THERAPY

Long-term benefits of didanosine Long-term follow-up of a phase I trial has shown

that didanosine-based therapy can be tolerated for ~ 4 years by patients with advanced mv infection, say researchers from the National Cancer Institute, US. Furthermore, the study showed that there was a high survival rate in patients with CD4+ cell counts of l00-300/mm3 on study entry.

Follow-up involved 72 patients with advanced mv infection (n = 43) or AIDS (29) on study entry who received didanosine for 0.1-58 (mean 20.1) months. After initial treatment with didanosine alone, 16 patients received combination therapy with zidovudine + didanosine. 53 patients had previously received zidovudine.

The estimated median survival time was 28 months over a median duration of follow-up of 51 months. The estimated median survival time for patients with AIDS was 23 months, while that for the remaining patients was 55 months. Of note, the 27 patients with CD4+ cell counts of 100-300/mm3 on entry had an estimated 4-year survival rate of 80%.

The researchers noted that no major new toxicities were detected with long-term follow-up beyond those observed in shorter-term studies. Principal toxicities noted included acute pancreatitis (6 patients) and painful neuropathies (11 patients during didanosine monotherapy and 3 patients during combination therapy). Leucopenia, granulocytopenia and anaemia were also observed fairly frequently. Nguyen B· Y. Yarchoan R. Wyvill KM. Venzon Dl. Pluda 1M. et aI. Five-year follow-up of a phase I study of didanosine in patients with advanced human immunodeficiency virus infection. Journal ofIofectious Diseases 171: 1180-1189. May 1995 1IOOlS7911

0156·270319510988-00015J$01.000 Adls Interl1lltlOllllI Limited 1995. All rights reserved

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INPHARMA- 27 Mey 1995