Suppression of recurrent genital herpes simplex virus infection with recombinant alpha 2 interferon.

This double-blind, placebo-controlled study evaluated the efficacy and safety of sc administered recombinant alpha 2 interferon (IFN-alpha 2) in the suppression of frequently recurrent genital herpes simplex virus (HSV) infection. Seventy-six otherwise healthy subjects who had eight or more recurrences during the preceding year received 1 X 10(6) IU of IFN-alpha 2, 3 X 10(6) IU of IFN-alpha 2, or placebo three times per week for 12 weeks. Recipients of the higher dose of IFN-alpha 2, had fewer outbreaks during the study (2 vs. 3), a shorter period of viral shedding (2 vs. 4 days), less itching (1 vs. 3 days), and a faster healing time (6 vs. 8 days). The lower dose of IFN-alpha 2 was not effective. Significant side effects (fever, malaise, myalgia, fatigue, and arthralgia) occurred after the first injection of 3 X 10(6) IU of IFN-alpha 2 in 91% of the subjects, but subsequent injections produced only mild and intermittent side effects that were well tolerated. Mild leukopenia was noted in subjects treated with IFN-alpha 2. Treatment with IFN-alpha 2 resulted in moderate suppression and decreased duration of recurrent genital HSV infection in patients with frequent recurrences.