Studies from Autonomous University reveal new findings on HIV/AIDS
2009 JUL 13 - (NewsRx.com) -- "The OK04 trial has shown that 48 weeks of lopinavir-ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy with 2 nucleosides and lopinavir-ritonavir in patients with prior stable suppression. However, it is still uncertain if this experimental strategy can maintain suppression in the long term," investigators in Madrid, Spain report. "Patients entered this noninferiority trial (upper limit 95% confidence interval: +12%) with no history of virological failure while receiving a protease inhibitor and receiving 2 nucleosides plus lopinavir/ritonavir, with HIV RNA <50 copies per milliliter for more than 6 months. Primary end point was percent of patients without therapeutic failure, defined as confirmed HIV RNA >500 copies per milliliter with exclusion of monotherapy patients who resuppressed to <50 copies per milliliter after resuming baseline nucleosides, or loss to follow-up, or change of randomized therapy other than reinduction. Through 96 weeks, percentage of patient without therapeutic failure was 87% (monotherapy, n = 100) vs. 78% (triple therapy, n = 98; 95% confidence interval: -20% to +1.2%). Percentage with HIV RNA <50 copies per milliliter (intention to treat, missing = failure, reinduction = failure): 77% (monotherapy) vs. 78% (triple therapy). Low-level viral rebound was more frequent in the monotherapy group. Twelve patients in the monotherapy group (12%) needed reinduction with nucleosides. Discontinuations due to adverse events were significantly more frequent in the triple therapy group (8%) than in the monotherapy group (0%); P = 0.003. At 96-week lopinavir/ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy," wrote J.R. Arribas and colleagues, Autonomous University. The researchers concluded: "Incidence of adverse events leading to treatment discontinuation was significantly lower with monotherapy. (ClinicalTrials.gov number, NCT00114933).." Arribas and colleagues published their study in Jaids - Journal of Acquired Immune Deficiency Syndromes (Lopinavir-Ritonavir Monotherapy Versus Lopinavir-Ritonavir and 2 Nucleosides for Maintenance Therapy of HIV: 96-Week Analysis. Jaids - Journal of Acquired Immune Deficiency Syndromes, 2009;51(2):147-152). For additional information, contact J.R. Arribas, Autonomous University of Madrid, Hospital La Paz, Medical Interna Service, Paseo Castellana 261, Madrid 28046, Spain. The publisher of the Jaids - Journal of Acquired Immune Deficiency Syndromes can be contacted at: Lippincott Williams & Wilkins, 530 Walnut St., Philadelphia, PA 19106-3621, USA. Keywords: Spain, Madrid, HIV/AIDS, AIDS, Acquired Immune Deficiency Syndrome, Acquired Immunodeficiency Syndrome, Drugs, Enzymology, HIV, Human Immunodeficiency Virus, Immunology, Pharmaceuticals, Protease Inhibitor, Protease Inhibitors, Ritonavir, Sexually Transmitted Disease, Therapy, Treatment, Virology, Autonomous University. This article was prepared by AIDS Weekly editors from staff and other reports. Copyright 2009, AIDS Weekly via NewsRx.com.
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