Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

Novartis

Status and phase: Completed; Phase 3

Conditions: Genital Herpes

Treatments: Drug: Placebo matching valacyclovir; Drug: Valacyclovir; Drug: Placebo matching famciclovir; Drug: Famciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306787

CFAM810A2308

Details and patient eligibility

About

This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).

Enrollment: 1,179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old
• History of at least 4 recurrences of genital herpes in the preceding 12 months
• Lesions located on the external genitalia or anogenital region
• Willing to discontinue suppressive treatment
• Documented positive herpes simplex virus (HSV)
• General good health, and history of normal renal function

Exclusion criteria

• Women of childbearing potential not using approved form of contraceptive
• Pregnant or nursing women
• History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
• Known to be immunosuppressed
• Known to have renal dysfunction
• Receiving anti-herpes therapy
• Known to have other genital tract disorders
• Known to have condition which could interfere with drug absorption

Additional protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,179 participants in 2 patient groups

Famciclovir

Experimental group

Description:

Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.

Treatment:

Drug: Famciclovir

Drug: Placebo matching valacyclovir

Valacyclovir

Active Comparator group

Description:

Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.

Treatment:

Drug: Placebo matching famciclovir

Drug: Valacyclovir