To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ROI CONFERENCE: Use Of Rescriptor With Indinavir At Lower Doses Decreases Viral Load URL: http://www.pslgroup.com/dg/E133A.htm Doctor's Guide February 3, 1999
BRIDGEWATER, NJ -- Feb. 3, 1999 -- Preliminary study results from an ongoing clinical trial suggest using Pharmacia & Upjohn's Rescriptor(R) (delavirdine mesylate tablets, DLV) with the protease inhibitor indinavir (IDV) significantly decreases viral load in triple or quadruple combination therapy with zidovudine (AZT) and lamivudine (3TC) in HIV-infected patients. Lower doses of IDV (600 mg instead of the standard 800 mg) were used in the Rescriptor + IDV arms since pharmacokinetic studies demonstrated two to seven-fold increases in trough concentrations when the two drugs were taken in combination. Trough concentrations or trough levels are the lowest concentrations of a drug reached in the blood between doses. In addition, all patients in the quadruple arm of the four-arm study who reached week 24 at the time of this analysis achieved viral load below quantifiable levels (BQL less than 400 copies/ml, using the Roche Amplicor HIV-1 RNA PCR assay). The findings were presented today at the sixth conference on Retroviruses and Opportunistic Infections. The preliminary results of this trial confirm the findings of an earlier trial which showed that Rescriptor, added to various antiretroviral combinations, allows for a reduction of the indinavir dose by 25 percent. "The data suggest new treatment options for using Rescriptor with lower doses of indinavir while maintaining antiretroviral potency," said Joe Eron, MD, associate professor of medicine at the University of North Carolina, who presented the data for the study team. "This trial will help physicians and people living with HIV determine which combinations of drugs can best provide undiminished antiviral activity." The ongoing open-label trial includes 184 HIV-1 infected patients. Patients were divided into four treatment groups: Rescriptor (400 mg TID) + AZT (200 mg TID) + IDV (600 mg q8h); Rescriptor (400 mg TID) + 3TC (150 mg BID) + IDV (600 mg q8h); Rescriptor (400 mg TID) + AZT (200 mg TID) + 3TC (150 mg BID) + IDV (600 mg q8h); and AZT (200 mg TID) + 3TC (150 mg BID) + IDV (800 mg q8h). The participants' mean pre-treatment CD4 cell count was 265 cells/ml and mean pre-treatment HIV-1 RNA level was 5.0 log10; and baseline values were not significantly different between arms. In the three arms containing Rescriptor, the patients who reached 24 weeks of treatment in this ongoing study achieved a mean 2.8-3.3 log10 decrease in viral load using the experimental Ultrasensitive Roche HIV-1 RNA PCR assay, compared to a mean 2.7 log10 decrease in viral load for patients in the control arm who reached 24 weeks. By week 24, viral load was below quantifiable levels (BQL less than 400 copies/ml) in: 100 percent of the quadruple therapy (Rescriptor + AZT + 3TC + IDV 600 mg) group; 95 percent of the Rescriptor + 3TC + IDV group; 67 percent of the Rescriptor + AZT + IDV group; 73 percent of the AZT + 3TC + IDV group -- control arm. The control arm, which did not contain Rescriptor, and the Rescriptor + AZT + IDV arm had the lowest percentages of patients (73 percent and 67 percent) who achieved HIV RNA BQL. The CD4 cell count rose at least 100 cells in the four groups and treatment was well tolerated. Previous studies have indicated that co-administration of a 600 mg dose of indinavir with Rescriptor (400 mg) resulted in indinavir AUC values approximately 40 percent greater than those observed following an administration of 800 mg of indinavir alone. All treatment arms were well tolerated and there were no significant differences in adverse events between treatment groups. The most commonly reported side effects in patients treated with Rescriptor include nausea and rash. The study will continue until patients complete 96 weeks on therapy. Rescriptor tablets are indicated for the treatment of HIV-1 infection in combination with appropriate antiretroviral agents when therapy is warranted. The indication is based on surrogate marker changes in clinical studies. Clinical benefit has not been demonstrated with Rescriptor based on survival or incidence of AIDS- defining clinical events. Rescriptor has been shown to be generally well tolerated. The most commonly reported side effect attributable to Rescriptor was a skin rash that occurred in 18 percent of patients. In most cases, the rash disappeared within three to 14 days without a dosage reduction or interruption of treatment (4.3 percent of patients in clinical trials discontinued due to rash). The recommended dose for Rescriptor is 400 mg, taken three times daily with or without food. Rescriptor should always be administered in combination with appropriate antiretroviral therapy. The tablets are 100 mg each and are dispersible in water to make consumption easier, while 200mg and 300mg tablets are under development. Related Links: Rescriptor, Pharmacia & Upjohn, --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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