High-dose zidovudine plus valganciclovir for Kaposi sarcoma herpesvirus-associated multicentric Castleman disease: a pilot study of virus-activated cytotoxic therapy

Blood. 2011 Jun 30;117(26):6977-86. doi: 10.1182/blood-2010-11-317610. Epub 2011 Apr 12.

Abstract

Kaposi sarcoma herpesvirus (KSHV)-associated multicentric Castleman disease (MCD) is a lymphoproliferative disorder most commonly observed in HIV-infected patients. It is characterized by KSHV-infected plasmablasts that frequently express lytic genes. Patients manifest inflammatory symptoms attributed to overproduction of KSHV viral IL-6, human IL-6, and human IL-6. There is no standard therapy and no established response criteria. We investigated an approach targeting 2 KSHV lytic genes, ORF36 and ORF21, the protein of which, respectively, phosphorylate ganciclovir and zidovudine to toxic moieties. In a pilot study, 14 HIV-infected patients with symptomatic KSHV-MCD received high-dose zidovudine (600 mg orally every 6 hours) and the oral prodrug, valganciclovir (900 mg orally every 12 hours). Responses were evaluated using new response criteria. A total of 86% of patients attained major clinical responses and 50% attained major biochemical responses. Median progression-free survival was 6 months. With 43 months of median follow-up, overall survival was 86% at 12 months and beyond. At the time of best response, the patients showed significant improvements in C-reactive protein, albumin, platelets, human IL-6, IL-10, and KSHV viral load. The most common toxicities were hematologic. These observations provide evidence that therapy designed to target cells with lytic KSHV replication has activity in KSHV-MCD. This trial was registered at www.clinicaltrials.gov as #NCT00099073.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use*
  • Castleman Disease / complications
  • Castleman Disease / drug therapy*
  • Castleman Disease / virology*
  • Drug Therapy, Combination / adverse effects
  • Female
  • Ganciclovir / administration & dosage
  • Ganciclovir / adverse effects
  • Ganciclovir / analogs & derivatives*
  • Ganciclovir / therapeutic use
  • HIV Infections / complications
  • HIV Infections / drug therapy
  • Herpesviridae Infections / complications
  • Herpesviridae Infections / virology
  • Herpesvirus 8, Human / drug effects*
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Prodrugs / administration & dosage
  • Prodrugs / adverse effects
  • Prodrugs / therapeutic use*
  • Protein Kinase Inhibitors / administration & dosage
  • Protein Kinase Inhibitors / therapeutic use
  • Protein Kinases / chemistry
  • Survival Analysis
  • Valganciclovir
  • Viral Load / drug effects
  • Viral Proteins / antagonists & inhibitors
  • Virus Activation / drug effects
  • Zidovudine / administration & dosage
  • Zidovudine / adverse effects
  • Zidovudine / therapeutic use*

Substances

  • Anti-HIV Agents
  • Prodrugs
  • Protein Kinase Inhibitors
  • Viral Proteins
  • Zidovudine
  • Protein Kinases
  • ORF36 protein kinase, Kaposi's sarcoma herpesvirus
  • Valganciclovir
  • Ganciclovir

Supplementary concepts

  • Multi-centric Castleman's Disease

Associated data

  • ClinicalTrials.gov/NCT00099073