Schering-Plough Wins FDA Approval for New Hepatitis C Combination Therapy

Drug maker Schering-Plough announced Wednesday that it had received FDA approval to market its new hepatitis C drug Peg-Intron in combination with Rebetol, the company's brand of ribavirin, the Los Angeles Times reports (Los Angeles Times, 8/9). Schering had previously only offered Rebetol through a two-drug package that combined the drug with the company's brand of interferon-alpha. The company received FDA approval late last month to sell Rebetol separately (Kaiser Daily HIV/AIDS Report, 7/27). Peg-Intron, a new version of interferon-alpha, is made with new "pegylation" technology that "cloaks it from the immune system so it stays active longer" (Kaiser Daily HIV/AIDS Report, 1/23). The new combination treatment of Rebetol and Peg-Intron is expected to be "significantly more effective" than the company's older therapy of Rebetol and interferon-alpha, the Newark Star-Ledger reports. Schering-Plough has stated that 54% of patients taking the newer treatment have undetectable viral levels, compared with 41% of patients taking the previous combination therapy (Schwab, Newark Star-Ledger, 8/9). Dr. John McHutchison, medical director of liver transplantation at the Scripps Clinic and Research Foundation, said, "This combination therapy represents a new and effective treatment option for hepatitis C, increasing our ability to eradicate detectable levels of the virus in some patients, while providing the convenience of once-weekly dosing of Peg-Intron vs. the three-times-a-week dosing of standard interferon" (Schering-Plough release, 8/8). Schering-Plough spokesperson Robert Consalvo said that the new combination therapy will be available in the fall (Newark Star-Ledger, 8/9). Shares of Schering-Plough "remained relatively flat" after yesterday's announcement, closing at $38.35, up 17 cents per share (Los Angeles Times, 8/9).

Advocates Concerned
The Peg-Intron/Rebetol treatment is expected to "quickly" become "the leading treatment for hepatitis C," but some advocates fear that the drugs will be priced out of reach for many patients. Some advocates are concerned that Schering-Plough will "make Rebetol so expensive that patients will use the combination therapy" instead of choosing more individually tailored doses and treatment regimens. Brian Klein, a founding member of the Hepatitis C Action & Advocacy Coalition, said that some advocates worry that Schering-Plough "will try to force consumers to buy the new combination of Peg-Intron and Rebetol" through "market manipulation" (Newark Star-Ledger, 8/9).