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Atazanvir/Ritonavir Monotherapy Maintains Viral Suppression in Pilot Study: Presented at CROI

By Ed Susman

DENVER, CO -- February 8, 2006 -- Results of a small pilot study show that patients infected with HIV maintained viral suppression with atazanavir/ritonavir for at least 24 weeks after stopping their nucleoside analog therapy.

"Simplified maintenance therapy with the boosted protease inhibitor atazanavir alone appears safe and effective. Larger, randomized trials are now warranted to define further the efficacy of this strategy," said researcher Susan Swindells, MBBS, the Terry K. Watanabe professor and medical director, HIV Clinic, University of Nebraska Medical Center, Omaha, Nebraska.

Dr. Swindells discussed her study findings here on February 7^th at the 13^th Conference on Retroviruses and Opportunistic Infections (CROI).
Dr. Swindells and colleagues began the study with 36 patients, all of whom had shown due diligence in maintaining adherence to highly active antiretroviral therapy (HAART) and had suppressed viral loads to undetectable levels using the 50-copy/mL assay for more than 1 year.

Two patients were eliminated from the cohort before simplification could be started -- 1 withdrew consent and the other showed viral load blips above the detectable threshold and was not allowed in the study because of concerns that his virus was not fully suppressed.

Of the remaining 34 patients, all but 3 continued to have undetectable viral loads. Dr. Swindells said 2 of the individuals had no signs of atazanavir in their bloodstream, an indication that they might have carried the simplification of the regimen further than was warranted. The third person had measurable atazanavir in his blood and was able to resuppress the virus to undetectable levels on boosted atazanavir alone.

No resistant mutations were seen during the study period.

"We have to emphasize that this is a pilot study; the numbers of patients are few, and these results are definitely preliminary in nature," commented John Mellors, MD, professor of medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.

"This study suggests that once you have induced suppression with a combination of drugs and have put a lid on the rapid replication of the virus, you may not need all the drugs," said Dr. Mellors.

The trial was supported by Bristol-Myers Squibb, Plainsboro, New Jersey.


[Presentation title: A Prospective, Open-Label, Pilot Trial of Regimen Simplification to Atazanavir/Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression (ACTG 5201). Abstract 108LB]

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