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

This double-blind, placebo-controlled study examined the clinical effi cacy and tolerance of human leukocyte interferon-alpha (2 x 10(6) IU/g ) in hydrophilic cream to cure patients afflicted with first episodes of genital herpes. Sixty patients aged 18-40 years (mean 24.5) with cu lture-confirmed herpes simplex genitalis, bearing 755 lesions (mean 12 .6) were randomized to active and placebo groups. Patients joined the study within 7 days (mean 4.1) of the manifestation of lesions. Each p atient was given a preceded 40-g tube containing placebo/active prepar ation with instructions on self-application of the trial medication to their lesions three times daily for 5 consecutive days (max. 15 topic al applications per week). Patients were examined three times a week t o evaluate clinical efficacy and other beneficial effects. A reepithel ialized lesion with some residual erythema was recorded as healed. Pat ients resolved during the active treatment period (1-4 weeks) were spa red further therapy and were requested to visit us as scheduled for po sttreatment control after 16 weeks. From the remaining patients empty tubes were collected, and similarly coded replacement tubes were given to continue the treatment (in total 160 tubes were used). Patients tr eated with leukocyte interferon-alpha cream had significantly shorter mean duration of viral shedding/healing than placebo recipients, (6.2 days vs .15 days; P < 0.01);thus the number of healed patients was 25/ 30 (83.3%) vs. 5/30 (17%; P < 0.001. Of the 60 patients 49 (81.6%) com plained no drug-related side effects. Transitory increase in body temp erature (> 38 degrees C) accompanied by mild headache, malaise, and my algia were experienced by 11 (18.3%) patients; however, treatment was well tolerated by all the patients, and there were no dropouts. After 16 weeks only the cured patients were monitored on a monthly basis up to 20 months. Three (10%) cured patients showed recurrence after 22 mo nths. In conclusion, the clinical results demonstrated that human leuk ocyte interferon-alpha (2 x 10(6) IU/g) in hydrophilic cream is more e fficacious than placebo, and further support the adequacy of leukocyte interferon-alpha therapy as an effective and reliable treatment to cu re first-episode genital herpes in women.