AEGiS-ATDN: HCV Treatment Approved / Accessing Peg-Intron

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

HCV Treatment Approved / Accessing Peg-Intron

Information Bulletin #14 - March 2002

Liver disease is now the leading cause of death among people with HIV, regardless of CD4 count. There are several reasons why liver disease has become a major issue for people with HIV, including chronic infection with hepatitis B or hepatitis C, as well as drug toxicity. Being co-infected with HIV and HCV is different than being infected solely with either HIV or HCV. The Network will distribute new information about HCV co-infection as it becomes available.

The FDA has recently approved a combination of pegylated alfa interferon (PEG-Intron), and Rebetol (ribavirin) for the treatment of people who have Hepatitis C (HCV). Neither Schering-Plough's PEG-Intron, nor Hoffman-LaRoche's Pegasys has been specifically approved to treat people who are both HIV and HCV co-infected, although both companies have been conducting clinical trials in this group of people.

Because PEG-Intron is now available as an approved drug, it is expected that some doctors will prescribe the combination of PEG-Intron and Rebetol for people who are co-infected. In order to get a prescription for PEG-Intron patients must enroll in the Schering sponsored Access Assurance program and receive an ID number and card.

Unless you are a registered Access Assurance program member, you will not be able to fill a prescription for PEG-Intron. Once you receive the ID card, you take it to a pharmacy, where the pharmacist gets an authorization number to fill the prescription. This could take up to five days. You have the option of providing contact information when enrolling in the program. If you chose this option, someone from a Schering-Plough contracted consulting firm will contact you if you haven't refilled your prescription within a 60 day period. You will also have a 12 month supply of the drug set aside for you.

If you don't refill your prescription within 60 days of receiving the drug, you will need to reapply to the program. The Schering-Plough Access Assurance ID# phone number (toll-free) is 1-888-437-2608.

Because of the number of people who have enrolled in the program so far, and the limited availability of PEG-Intron, a wait list began in mid-January. According to Schering-Plough, "As originally intended, patients are being released from the wait list on a first-come, first-served basis, and the first block of patients placed on the wait list have already begun treatment as product became available for them (note: this happened earlier than the 10-12 week wait originally projected.) We anticipate that the program will be administered in this way going forward, with "blocks" of patients coming off the wait list simultaneously, rather than one patient at a time, which would be a logistical nightmare.

While some additional blocks of patients may come off the wait list between now and April, we do expect to be able to start a large number of patients in April, as our efforts to maximize use of current product continue and new supply of product (from our production facilities) will come into the market at that time. The Access Assurance program and the wait list will remain in place as long as necessary to assure uninterrupted access for patients on therapy. We cannot accurately predict when we will end the program, since we don't know how many potential patients are out there and how quickly they will want to start therapy. Of course, as soon as it is prudent to do so, we will end the registration program -- it is not going to be permanent. For those people waiting to start studies (assuming these are investigator-initiated), those patients would also have to register for Access Assurance and will be placed on the wait list. "

There is a special mechanism in place for people who need the drug urgently. According to a representative of the company, " For example, if a patient has not yet begun therapy and his/her physician determines that immediate treatment is needed, the physician can go to the independent 3rd party medical review board which evaluates critical situations on an individual basis. A dedicated supply of PEG-Intron has been allocated for these emergency needs." Hepatologists have made the observation that this specific aspect of the program is for especially ill patients.

"In addition, if a patient is already on therapy and is in danger of missing a dose, he/she should contact the Access Assurance program and explain the situation. Customers service representatives can arrange for expedited delivery of drug in these instances." Schering anticipates that by April there should be a more steady supply of the drug, as they become better able to calculate ongoing demand for the drug.
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