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Published on: February 15, 2011
Recombinant interferon- gamma 1b as adjunctive therapy for AIDS-related acute cryptococcal meningitis
Peter G Pappas1, Beatriz Bustamante, Eduardo Ticona
1University of Alabama School of Medicine, Birmingham, Alabama 35294-0006, USA. pappas@uab.edu.
Insights
Recombinant interferon gamma 1b showed promise as an adjuvant therapy for cryptococcal meningitis in AIDS patients. This treatment was well-tolerated and demonstrated a trend toward improved outcomes in a phase 2 study.
Area of Science:
- Immunology
- Infectious Diseases
- Clinical Medicine
Background:
- Cryptococcal meningitis is a serious opportunistic infection in patients with acquired immunodeficiency syndrome (AIDS).
- Standard antifungal therapy can be limited by toxicity and treatment failure.
- Novel adjuvant therapies are needed to improve outcomes for AIDS patients with cryptococcal meningitis.
Purpose of the Study:
- To evaluate the safety and antifungal activity of adjuvant recombinant interferon (rIFN)-gamma 1b in patients with AIDS and acute cryptococcal meningitis.
- To assess the impact of rIFN-gamma 1b on cerebrospinal fluid (CSF) fungal culture conversion, symptom resolution, and survival.
Main Methods:
- A phase 2, double-blind, placebo-controlled study was conducted.
- 75 patients with AIDS and acute cryptococcal meningitis received standard antifungal therapy plus either 100 or 200 microg of rIFN-gamma 1b or placebo, thrice weekly for 10 weeks.
- End points included 2-week CSF fungal culture conversion, symptom resolution, and survival.
Main Results:
- Two-week culture conversion rates were 13% for placebo, 36% for 100 microg rIFN-gamma 1b, and 32% for 200 microg rIFN-gamma 1b.
- A trend towards improved combined mycologic and clinical success was observed in rIFN-gamma 1b recipients (26% vs. 8%; P=.078).
- rIFN-gamma 1b was well-tolerated, with no significant impact on CD4 cell counts or HIV viral load.
Conclusions:
- Adjunctive rIFN-gamma 1b therapy appears safe and potentially effective for patients with acute cryptococcal meningitis and AIDS.
- Further investigation in larger trials is warranted to confirm these promising findings.
Abstract:
We conducted a phase 2, double-blind, placebo-controlled study to evaluate the safety and antifungal activity of adjuvant recombinant interferon (rIFN)- gamma 1b in patients with acquired immunodeficiency syndrome and acute cryptococcal meningitis. Patients received 100 or 200 microg of rIFN- gamma 1b or placebo, thrice weekly for 10 weeks, plus standard therapy with intravenous amphotericin B, with or without flucytosine, followed by therapy with fluconazole. End points included conversion of cerebrospinal fluid fungal cultures from positive to negative at 2 weeks, resolution of symptoms, and survival. Among 75 patients, 2-week culture conversion occurred in 13% of placebo recipients, 36% of rIFN- gamma 1b (100 microg) recipients, and 32% of rIFN- gamma 1b (200 microg) recipients. There was a trend toward improved combined mycologic and clinical success in rIFN- gamma 1b recipients (26% vs. 8%; P=.078). Therapy with rIFN- gamma 1b was well tolerated, and there was no apparent influence on serial CD4 cell counts and human immunodeficiency virus load measurements. Adjunctive therapy with rIFN- gamma 1b holds promise for patients with acute cryptococcal meningitis and warrants further study.
