AIDS TREATMENT NEWS Issue #302, September 4, 1998
Jeffery Stoia

Until June of this year, only one drug, ineffective and expensive, had been approved by the FDA to treat hepatitis C (HCV). That was alpha interferon. At best it was said to produce a long-term remission rate of 5% in relapsed hepatitis C patients. Side effects included fatigue, joint pains, fever, anxiety, and severe depression. According to the HCV Global Foundation, interferon was considered for people with HCV and HIV co-infection only if their HIV was well controlled.

On June 3, 1998 the picture changed when the FDA approved a second therapy. This was Schering-Plough Corporation's REBETRON(TM), which combines in a single "bundled" package alpha interferon for injection, and oral doses of ribavirin.

Ribavirin, a synthetic nucleoside, has been approved throughout the world as a broad-spectrum antiviral but has been stalled in the U.S. because of questions concerning its potential usefulness in treating HIV. Its chief side effect is anemia. (Ribavirin is now also called REBETOL(R), which is a brand name of Schering-Plough, which recently acquired worldwide rights to the drug from its developer, ICN Pharmaceuticals.)

In approving the new combination therapy, the FDA labeled it as indicated only for patients who had "relapsed" following interferon alone. (This may change soon; Schering-Plough has submitted a supplemental new drug application to the FDA for the treatment of naive patients, and the new application is currently under priority review.) For relapsed patients, the cure rate climbed sharply with the combination ("cure" defined as undetectable HCV virus, even after therapy has ended). In two major clinical studies, patients given interferon plus placebo had a cure rate of 5%, while those given interferon plus ribavirin achieved a rate of 46%. The usual length of the two-drug treatment is six months.

Meanwhile, Schering-Plough, which markets the bundled drugs, was sharply criticized from several quarters. Some saw Amgen's brand of interferon as more effective than Schering's, but hard to prescribe because of the way the two drugs were packaged and sold together. Some pointed to the unfair monopolistic advantage Schering-Plough had received with the FDA decision. Others objected to patient restrictions and to drug "bundling" in a single package which sells for as much as $1440 a month, nearly double the cost of interferon treatment alone. One protester wrote, "This is as absurd as the notion that aspirin would need separate approvals when used in conjunction with each possible kind of antibiotic on the market."

Robert Consalvo, on behalf of the drug company, pointed out that in controlled clinical studies, the combination of INTRON(R) A (Schering-Plough's alpha interferon) and ribavirin demonstrated a significant improvement over standard monotherapyïand that Schering is supplying the product free to many research volunteers. "Both alpha interferon and ribavirin have known side effects," he added, "but no synergistic toxicity was seen in clinical studies with REBETRON."

HCV is a blood-borne virus. Testing is all-important, and patients usually need to take the initiative to be tested. The virus tends to progress slowly and insidiously over 20 to 30 years, so that until they reach an advanced, chronic stage, as many as 75% of infected people are totally asymptomatic. People at risk of acquiring HCV include drug users, hemodialysis patients, those with tattoos, those with multiple sex partners, and anyone who had a blood transfusion before 1990. Some people may contract the virus through unprotected sex. People with HIV and other immunodeficiencies are considered a major risk group.

AmFAR (the American Foundation for AIDS Research) is conducting the first study of ribavirin plus alpha interferon for treating hepatitis C in persons who also have HIV. Two hundred volunteers will be enrolled in 14 U.S. cities. (For more information about this study, see AIDS TREATMENT NEWS #295, May 15, 1998.)

[Jeffery Stoia is a medical writer and editor who also volunteers for AIDS service organizations in San Francisco.]

For More Information

* At this time the most current and in-depth medical information on the use of the newly approved combination treatment is the transcript of the discussion of the FDA's Antiviral Drugs Advisory Committee meeting of May 4, 1998. This transcript, about 90 pages single spaced, is available on the FDA's Web site, http://www.fda.gov. Select "Dockets," then "FDA Advisory Committees Menu," then "Center for Drug Evaluation and Research (CDER)," then "Antiviral Drugs Advisory Committee." The hearings are listed by date, and can be downloaded in either pdf or rtf file format. (The rtfïrich text formatïis much more compact and downloads faster, but you may need to turn off automatic line numbers in your word processor, to prevent overprinting.)

* A major article on the controversy about the bundling of the two drugsïforcing patients to pay for Schering-Plough's interferon in order to buy ribavirin in the U.S.ïis scheduled to be published in the San Francisco Bay Times, September 3, 1998. You can obtain a copy by sending a self-addressed stamped envelope to: San Francisco Bay Times, 525 Bryant St., San Francisco, 94107; request the hepatitis C article by Bruce Mirken.

* A number of articles are on the Web site of The American Liver Foundation, http://sadieo.ucsf.edu/alf/alffinal.

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