Cutaneous side effects induced by indinavir

HIV-protease inhibitors demonstrated such high efficacy in short-term studi es that they have been approved by the FDA, even though possible toxicity s till needs further investigation. In the period between January 1997 and August 1998, 101 patients, staying a t San Patrignano Medical Centre (Italy), received an HIV protease inhibitor (indinavir) plus two nucleoside reverse transcriptase inhibitors (NRTI's) selected from the following: AZT, didanosine, zalcitabine, lamivudine or st avudine. Seventy-three patients were male, 28 female and their ages ranged from 25 to 60 years, with an average of 34. At the end of the study, 84 patients were suitable for evaluation, as the o ther 17 dropped out for various reasons. Forty-eight patients (57.1%) devel oped cheilitis, 34 (40.5%) experienced diffuse cutaneous dryness and prurit us, 10 (11.9%) developed asteatotic dermatitis on the trunk, arms and thigh s and another 10 (11.9%) complained of scalp defluvium. A severe alopecia w as observed in only 1 patient (1.2%), while 6 reported that their body hair had become fairer, thinner and shed considerably. Multiple pyogenic granul omas were observed in the toenails of 5 patients (5.9%). Softening of the n ail plate was noted in 5 subjects as well. A peripheral lipodystrophy syndr ome was noted in 12 patients (14.3%). Among these, one patient only develop ed a "buffalo hump" and another had diffused lipomatosis. The temporal relationship between the taking of indinavir and the onset of such cutaneous effects was striking. This was confirmed by the regression o f symptoms in those patients who later discontinued indinavir. The emerging side effects of protease inhibitors require a multidisciplinary team for a dequate diagnosis and treatment. Cutaneous toxicity involving the patient's own body image has a peculiar influence on compliance to the treatment and the patient's quality of life.