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Single-day drug for genital herpes matches 3-day drug.

WASHINGTON -- Single-day famciclovir therapy was similar in safety and efficacy to a 3-day course of valacyclovir 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%, reduced healing time by 2 days, and reduced duration of symptoms by 2 days, compared with placebo (Clin. Infect. Dis. 2006;42:8-13). Single-day famciclovir was approved by the FDA in 2006 for the treatment of recurrent genital herpes.

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.) thus representing a more convenient treatment option, Dr. Stephen Tyring said at the jointly held annual Intersciencc 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 four 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. All were immunocompetent. 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--defined as lesions that did not progress beyond papule stage-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 1-day famciclovir and 4.08 days with 3-day valacyclovir, a nonsignificant 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. Nausea, diarrhea, vomiting, and abdominal pain were reported in less than 10%, and discontinuations because of adverse events and serious adverse events in less than 1 %, of each group.

Dr. Tyring receives research funding from and is on the speakers' bureaus for Novar-tis and GlaxoSmithKline, the respective manufacturers of Famvir and Valtrex.


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Author:Tucker, Miriam E.
Publication:OB GYN News
Date:Dec 1, 2008
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