On June 3rd, Schering-Plough announced that they had received FDA approval to market a combination of ribavirin and interferon alpha for the treatment of hepatitis C. This approval was granted for people with hepatitis C, who had previously responded to interferon alone but relapsed, meaning their "liver enzymes" went back up after treatment. The PWA Health Group has been importing ribavirin since the late 80s.
In Folks Experiencing Relapse
This approval was granted based on two clinical trials, one in the United States (153 people) and one international study (192 people). Volunteers with hepatitis C who had relapsed after being treated with interferon alpha alone were given either interferon alone again, or interferon in combination with ribavirin for 24 weeks. Participants were then followed for an additional 24 weeks after therapy was completed. The primary laboratory test used to determine if the treatment was successful was hepatitis C RNA (also known as hepatitis C viral load or PCR; a marker of viral activity). This laboratory test cannot measure viral load levels below 100 copies per ml. Therefore, anything below 100 was considered a response. This does not necessarily mean that the virus is gone but that viral activity is at very low levels.
The results of the U.S. and international studies were similar. In the U.S. 43% of those on the combination therapy experienced a viral load response, meaning hepatitis C viral load fell below 100 both at the end of 24 weeks of treatment and at the end of the 24 week follow-up period. Only 4% of those treated with interferon alone had a response. In the international study, 48% of those on the combination had a viral load response, far better than the 5% on interferon therapy alone.
Preliminary Results In Those Not Previously Treated
Schering-Plough has also announced positive results from a clinical trial in those with hepatitis C who have not been previously treated. These data have yet to be published. The two studies in this group of volunteers were similar to those described in those who relapsed except there were groups treated for a longer period, 48 weeks. Once again, participants were assessed for viral activity 24 weeks after treatment was completed. In those treated for 48 weeks with the combination therapy, 41% experienced a response (viral load below 100) versus 16% on interferon alone. In those treated for 24 weeks, the response rate was 33% for the combination versus 6% with interferon alone.
In mid-June, Schering-Plough applied to the FDA to expand the approval of combination ribavirin and interferon to include those who have yet to be treated. This approval could be granted by year-end. It is important to note that there are no data, to date, on interferon plus ribavirin treatment in those co-infected with hepatitis C and HIV.
The High Cost of Therapy
Schering-Plough not only launched ribavirin at a high price but they are packaging it together with their own brand of interferon which limits the choice of which interferon can be used in combination therapy. The brand name of ribavirin is Rebetol. The brand name of Schering's interferon alpha is Intron A. They are packaged together as a treatment for hepatitis C, called Rebetron.
Before Rebetron, the most common treatment for hepatitis C was 3 million IUs of interferon injected subcutaneously (under the skin), three-times weekly, for 24 weeks. At the average wholesale price, this treatment costs approximately $2,500. The approved Rebetron dose includes the same dosing scheme of interferon plus oral ribavirin 1,200 mg daily for those who weigh more than 75 kg, (165 lbs) or 1,000 mg daily for those 75 kg or less. The average wholesale price of 24 weeks of Rebetron treatment, depending on the individual's weight, ranges from approximately $7,800 to $8,600! Therefore, 24 weeks of ribavirin therapy has been priced at $5,300 (for 1,000 mg per day) to $6,100 (for 1,200 mg per day)!!
The PWA Health Group helps people import "Vilona", ribavirin manufactured by ICN pharmaceuticals, from Mexico under the FDA's Personal Import Regulations. Our price is $82 per box of 18, 400 mg tablets. Treatment for 24 weeks at 1,200 mg daily, costs approximately $2,300.
Schering's price is 265% greater than what's available through Mexico. That's quite a premium considering they simply conducted 24 to 48 week clinical trials in approximately 2,000 people. No wonder they recently renegotiated for exclusive worldwide rights to market oral ribavirin for hepatitis C. Analysts estimate that revenues from Rebetron will approach $1 billion in four years! Did anyone need another example of out-of-control drug prices? Well, here it is.
HAAC Calls for Action in Fight Against HCV!
A new national direct action group called HAAC (Hepatitis C Action and Advocacy Coalition) has been formed in San Francisco. The group's mission statement says it all:
HAAC is a grassroots, all-volunteer group of individuals committed to non-violent direct action to end the Hepatitis C (HCV) crisis. We work to provide access to life-extending treatments to PEOPLE WITH HCV, foster effective prevention efforts, encourage sound public health policies, and ensure prevention of HCV. We work cooperatively with government and industry when progress is being made, and take to focused non-violent direct action when progress is stalled. We accept no money from pharmaceutical companies. Ending the HCV crisis is our highest priority.