WASHINGTON Single-day famciclovir therapy was similar in safety and efficacy to a 3-day course of valacylovir in the first head-to-head comparison of the two oral medications for the treatment of recurrent genital herpes.
Previous data showed that, when taken within 6 hours of symptom onset, single-day famciclovir (Famvir, 1,000 mg b.i.d.) increased the proportion of patients with aborted episodes from 13% to 23%, and reduced healing time and duration of symptoms by 2 days, compared with placebo (Clin Infect Dis 2006;42:813).
Now, the findings of a multicenter, randomized, double-blind, parallel group study of 751 adults with recurrent genital herpes suggest that single-day famciclovir is as safe and effective as 3-day valacyclovir (Valtrex, 500 mg b.i.d.), Dr. Stephen Tyring said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.
Patients were at least 18 years of age and had experienced at least 4 outbreaks of lesions on the external genitalia or anogenital area in the preceding 12 months, with positive herpes simplex virus serology. About two-thirds were female, and most had used suppressive therapy in the previous 12 months. Of the 1,179 patients who were randomized, 751 initiated the study medication within 6 hours of their next recurrence and were included in the analysis.
The proportion of patients with aborted lesions in the intent-to-treat population was 32.7% among the 370 famciclovir patients and 33.6% among the 381 valacyclovir patients. Time to healing of nonaborted lesions was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir, an insignificant difference. There were also no differences in time to resolution of burning, pain, tingling, itching, tenderness, or all symptoms together, said Dr. Tyring of the Center for Clinical Studies at Texas Medical Center, Houston.
Adverse events were reported in about one-fifth of each group, with drug-related events reported in 11% with famciclovir and 9% with valacyclovir. Headache was the most common adverse event, reported in 8% with famciclovir and 4% with valacyclovir.
Dr. Tyring receives research funding and is on the speakers bureau for Novartis, manufacturer of Famvir, and GlaxoSmithKline, manufacturer of Valtrex.
Time to lesion healing was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir. DR. TYRING