as cirrhosis. Because of the scarring the liver cells cannot function properly. The main function of the liver is to breakdown compounds we ingest through diet and drugs and ones that we make. If the liver cannot do that, compounds that are toxic build up in our bloodstream and go to our brain, which can make us very ill. Liver failure can also occur and is fatal without a liver transplant. Liver cancer can also occur as a result of becoming infected with HCV.
Treatment for HCV
The standard treatment for hepatitis c is alpha interferon and ribavirin received in an injection and taken orally, respectively. Both have many side effects including depression, fatigue, nausea, fever, anemia and loss of appetite and treatment lasts for about a year.
Phase 3 Clinical Trials
The New York Times is reporting on a Phase 3 clinical trial that involved 1,095 HCV infected patients from 114 clinical trial sites around the world who had not received any previous treatments. Some received the experimental drug telaprevir or placebo for 8 or 12 weeks followed by the standard treatment that varied in length depending on their progress at week 4 and week 12 of the study. The control group received 48 weeks of interferon and ribavirin.
Those who received 12 weeks of telaprevir plus the standard treatment saw a cure rate of 75%, compared to 44% of those who only received interferon and ribavirin. Seventy percent of those cured in the telaprevir treatment group were cured within 6 months.
Telaprevir
Telaprevir works by inhibiting one of the viruses enzymes called a protease, which helps the virus reproduce once it infects the liver cells. Two side effects of the drug are a rash and anemia. One course of treatment will likely cost tens of thousands of dollars. But Lorren Sandt of the National Viral Hepatitis Roundtable said she hopes “that if telaprevir is approved by the F.D.A. that it will be accessible and affordable to everyone.”
