Publications by authors named "M J Kozal"

Objectives: The main objective of this analysis was to evaluate the impact of pre-existing drug resistance by next-generation sequencing (NGS) on the risk of treatment failure (TF) of first-line regimens in participants enrolled in the START study.

Methods: Stored plasma from participants with entry HIV RNA >1000 copies/mL were analysed using NGS (llumina MiSeq). Pre-existing drug resistance was defined using the mutations considered by the Stanford HIV Drug Resistance Database (HIVDB v8.

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The historic academic affiliation program between the U.S. Department of Veterans Affairs and academic medical centers recently marked its 75th anniversary.

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In the phase 3 BRIGHTE study in heavily treatment-experienced adults with multidrug-resistant HIV-1, fostemsavir plus optimized background therapy (OBT) resulted in sustained rates of virologic suppression through 96 weeks. HIV-1 RNA <40 copies/mL was achieved in 163/272 (60%) Randomized Cohort (RC) participants (with 1 or 2 remaining approved fully active antiretrovirals) and 37/99 (37%) Non-randomized Cohort (NRC) participants (with 0 fully active antiretrovirals). Here we report genotypic and phenotypic analyses of HIV-1 samples from 63/272 (23%) RC participants and 49/99 (49%) NRC participants who met protocol-defined virologic failure (PDVF) criteria through Week 96.

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Article Synopsis
  • Fostemsavir is an FDA-approved HIV-1 attachment inhibitor that prevents the virus from attaching to host cells by targeting the gp120 protein.
  • Fostemsavir is effective and well-tolerated, showing virologic suppression in many patients with multidrug-resistant HIV-1 when used alongside other therapies.
  • The drug's unique mechanism and lack of cross-resistance make it a significant option for patients who have exhausted other treatment avenues, indicating potential for broader use in the future.
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Objective: Persistence of the viral reservoir is the main barrier to curing HIV. Initiation of ART during acute HIV infection can limit the size and diversity of the reservoir. In depth characterization of the reservoir in individuals who initiate ART during acute infection will be critical for clinical trial design and cure strategies.

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