Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance

Abstract

Background Episodic therapy of genital herpes is usually recommended for patients with infrequent symptomatic recurrences and where transmission is not a concern. While shorter courses are as effective as standard 5-day regimens, it is unknown whether abbreviated therapy has detrimental effects on natural history and the development of antiviral resistance. Objectives To assess time to next recurrence and development of antiviral resistance in patients with recurrent genital herpes treated with either single-day famciclovir (1 g twice-daily) or 3-day valacyclovir (500 mg twice-daily). Methods Longer-term, follow-up data on the time to next recurrence and antiviral sensitivity were collected from a previously reported multicenter, multinational, double-blind, parallel group study in which 1179 immunocompetent adults were randomized 1:1 to receive either single-day famciclovir or 3-day valacyclovir. Treatment was self-initiated within 6 hours of a recurrence. Swabs for viral culture and sensitivity testing were collected for two sequential recurrences. Results The median time to next recurrence from treatment initiation was 33.5 days for famciclovir and 38.0 days for valacyclovir. No drug resistance to penciclovir, the active metabolite of famciclovir, was observed at baseline nor did any develop by the time of the next recurrence. Limitations The study had no placebo arm, typing of viral isolates was not performed and viral resistance testing was restricted to penciclovir only. Conclusion Treatment with single-day famciclovir for recurrent genital herpes did not shorten the time to the next recurrence. Drug resistance to penciclovir continues to be a rare event in immunocompetent patients.

Single-Dose Pharmacokinetics of Famciclovir in Infants and Population Pharmacokinetic Analysis in Infants and Children

“…Famciclovir was well tolerated in infants 1 to 12 months of age. Similar to adults and older children (1,3,5,6,19,24), the most frequent AEs in the 18 infants given famciclovir were vomiting, diarrhea, pyrexia, and dehydration. No infants discontinued famciclovir for safety reasons, and none of the infants had serious drug-related AEs.…”

“…The pharmacokinetics of penciclovir in earlier studies with adults show that peak penciclovir concentration and exposure (AUC) increase linearly with dose after the administration of famciclovir (10, 16). Famciclovir is approved for use in immunocompetent adults based on findings from clinical trials for herpes zoster, recurrent genital herpes, recurrent herpes labialis, and mucocutaneous HSV infections in human immunodeficiency virus-infected patients (1,3,5,6,18,21,24,29).An experimental famciclovir oral formulation (i.e., "sprinkle" hard gelatin capsules containing famciclovir oral granules) was developed for use in pediatric trials. The capsules were to be opened and the granules sprinkled on OraSweet syrup vehicle before the mixture was ingested.…”

Single-Dose, Patient-Initiated Amenamevir Therapy for Recurrent Genital Herpes: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study

“…Patients took a single dose of 6 tablets of the study drug (amenamevir 1200 mg [200 mg per tablet] or placebo) after a meal as a patient-initiated therapy within 6 hours after onset of prodromal symptoms of recurrent genital herpes. The timing of study administration was based on prior studies indicating suppression of rash when antiviral treatment was initiated within 6 hours of prodromal symptoms [ 20 , 21 ]. Exposure to amenamevir in blood is increased by food intake [ 22 ]; thus, to ensure sufficient exposure in blood, treatment in the current study was to be taken after a meal.…”

Probiotics against Viral Infections: Current Clinical Trials and Future Perspectives

“…HSV-2 infection (for which there is currently no cure) is life-threatening and is almost exclusively sexually transmitted [119]. Treatment for this type of infection consists of the use of antivirals drugs; however, although they can reduce the intensity and frequency of symptoms, they cannot reduce HSV-2 transmission [119,120]. A potential therapeutic alternative to combat HSV-2 infections would be the use of probiotics, due to their ability to secrete bacterial metabolites (e.g., lactic acid, hydrogen peroxide, andbacteriocin), modulate the immune system (Figure 1), and restore the vaginal microbiota [121].…”