mediated amplification (TMA). The presence of HCV RNA in serum indicates an active infection . After the blood test, further information can be obtained through an ultrasound and other liver scans. In some rare cases, a biopsy (taking a tiny piece of the liver to be analyzed) of the liver can be recommended.
Acute viral hepatitis is generally straightforward to diagnose. Patients who report symptoms of fatigue, nausea, abdominal pain, darkening of the urine, and jaundice (a yellow appearance to the skin, and to the white portion of the eyes), are given a blood test to confirm viral hepatitis.
Chronic viral hepatitis B and C, on the other hand, are commonly asymptomatic, or result in mild nonspecific symptoms such as chronic fatigue. Jaundice, for chronic viral hepatitis patients, develops only when the liver is considerably damaged. Thus, these patients can remain undiagnosed for years or even decades.
The Situation Prior to Launch
Background
Prior to 1990:
In 1963, a blood test to detect the Hepatitis B virus was developed; similarly, in 1973, an effective screen for Hepatitis A was approved. Still, there were many cases of the Hepatitis virus after 1973, from blood transfusion, that were neither Hepatitis A nor B. It is was believed that most of these negative Hepatitis-A and –B results were, in fact, Hepatitis C. It took a joint effort by the Center for Disease Control (CDC) and Chiron to identify the Hepatitis C virus in 1989, and a year later, blood banks began screening its donors for the virus. It is believed that “300,000 Americans contracted hepatitis C through blood transfusions or blood products” prior to 1990.
In the 1990s:
Pharmaceutical companies began introducing medications based on the “interferon”, a naturally occurring substance that, in 1957, scientists discovered to have antiviral properties. Specifically, it has the ability to interfere with viral replication. Of the three forms, “alfa”, “beta” and “gamma”, only alfa can be found in many forms, and its promise to treat a variety of disorders led scientist to experiment on the Hepatitis viruses.
When interferon alfa treatments were first introduced into the market, treatment dictated that 3 million units of interferon were injected three times a week for 48 weeks. Sustained virological response rates, (i.e., virus suppression to undetectable levels so that during the six months post-treatment, there is no detectable hepatitis C virus in your blood ) were approximately 9% for genotype 1 and 30% for genotypes 2 and 3.