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| |  People Using Viramune In Triple Therapy Achieve HIV Suppression For One Year http://www.ama-assn.org/public/journals/jama/jamahome.htm COLUMBUS, OH -- March 25, 1998 -- Triple combination therapy using Roxane Laboratories, Inc.’s AIDS drug Viramune(R) (nevirapine) demonstrated a sustained 52-week reduction of virus in the blood to undetectable levels in 51 percent of patients when used in combination with Retrovir(R) (zidovudine, AZT) and Videx(R) (didanosine, ddI). All three study medications are known as reverse transcriptase (RT) inhibitors. Results from this large, multi-centre study known as the INCAS Group Trial appear in today’s issue of The Journal of the American Medical Association. "These results are promising because a majority of study participants receiving Viramune in combination with two other RT inhibitors suppressed HIV in the blood to undetectable levels for one year," said lead investigator and study author Julio Montaner, MD, Canadian HIV Trial Network. Compared with two other study arms (AZT/ddI and AZT/Viramune), Viramune combined with AZT and ddI resulted in a greater decrease in plasma HIV-1 RNA in HIV-infected adults with no previous anti-HIV therapy. The Viramune triple combination also showed a greater increase in CD4+ cell counts. Fifty-one percent of patients maintained undetectable levels, of HIV-1 RNA in the blood after 52 weeks of triple therapy. The mean HIV-1 RNA change from baseline (4.24 log 10) in the triple therapy arm was 2.0 logs at one year, which represents a 99 percent reduction of virus in the plasma. These results were based on the evaluation of 37/51 patients remaining on triple therapy at 52 weeks. In contrast to the triple arm, less than six percent of patients in the two-drug arms achieved HIV-1 RNA levels in the plasma below detectable levels at all visits between weeks 40 and 52. The mean CD4+ cell count increase from baseline was 139 cells/mm3 in the triple therapy arm versus less than 90 cells/mm3 in the other two study arms. "Our results are of particular importance because they demonstrate that Viramune, when used in combination with two other RT inhibitors, is an HIV therapy that offers sustained potency on par with protease-containing regimens," explained study investigator Marianne Harris, MD, Canadian HIV Trial Network. "They also indicate that full and sustained suppression of viral replication can be achieved using a simplified, easy-to-take regimen that does not require a protease inhibitor." Researchers also noted that in the triple therapy and AZT/ddI arms, treatment failures were frequently associated with patient non-adherence to their regimens. In contrast, in the triple therapy arm 96 percent of adherent patients had HIV-1 RNA levels below the limit of detection at six months. "Part of what our results show is that adherence is critically important in maintaining a high level of viral suppression," Montaner said. The INCAS trial (Italy, Netherlands, Canada, Australia, and the United States) is an international randomised, double-blind, placebo-controlled investigation of the use of Viramune in 150 HIV-infected, AIDS-free patients with no previous antiretroviral experience. Fifty-one patients received triple therapy with Viramune, AZT and ddI; 47 patients received AZT plus Viramune; and 52 patients received AZT plus ddI. The mean baseline HIV-1 RNA levels for the three arms were 4.24 log 10 (Viramune/ddI/AZT); 4.54 log 10 (Viramune/AZT); and 4.47 log 10 (ddI/AZT). Dosing was as follows: Viramune: 200 mg once daily for two weeks and 200 mg twice daily thereafter; AZT: 200 mg three times daily; and ddI: 125 or 200 mg twice daily based on body weight. The INCAS Group trial remained blinded for patients and investigators for its entirety. Gastrointestinal complaints were the most frequently observed adverse event in all treatment arms. Treatment-related rash occurred in 22 percent (22/98) of patients in Viramune treatment arms, versus eight percent (3/53) in the AZT/ddI arm. Severe rash developed in four percent of patients in the Viramune groups compared to two percent in the AZT/ddI arm. The remainder of the rashes were mild to moderate and there were no episodes of Stevens-Johnson syndrome. Viramune, the first non-nucleoside reverse transcriptase inhibitor to be made available in the U.S., received marketing clearance by the United States Food and Drug Administration in June 1996 for use in combination with nucleoside analogues for the treatment of HIV-infected adults who have experienced clinical and/or immunologic deterioration. This indication is based on analysis of changes in surrogate endpoints in studies of up to 48 weeks duration. The recommended adult dosing of Viramune is one 200 mg tablet taken twice a day with or without food. Viramune is currently being studied in combination with protease inhibitors. Viramune is generally well tolerated. The most commonly reported adverse events associated with Viramune are rash, fever, nausea and headache. Severe and life-threatening skin reactions have occurred in patients treated with Viramune, including SJS. More information on: Viramune, Roxane Laboratories, Inc.
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