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| |  Largest-Ever AIDS Study Finds Three Drug AIDS Cocktail Better Than Two NUTLEY, N.J., June 23, 1997 -- New data from the largest-ever AIDS study shows that using a three drug cocktail -- the protease inhibitor Invirase(R) (saquinavir mesylate) and the nucleoside analogues AZT and Hivid(R) (ddC) -- reduces time to disease progression or death by 50 percent compared to the two drug combination of AZT and Hivid. The global study, which took place in 22 countries, enrolled 3,485 people who have never been treated with antiretroviral therapy. These data, which come from an international clinical endpoint study, Hoffmann-La Roche Inc. trial SV 14604, demonstrate that three-drug therapy with a protease inhibitor is clinically superior to the standard two-drug regimen. However, a significant number of people with HIV and AIDS are still being treated with just two nucleoside analogues. "Thirty-eight percent of patients under a physician's care for HIV are not receiving a protease inhibitor, according to a study we completed this month with 300 AIDS-treating physicians in the U.S.," said Stephen Ketterer, president of HIV Research in Washington, D.C. The international clinical endpoint trial enrolled patients in four treatment arms who were followed for approximately one and one-half years. Patients were naive to antiretroviral drugs, with no patient having more than 16 weeks of prior AZT therapy. Patients enrolled in the triple combination Invirase/AZT/Hivid arm experienced a total of 76 clinical endpoints (first AIDS-defining event or death) compared with 142 endpoints in the AZT/Hivid arm and 116 endpoints in the Invirase/AZT arm. Patients in the triple combination arm had a median baseline viral load of 5.0 logs and a median baseline CD4 count of 204; patients in the AZT/Hivid arm had a median baseline viral load of 5.1 logs and a median baseline CD4 count of 199; and patients in the Invirase/AZT arm had a median baseline viral load of 5.0 logs and a median baseline CD4 count of 202. Results from this clinical trial have not yet been reviewed by the FDA and will be submitted in order to update the product labeling for Invirase. About Invirase Invirase is indicated in combination with nucleoside analogues for the treatment of HIV infection when therapy is warranted. This indication is based on results from studies of surrogate marker responses and from a clinical study that showed a reduction in both mortality and AIDS-defining clinical events for patients who received Invirase in combination with Hivid compared to patients who received either Hivid or Invirase alone. 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). About Roche Laboratories Inc. Roche Laboratories Inc. is the marketing and sales subsidiary of Hoffmann-La Roche Inc., a leading research-intensive pharmaceutical company. Roche Laboratories markets more than 35 medications in major therapeutic areas including AIDS, oncology, transplantation, infectious diseases, cardiovascular diseases and dermatology. More information about: AZT, Invirase, Hivid
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