HUMAN-LEUKOCYTE INTERFERON-ALPHA IN CREAM FOR THE TREATMENT OF GENITAL HERPES IN ASIAN MALES - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY

Background: Genital herpes simplex virus infection, a sexually transmi tted disease, is the commonest cause of ulcerative genital infections among the young and adult population. The recurrent nature of the dise ase, possible cause of cervical dysplasia and neonatal herpes are the primary concern associated with this infection. Objective: The purpose of this double-blind, placebo-controlled study was to evaluate the cl inical efficacy and tolerance of human leukocyte inferon-alpha in hydr ophilic cream (2 x 1O(6) lU/g) to cure patients afflicted with first e pisodes of genital herpes. Methods: Patients (n = 60), aged 18-30 year s (mean: 22.8) with culture-confirmed diagnosis of herpes simplex geni talis, harboring 751 lesions (mean: 12.5) were randomly allocated to t wo parallel groups (active/placebo). Patients entered the study within 7 days (mean: 4.2) of the onset of lesions. Each patient received a p receded 40-gram tube with instructions to apply the trial medication ( at home) on their lesions thrice daily for 5 consecutive days (max, 15 topical applications/week). To assess the clinical efficacy patients were examined twice a week. A completely reepithelized lesion with per sistent erythema was evaluated as healed or cured, Patients cured duri ng the subsequent treatment period were spared further therapy and wer e requested to visit us as scheduled for recurrence control. As for th e remaining patients, the same course was continued further (max. 4 we eks active treatment). The study was scheduled for 16 weeks, with 20 m onths of follow-up (on a monthly basis). Results: The treatment was we ll tolerated by all the patients. Patients treated with leukocyte inte rferon-alpha cream had a significantly shorter mean duration of healin g than placebo recipients, 5.9 versus 15 days (p < 0.01), as well as t he number of cured patients, 24/30 (80%) versus 5/30 (17%; p < 0.001), with mild and nonobjective complaints of drug-related adverse symptom s; there were no dropouts. Five of the cured patients (5/29, 17%) show ed recurrence after 22 months. Conclusions: The results substantiate t hat human leukocyte interferon-alpha (2 x 10(6) IU/g) in hydrophilic c ream is more efficacious than placebo and testify that the regimen can be considered a home-based reliable treatment to cure first episodes of genital herpes in males.