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Regimen Simplification to Atazanavir-Ritonavir Alone as Maintenance Antiretroviral Therapy: Final 48-Week Clinical and Virologic Outcomes.

Author(s): Wilkin TJ, McKinnon JE, Dirienzo AG, Mollan K, Fletcher CV, Margolis DM, Bastow B, Thal G, Woodward W, Godfrey C, Wiegand A, Maldarelli F, Palmer S, Coffin JM, Mellors JW, Swindells S

Affiliation(s): 1Division of International Medicine and Infectious Diseases, Weill-Cornell Medical College, New York, and 2University at Albany-State University of New York, Rensselaer, New York; 3University of Pittsburgh, Pittsburgh, and 4Abbott Laboratories, Sinking Spring, Pennsylvania; 5Harvard School of Public Health and 6Tufts University, Boston, Massachusetts; 7University of Nebraska Medical Center, Omaha; 8University of North Carolina at Chapel Hill, Chapel Hill; 9Social and Scientific Systems, Inc., Silver Spring, 10Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, and 11HIV Drug Resistance Program, National Cancer Institute, Frederick, Maryland; 12Bristol-Meyers Squibb, Princeton, New Jersey.

Publication date & source: 2009-02-01, J Infect Dis., [Epub ahead of print]

Background. Simplified maintenance therapy with ritonavir-boosted atazanavir (ATV/RTV) alone is attractive because of nucleoside reverse-transcriptase inhibitor (NRTI)-sparing benefits, low pill burden, once-daily dosage, and safety. Methods. Subjects with virologic suppression after 48 weeks of initial antiretroviral therapy with 2 NRTIs and a protease inhibitor (PI) were enrolled. Subjects switched to ATV/RTV at entry and discontinued NRTIs after 6 weeks. The primary end point was time to virologic failure (confirmed HIV-1 RNA level 200 copies/mL). Drug resistance at virologic failure was evaluated by standard genotyping and single-genome sequencing (SGS). Residual viremia (1.1-49 copies/mL) was measured by single-copy assay. Results. Thirty-four subjects simplified to ATV/RTV alone, of whom 30 (88%) did not experience virologic failure by 48 weeks after simplification. Residual viremia did not change significantly after NRTI discontinuation among those without virologic failure but did increase 4-12 weeks before confirmed virologic failure. No major PI-resistance mutations were identified at virologic failure by standard genotyping or SGS. Conclusions. In this pilot study, simplified maintenance therapy with ATV/RTV alone maintained viral suppression in most subjects through 48 weeks. PI resistance was not detected among subjects experiencing virologic failure. Larger, randomized trials are warranted to further define the efficacy and safety of this strategy. Trial registration. ClinicalTrials.gov identifier: NCT00084019 .

Page last updated: 2009-02-08

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