Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - October 23, 2000
The retrospective analysis of 236 HIV-positive patients in the Swiss HIV Cohort Study (SHCS) showed that, after a mean follow up of 13.6 months, there was a significant difference in durability favouring Viracept regimens when compared to indinavir regimens. Patients were significantly more likely to remain on Viracept compared to Indinavir (p=0.01). Data also showed that after two years, the probability of a patient remaining on Viracept-based therapy was approximately 0.75 compared to less than 0.5 for indinavir.
Representing, the Swiss Cohort Group Professor Manuel Battegay, said, "In this Swiss Cohort Study analysis patients treated with nelfinavir changed their initial HAART regimen less frequently and stayed on nelfinavir longer when compared to indinavir. This finding was still statistically significant in the multivariate analysis when we adjusted for naivety to antiretroviral drugs, CD4 cell count at baseline and age."
The data suggest that one major reason for the superior durability of Viracept compared to indinavir is the better tolerability profile of Viracept. Patients receiving Viracept were significantly less likely to stop therapy due to adverse drug reactions than patients receiving indinavir (Odds Ratio: Viracept = 0.13, Indinavir = 1, p=0.001). One out of every four patients taking indinavir experienced adverse drug reactions leading to discontinuation.
The study enrolled 236 patients who were proteinase inhibitor naive with mean CD4 cell count of 246 cells/mm3 and viral load of 4.9 log10 copies/ml.
Nearly 85% of the patients in the study were receiving either Viracept (42.8%) or indinavir (42%). The aims of the study were twofold: to evaluate the reasons for stopping or changing initial HAART regimens and to determine differences in durability, toxicity and drug failure of different proteinase inhibitors. At the mean follow up of 13.6 months, 55.5% of study participants were still on their initial HAART regimen of whom 69.5% had viral load below the limit of detection (400 copies/ml). Approximately half (20.3%) of all the patients who discontinued or changed therapy (44.1%), stopped due to adverse drug reactions.
The investigators reported three main findings of the study:
-- The two main factors predicting drug failure were, experience with antiretroviral drugs and low baseline CD4 cell count.
-- Adverse drug reactions, observed in 21.6% of patients, were the main reason for discontinuation of therapy.
-- The durability of the initial proteinase inhibitor regimen varied considerably. Time to discontinuation was longer for Viracept compared to indinavir.
About F. Hoffmann-La Roche Ltd.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented health care groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people's well-being and quality of life. Roche has approximately 62,000 employees and sells its products in over 170 countries. In the first half of 2000 the company invested 1.9 billion CHF in Research and Development.
For more information on HIV, its biology and treatment visit the company's web site at: http://www.roche-hiv.com .
SOURCE F. Hoffman-La Roche Ltd. Web Site: http://www.roche-hiv.com
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