Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - November 7, 1995
Studies show that Invirase(TM) can work together with conventional HIV therapies -- nucleoside analogues such as AZT (ZDV) and HIVID(R) (ddC) -- but has fewer side effects and is well tolerated by patients. Unlike nucleoside analogues, which inhibit the enzyme reverse transcriptase, Invirase(TM) blocks the enzyme proteinase. Both ezymes are critical to the replication of HIV, the virus that causes AIDS.
"Recent research supports the use of combination therapy in AIDS but, until now, all treatments have had the same mechanism of action," says Gabriel Torres, M.D., medical director of the AIDS Center at St. Vincent's Hospital in New York. "With the advent of proteinase inhibitors, it will be possible to interfere at two phases of the HIV replication cycle, rather than concentrating all our efforts at one phase. In this way, we hope to improve efficacy without increasing toxicity."
The Committee recommended that Invirase(TM) be approved for use in combination with approved nucleoside analogues in people with advanced HIV disease. (Advanced HIV is defined as a CD4 count of 300 cells/mm3 or less. CD4 count is the most widely used method for assessing the state of the immune system.) The recommended dosage is 600mg taken orally three times daily. The Committee did not, however, recommend approval of Invirase(TM) as monotherapy.
"Roche was the first company to initiate research into proteinase inhibitors. We are excited at the prospect of being the first to make these important treatments available to physicians and patients in the U.S.," says Juergen Drews, M.D., president of international research, Roche Group. "It is evident from the success of our compassionate use program that there is a real need for these innovative treatments."
Extensive Data
There is more clinical experience with Invirase(TM) than with any other proteinase inhibitor. A broad clinical program including 4,600 participants has been implemented and large Phase III studies are ongoing. The results of Invirase(TM) treatment in 920 patients at various stages of disease and with differing histories of prior AZT treatment were included in the FDA submission. The treatment's safety has been tested in over 1,600 patients receiving 600mg Invirase(TM) three times a day.
The FDA Advisory Committee's recommendations were based on data that show:
-- Patients treated with combinations including Invirase(TM) have greater increases in CD4 count and greater suppression of viral load (the amount of HIV found in blood plasma) than patients given corresponding treatments without Invirase(TM). -- Invirase(TM) is well-tolerated in combination. The most frequently reported adverse events occurred in less than four percent of patients and were gastrointestinal, including diarrhea, abdominal discomfort and nausea.
Four thousand patients with HIV disease are currently enrolled in two Phase III clinical trials. These trials are designed to evaluate the effect of Invirase(TM) on disease progression.
Resistance Profile
Resistance (decreased sensitivity to treatment) is a phenomenon with all antiretrovirals. Data presented at the FDA Advisory Committee meeting indicate that more than 50 percent of patients are still sensitive to Invirase(TM) after one year of treatment. The data also suggest that a combination of Invirase(TM) and AZT may delay the emergence of resistance to either treatment.
In response to the FDA Advisory Committee's discussion that more studies be undertaken to determine the resistance profile of Invirase(TM) and the ability of proteinase inhibitors to work in combination, Whaijen Soo, vice president of virology at Roche, said: "We are supportive of working with other pharmaceutical companies to explore the role of proteinase inhibitors and how these compounds can be used effectively in combination or sequentially for maximum clinical benefit and minimum emergence of resistance."
About Hoffmann-La Roche
Hoffman-La Roche of Nutley, N.J., is a research-based health care company that is a member of the Roche Group with headquarters in Basel, Switzerland. Roche is a leading health care company dedicated to the research, development and delivery of diagnostic tests, treatments and services for people with life-threatening diseases.
CONTACT: Joy Schmitt, 201-562-2202, or MaryEllen O'Donohue, 212-213-7065, both for Hoffmann-La Roche, / 04:18 EST
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