Regimen Simplification to Atazanavir‐Ritonavir Alone as Maintenance Antiretroviral Therapy: Final 48‐Week Clinical and Virologic Outcomes
Year: 2009
Type: article
Study design: Clinical Trial
Abstract: 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 > or = 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 > or = 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.
DOI: 10.1086/597119
Institutions: Weill Cornell Medicine, University of Pittsburgh, University at Albany, State University of New York, Harvard University, University of Nebraska Medical Center, University of North Carolina at Chapel Hill, Social and Scientific Systems (United States), Bristol-Myers Squibb (United States), Abbott (United States), National Institutes of Health, National Institute of Allergy and Infectious Diseases, National Cancer Institute, Tufts University
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Abbott Laboratories, Bristol-Myers Squibb, Pfizer, University of Nebraska Medical Center, University of Pittsburgh, University of Cincinnati, ACT Government, Bavarian Nordic, National Institutes of Health, Center for AIDS Research, University of Washington, National Institute of Allergy and Infectious Diseases, National Center for Research Resources, National Center for Advancing Translational Sciences
Awards: G1078001155, G115468880, G1158968046, G1355238660, G1380633192, G1507718124, Stanford AIDS Clinical Trials Unit, G1535406927, G1840998190, G185513119, G1865158448, G18989281, G1939027404, G2027736814, G2093356446, G2127051194, G2241242742, G232810045, G2394140265, G251702431, G2643340084, G284587329, ADULT AIDS CLINICAL TRIALS UNIT, Cornell Clinical Trials Unit, G3277483280, General Clinical Research Center, Training in AIDS Molecular Epi/Microbiology & STDs, G374818150, G3810609436, G3922356, G4122054131, G45471288, G4553935269, G4614481423, G4649361189, G4674963424, G488872913, G5031627105, G6103943158, G610496905, G650174051, University of Cincinnati AIDS Clinical Trials Unit- UC ACTU, G6687940712, University of Pittsburgh Clinical and Translational Science Institution, University of Pittsburgh Clinical and Translational Science Institution, Anal Dysplasia in HIV+ and HIV- men, G7641155071, G77050141, G7807354757, G7868490553, G83299872, HIV/AIDS Clinical Trials Unit, G8541996175, G857487509, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), The University of North Carolina Center for AIDS Research, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit
OpenAlex ID: W2172124176