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Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection.

Michael Kozal1, Judith Aberg1, Gilles Pialoux1

  • 1From Yale University School of Medicine and the Veterans Affairs Connecticut Healthcare System, New Haven (M.K.), and ViiV Healthcare, Branford (P.A., C.L., M.L.) - all in Connecticut; Icahn School of Medicine at Mount Sinai, New York (J.A.); Hôpital Tenon, Assistance Publique-Hôpitaux de Paris (AP-HP) (G.P.), and Hôpital Saint Louis, AP-HP, and University of Paris Diderot Paris 7 (J.-M.M.), Paris; Fundación Huesped, Buenos Aires (P.C.); AIDS Research Consortium of Atlanta, Atlanta (M.T.); Instituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro (B.G.), and Federal University of São Paulo, São Paulo (R.D.); San Raffaele Scientific Institute, Milan (A.C.); Georgetown University Hospital, Washington, DC (P.K.); Maxwell Center, Durban, South Africa (G.L.); Orlando Immunology Center, Orlando, FL (E.D.); GlaxoSmithKline, Upper Providence, PA (M. Gummel); and ViiV Healthcare, Research Triangle Park, NC (M. Gartland, A.P.).

The New England Journal of Medicine
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New HIV-1 attachment inhibitor fostemsavir significantly reduced viral load in patients with multidrug-resistant infections. This novel therapy demonstrated sustained efficacy over 48 weeks, offering hope for treatment-experienced individuals.

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Area of Science:

  • Virology
  • Infectious Diseases
  • Pharmacology

Background:

  • Novel antiretroviral drugs are crucial for patients with human immunodeficiency virus type 1 (HIV-1) infection who have limited treatment options due to multidrug resistance.
  • Fostemsavir, a prodrug of the HIV-1 attachment inhibitor temsavir, represents a new class of antiretroviral agents.

Purpose of the Study:

  • To evaluate the efficacy and safety of fostemsavir in patients with multidrug-resistant HIV-1 infection.
  • To assess the viral load reduction and virologic response in patients receiving fostemsavir compared to placebo.

Main Methods:

  • A phase 3, randomized, double-blind, placebo-controlled trial enrolled patients with multidrug-resistant HIV-1 infection.
  • Patients received either fostemsavir or placebo for 8 days, followed by open-label fostemsavir plus optimized background therapy.
  • A nonrandomized cohort received open-label fostemsavir plus optimized background therapy from day 1.

Main Results:

  • Fostemsavir treatment resulted in a significantly greater mean decrease in HIV-1 RNA levels from day 1 to day 8 compared to placebo (0.79 vs. 0.17 log10 copies/mL).
  • At 48 weeks, virologic response (<40 copies/mL) was achieved in 54% of the randomized cohort and 38% of the nonrandomized cohort.
  • Mean CD4+ T-cell count increases were observed in both cohorts (139 cells/mm³ and 64 cells/mm³, respectively).

Conclusions:

  • Fostemsavir demonstrated significant and sustained viral load reduction in patients with multidrug-resistant HIV-1 infection.
  • The drug was generally well-tolerated, with adverse events leading to discontinuation in 7% of patients.
  • Fostemsavir offers a valuable new therapeutic option for individuals with limited treatment alternatives.