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| |  AIDS 2000: Viramune (Nevirapine)-Based Treatment Combo Comparable To Protease Inhibitor-Based Regimen In HIV Therapy DURBAN, SOUTH AFRICA -- July 13, 2000 -- Findings from the Atlantic study indicate that Viramune® (nevirapine) plus two nucleoside analogues has shown similar efficacy to indinavir plus two nucleoside analogues. The multi-centre, international Atlantic study is the first head-to-head comparison trial of agents in the three currently available classes of HIV/AIDS drugs: non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors and nucleoside analogues. Atlantic was presented as a "latebreaker" today at the 13th International AIDS Conference. The treatment combinations evaluated in the Atlantic study consist of the nucleoside analogues ddI and d4T combined with either once-daily Viramune, thrice-daily indinavir (a protease inhibitor) or twice-daily 3TC (a nucleoside analogue). The approved dosing regimen for Viramune is one tablet taken twice daily. A protease inhibitor-based regimen has often been described as the "standard of care" for HIV/AIDS but can require patients to take numerous tablets. The dose of indinavir required per day is six capsules. The dose of Viramune required is two tablets per day. All of the 298 study participants have been analyzed through 48 weeks of the study; HIV RNA measures for the entire study population were presented. The three groups of patients were comparable with respect to gender, risk factor for HIV-infection, disease stage, CD4+ cell count (median baseline = 406 cells/mm3) and HIV RNA levels (median baseline = 4.2 log10). At 48 weeks, the 'intent-to-treat' analysis, which accounts for all patients, including those who stopped treatment before the end of the study, found that the percentage of patients who were successfully treated [undetectable HIV levels (below 50 copies/mL using the Amplicor Ultrasensitive assay) and still on treatment] was 49 percent in the Viramune arm, 49 percent in the indinavir arm and 40 percent in the 3TC arm. Using an 'as-treated' analysis, which eliminates patients who stopped therapy due to toxicity or loss to follow-up, the percentage of patients with undetectable levels of HIV was 82 percent in the Viramune arm, 91 percent in the indinavir arm and 67 percent in the 3TC arm. The difference in the proportions of patients responding to Viramune and indinavir was not statistically significant. No differences were found between the regimens regarding treatment discontinuation due to toxicities. Researchers plan to follow patients for more than 144 weeks. Viramune, the first member of the NNRTI class of anti-HIV drugs to be approved, is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points, such as viral load or changes in CD4+ count. Viramune should always be administered in combination with other antiretroviral agents. The most clinically important adverse events associated with Viramune are rash (16 percent) and increases in liver function tests. Other commonly reported events include fever, nausea and headache. Cases of hypersensitivity reactions have been observed. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with Viramune. Related Link: Viramune (nevirapine).
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