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| |  Roferon-A Now Licensed for Treatment of Chronic Hepatitis C NUTLEY, N.J.—Nov. 11, 1996 -- Hoffmann-La Roche launches therapeutic tool to increase the success of therapy. Known for its high relapse rate, the standard therapy for chronic hepatitis C infection has left some physicians -- and their patients -- disappointed. To combat this problem, Hoffmann-La Roche has launched a two-pronged treatment program to help increase the success of Roferon-A (interferon alfa-2a, recombinant) therapy, which received U.S. marketing clearance today for the treatment of chronic hepatitis C. "Treatment of chronic hepatitis C has been extremely frustrating to both physicians and patients, because of the high relapse rate following standard therapy and the serious, long-term consequences of ongoing infection," said Raymond S. Koff, M.D., chairman of the Department of Medicine at MetroWest Medical Center in Framingham, Mass. "The availability of Roferon-A, which offers a longer dosing regimen with a physician support system to help optimize treatment, should give clinicians an edge in fighting this serious infection." Two-Pronged Support System Recognizing that treatment of any chronic infection may be challenging for doctors and patients alike, Roche's new programs are designed to increase the success of Roferon-A (interferon alfa-2a, recombinant) therapy. The new Roferon-A Therapeutic System for Physicians provides useful guidelines for initiating therapy with new patients as well as for treating patients who completely or partially respond to therapy but relapse. The new Roferon-A HCV Patient Support System is designed to educate patients about the side effects of therapy with Roferon-A. The kit contains an educational brochure and a Spanish-and English-language video; a booklet with "Frequently Asked Questions about Hepatitis C;" and a workbook/diary so that patients can monitor their responses to therapy. All of the materials will be available in early 1997. In the meantime, physicians may call a toll-free number, 1-800-LAROCHE, to learn more about this program. "Treatment of hepatitis C requires more than a simple shot of medication," said Dr. Koff. "This elusive disease, which often produces no symptoms and persists in the large majority of those infected, must be fought with education and information that will help us deal more effectively with its clinical course." Response Rate Improves with High Dose, Longer Therapy The recommended dosage of Roferon-A for the treatment of chronic hepatitis C is 3 MIU administered subcutaneously or intramuscularly for 12 months (48 to 52 weeks), three times per week. Normalization of abnormal liver function test (ALT) generally occurs within a few weeks in those who respond to therapy. Approximately 90% of patients who respond to Roferon-A (interferon alfa-2a, recombinant) do so within the first 3 months of treatment; however, patients who respond to Roferon-A with a reduction in ALT should complete 12 months of treatment to achieve optimal results. Retreatment with either the 3 MIU dose, or with the 6 MIU dose, for 6 to 12 months, may be considered for those who relapse. In clinical trials, side effects were mild to moderate and included flu-like symptoms such as fatigue, muscle aches, headache, fever/chills, nausea, vomiting, or diarrhea, and skin irritation at the injection site. Depression, irritability, insomnia, and anxiety were other side effects associated with interferon alfa therapy. These side effects usually were manageable and reversible upon discontinuation of therapy. Hoffmann-La Roche and Gilead Sciences (Nasdaq: GILD) will co-promote Roferon-A for the treatment of chronic hepatitis C, as previously announced. Headquartered in Nutley, N.J., Hoffmann-La Roche Inc., is an affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland. One of the world's leading research-intensive health care companies, Roche has discovered, developed and introduced numerous important prescription pharmaceuticals. The company is also a major provider of diagnostic products and services as well as vitamins, premixes and other products for human and animal nutrition and health. Recognized for excellence in both biotechnology and traditional chemistry, Roche is also widely known for its current efforts in the research, development and commercialization of polymerase chain reaction (PCR), a revolutionary advance in diagnostics and other fields, including biomedical research, forensics and environmental testing.
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