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| |  Invirase Combined with Hivid Reduces Deaths by More Than Two Thirds NUTLEY, N.J., May 7, 1996 -- Deaths were reduced by more than two thirds when the AIDS drug Invirase(TM) (saquinavir) was combined with Hivid(R)(ddC) versus taking Hivid alone, according to data from a North American clinical trial with 978 patients. All patients in the study had previously discontinued AZT therapy. The data also demonstrated that Invirase, when used in combination with Hivid, delayed disease progression (as measured by the occurrence of AIDS-defining events) by more than half when compared to treatment with Hivid alone. The study, which had a median follow-up of 73 weeks, has the longest duration of any clinical endpoint study with a protease inhibitor to date. The results confirm the clinical benefit of Invirase and Hivid over ddC monotherapy. There was no significant difference in the comparison of Invirase to Hivid monotherapy for either disease progression or death. Invirase is the first protease inhibitor which was made widely available under the FDA's accelerated approval mechanism. "AIDS research is designed to find treatments and combinations of treatments that slow the progression of AIDS and ultimately extend patients' lives," said Stephen Follansbee, M.D., chief of staff, Davies Medical Center, San Francisco, CA. "The data from this trial demonstrate that both these goals can be reached when saquinavir and ddC are combined." The study, called NV14256, is a phase III randomized, double blind comparison of Hivid, Invirase, and the combination of Invirase and Hivid in 978 HIV-infected patients with CD4 cell counts (measure of immune system) between 50-300 and with 16 or more weeks of prior AZT therapy. Data released today are from the final analysis of the primary endpoints of the study -- time to first AIDS-defining event or death -- and the analysis of the secondary endpoint, death alone. The patients were balanced across the three treatment arms, with respect to sex, age, race, baseline viral load (a measure of the amount of HIV in the blood), baseline CD4 count, and the reason for discontinuing prior AZT therapy. The medium duration of prior AZT therapy was 68 weeks in the Invirase plus Hivid group. Duration of follow-up was similar in the three treatment arms. Slightly more patients in the Invirase and Hivid group than in the monotherapy arms completed the protocol, and discontinuations for protocol-mandated toxicity was highest in the Hivid arm. Lost to follow-up rates were low. Invirase has been administered to more than 10,000 patients worldwide during clinical trials and compassionate use programs. Currently Invirase is indicated in combination with nucleoside analogues, such as AZT or Hivid, for the treatment of advanced HIV infection in selected patients. The current indication is based on changes in surrogate markers in patients who initiated Invirase concomitantly either with AZT (in previously untreated patients) or Hivid (in patients previously treated with prolonged AZT therapy). At present, there are no results available from trials evaluating the activity of Invirase in combination with nucleoside analogues other than AZT or Hivid. Outside of the U.S. Invirase was granted approval in Switzerland, Brazil and Canada early this year. In clinical studies Invirase was well tolerated by most patients and reported adverse events were mostly of mild intensity. The most frequently reported adverse events, at least possibly related to Invirase treatment and of at least moderate intensity included diarrhea (3.8 percent), abdominal discomfort (1.3 percent), and nausea (1.9 percent). Hoffmann-La Roche Inc. of Nutley, N.J., a research-based health care company, has a long history in the area of HIV that includes Hivid, Invirase, Cytovene(R), Vitrasert(TM) (Vitrasert is a trademark of Chiron Vision), Roferon-A(R) and Bactrim(TM). Roche is also active in the development of diagnostic tests such as Polymerase Chain Reaction (PCR) technology, that quantifies levels of HIV in blood. Hoffmann-La Roche is a member of theRoche Group headquartered in Basel, Switzerland. A world leader in health care, the Roche group is dedicated to research and the development and delivery of diagnostic tests, treatment and services for people with life-threatening diseases.
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