One hundred patients experiencing recurrence of
genital herpes were randomly assigned to treatment with either
recombinant DNA-derived human
leukocyte interferon (
interferon alfa-2a,
Roferon-A, Hoffmann-LaRoche & Co., Ltd.) or placebo in a double-blind study. All patients were given a three-day course of treatment by
subcutaneous injection within 24 hr after the first signs of recurrence.
Interferon alfa-2a was given according to one of two daily regimens (6 X 10(6) or 18 X 10(6) units), either as a single dose followed by two doses of placebo or as three consecutive doses. In comparison with placebo,
interferon alfa-2a reduced the duration of a single recurrent episode of
genital herpes by approximately 50% (P less than .05) compared with placebo. As compared with pretreatment episodes, a reduction of greater than 50% in healing time was observed in 81% of those receiving
interferon alfa-2a in comparison with only 10% of placebo recipients. Response was not related to size of dose, and treatment did not significantly prolong the interval between the first and second recurrences. No serious adverse reactions were observed, but most patients developed flu-like symptoms after the
subcutaneous injection.
Leukopenia and
thrombocytopenia were minimal and transient. On the basis of overall efficacy and adverse effects, the single dose of 6 X 10(6) units of
interferon alfa-2a was considered optimal, and this regimen may be of value in the routine treatment of recurrent herpes.