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Joseph A. Kovacs, Chris Bechtel, Richard T. Davey, Judith Falloon, Michael A. Polis, Robert E. Walker, Julia A. Metcalf, Victoria Davey, Stephen C. Piscitelli, Michael Baseler, Robin Dewar, Norman P. Salzman, Henry Masur, H. Clifford Lane, Combination Therapy with Didanosine and Interferon-a in Human Immunodeficiency Virus-Infected Patients: Results of a Phase I/II Trial, The Journal of Infectious Diseases, Volume 173, Issue 4, April 1996, Pages 840–848, https://doi.org/10.1093/infdis/173.4.840
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Abstract
A nonrandomized trial was undertaken to evaluate the combination of didanosine and interferon-α (IFN-α) in human immunodeficiency virus (HIV)-infected patients. Thirty-six volunteers with >200 × 106 CD4 cellslL received didanosine (one 100-,250-, or 375-mg sachet twice daily) for at least 6 weeks, following which IFN-α (1, 5, 10, or 15 MU/day) was begun. Didanosine (one 375-mg sachet twice daily) was substituted for zidovudine in 14 additional patients who had received IFN-α and zidovudine for 7-45 months. Thirty-five patients completed the 34-week study. Clinical or chemical pancreatitis was the most common (6 patients) dose-limiting toxicity. CD4 cell counts increased with didanosine but declined following the addition of IFN-a; CD4 cell percents tended to increase and remain elevated. Thus, combination therapy with didanosine and IFN-α can be safely administered to patients with HIV infection. The clinical benefit of this combination therapy will require further evaluation.
