Famvir Clinical Trials and Studies
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Famvir Clinical Trials and Studies
Herpes Zoster
Famvir (famciclovir) was studied in a placebo-controlled, double-blind trial of 419 immunocompetent adults with uncomplicated herpes zoster. Comparisons included Famvir 500 mg t.i.d., Famvir 750 mg t.i.d., or placebo. Treatment was begun within 72 hours of initial lesion appearance and therapy was continued for 7 days.
The median time to full crusting in Famvir-treated patients was 5 days compared to 7 days in placebo-treated patients. The times to full crusting, loss of vesicles, loss of ulcers, and loss of crusts were shorter for Famvir 500 mg treated patients than for placebo-treated patients in the overall study population. The effects of Famvir were greater when therapy was initiated within 48 hours of rash onset; it was also more pronounced in patients 50 years of age or older. Among the 65.2% of patients with at least one positive viral culture, Famvir-treated patients had a shorter median duration of viral shedding than placebo-treated patients (1 day and 2 days, respectively).
There were no overall differences in the duration of pain before rash healing between Famvir and placebo-treated groups. In addition, there was no difference in the incidence of pain after rash healing (postherpetic neuralgia) between the treatment groups. In the 186 patients (44.4% of total study population) who did develop postherpetic neuralgia, the median duration of postherpetic neuralgia was shorter in patients treated with Famvir 500 mg than in those treated with placebo (63 days and 119 days, respectively). No additional efficacy was demonstrated with higher doses of Famvir.
A double-blind controlled trial in 545 immunocompetent adults with uncomplicated herpes zoster treated within 72 hours of initial lesion appearance compared three doses of Famvir to acyclovir 800 mg 5 times per day. Times to full lesion crusting and times to loss of acute pain were comparable for all groups and there were no statistically significant differences in the time to loss of postherpetic neuralgia between Famvir and acyclovir-treated groups.
Herpes Simplex Infections
Recurrent Genital Herpes: In two placebo-controlled trials, 626 immunocompetent adults with a recurrence of genital herpes were treated with Famvir 125 mg b.i.d.(n=160), Famvir 250 mg b.i.d.(n=169), Famvir 500 mg b.i.d.(n=154) or placebo (n=143) for 5 days. Treatment was initiated within 6 hours of either symptom onset or lesion appearance. In the two studies combined, the median time to healing in Famvir 125 mg-treated patients was 4 days compared to 5 days in placebo-treated patients and the median time to cessation of viral shedding was 1.8 vs. 3.4 days in Famvir 125 mg and placebo recipients, respectively. The median time to loss of all symptoms was 3.2 days in Famvir 125 mg-treated patients vs. 3.8 days in placebo-treated patients. No additional efficacy was demonstrated with higher doses of Famvir
Suppression of Recurrent Genital Herpes: 934 immunocompetent adults with a history of 6 or more recurrences per year were randomized into two double-blind, 1-year, placebo-controlled trials. Comparisons included Famvir 125 mg t.i.d., 250 mg b.i.d., 250 mg t.i.d. and placebo. At one-year, 60% to 65% of patients were still receiving Famvir and 25% were receiving placebo treatment.
Recurrent Mucocutaneous Herpes Simplex Infection in HIV-lnfected Patients: A randomized, double-blind, multicenter study compared Famvir (famciclovir) 500 mg twice daily for 7 days (n=150) with oral acyclovir 400 mg 5 times daily for 7 days (n=143) in HIV-infected patients with recurrent mucocutaneous HSV infection treated within 48 hours of lesion onset. Approximately 40% of patients had a CD4 count below 200 cells/mm3 ,54% of patients had anogenital lesions and 35% had orolabial lesions. Famvir (famciclovir) therapy was comparable to oral acyclovir in reducing new lesion formation and in time to complete healing.
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