1522. Switching Undetectables to Once Daily Selzentry®: The SUDS Study
Session: Poster Abstract Session: HIV: Antiretroviral Therapy
Friday, October 28, 2016
Room: Poster Hall
Posters
  • The SUDS Poster_ID Week 2016.pdf (199.5 kB)
  • Background: Treatment of Human Immunodeficiency Virus (HIV) requires a combination of multiple antiretroviral medications to prevent viral replication. Most HIV patients prefer to be on a “once daily” treatment. Maraviroc (Selzentry®), is currently administered twice daily. Studies have been conducted to evaluate the efficacy of Maraviroc if given once daily; however, not in virologically suppressed patients. There is an advantage to a once daily regimen from an adherence prospective; hence, the need to assess the virologic and immunologic efficacy, also the tolerability and potential toxicity of two tablets of Maraviroc once daily.

    Methods: CCR5 tropic HIV positive patients with undetectable viral load, on regimens including a Protease Inhibitor,Non-Nucleoside Reverse Transcriptase Inhibitor or an Integrase Inhibitor in addition to two Nucleoside Reverse Transcriptase Inhibitors. The patients were switched to once daily Maraviroc (2 pills/600mg) in combination with two NRTI’s and were followed for 48 weeks. Assessing Virologic and immunologic efficacy at weeks 24 and 48.

    Results: 34 patients were screened. Week 48 Interim analysis on 28 patients showed high regimen tolerance, virologic and immunologic efficacy with minimal or no side effects and no serious adverse events. Treatment satisfaction questionnaires showed an overall increased satisfaction with once daily Maraviroc regimen.

    Conclusion: Maraviroc administered once daily (2 pills/600 mg) proved to be safe and effective. Demonstrated positive impact on patients’ adherence to treatment regimen. 

                                                                                                               

                                                                                                         Table: Analysis of Subjects at Week 48

    Criteria

    Subjects

    (n=32)

    HIV-1 RNA > 50 copies/mL (ITT)

    7%

    HIV-1 RNA < 50 copies/mL (AT)

    93%

    Mean change in CD4 count from baseline (BL)

    +94 cells/mm3

    Serious Adverse Events (AEs)

    0

    AEs leading to Discontinuations

    0

    Cholesterol, Mean Change from BL (mg/dL)

    TC -2.3

    LDL 0

    HDL 5.4

    Triglycerides, Mean Change from BL (mg/dL)

    TG -41.11

     

                  Intent To Treat (ITT) = value at Week 48; As Treated (AT) = value at WK 48; Total cholesterol (TC); Low and High Density Lipoprotein (LDL, HDL); Triglycerides (TG)

                     

    Stanley Lewis, MD1, Kenneth Degazon, MD2, Chymbeelyn Larisma, MD1 and Katherine Asuncion, MD1, (1)ST. Hope Foundation, Inc., Bellaire, TX, (2)ST. Hope Foundation, Inc, Bellaire, TX

    Disclosures:

    S. Lewis, None

    K. Degazon, None

    C. Larisma, None

    K. Asuncion, None

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