Case series assessing the safety of mycophenolate as part of multidrug rescue treatment regimens

HIV Clin Trials. 2002 Jan-Feb;3(1):17-20. doi: 10.1310/B6T0-N98J-1J3M-EQPK.

Abstract

Background: Mycophenolate mofetil (MMF), an inhibitor of lymphocyte proliferation, is emerging as a potential adjunct in the treatment of HIV-1 infection. By potentiating the activity of abacavir, MMF may improve antiviral efficacy. However, it may also lead to myelosuppression, such as was seen in patients taking hydroxyurea-containing regimens.

Purpose: To assess the safety of MMF as adjunctive therapy for HIV infection.

Method: Eighteen HIV-positive outpatients, given MMF (500 mg po bid) on a compassionate basis as part of their salvage therapy, were monitored for adverse effects.

Results: Five patients discontinued MMF between 26-68 days of follow-up due to adverse effects likely related to other factors. Among the remaining 13 patients, no new clinically significant cytopenias occurred over 107-154 days of follow-up. Three patients exhibited decreases in CD4 counts, despite decreases in plasma HIV-1 RNA.

Conclusion: Short-term follow-up suggests that MMF (500 mg po bid) does not cause lymphocyte suppression. However, further studies are ongoing to determine its safety and efficacy profile in HIV infection.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial

MeSH terms

  • Administration, Oral
  • Adult
  • CD4-Positive T-Lymphocytes
  • Drug Resistance, Viral
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV-1 / genetics*
  • Humans
  • IMP Dehydrogenase / antagonists & inhibitors*
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / pharmacology
  • Immunosuppressive Agents / therapeutic use*
  • Leukocyte Count
  • Male
  • Middle Aged
  • Mycophenolic Acid / administration & dosage
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / pharmacology
  • Mycophenolic Acid / therapeutic use*
  • RNA, Viral / blood*
  • Salvage Therapy
  • Treatment Outcome
  • Viral Load

Substances

  • Immunosuppressive Agents
  • RNA, Viral
  • IMP Dehydrogenase
  • Mycophenolic Acid