Regimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy: final 48-week clinical and virologic outcomes.

TitleRegimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy: final 48-week clinical and virologic outcomes.
Publication TypeJournal Article
Year of Publication2009
AuthorsWilkin TJ, McKinnon JE, A DiRienzo G, 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
JournalJ Infect Dis
Volume199
Issue6
Pagination866-71
Date Published2009 Mar 15
ISSN0022-1899
KeywordsAdult, Anti-HIV Agents, Atazanavir Sulfate, CD4 Lymphocyte Count, Drug Therapy, Combination, Female, HIV Infections, HIV Protease Inhibitors, Humans, Male, Middle Aged, Oligopeptides, Pilot Projects, Pyridines, Ritonavir, Treatment Outcome, Viremia, Young Adult
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.

DOI10.1086/597119
Alternate JournalJ. Infect. Dis.
PubMed ID19191590
PubMed Central IDPMC2680942
Grant ListAI069415 / AI / NIAID NIH HHS / United States
AI27661 / AI / NIAID NIH HHS / United States
AI34853 / AI / NIAID NIH HHS / United States
AI46376 / AI / NIAID NIH HHS / United States
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RR024154 / RR / NCRR NIH HHS / United States
RR024996 / RR / NCRR NIH HHS / United States
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T32 AI007333 / AI / NIAID NIH HHS / United States
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U01 AI034853 / AI / NIAID NIH HHS / United States
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UL1 RR024996 / RR / NCRR NIH HHS / United States
UL1 RR024996-01 / RR / NCRR NIH HHS / United States